TBD Meeting (3226-23)

HONOLULU – Old habits die hard, especially when it comes to pulmonary function testing in a diverse population of patients with interstitial lung disease (ILD).

Specifically, pulmonary care clinicians may be habitually relying on outdated and inaccurate race-specific reference values when evaluating respiratory impairment in persons of African and Hispanic/Latino ancestry, which can result in underrecognition, underdiagnosis, and undertreatment, reported Ayodeji Adegunsoye, MD, from the University of Chicago, and colleagues.

“Our results make a compelling case for re-evaluating the use of race as a physiological variable, and highlight the need to offer equitable and optimal care for all patients, regardless of their race or ethnicity,” Dr. Adegunsoye said in an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).
 

Flawed assumptions

In an interview, Dr. Adegunsoye noted that race-specific notions, such as the automatic assumption that Black people have less lung capacity than White people, are baked into clinical practice and passed on as clinical wisdom from one generation of clinicians to the next.

Pulmonary function reference values that are used to make a diagnosis of idiopathic pulmonary fibrosis in Black or Hispanic/Latino patients “appear flawed when we use race-specific values. And beyond the diagnosis, it also appears to impact eligibility for key interventional strategies for managing the disease itself,” he said.

The use of race-specific equations can falsely inflate percent-predicted pulmonary function values in non-White patients, and make it seem as if a patient has normal lung function when in fact he may be have impaired function.

For example, using race-based reference values a Black patient and a White patient may appear to have the same absolute forced vital capacity readings, but different FVC percent predicted (FVCpp), which can mean a missed diagnosis.

Investigators who studied the association between self-identified race and visually identified emphysema among 2,674 participants in the Coronary Artery Risk Development in Young Adults study found that using standard equations to adjust for racial differences in lung-function measures appeared to miss emphysema in a significant proportion of Black patients.
 

PF registry study

In the current study, to see whether the use of race-neutral equations for evaluating FVCpp could change access to health care in patients with ILD, Dr. Adegunsoye and colleagues used both race-specific and race-neutral equations to calculate FVCpp values among separate cohorts of Black, Hispanic/Latino, and White patients enrolled in the Pulmonary Fibrosis Foundation Patient Registry who had pulmonary functions test within about 90 days of enrollment.

The race-specific equations used to calculate FVCpp was that published in 1999 by Hankinson and colleagues in American Journal of Respiratory and Critical Care Medicine. The race-neutral Global Lung Function Initiative (GLI) equations by Bowerman and colleagues were developed in 2022 and published in March 2023 in the same journal.

The investigators defined access to care as enrollment in ILD clinical trials for patients with FVCpp greater than 45% but less than 90%, and US payer access to antifibrotic therapy for patients with FVCpp of greater than 55% but less than 82%.

They found that 22% of Black patients were misclassified in their eligibility for clinical trials in each of two scenarios – those who would be excluded from trials using the 1999 criteria but included using the 2022 criteria, and vice versa, that is included with 1999 criteria but excluded by the 2022 GLI criteria. In contrast, 14% of Hispanic Latino patients and 12% of White patients were misclassified.

Using the 1999 criteria to exclude patients because their values were ostensibly higher than the upper cutoff meant that 10.3% of Black patients who might benefit would be ineligible for clinical trial, compared with 0% of Hispanic/Latinos and 0.1% of Whites.

Similarly, 11.5% of Black patients but no Hispanic/Latino or White patients would be considered eligible for clinical trials using the old criteria but ineligible under the new criteria.

Regarding antifibrotic therapy eligibility, the respective misclassification rates were 21%, 17%, and 19%.­

“Our study showed that use of race-specific equations may confound lung function tests, potentially leading to misclassification, delayed diagnosis, and inadequate treatment provision. While our study suggests potential disparities in access to health care for patients with interstitial lung disease facilitated by race-specific equations, further research is required to fully comprehend the implications,” the investigators wrote.
 

ATS statement

In an interview, Juan Wisnievsky, MD, DrPh, from Mount Sinai Medical Center, New York, who also chairs the Health Equity and Diversity Committee for the American Thoracic Society, pointed to a recent ATS statement he coauthored citing evidence for replacing race and ethnicity-specific equations with race-neutral average reference equations.

“This use of race and ethnicity may contribute to health disparities by norming differences in pulmonary function. In the United States and globally, race serves as a social construct that is based on appearance and reflects social values, structures, and practices. Classification of people into racial and ethnic groups differs geographically and temporally. These considerations challenge the notion that racial and ethnic categories have biological meaning and question the use of race in PFT interpretation,” the statement authors wrote.

“There is some agreement that race-based equations shouldn’t be used, but all the potential consequences of doing that and which equations would be the best ones to use to replace them is a bit unclear,” Dr. Wisnievsky said.

He was not involved in the study by Dr. Adegunsoye and colleagues.

Data used in the study were derived from research sponsored by F. Hoffman–La Roche and Genentech. Dr. Adegunsoye disclosed consultancy fees from AbbVie, Inogen, F. Hoffman–La Roche, Medscape, and PatientMpower; speaking/advisory fees from Boehringer Ingelheim; and grants/award from the CHEST Foundation, Pulmonary Fibrosis Foundation, and National Institutes of Health. Dr. Wisnievsky had no relevant disclosures.

HONOLULU – Old habits die hard, especially when it comes to pulmonary function testing in a diverse population of patients with interstitial lung disease (ILD).

Specifically, pulmonary care clinicians may be habitually relying on outdated and inaccurate race-specific reference values when evaluating respiratory impairment in persons of African and Hispanic/Latino ancestry, which can result in underrecognition, underdiagnosis, and undertreatment, reported Ayodeji Adegunsoye, MD, from the University of Chicago, and colleagues.

“Our results make a compelling case for re-evaluating the use of race as a physiological variable, and highlight the need to offer equitable and optimal care for all patients, regardless of their race or ethnicity,” Dr. Adegunsoye said in an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).
 

Flawed assumptions

In an interview, Dr. Adegunsoye noted that race-specific notions, such as the automatic assumption that Black people have less lung capacity than White people, are baked into clinical practice and passed on as clinical wisdom from one generation of clinicians to the next.

Pulmonary function reference values that are used to make a diagnosis of idiopathic pulmonary fibrosis in Black or Hispanic/Latino patients “appear flawed when we use race-specific values. And beyond the diagnosis, it also appears to impact eligibility for key interventional strategies for managing the disease itself,” he said.

The use of race-specific equations can falsely inflate percent-predicted pulmonary function values in non-White patients, and make it seem as if a patient has normal lung function when in fact he may be have impaired function.

For example, using race-based reference values a Black patient and a White patient may appear to have the same absolute forced vital capacity readings, but different FVC percent predicted (FVCpp), which can mean a missed diagnosis.

Investigators who studied the association between self-identified race and visually identified emphysema among 2,674 participants in the Coronary Artery Risk Development in Young Adults study found that using standard equations to adjust for racial differences in lung-function measures appeared to miss emphysema in a significant proportion of Black patients.
 

PF registry study

In the current study, to see whether the use of race-neutral equations for evaluating FVCpp could change access to health care in patients with ILD, Dr. Adegunsoye and colleagues used both race-specific and race-neutral equations to calculate FVCpp values among separate cohorts of Black, Hispanic/Latino, and White patients enrolled in the Pulmonary Fibrosis Foundation Patient Registry who had pulmonary functions test within about 90 days of enrollment.

The race-specific equations used to calculate FVCpp was that published in 1999 by Hankinson and colleagues in American Journal of Respiratory and Critical Care Medicine. The race-neutral Global Lung Function Initiative (GLI) equations by Bowerman and colleagues were developed in 2022 and published in March 2023 in the same journal.

The investigators defined access to care as enrollment in ILD clinical trials for patients with FVCpp greater than 45% but less than 90%, and US payer access to antifibrotic therapy for patients with FVCpp of greater than 55% but less than 82%.

They found that 22% of Black patients were misclassified in their eligibility for clinical trials in each of two scenarios – those who would be excluded from trials using the 1999 criteria but included using the 2022 criteria, and vice versa, that is included with 1999 criteria but excluded by the 2022 GLI criteria. In contrast, 14% of Hispanic Latino patients and 12% of White patients were misclassified.

Using the 1999 criteria to exclude patients because their values were ostensibly higher than the upper cutoff meant that 10.3% of Black patients who might benefit would be ineligible for clinical trial, compared with 0% of Hispanic/Latinos and 0.1% of Whites.

Similarly, 11.5% of Black patients but no Hispanic/Latino or White patients would be considered eligible for clinical trials using the old criteria but ineligible under the new criteria.

Regarding antifibrotic therapy eligibility, the respective misclassification rates were 21%, 17%, and 19%.­

“Our study showed that use of race-specific equations may confound lung function tests, potentially leading to misclassification, delayed diagnosis, and inadequate treatment provision. While our study suggests potential disparities in access to health care for patients with interstitial lung disease facilitated by race-specific equations, further research is required to fully comprehend the implications,” the investigators wrote.
 

ATS statement

In an interview, Juan Wisnievsky, MD, DrPh, from Mount Sinai Medical Center, New York, who also chairs the Health Equity and Diversity Committee for the American Thoracic Society, pointed to a recent ATS statement he coauthored citing evidence for replacing race and ethnicity-specific equations with race-neutral average reference equations.

“This use of race and ethnicity may contribute to health disparities by norming differences in pulmonary function. In the United States and globally, race serves as a social construct that is based on appearance and reflects social values, structures, and practices. Classification of people into racial and ethnic groups differs geographically and temporally. These considerations challenge the notion that racial and ethnic categories have biological meaning and question the use of race in PFT interpretation,” the statement authors wrote.

“There is some agreement that race-based equations shouldn’t be used, but all the potential consequences of doing that and which equations would be the best ones to use to replace them is a bit unclear,” Dr. Wisnievsky said.

He was not involved in the study by Dr. Adegunsoye and colleagues.

Data used in the study were derived from research sponsored by F. Hoffman–La Roche and Genentech. Dr. Adegunsoye disclosed consultancy fees from AbbVie, Inogen, F. Hoffman–La Roche, Medscape, and PatientMpower; speaking/advisory fees from Boehringer Ingelheim; and grants/award from the CHEST Foundation, Pulmonary Fibrosis Foundation, and National Institutes of Health. Dr. Wisnievsky had no relevant disclosures.

HONOLULU – Old habits die hard, especially when it comes to pulmonary function testing in a diverse population of patients with interstitial lung disease (ILD).

Specifically, pulmonary care clinicians may be habitually relying on outdated and inaccurate race-specific reference values when evaluating respiratory impairment in persons of African and Hispanic/Latino ancestry, which can result in underrecognition, underdiagnosis, and undertreatment, reported Ayodeji Adegunsoye, MD, from the University of Chicago, and colleagues.

“Our results make a compelling case for re-evaluating the use of race as a physiological variable, and highlight the need to offer equitable and optimal care for all patients, regardless of their race or ethnicity,” Dr. Adegunsoye said in an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).
 

Flawed assumptions

In an interview, Dr. Adegunsoye noted that race-specific notions, such as the automatic assumption that Black people have less lung capacity than White people, are baked into clinical practice and passed on as clinical wisdom from one generation of clinicians to the next.

Pulmonary function reference values that are used to make a diagnosis of idiopathic pulmonary fibrosis in Black or Hispanic/Latino patients “appear flawed when we use race-specific values. And beyond the diagnosis, it also appears to impact eligibility for key interventional strategies for managing the disease itself,” he said.

The use of race-specific equations can falsely inflate percent-predicted pulmonary function values in non-White patients, and make it seem as if a patient has normal lung function when in fact he may be have impaired function.

For example, using race-based reference values a Black patient and a White patient may appear to have the same absolute forced vital capacity readings, but different FVC percent predicted (FVCpp), which can mean a missed diagnosis.

Investigators who studied the association between self-identified race and visually identified emphysema among 2,674 participants in the Coronary Artery Risk Development in Young Adults study found that using standard equations to adjust for racial differences in lung-function measures appeared to miss emphysema in a significant proportion of Black patients.
 

PF registry study

In the current study, to see whether the use of race-neutral equations for evaluating FVCpp could change access to health care in patients with ILD, Dr. Adegunsoye and colleagues used both race-specific and race-neutral equations to calculate FVCpp values among separate cohorts of Black, Hispanic/Latino, and White patients enrolled in the Pulmonary Fibrosis Foundation Patient Registry who had pulmonary functions test within about 90 days of enrollment.

The race-specific equations used to calculate FVCpp was that published in 1999 by Hankinson and colleagues in American Journal of Respiratory and Critical Care Medicine. The race-neutral Global Lung Function Initiative (GLI) equations by Bowerman and colleagues were developed in 2022 and published in March 2023 in the same journal.

The investigators defined access to care as enrollment in ILD clinical trials for patients with FVCpp greater than 45% but less than 90%, and US payer access to antifibrotic therapy for patients with FVCpp of greater than 55% but less than 82%.

They found that 22% of Black patients were misclassified in their eligibility for clinical trials in each of two scenarios – those who would be excluded from trials using the 1999 criteria but included using the 2022 criteria, and vice versa, that is included with 1999 criteria but excluded by the 2022 GLI criteria. In contrast, 14% of Hispanic Latino patients and 12% of White patients were misclassified.

Using the 1999 criteria to exclude patients because their values were ostensibly higher than the upper cutoff meant that 10.3% of Black patients who might benefit would be ineligible for clinical trial, compared with 0% of Hispanic/Latinos and 0.1% of Whites.

Similarly, 11.5% of Black patients but no Hispanic/Latino or White patients would be considered eligible for clinical trials using the old criteria but ineligible under the new criteria.

Regarding antifibrotic therapy eligibility, the respective misclassification rates were 21%, 17%, and 19%.­

“Our study showed that use of race-specific equations may confound lung function tests, potentially leading to misclassification, delayed diagnosis, and inadequate treatment provision. While our study suggests potential disparities in access to health care for patients with interstitial lung disease facilitated by race-specific equations, further research is required to fully comprehend the implications,” the investigators wrote.
 

ATS statement

In an interview, Juan Wisnievsky, MD, DrPh, from Mount Sinai Medical Center, New York, who also chairs the Health Equity and Diversity Committee for the American Thoracic Society, pointed to a recent ATS statement he coauthored citing evidence for replacing race and ethnicity-specific equations with race-neutral average reference equations.

“This use of race and ethnicity may contribute to health disparities by norming differences in pulmonary function. In the United States and globally, race serves as a social construct that is based on appearance and reflects social values, structures, and practices. Classification of people into racial and ethnic groups differs geographically and temporally. These considerations challenge the notion that racial and ethnic categories have biological meaning and question the use of race in PFT interpretation,” the statement authors wrote.

“There is some agreement that race-based equations shouldn’t be used, but all the potential consequences of doing that and which equations would be the best ones to use to replace them is a bit unclear,” Dr. Wisnievsky said.

He was not involved in the study by Dr. Adegunsoye and colleagues.

Data used in the study were derived from research sponsored by F. Hoffman–La Roche and Genentech. Dr. Adegunsoye disclosed consultancy fees from AbbVie, Inogen, F. Hoffman–La Roche, Medscape, and PatientMpower; speaking/advisory fees from Boehringer Ingelheim; and grants/award from the CHEST Foundation, Pulmonary Fibrosis Foundation, and National Institutes of Health. Dr. Wisnievsky had no relevant disclosures.

Among patients with asthma and comorbid gastroesophageal reflux disease (GERD), the biologic tezepelumab (Tezspire, Amgen) had similar efficacy at reducing exacerbations, improving lung function, and symptom control as observed in patients with asthma alone, according to a new post-hoc analysis of the phase 2b PATHWAY and phase 3 NAVIGATOR clinical trials.

GERD occurs in about 60% of asthma patients, and the comorbidity is associated with a greater risk of asthma exacerbations. “As we start doing subgroup analyses, we are looking at different comorbidities and reflux is one that’s very common and very impactful on asthma outcomes in a negative way, so it became an area of interest,” said Njira Lugogo, MD, who presented the study during a poster session at the annual meeting of the American College of Chest Physicians (CHEST). She is a professor of internal medicine and pulmonary critical care at the University of Michigan, Ann Arbor.

The analysis confirmed other findings, with comorbid GERD associated with more exacerbations, use of maintenance steroids, and high-dose inhaled steroids. “They had more disease activity, and the effect [of tezepelumab treatment] was similar whether you had reflux or didn’t have reflux. It did seem like the people without reflux had a slightly higher reduction in exacerbations, so maybe there is a slight difference, but overall it looked like both groups were really improving,” said Dr. Lugogo.

Tezepelumab is a newer biologic, having received Food and Drug Administration approval in 2021. It targets the epithelial cytokine thymic stromal lymphopoietin (TSLP), which contributes allergic inflammatory responses by acting on various innate immune cells, including dendritic cells, mast cells, and CD34+ progenitor cells. It is upregulated in the airways of asthma patients, with higher levels linked to more severe disease. A single-nucleotide polymorphism in the gene that codes TSLP has also been found to be protective against asthma, atopic asthma, and airway hyper-responsiveness.

Dr. Lugogo noted that TSLP could be a factor in how GERD may worsen trigger or worsen asthma. It is produced in the epithelium of the upper airway in response to injury, which could include aspiration into bronchial tubes attributable to GERD, and this could lead to a downstream inflammatory and immune response. “Reducing the production of or at least blocking TSLP from an epithelium that’s being irritated by acid reflux could have potential benefits. On the reverse side, could the continued presence of reflux blunt the expected response [to tezepelumab]? If someone has very severe reflux, maybe you’ve treated their asthma with tezepelumab, and they’re still having symptoms. Could it be a masquerading issue [where] you have untreated reflux contributing to ongoing symptoms, which you’re attributing to not being related to asthma? So it’s looking at it in two different ways,” said Dr. Lugogo.

TSLP is the only biologic available to treat patients with non–type 2 inflammation, which includes about 10% of adult patients, according to Dr. Lugogo. Its mechanism also influences eosinophilic and allergic asthma. When tezepelumab first became available, Dr. Lugogo noticed that physicians tended to switch to it from another biologic rather than starting it up front, but that may be changing. “I feel like more and more people are starting it up front as a therapeutic intervention, so there seems to be more and more people embracing its use in the treatment of severe asthma,” she said.

The analysis included 294 patients with asthma and GERD and 1,040 with asthma alone. Patients in the GERD comorbidity group were older (55.0 versus 48.6 years), had a higher mean body mass index (30.8 versus 27.8), and were more likely to be female (67.3% versus 63.0%).

Maintenance oral corticosteroid use was higher in the GERD group (17.0% versus 6.9%), as was use of high inhaled corticosteroid dose (78.2% versus 67.0%), frequency of nasal polyps in the previous 2 years (21.4% versus 13.8%), and experience of more than two exacerbations in the previous year (42.2% versus 34.6%).

There was a 65% reduction (95% confidence interval, 50%-76%) in annualized asthma exacerbation rate versus placebo with tezepelumab treatment in the GERD group, compared with a 58% reduction in the asthma-only group (95% CI, 48%-66%). The drug led to a 0.10 increase in forced expiratory volume in 1 second versus placebo (95% CI, 0.00-0.19) at week 52 in the GERD group, versus 0.15 (95% CI, 0.10-0.20) in the asthma-only group. Tezepelumab also improved week 52 ACQ-6 scores in the GERD group (–0.39 versus placebo; 95% CI, –0.63 to –0.14) and the asthma-only group (–0.32 versus placebo; 95% CI, –0.45 to –0.19).

The study adds to the evidence supporting tezepelumab as a promising new therapy, according to Muhammad Adrish, MD, who attended the poster session and was asked to comment on the study. “I think that this is a very interesting analysis in the sense that gastric reflux disease is a frequent comorbid condition that we see in patients with asthma, and a lot of these patients can have poor outcomes. When you look at the results from the data, you see that regardless of how sick they were and how much medication utilization these patients have at baseline, they still had a pretty decent response to tezepelumab. That speaks to the efficacy of that drug along a wide spectrum of patients,” said Dr. Adrish, who is an associate professor of pulmonary, critical care, and sleep medicine at Baylor College of Medicine, Houston.

The PATHWAY and NAVIGATOR studies were funded by Amgen. Dr. Lugogo has advised or consulted for AstraZeneca, Amgen, Regeneron, TEVA, Avillion, Sanofi, Novartis, Genentech, GSK, and Janssen. Dr. Adrish has no relevant financial disclosures.

Among patients with asthma and comorbid gastroesophageal reflux disease (GERD), the biologic tezepelumab (Tezspire, Amgen) had similar efficacy at reducing exacerbations, improving lung function, and symptom control as observed in patients with asthma alone, according to a new post-hoc analysis of the phase 2b PATHWAY and phase 3 NAVIGATOR clinical trials.

GERD occurs in about 60% of asthma patients, and the comorbidity is associated with a greater risk of asthma exacerbations. “As we start doing subgroup analyses, we are looking at different comorbidities and reflux is one that’s very common and very impactful on asthma outcomes in a negative way, so it became an area of interest,” said Njira Lugogo, MD, who presented the study during a poster session at the annual meeting of the American College of Chest Physicians (CHEST). She is a professor of internal medicine and pulmonary critical care at the University of Michigan, Ann Arbor.

The analysis confirmed other findings, with comorbid GERD associated with more exacerbations, use of maintenance steroids, and high-dose inhaled steroids. “They had more disease activity, and the effect [of tezepelumab treatment] was similar whether you had reflux or didn’t have reflux. It did seem like the people without reflux had a slightly higher reduction in exacerbations, so maybe there is a slight difference, but overall it looked like both groups were really improving,” said Dr. Lugogo.

Tezepelumab is a newer biologic, having received Food and Drug Administration approval in 2021. It targets the epithelial cytokine thymic stromal lymphopoietin (TSLP), which contributes allergic inflammatory responses by acting on various innate immune cells, including dendritic cells, mast cells, and CD34+ progenitor cells. It is upregulated in the airways of asthma patients, with higher levels linked to more severe disease. A single-nucleotide polymorphism in the gene that codes TSLP has also been found to be protective against asthma, atopic asthma, and airway hyper-responsiveness.

Dr. Lugogo noted that TSLP could be a factor in how GERD may worsen trigger or worsen asthma. It is produced in the epithelium of the upper airway in response to injury, which could include aspiration into bronchial tubes attributable to GERD, and this could lead to a downstream inflammatory and immune response. “Reducing the production of or at least blocking TSLP from an epithelium that’s being irritated by acid reflux could have potential benefits. On the reverse side, could the continued presence of reflux blunt the expected response [to tezepelumab]? If someone has very severe reflux, maybe you’ve treated their asthma with tezepelumab, and they’re still having symptoms. Could it be a masquerading issue [where] you have untreated reflux contributing to ongoing symptoms, which you’re attributing to not being related to asthma? So it’s looking at it in two different ways,” said Dr. Lugogo.

TSLP is the only biologic available to treat patients with non–type 2 inflammation, which includes about 10% of adult patients, according to Dr. Lugogo. Its mechanism also influences eosinophilic and allergic asthma. When tezepelumab first became available, Dr. Lugogo noticed that physicians tended to switch to it from another biologic rather than starting it up front, but that may be changing. “I feel like more and more people are starting it up front as a therapeutic intervention, so there seems to be more and more people embracing its use in the treatment of severe asthma,” she said.

The analysis included 294 patients with asthma and GERD and 1,040 with asthma alone. Patients in the GERD comorbidity group were older (55.0 versus 48.6 years), had a higher mean body mass index (30.8 versus 27.8), and were more likely to be female (67.3% versus 63.0%).

Maintenance oral corticosteroid use was higher in the GERD group (17.0% versus 6.9%), as was use of high inhaled corticosteroid dose (78.2% versus 67.0%), frequency of nasal polyps in the previous 2 years (21.4% versus 13.8%), and experience of more than two exacerbations in the previous year (42.2% versus 34.6%).

There was a 65% reduction (95% confidence interval, 50%-76%) in annualized asthma exacerbation rate versus placebo with tezepelumab treatment in the GERD group, compared with a 58% reduction in the asthma-only group (95% CI, 48%-66%). The drug led to a 0.10 increase in forced expiratory volume in 1 second versus placebo (95% CI, 0.00-0.19) at week 52 in the GERD group, versus 0.15 (95% CI, 0.10-0.20) in the asthma-only group. Tezepelumab also improved week 52 ACQ-6 scores in the GERD group (–0.39 versus placebo; 95% CI, –0.63 to –0.14) and the asthma-only group (–0.32 versus placebo; 95% CI, –0.45 to –0.19).

The study adds to the evidence supporting tezepelumab as a promising new therapy, according to Muhammad Adrish, MD, who attended the poster session and was asked to comment on the study. “I think that this is a very interesting analysis in the sense that gastric reflux disease is a frequent comorbid condition that we see in patients with asthma, and a lot of these patients can have poor outcomes. When you look at the results from the data, you see that regardless of how sick they were and how much medication utilization these patients have at baseline, they still had a pretty decent response to tezepelumab. That speaks to the efficacy of that drug along a wide spectrum of patients,” said Dr. Adrish, who is an associate professor of pulmonary, critical care, and sleep medicine at Baylor College of Medicine, Houston.

The PATHWAY and NAVIGATOR studies were funded by Amgen. Dr. Lugogo has advised or consulted for AstraZeneca, Amgen, Regeneron, TEVA, Avillion, Sanofi, Novartis, Genentech, GSK, and Janssen. Dr. Adrish has no relevant financial disclosures.

Among patients with asthma and comorbid gastroesophageal reflux disease (GERD), the biologic tezepelumab (Tezspire, Amgen) had similar efficacy at reducing exacerbations, improving lung function, and symptom control as observed in patients with asthma alone, according to a new post-hoc analysis of the phase 2b PATHWAY and phase 3 NAVIGATOR clinical trials.

GERD occurs in about 60% of asthma patients, and the comorbidity is associated with a greater risk of asthma exacerbations. “As we start doing subgroup analyses, we are looking at different comorbidities and reflux is one that’s very common and very impactful on asthma outcomes in a negative way, so it became an area of interest,” said Njira Lugogo, MD, who presented the study during a poster session at the annual meeting of the American College of Chest Physicians (CHEST). She is a professor of internal medicine and pulmonary critical care at the University of Michigan, Ann Arbor.

The analysis confirmed other findings, with comorbid GERD associated with more exacerbations, use of maintenance steroids, and high-dose inhaled steroids. “They had more disease activity, and the effect [of tezepelumab treatment] was similar whether you had reflux or didn’t have reflux. It did seem like the people without reflux had a slightly higher reduction in exacerbations, so maybe there is a slight difference, but overall it looked like both groups were really improving,” said Dr. Lugogo.

Tezepelumab is a newer biologic, having received Food and Drug Administration approval in 2021. It targets the epithelial cytokine thymic stromal lymphopoietin (TSLP), which contributes allergic inflammatory responses by acting on various innate immune cells, including dendritic cells, mast cells, and CD34+ progenitor cells. It is upregulated in the airways of asthma patients, with higher levels linked to more severe disease. A single-nucleotide polymorphism in the gene that codes TSLP has also been found to be protective against asthma, atopic asthma, and airway hyper-responsiveness.

Dr. Lugogo noted that TSLP could be a factor in how GERD may worsen trigger or worsen asthma. It is produced in the epithelium of the upper airway in response to injury, which could include aspiration into bronchial tubes attributable to GERD, and this could lead to a downstream inflammatory and immune response. “Reducing the production of or at least blocking TSLP from an epithelium that’s being irritated by acid reflux could have potential benefits. On the reverse side, could the continued presence of reflux blunt the expected response [to tezepelumab]? If someone has very severe reflux, maybe you’ve treated their asthma with tezepelumab, and they’re still having symptoms. Could it be a masquerading issue [where] you have untreated reflux contributing to ongoing symptoms, which you’re attributing to not being related to asthma? So it’s looking at it in two different ways,” said Dr. Lugogo.

TSLP is the only biologic available to treat patients with non–type 2 inflammation, which includes about 10% of adult patients, according to Dr. Lugogo. Its mechanism also influences eosinophilic and allergic asthma. When tezepelumab first became available, Dr. Lugogo noticed that physicians tended to switch to it from another biologic rather than starting it up front, but that may be changing. “I feel like more and more people are starting it up front as a therapeutic intervention, so there seems to be more and more people embracing its use in the treatment of severe asthma,” she said.

The analysis included 294 patients with asthma and GERD and 1,040 with asthma alone. Patients in the GERD comorbidity group were older (55.0 versus 48.6 years), had a higher mean body mass index (30.8 versus 27.8), and were more likely to be female (67.3% versus 63.0%).

Maintenance oral corticosteroid use was higher in the GERD group (17.0% versus 6.9%), as was use of high inhaled corticosteroid dose (78.2% versus 67.0%), frequency of nasal polyps in the previous 2 years (21.4% versus 13.8%), and experience of more than two exacerbations in the previous year (42.2% versus 34.6%).

There was a 65% reduction (95% confidence interval, 50%-76%) in annualized asthma exacerbation rate versus placebo with tezepelumab treatment in the GERD group, compared with a 58% reduction in the asthma-only group (95% CI, 48%-66%). The drug led to a 0.10 increase in forced expiratory volume in 1 second versus placebo (95% CI, 0.00-0.19) at week 52 in the GERD group, versus 0.15 (95% CI, 0.10-0.20) in the asthma-only group. Tezepelumab also improved week 52 ACQ-6 scores in the GERD group (–0.39 versus placebo; 95% CI, –0.63 to –0.14) and the asthma-only group (–0.32 versus placebo; 95% CI, –0.45 to –0.19).

The study adds to the evidence supporting tezepelumab as a promising new therapy, according to Muhammad Adrish, MD, who attended the poster session and was asked to comment on the study. “I think that this is a very interesting analysis in the sense that gastric reflux disease is a frequent comorbid condition that we see in patients with asthma, and a lot of these patients can have poor outcomes. When you look at the results from the data, you see that regardless of how sick they were and how much medication utilization these patients have at baseline, they still had a pretty decent response to tezepelumab. That speaks to the efficacy of that drug along a wide spectrum of patients,” said Dr. Adrish, who is an associate professor of pulmonary, critical care, and sleep medicine at Baylor College of Medicine, Houston.

The PATHWAY and NAVIGATOR studies were funded by Amgen. Dr. Lugogo has advised or consulted for AstraZeneca, Amgen, Regeneron, TEVA, Avillion, Sanofi, Novartis, Genentech, GSK, and Janssen. Dr. Adrish has no relevant financial disclosures.

Extracorporeal membrane oxygen support appears to be beneficial in patients with advanced interstitial lung disease (ILD), according to a new meta-analysis. Specifically, among patients undergoing ECMO as a bridge to transplant, mortality was lower with venoarterial (VA) ECMO than with venovenous (VV) ECMO, although the confidence in the finding was low.

ECMO has been used increasingly in ILD patients over the past 10-15 years for acute decompensation as well as a bridge to lung transplant, according to Prasanth Balasubramanian, MD, but clinical evidence for its use is limited to case series or short-term retrospective studies. “We don’t have robust evidence on whether it really helps with the outcome, and which mode is better, so that’s why we decided to do a study on this,” said Dr. Balasubramanian, who is a fellow in pulmonary critical care at Mayo Clinic (Jacksonville, Fla.). He presented the new research at the annual meeting of the American College of Chest Physicians (CHEST).

The results were encouraging, according to the study’s lead author Pramod Guru, MD. “I think what we take from this analysis is that ECMO should not be considered as a contraindication for people you are considering for lung transplant. If we have this population of people who are very sick, but we have the opportunity to solve them with VA ECMO and then give the transplantation possibly, that may be the way,” said Dr. Guru, who is a critical care specialist at Mayo Clinic, Jacksonville, Fla. He acknowledged that more work needs to be done to determine whether VA or VV is best in specific patient populations.

The meta-analysis included 18 studies with a total of 1,341 patients, who were a mean age of 55.89 years and 61.08% of whom were male. Most procedures (75.3%) were VV. The overall mortality was 52.6%, including 59.7% for VV ECMO and 34.2% for VA ECMO. The survival difference did not reach statistical significance (odds ratio, 0.48; P = .11). There was also no significant difference in survival between patients who underwent ECMO and those who did not undergo ECMO (OR, 0.48; P = .43).

The researchers also analyzed 13 studies with 1,002 patients that looked at ECMO as a bridge to transplant (mean age, 52.1; 52.2% male; 49.3% VV, 31.1% VA, 32.4% cardiopulmonary bypass). Mortality was lower in the VA group than in the VV group (odds ratio, 0.62; P = .04).

“VA ECMO is generally for sicker patients, so it’s odd that the patients who are on the more aggressive support had lower mortality. But it’s good, it says it works,” said Chris Carroll, MD, an intensivist at the University of Florida, Jacksonville, who was asked to comment on the study.

The finding may also be an artifact of bias in the retrospective data, according to Joshua Diamond, MD, who comoderated the session where the study was presented. He noted age, physical function, and illness severity, among other factors can play a role in decision-making. “I have a feeling that what you’re seeing is a very carefully selected patient population as opposed to a true mortality benefit with VA versus VV ECMO,” said Dr. Diamond, who is associate medical director of the Penn Lung Transplant Program in Philadelphia.

Another weakness of the study is that ECMO techniques and devices have changed over time, making some of the older data less relevant to current practice. Overall Dr. Diamond described the study as interesting, but “I’d like to see a bit more granularity of data to figure out who makes or doesn’t make a good candidate,” said Dr. Diamond.

Patients with ILD undergoing ECMO as a bridge to transplant had a higher 1-year posttransplant mortality than patients with other causes for transplant (OR, 1.78; P<.01). However, this finding relied on two retrospective studies using the UNOS database at different time points (2001-2012 and 2015-2020), leading to potential confounders and risk of bias.

Dr. Balasubramanian recognized the limitations of the analysis. “We do think that further prospective studies comparing various modalities would be essential, although it would be challenging,” he said.

Nevertheless, Dr. Guru said that his own center is changing its patient selection criteria for ECMO and will begin to collect prospective data: “I would say that in 12 months we’ll have our own data to support what we are doing.”

The study can also inform patients and family who are trying to make a potential end-of-life decision about pursuing aggressive ECMO therapy. “This study says that if you choose to pursue that more aggressive therapy, you may still have a good outcome. A patient might say, ‘Why am I going to go through all this? Is it just prolonging my death, or is there a chance of saving my life? I think what this study shows is that it does have potential of saving their life,” said Dr. Carroll.

Dr. Balasubramanian, Dr. Guru, and Dr. Carroll have no relevant financial disclosures.

Extracorporeal membrane oxygen support appears to be beneficial in patients with advanced interstitial lung disease (ILD), according to a new meta-analysis. Specifically, among patients undergoing ECMO as a bridge to transplant, mortality was lower with venoarterial (VA) ECMO than with venovenous (VV) ECMO, although the confidence in the finding was low.

ECMO has been used increasingly in ILD patients over the past 10-15 years for acute decompensation as well as a bridge to lung transplant, according to Prasanth Balasubramanian, MD, but clinical evidence for its use is limited to case series or short-term retrospective studies. “We don’t have robust evidence on whether it really helps with the outcome, and which mode is better, so that’s why we decided to do a study on this,” said Dr. Balasubramanian, who is a fellow in pulmonary critical care at Mayo Clinic (Jacksonville, Fla.). He presented the new research at the annual meeting of the American College of Chest Physicians (CHEST).

The results were encouraging, according to the study’s lead author Pramod Guru, MD. “I think what we take from this analysis is that ECMO should not be considered as a contraindication for people you are considering for lung transplant. If we have this population of people who are very sick, but we have the opportunity to solve them with VA ECMO and then give the transplantation possibly, that may be the way,” said Dr. Guru, who is a critical care specialist at Mayo Clinic, Jacksonville, Fla. He acknowledged that more work needs to be done to determine whether VA or VV is best in specific patient populations.

The meta-analysis included 18 studies with a total of 1,341 patients, who were a mean age of 55.89 years and 61.08% of whom were male. Most procedures (75.3%) were VV. The overall mortality was 52.6%, including 59.7% for VV ECMO and 34.2% for VA ECMO. The survival difference did not reach statistical significance (odds ratio, 0.48; P = .11). There was also no significant difference in survival between patients who underwent ECMO and those who did not undergo ECMO (OR, 0.48; P = .43).

The researchers also analyzed 13 studies with 1,002 patients that looked at ECMO as a bridge to transplant (mean age, 52.1; 52.2% male; 49.3% VV, 31.1% VA, 32.4% cardiopulmonary bypass). Mortality was lower in the VA group than in the VV group (odds ratio, 0.62; P = .04).

“VA ECMO is generally for sicker patients, so it’s odd that the patients who are on the more aggressive support had lower mortality. But it’s good, it says it works,” said Chris Carroll, MD, an intensivist at the University of Florida, Jacksonville, who was asked to comment on the study.

The finding may also be an artifact of bias in the retrospective data, according to Joshua Diamond, MD, who comoderated the session where the study was presented. He noted age, physical function, and illness severity, among other factors can play a role in decision-making. “I have a feeling that what you’re seeing is a very carefully selected patient population as opposed to a true mortality benefit with VA versus VV ECMO,” said Dr. Diamond, who is associate medical director of the Penn Lung Transplant Program in Philadelphia.

Another weakness of the study is that ECMO techniques and devices have changed over time, making some of the older data less relevant to current practice. Overall Dr. Diamond described the study as interesting, but “I’d like to see a bit more granularity of data to figure out who makes or doesn’t make a good candidate,” said Dr. Diamond.

Patients with ILD undergoing ECMO as a bridge to transplant had a higher 1-year posttransplant mortality than patients with other causes for transplant (OR, 1.78; P<.01). However, this finding relied on two retrospective studies using the UNOS database at different time points (2001-2012 and 2015-2020), leading to potential confounders and risk of bias.

Dr. Balasubramanian recognized the limitations of the analysis. “We do think that further prospective studies comparing various modalities would be essential, although it would be challenging,” he said.

Nevertheless, Dr. Guru said that his own center is changing its patient selection criteria for ECMO and will begin to collect prospective data: “I would say that in 12 months we’ll have our own data to support what we are doing.”

The study can also inform patients and family who are trying to make a potential end-of-life decision about pursuing aggressive ECMO therapy. “This study says that if you choose to pursue that more aggressive therapy, you may still have a good outcome. A patient might say, ‘Why am I going to go through all this? Is it just prolonging my death, or is there a chance of saving my life? I think what this study shows is that it does have potential of saving their life,” said Dr. Carroll.

Dr. Balasubramanian, Dr. Guru, and Dr. Carroll have no relevant financial disclosures.

Extracorporeal membrane oxygen support appears to be beneficial in patients with advanced interstitial lung disease (ILD), according to a new meta-analysis. Specifically, among patients undergoing ECMO as a bridge to transplant, mortality was lower with venoarterial (VA) ECMO than with venovenous (VV) ECMO, although the confidence in the finding was low.

ECMO has been used increasingly in ILD patients over the past 10-15 years for acute decompensation as well as a bridge to lung transplant, according to Prasanth Balasubramanian, MD, but clinical evidence for its use is limited to case series or short-term retrospective studies. “We don’t have robust evidence on whether it really helps with the outcome, and which mode is better, so that’s why we decided to do a study on this,” said Dr. Balasubramanian, who is a fellow in pulmonary critical care at Mayo Clinic (Jacksonville, Fla.). He presented the new research at the annual meeting of the American College of Chest Physicians (CHEST).

The results were encouraging, according to the study’s lead author Pramod Guru, MD. “I think what we take from this analysis is that ECMO should not be considered as a contraindication for people you are considering for lung transplant. If we have this population of people who are very sick, but we have the opportunity to solve them with VA ECMO and then give the transplantation possibly, that may be the way,” said Dr. Guru, who is a critical care specialist at Mayo Clinic, Jacksonville, Fla. He acknowledged that more work needs to be done to determine whether VA or VV is best in specific patient populations.

The meta-analysis included 18 studies with a total of 1,341 patients, who were a mean age of 55.89 years and 61.08% of whom were male. Most procedures (75.3%) were VV. The overall mortality was 52.6%, including 59.7% for VV ECMO and 34.2% for VA ECMO. The survival difference did not reach statistical significance (odds ratio, 0.48; P = .11). There was also no significant difference in survival between patients who underwent ECMO and those who did not undergo ECMO (OR, 0.48; P = .43).

The researchers also analyzed 13 studies with 1,002 patients that looked at ECMO as a bridge to transplant (mean age, 52.1; 52.2% male; 49.3% VV, 31.1% VA, 32.4% cardiopulmonary bypass). Mortality was lower in the VA group than in the VV group (odds ratio, 0.62; P = .04).

“VA ECMO is generally for sicker patients, so it’s odd that the patients who are on the more aggressive support had lower mortality. But it’s good, it says it works,” said Chris Carroll, MD, an intensivist at the University of Florida, Jacksonville, who was asked to comment on the study.

The finding may also be an artifact of bias in the retrospective data, according to Joshua Diamond, MD, who comoderated the session where the study was presented. He noted age, physical function, and illness severity, among other factors can play a role in decision-making. “I have a feeling that what you’re seeing is a very carefully selected patient population as opposed to a true mortality benefit with VA versus VV ECMO,” said Dr. Diamond, who is associate medical director of the Penn Lung Transplant Program in Philadelphia.

Another weakness of the study is that ECMO techniques and devices have changed over time, making some of the older data less relevant to current practice. Overall Dr. Diamond described the study as interesting, but “I’d like to see a bit more granularity of data to figure out who makes or doesn’t make a good candidate,” said Dr. Diamond.

Patients with ILD undergoing ECMO as a bridge to transplant had a higher 1-year posttransplant mortality than patients with other causes for transplant (OR, 1.78; P<.01). However, this finding relied on two retrospective studies using the UNOS database at different time points (2001-2012 and 2015-2020), leading to potential confounders and risk of bias.

Dr. Balasubramanian recognized the limitations of the analysis. “We do think that further prospective studies comparing various modalities would be essential, although it would be challenging,” he said.

Nevertheless, Dr. Guru said that his own center is changing its patient selection criteria for ECMO and will begin to collect prospective data: “I would say that in 12 months we’ll have our own data to support what we are doing.”

The study can also inform patients and family who are trying to make a potential end-of-life decision about pursuing aggressive ECMO therapy. “This study says that if you choose to pursue that more aggressive therapy, you may still have a good outcome. A patient might say, ‘Why am I going to go through all this? Is it just prolonging my death, or is there a chance of saving my life? I think what this study shows is that it does have potential of saving their life,” said Dr. Carroll.

Dr. Balasubramanian, Dr. Guru, and Dr. Carroll have no relevant financial disclosures.

Hospitalized patients with both asthma and eosinophilic esophagitis (EoE) were a younger average age than those hospitalized with asthma alone, according to a new analysis of data from HCA Healthcare.

Not much work has been done on the overlap between the two conditions, both of which are believed to be driven by the action of both eosinophils and helper T cells, according to Linda Pham, DO, who presented the research at the annual meeting of the American College of Chest Physicians (CHEST).

“I have a colleague who is interested in GI and he’s really interested in EOE. We thought it would be nice to look at those populations of patients to see if there’s a correlation between them aside from just the atopic disease,” said Dr. Pham, who is an internal medicine resident at Riverside (Calif.) Community Hospital.

The findings underscore the need for assessing individual patient risk. “Having another concomitant disease like EoE, or maybe like atopic dermatitis, might cause you to have more severe [asthma] exacerbations causing you to go into the hospital more. I think if patients have more of these diseases, doctors can be more cognizant that they need to really be on top of treatment and make sure that [their patients] are aware of themselves so that if their symptoms exacerbate, they can go to the hospital and seek care,” said Dr. Pham.

The study was a retrospective analysis of 3,678,812 patients with asthma and 5,823 patients with both EoE and asthma. The data was drawn from 185 HCA hospitals, with records between 2016 and 2021.

The incidence of both asthma and asthma with EoE remained stable between 2016 and 2021. Dr. Pham pointed out that there are good methods to diagnose both conditions, which suggests that existing treatments are effective enough to be limiting the need for emergency treatment, according to Dr. Pham.

Among patients hospitalized with asthma alone, 72.55% were female, while 27.45% were male (P < .001). The numbers were much more evenly split among those with asthma and EoE, at 51.78% and 48.22%, respectively. The differing gender statistics aren’t easy to explain. “It’s not quite clear whether it’s because they just have more severe symptoms, or if it is other factors causing women to seek care more than their male counterparts. It could be personal biases, or it could be the asthma itself that is more severe in women,” said Dr. Pham.

When they broke down the analysis by sex, the researchers found that male EoE patients without asthma were a mean value of 5.517 years older than male EoE patients with asthma, and the mean difference was 5.480 years in female patients (P < .001 for both).

Although the direct cause of earlier hospitalization among patients with concomitant EoE and asthma is unclear, Dr. Pham speculated that the combination of atopic diseases may be leading to a stronger inflammatory response.

It remains to be seen if a similar relationship occurs with other atopic diseases, and future research could examine other factors. “I think it’d be good to look at not just age and gender, but BMI and occupation, things like that,” said Dr. Pham.

The study was of particular interest to Michelle Robertson, MD, who was in the audience. She is the director for clinical services at the Airborne Hazards and Burn Pits Center of Excellence at the New Jersey War-Related Illness and Injury Study Center. “We see a significant number of [veterans] who have been diagnosed with both asthma and eosinophilic esophagitis, and our thinking is that that is likely related to some of the military exposures: In particular, [what the] deployed veterans encountered in the Gulf War, [such as] the smoke from burn pits, sand and dust storms, and smoke from oil well fires. Our thinking is that the particulate matter, the PM 2.5, the very, very tiny particles, may be either sensitizing the lung area and/or esophagus and predisposing them to having those symptoms when they return home,” said Dr. Robertson, in an interview.

Particles in this size range may be able to bypass the protected areas of the nose and the lungs to reach the alveoli, where they could potentially interfere with the transfer of air between the lungs and the rest of the body, which could in turn lead to a variety of inflammatory conditions, according to Dr. Robertson.

She noted that particle exposure varies with a soldier’s wartime occupation, with higher exposures among mechanics and burn pit managers, for example. However, the highest levels of exposure do not predict later illness, which is a natural prompt for future research. “The second part of this whole pathophysiology is susceptibility. Is there something about those people that do get sick that makes them more susceptible than folks that don’t, even though they both have the same jobs?”

Dr. Pham and Dr. Robertson have no relevant financial disclosures.
 

Hospitalized patients with both asthma and eosinophilic esophagitis (EoE) were a younger average age than those hospitalized with asthma alone, according to a new analysis of data from HCA Healthcare.

Not much work has been done on the overlap between the two conditions, both of which are believed to be driven by the action of both eosinophils and helper T cells, according to Linda Pham, DO, who presented the research at the annual meeting of the American College of Chest Physicians (CHEST).

“I have a colleague who is interested in GI and he’s really interested in EOE. We thought it would be nice to look at those populations of patients to see if there’s a correlation between them aside from just the atopic disease,” said Dr. Pham, who is an internal medicine resident at Riverside (Calif.) Community Hospital.

The findings underscore the need for assessing individual patient risk. “Having another concomitant disease like EoE, or maybe like atopic dermatitis, might cause you to have more severe [asthma] exacerbations causing you to go into the hospital more. I think if patients have more of these diseases, doctors can be more cognizant that they need to really be on top of treatment and make sure that [their patients] are aware of themselves so that if their symptoms exacerbate, they can go to the hospital and seek care,” said Dr. Pham.

The study was a retrospective analysis of 3,678,812 patients with asthma and 5,823 patients with both EoE and asthma. The data was drawn from 185 HCA hospitals, with records between 2016 and 2021.

The incidence of both asthma and asthma with EoE remained stable between 2016 and 2021. Dr. Pham pointed out that there are good methods to diagnose both conditions, which suggests that existing treatments are effective enough to be limiting the need for emergency treatment, according to Dr. Pham.

Among patients hospitalized with asthma alone, 72.55% were female, while 27.45% were male (P < .001). The numbers were much more evenly split among those with asthma and EoE, at 51.78% and 48.22%, respectively. The differing gender statistics aren’t easy to explain. “It’s not quite clear whether it’s because they just have more severe symptoms, or if it is other factors causing women to seek care more than their male counterparts. It could be personal biases, or it could be the asthma itself that is more severe in women,” said Dr. Pham.

When they broke down the analysis by sex, the researchers found that male EoE patients without asthma were a mean value of 5.517 years older than male EoE patients with asthma, and the mean difference was 5.480 years in female patients (P < .001 for both).

Although the direct cause of earlier hospitalization among patients with concomitant EoE and asthma is unclear, Dr. Pham speculated that the combination of atopic diseases may be leading to a stronger inflammatory response.

It remains to be seen if a similar relationship occurs with other atopic diseases, and future research could examine other factors. “I think it’d be good to look at not just age and gender, but BMI and occupation, things like that,” said Dr. Pham.

The study was of particular interest to Michelle Robertson, MD, who was in the audience. She is the director for clinical services at the Airborne Hazards and Burn Pits Center of Excellence at the New Jersey War-Related Illness and Injury Study Center. “We see a significant number of [veterans] who have been diagnosed with both asthma and eosinophilic esophagitis, and our thinking is that that is likely related to some of the military exposures: In particular, [what the] deployed veterans encountered in the Gulf War, [such as] the smoke from burn pits, sand and dust storms, and smoke from oil well fires. Our thinking is that the particulate matter, the PM 2.5, the very, very tiny particles, may be either sensitizing the lung area and/or esophagus and predisposing them to having those symptoms when they return home,” said Dr. Robertson, in an interview.

Particles in this size range may be able to bypass the protected areas of the nose and the lungs to reach the alveoli, where they could potentially interfere with the transfer of air between the lungs and the rest of the body, which could in turn lead to a variety of inflammatory conditions, according to Dr. Robertson.

She noted that particle exposure varies with a soldier’s wartime occupation, with higher exposures among mechanics and burn pit managers, for example. However, the highest levels of exposure do not predict later illness, which is a natural prompt for future research. “The second part of this whole pathophysiology is susceptibility. Is there something about those people that do get sick that makes them more susceptible than folks that don’t, even though they both have the same jobs?”

Dr. Pham and Dr. Robertson have no relevant financial disclosures.
 

Hospitalized patients with both asthma and eosinophilic esophagitis (EoE) were a younger average age than those hospitalized with asthma alone, according to a new analysis of data from HCA Healthcare.

Not much work has been done on the overlap between the two conditions, both of which are believed to be driven by the action of both eosinophils and helper T cells, according to Linda Pham, DO, who presented the research at the annual meeting of the American College of Chest Physicians (CHEST).

“I have a colleague who is interested in GI and he’s really interested in EOE. We thought it would be nice to look at those populations of patients to see if there’s a correlation between them aside from just the atopic disease,” said Dr. Pham, who is an internal medicine resident at Riverside (Calif.) Community Hospital.

The findings underscore the need for assessing individual patient risk. “Having another concomitant disease like EoE, or maybe like atopic dermatitis, might cause you to have more severe [asthma] exacerbations causing you to go into the hospital more. I think if patients have more of these diseases, doctors can be more cognizant that they need to really be on top of treatment and make sure that [their patients] are aware of themselves so that if their symptoms exacerbate, they can go to the hospital and seek care,” said Dr. Pham.

The study was a retrospective analysis of 3,678,812 patients with asthma and 5,823 patients with both EoE and asthma. The data was drawn from 185 HCA hospitals, with records between 2016 and 2021.

The incidence of both asthma and asthma with EoE remained stable between 2016 and 2021. Dr. Pham pointed out that there are good methods to diagnose both conditions, which suggests that existing treatments are effective enough to be limiting the need for emergency treatment, according to Dr. Pham.

Among patients hospitalized with asthma alone, 72.55% were female, while 27.45% were male (P < .001). The numbers were much more evenly split among those with asthma and EoE, at 51.78% and 48.22%, respectively. The differing gender statistics aren’t easy to explain. “It’s not quite clear whether it’s because they just have more severe symptoms, or if it is other factors causing women to seek care more than their male counterparts. It could be personal biases, or it could be the asthma itself that is more severe in women,” said Dr. Pham.

When they broke down the analysis by sex, the researchers found that male EoE patients without asthma were a mean value of 5.517 years older than male EoE patients with asthma, and the mean difference was 5.480 years in female patients (P < .001 for both).

Although the direct cause of earlier hospitalization among patients with concomitant EoE and asthma is unclear, Dr. Pham speculated that the combination of atopic diseases may be leading to a stronger inflammatory response.

It remains to be seen if a similar relationship occurs with other atopic diseases, and future research could examine other factors. “I think it’d be good to look at not just age and gender, but BMI and occupation, things like that,” said Dr. Pham.

The study was of particular interest to Michelle Robertson, MD, who was in the audience. She is the director for clinical services at the Airborne Hazards and Burn Pits Center of Excellence at the New Jersey War-Related Illness and Injury Study Center. “We see a significant number of [veterans] who have been diagnosed with both asthma and eosinophilic esophagitis, and our thinking is that that is likely related to some of the military exposures: In particular, [what the] deployed veterans encountered in the Gulf War, [such as] the smoke from burn pits, sand and dust storms, and smoke from oil well fires. Our thinking is that the particulate matter, the PM 2.5, the very, very tiny particles, may be either sensitizing the lung area and/or esophagus and predisposing them to having those symptoms when they return home,” said Dr. Robertson, in an interview.

Particles in this size range may be able to bypass the protected areas of the nose and the lungs to reach the alveoli, where they could potentially interfere with the transfer of air between the lungs and the rest of the body, which could in turn lead to a variety of inflammatory conditions, according to Dr. Robertson.

She noted that particle exposure varies with a soldier’s wartime occupation, with higher exposures among mechanics and burn pit managers, for example. However, the highest levels of exposure do not predict later illness, which is a natural prompt for future research. “The second part of this whole pathophysiology is susceptibility. Is there something about those people that do get sick that makes them more susceptible than folks that don’t, even though they both have the same jobs?”

Dr. Pham and Dr. Robertson have no relevant financial disclosures.
 

HONOLULU – The diversity of species in the sputum of patients undergoing therapy for nontuberculosis mycobacterial pulmonary disease (NTM-PD) could be a marker for treatment efficacy, authors of a small prospective study suggest.

Noeul Kang_ MD_ PhD_web.JPG

Among 14 patients treated for NTM-PD, 7 of whom had treatment-refractory disease and 7 of whom had microbiological cures after antibiotic therapy, the diversity of the microbiome in sputum was greater for those patients who were cured, indicating that the variety of species found in sputum during treatment could help clinicians evaluate the efficacy of therapy and guide patient management, said Noeul Kang, MD, PhD, from Samsung Medical Center in Seoul, South Korea.

“What we found was that in NTM-PD patients, the sputum of the patients who remained in long-time stabilization without recurrence exhibited higher microbiome diversity than that of treatment-refractory patients, and several genera were identified in the samples of the cured group. We hope to do more research on this, and we are planning to compare the patients who have never been treated with those who respond to treatment,” she said at the annual meeting of the American College of Chest Physicians (CHEST).
 

NTM-PD on the rise

The incidence and prevalence of NTM-PD in both South Korea and the United States have been rising steadily since 2007, with the highest incidence occurring among those 65 and older.

“NTM-PD is becoming a global burden,” Dr. Kang said.

Across the world the most commonly occurring organisms in NTM-PD patients are Mycobacterium avium complex (MAC), with other mycobacteria species varying in frequency by region.

Outcomes of treatment differ according to the etiologic organism, with M. avium complex infections being successfully treated in about 60% of patients, compared with 70% of patients’ infections with the M. abscessus massiliense, and 30%-40% of infections yielding to antibiotics in patients with M. abscessus abscessus, Dr. Kang said.

To compare the characteristics of the sputum microbiota of NTM-PD patients based on their treatment outcomes, Dr. Kang and colleagues looked at sputum from all patients with NTM-PD who agreed to provide samples at their center from 2018 through 2022.

After excluding those who did not receive antibiotics, those who were on treatment but did not have refractory disease, and those who were lost to follow-up or whose samples did not pass quality control, they identified seven patients who had microbiological cures, and seven whose disease remained refractory to treatment.

They defined culture conversion at three or more consecutive negative sputum cultures after treatment, collected at least 4 weeks apart, and microbiological cures at maintenance of multiple consecutive negative cultures without any positive cultures of the causative species from respiratory samples.

Infections were deemed to be refractory if there were sustained positive cultures from respiratory samples of causative NTM species after at least 1 year of antibiotic therapy.
 

Diversity analysis

Samples from 8 of the 14 participants had M. abscessus-PD, with the proportion higher among those who had a sustained microbiological cure (71.4% vs. 42.9%).

At baseline, patients with refractory disease were found to have significantly lower alpha diversity, a measure of microbial diversity within a single sample, compared with those whose infections were cured (P = .025).

In addition, samples at 6-month follow-up from those with baseline ­refractory infections ­had differences in the species level of beta-diversity (that is, differences among samples), compared with both baseline and follow-up samples from the cured group (P = .022 and .024, respectively).

The investigators also used linear discriminant analysis to look at taxonomic biomarkers, and observed that several species were more abundant in samples from the microbiological cure group than from the refractory disease group (P < .05) These species included organisms in the Streptococcus pneumoniae group, Prevotella melaninogenica, and Haemophilus parahaemolyticus group.
 

Promising start

A pulmonologist who was not involved in the study commented in an interview that, although the findings need further study, the microbiome of sputum samples has the potential for predictive value.

“I think this will be clinically useful, actually, if we’re able to identify and diagnose patients with MAC disease and then we identify their sputum microbiome, it might give us an idea whether these patients are more sensitive or refractory to treatment,” said Muhammad U. Khawar, MD, from the University of Cincinnati.

Dr. Khawar moderated the session where Dr. Kang reported her data.

The investigators did not report a funding source. Dr. Kang and Dr. Khawar reported that they had no relevant disclosures.
 

HONOLULU – The diversity of species in the sputum of patients undergoing therapy for nontuberculosis mycobacterial pulmonary disease (NTM-PD) could be a marker for treatment efficacy, authors of a small prospective study suggest.

Noeul Kang_ MD_ PhD_web.JPG

Among 14 patients treated for NTM-PD, 7 of whom had treatment-refractory disease and 7 of whom had microbiological cures after antibiotic therapy, the diversity of the microbiome in sputum was greater for those patients who were cured, indicating that the variety of species found in sputum during treatment could help clinicians evaluate the efficacy of therapy and guide patient management, said Noeul Kang, MD, PhD, from Samsung Medical Center in Seoul, South Korea.

“What we found was that in NTM-PD patients, the sputum of the patients who remained in long-time stabilization without recurrence exhibited higher microbiome diversity than that of treatment-refractory patients, and several genera were identified in the samples of the cured group. We hope to do more research on this, and we are planning to compare the patients who have never been treated with those who respond to treatment,” she said at the annual meeting of the American College of Chest Physicians (CHEST).
 

NTM-PD on the rise

The incidence and prevalence of NTM-PD in both South Korea and the United States have been rising steadily since 2007, with the highest incidence occurring among those 65 and older.

“NTM-PD is becoming a global burden,” Dr. Kang said.

Across the world the most commonly occurring organisms in NTM-PD patients are Mycobacterium avium complex (MAC), with other mycobacteria species varying in frequency by region.

Outcomes of treatment differ according to the etiologic organism, with M. avium complex infections being successfully treated in about 60% of patients, compared with 70% of patients’ infections with the M. abscessus massiliense, and 30%-40% of infections yielding to antibiotics in patients with M. abscessus abscessus, Dr. Kang said.

To compare the characteristics of the sputum microbiota of NTM-PD patients based on their treatment outcomes, Dr. Kang and colleagues looked at sputum from all patients with NTM-PD who agreed to provide samples at their center from 2018 through 2022.

After excluding those who did not receive antibiotics, those who were on treatment but did not have refractory disease, and those who were lost to follow-up or whose samples did not pass quality control, they identified seven patients who had microbiological cures, and seven whose disease remained refractory to treatment.

They defined culture conversion at three or more consecutive negative sputum cultures after treatment, collected at least 4 weeks apart, and microbiological cures at maintenance of multiple consecutive negative cultures without any positive cultures of the causative species from respiratory samples.

Infections were deemed to be refractory if there were sustained positive cultures from respiratory samples of causative NTM species after at least 1 year of antibiotic therapy.
 

Diversity analysis

Samples from 8 of the 14 participants had M. abscessus-PD, with the proportion higher among those who had a sustained microbiological cure (71.4% vs. 42.9%).

At baseline, patients with refractory disease were found to have significantly lower alpha diversity, a measure of microbial diversity within a single sample, compared with those whose infections were cured (P = .025).

In addition, samples at 6-month follow-up from those with baseline ­refractory infections ­had differences in the species level of beta-diversity (that is, differences among samples), compared with both baseline and follow-up samples from the cured group (P = .022 and .024, respectively).

The investigators also used linear discriminant analysis to look at taxonomic biomarkers, and observed that several species were more abundant in samples from the microbiological cure group than from the refractory disease group (P < .05) These species included organisms in the Streptococcus pneumoniae group, Prevotella melaninogenica, and Haemophilus parahaemolyticus group.
 

Promising start

A pulmonologist who was not involved in the study commented in an interview that, although the findings need further study, the microbiome of sputum samples has the potential for predictive value.

“I think this will be clinically useful, actually, if we’re able to identify and diagnose patients with MAC disease and then we identify their sputum microbiome, it might give us an idea whether these patients are more sensitive or refractory to treatment,” said Muhammad U. Khawar, MD, from the University of Cincinnati.

Dr. Khawar moderated the session where Dr. Kang reported her data.

The investigators did not report a funding source. Dr. Kang and Dr. Khawar reported that they had no relevant disclosures.
 

HONOLULU – The diversity of species in the sputum of patients undergoing therapy for nontuberculosis mycobacterial pulmonary disease (NTM-PD) could be a marker for treatment efficacy, authors of a small prospective study suggest.

Noeul Kang_ MD_ PhD_web.JPG

Among 14 patients treated for NTM-PD, 7 of whom had treatment-refractory disease and 7 of whom had microbiological cures after antibiotic therapy, the diversity of the microbiome in sputum was greater for those patients who were cured, indicating that the variety of species found in sputum during treatment could help clinicians evaluate the efficacy of therapy and guide patient management, said Noeul Kang, MD, PhD, from Samsung Medical Center in Seoul, South Korea.

“What we found was that in NTM-PD patients, the sputum of the patients who remained in long-time stabilization without recurrence exhibited higher microbiome diversity than that of treatment-refractory patients, and several genera were identified in the samples of the cured group. We hope to do more research on this, and we are planning to compare the patients who have never been treated with those who respond to treatment,” she said at the annual meeting of the American College of Chest Physicians (CHEST).
 

NTM-PD on the rise

The incidence and prevalence of NTM-PD in both South Korea and the United States have been rising steadily since 2007, with the highest incidence occurring among those 65 and older.

“NTM-PD is becoming a global burden,” Dr. Kang said.

Across the world the most commonly occurring organisms in NTM-PD patients are Mycobacterium avium complex (MAC), with other mycobacteria species varying in frequency by region.

Outcomes of treatment differ according to the etiologic organism, with M. avium complex infections being successfully treated in about 60% of patients, compared with 70% of patients’ infections with the M. abscessus massiliense, and 30%-40% of infections yielding to antibiotics in patients with M. abscessus abscessus, Dr. Kang said.

To compare the characteristics of the sputum microbiota of NTM-PD patients based on their treatment outcomes, Dr. Kang and colleagues looked at sputum from all patients with NTM-PD who agreed to provide samples at their center from 2018 through 2022.

After excluding those who did not receive antibiotics, those who were on treatment but did not have refractory disease, and those who were lost to follow-up or whose samples did not pass quality control, they identified seven patients who had microbiological cures, and seven whose disease remained refractory to treatment.

They defined culture conversion at three or more consecutive negative sputum cultures after treatment, collected at least 4 weeks apart, and microbiological cures at maintenance of multiple consecutive negative cultures without any positive cultures of the causative species from respiratory samples.

Infections were deemed to be refractory if there were sustained positive cultures from respiratory samples of causative NTM species after at least 1 year of antibiotic therapy.
 

Diversity analysis

Samples from 8 of the 14 participants had M. abscessus-PD, with the proportion higher among those who had a sustained microbiological cure (71.4% vs. 42.9%).

At baseline, patients with refractory disease were found to have significantly lower alpha diversity, a measure of microbial diversity within a single sample, compared with those whose infections were cured (P = .025).

In addition, samples at 6-month follow-up from those with baseline ­refractory infections ­had differences in the species level of beta-diversity (that is, differences among samples), compared with both baseline and follow-up samples from the cured group (P = .022 and .024, respectively).

The investigators also used linear discriminant analysis to look at taxonomic biomarkers, and observed that several species were more abundant in samples from the microbiological cure group than from the refractory disease group (P < .05) These species included organisms in the Streptococcus pneumoniae group, Prevotella melaninogenica, and Haemophilus parahaemolyticus group.
 

Promising start

A pulmonologist who was not involved in the study commented in an interview that, although the findings need further study, the microbiome of sputum samples has the potential for predictive value.

“I think this will be clinically useful, actually, if we’re able to identify and diagnose patients with MAC disease and then we identify their sputum microbiome, it might give us an idea whether these patients are more sensitive or refractory to treatment,” said Muhammad U. Khawar, MD, from the University of Cincinnati.

Dr. Khawar moderated the session where Dr. Kang reported her data.

The investigators did not report a funding source. Dr. Kang and Dr. Khawar reported that they had no relevant disclosures.
 

HONOLULU – Sexual and gender minority (SGM) people are at increased risk for asthma severity, compared with non-SGM people, and asthma is especially exacerbated in SGM persons who use e-cigarettes compared with heterosexuals.

These findings come from a study of asthma severity among SGM people, with a special focus on the contribution of tobacco, reported Tugba Kaplan, MD, a resident in internal medicine at Luminis Health Anne Arundel Medical Center, Annapolis, Md.

“To the best of our knowledge, this is the first study assessing asthma severity among SGM people in a nationally representative longitudinal cohort study,” she said in an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).

There has been only limited research on the health status and health needs of SGM people, and most of the studies conducted have focused on issues such as HIV/AIDS, sexual health, and substance use, not respiratory health, she said.
 

Following the PATH

Dr. Kaplan and colleagues drew on data from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal cohort study with data on approximately 46,000 adults and adolescents in the United States.

The study uses self-reported data on tobacco use patterns; perceptions of risk and attitudes toward tobacco products; tobacco initiation, cessation, and relapse; and associated health outcomes.

The investigators combined data from three waves of the PATH Study, conducted from 2015 to 2019 on nonpregnant participants aged 18 years and older, and used mixed-effect logistic regression models to look for potential associations between sexual orientation and asthma severity.

They used standard definitions of asthma severity, based on lung function impairment measured by forced expiratory volume in 1 second and forced vital capacity, nighttime awakenings, use of a short-acting beta2-agonist for symptoms, interference with normal activity, and exacerbations requiring oral systemic corticosteroids.

The study also includes a sexual orientation question, asking participants, “do you consider yourself to be ...” with the options “straight, lesbian or gay, bisexual, something else, don’t know, or refused.”

Based on these responses, Dr. Kaplan and colleagues studied a total sample of 1,815 people who identify as SGM and 12,879 who identify as non-SGM.
 

Risks increased

In an analysis adjusted for age, sex, race/ethnicity, tobacco use, body mass index, physical activity, and asthma medication use, the authors found that, compared with non-SGM people, SGM respondents were significantly more likely to have had asthma attacks requiring steroid use in the past years (odds ratio, 1.47; 95% confidence interval, 1.01-2.15), asthma interfering with daily activities in the past month (OR, 1.33; CI, 1.10-1.61), and shortness of breath in any week over the 30 days (OR, 1.82; CI, 1.32-2.51). There was no significant difference between the groups in inhaler use over the past month, however.

They also found two interactions in the logistic regression models, one between urgent care visits and respondents who reported using both regular tobacco and e-cigarettes (dual users), and between exclusive e-cigarette use and waking up at night.

Among dual users, SGM respondents had a nearly fourfold greater risk for asthma attacks requiring urgent care visits, compared with non-SGM respondents (OR, 3.89; CI, 1.99-7.63). In contrast, among those who never used tobacco, there were no significant differences between the sexual orientation groups in regard to asthma attacks requiring urgent care visits.

Among those who reported using e-cigarettes exclusively, SGM respondents were nearly eight times more likely to report night awakening, compared with non-SGM users (OR, 7.81; CI, 2.93-20.8).

Among never users, in contrast, there was no significant difference in nighttime disturbances.
 

Possible confounders

The data suggest that “in the context of chronic illnesses like asthma, it is crucial to offer patients the knowledge and tools required to proficiently handle their conditions,” Dr. Kaplan said, adding that the differences seen between SGM and non-SGM respondents may be caused by health care disparities among SGM people that result in nonadherence to regular follow-ups.

In an interview, Jean Bourbeau, MD, MSc, who was a moderator for the session but was not involved in the study, commented that “we have to be very careful before making any conclusions, because this population could be at high risk for different reasons, and especially, do they get the same attention in terms of the care that is provided to the general population, and do they get access to the same medication?”

Nonetheless, Dr. Bourbeau continued, “I think this study is very important, because it shows us how much awareness we need to determine differences in populations, and [sexual orientation] is probably one thing that nobody had considered before, and for the first time we are now considering these potential differences in our population.”

The authors did not report a study funding source. Dr. Kaplan and Dr. Bourbeau reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

HONOLULU – Sexual and gender minority (SGM) people are at increased risk for asthma severity, compared with non-SGM people, and asthma is especially exacerbated in SGM persons who use e-cigarettes compared with heterosexuals.

These findings come from a study of asthma severity among SGM people, with a special focus on the contribution of tobacco, reported Tugba Kaplan, MD, a resident in internal medicine at Luminis Health Anne Arundel Medical Center, Annapolis, Md.

“To the best of our knowledge, this is the first study assessing asthma severity among SGM people in a nationally representative longitudinal cohort study,” she said in an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).

There has been only limited research on the health status and health needs of SGM people, and most of the studies conducted have focused on issues such as HIV/AIDS, sexual health, and substance use, not respiratory health, she said.
 

Following the PATH

Dr. Kaplan and colleagues drew on data from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal cohort study with data on approximately 46,000 adults and adolescents in the United States.

The study uses self-reported data on tobacco use patterns; perceptions of risk and attitudes toward tobacco products; tobacco initiation, cessation, and relapse; and associated health outcomes.

The investigators combined data from three waves of the PATH Study, conducted from 2015 to 2019 on nonpregnant participants aged 18 years and older, and used mixed-effect logistic regression models to look for potential associations between sexual orientation and asthma severity.

They used standard definitions of asthma severity, based on lung function impairment measured by forced expiratory volume in 1 second and forced vital capacity, nighttime awakenings, use of a short-acting beta2-agonist for symptoms, interference with normal activity, and exacerbations requiring oral systemic corticosteroids.

The study also includes a sexual orientation question, asking participants, “do you consider yourself to be ...” with the options “straight, lesbian or gay, bisexual, something else, don’t know, or refused.”

Based on these responses, Dr. Kaplan and colleagues studied a total sample of 1,815 people who identify as SGM and 12,879 who identify as non-SGM.
 

Risks increased

In an analysis adjusted for age, sex, race/ethnicity, tobacco use, body mass index, physical activity, and asthma medication use, the authors found that, compared with non-SGM people, SGM respondents were significantly more likely to have had asthma attacks requiring steroid use in the past years (odds ratio, 1.47; 95% confidence interval, 1.01-2.15), asthma interfering with daily activities in the past month (OR, 1.33; CI, 1.10-1.61), and shortness of breath in any week over the 30 days (OR, 1.82; CI, 1.32-2.51). There was no significant difference between the groups in inhaler use over the past month, however.

They also found two interactions in the logistic regression models, one between urgent care visits and respondents who reported using both regular tobacco and e-cigarettes (dual users), and between exclusive e-cigarette use and waking up at night.

Among dual users, SGM respondents had a nearly fourfold greater risk for asthma attacks requiring urgent care visits, compared with non-SGM respondents (OR, 3.89; CI, 1.99-7.63). In contrast, among those who never used tobacco, there were no significant differences between the sexual orientation groups in regard to asthma attacks requiring urgent care visits.

Among those who reported using e-cigarettes exclusively, SGM respondents were nearly eight times more likely to report night awakening, compared with non-SGM users (OR, 7.81; CI, 2.93-20.8).

Among never users, in contrast, there was no significant difference in nighttime disturbances.
 

Possible confounders

The data suggest that “in the context of chronic illnesses like asthma, it is crucial to offer patients the knowledge and tools required to proficiently handle their conditions,” Dr. Kaplan said, adding that the differences seen between SGM and non-SGM respondents may be caused by health care disparities among SGM people that result in nonadherence to regular follow-ups.

In an interview, Jean Bourbeau, MD, MSc, who was a moderator for the session but was not involved in the study, commented that “we have to be very careful before making any conclusions, because this population could be at high risk for different reasons, and especially, do they get the same attention in terms of the care that is provided to the general population, and do they get access to the same medication?”

Nonetheless, Dr. Bourbeau continued, “I think this study is very important, because it shows us how much awareness we need to determine differences in populations, and [sexual orientation] is probably one thing that nobody had considered before, and for the first time we are now considering these potential differences in our population.”

The authors did not report a study funding source. Dr. Kaplan and Dr. Bourbeau reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

HONOLULU – Sexual and gender minority (SGM) people are at increased risk for asthma severity, compared with non-SGM people, and asthma is especially exacerbated in SGM persons who use e-cigarettes compared with heterosexuals.

These findings come from a study of asthma severity among SGM people, with a special focus on the contribution of tobacco, reported Tugba Kaplan, MD, a resident in internal medicine at Luminis Health Anne Arundel Medical Center, Annapolis, Md.

“To the best of our knowledge, this is the first study assessing asthma severity among SGM people in a nationally representative longitudinal cohort study,” she said in an oral abstract session at the annual meeting of the American College of Chest Physicians (CHEST).

There has been only limited research on the health status and health needs of SGM people, and most of the studies conducted have focused on issues such as HIV/AIDS, sexual health, and substance use, not respiratory health, she said.
 

Following the PATH

Dr. Kaplan and colleagues drew on data from the Population Assessment of Tobacco and Health (PATH) Study, a nationally representative longitudinal cohort study with data on approximately 46,000 adults and adolescents in the United States.

The study uses self-reported data on tobacco use patterns; perceptions of risk and attitudes toward tobacco products; tobacco initiation, cessation, and relapse; and associated health outcomes.

The investigators combined data from three waves of the PATH Study, conducted from 2015 to 2019 on nonpregnant participants aged 18 years and older, and used mixed-effect logistic regression models to look for potential associations between sexual orientation and asthma severity.

They used standard definitions of asthma severity, based on lung function impairment measured by forced expiratory volume in 1 second and forced vital capacity, nighttime awakenings, use of a short-acting beta2-agonist for symptoms, interference with normal activity, and exacerbations requiring oral systemic corticosteroids.

The study also includes a sexual orientation question, asking participants, “do you consider yourself to be ...” with the options “straight, lesbian or gay, bisexual, something else, don’t know, or refused.”

Based on these responses, Dr. Kaplan and colleagues studied a total sample of 1,815 people who identify as SGM and 12,879 who identify as non-SGM.
 

Risks increased

In an analysis adjusted for age, sex, race/ethnicity, tobacco use, body mass index, physical activity, and asthma medication use, the authors found that, compared with non-SGM people, SGM respondents were significantly more likely to have had asthma attacks requiring steroid use in the past years (odds ratio, 1.47; 95% confidence interval, 1.01-2.15), asthma interfering with daily activities in the past month (OR, 1.33; CI, 1.10-1.61), and shortness of breath in any week over the 30 days (OR, 1.82; CI, 1.32-2.51). There was no significant difference between the groups in inhaler use over the past month, however.

They also found two interactions in the logistic regression models, one between urgent care visits and respondents who reported using both regular tobacco and e-cigarettes (dual users), and between exclusive e-cigarette use and waking up at night.

Among dual users, SGM respondents had a nearly fourfold greater risk for asthma attacks requiring urgent care visits, compared with non-SGM respondents (OR, 3.89; CI, 1.99-7.63). In contrast, among those who never used tobacco, there were no significant differences between the sexual orientation groups in regard to asthma attacks requiring urgent care visits.

Among those who reported using e-cigarettes exclusively, SGM respondents were nearly eight times more likely to report night awakening, compared with non-SGM users (OR, 7.81; CI, 2.93-20.8).

Among never users, in contrast, there was no significant difference in nighttime disturbances.
 

Possible confounders

The data suggest that “in the context of chronic illnesses like asthma, it is crucial to offer patients the knowledge and tools required to proficiently handle their conditions,” Dr. Kaplan said, adding that the differences seen between SGM and non-SGM respondents may be caused by health care disparities among SGM people that result in nonadherence to regular follow-ups.

In an interview, Jean Bourbeau, MD, MSc, who was a moderator for the session but was not involved in the study, commented that “we have to be very careful before making any conclusions, because this population could be at high risk for different reasons, and especially, do they get the same attention in terms of the care that is provided to the general population, and do they get access to the same medication?”

Nonetheless, Dr. Bourbeau continued, “I think this study is very important, because it shows us how much awareness we need to determine differences in populations, and [sexual orientation] is probably one thing that nobody had considered before, and for the first time we are now considering these potential differences in our population.”

The authors did not report a study funding source. Dr. Kaplan and Dr. Bourbeau reported having no relevant financial relationships.

A version of this article first appeared on Medscape.com.

HONOLULU – Patients with acute respiratory distress syndrome (ARDS) and coexisting pulmonary hypertension (PH) are significantly more likely to have longer and more costly hospital stays and to die in-hospital than patients with ARDS without PH, results of a retrospective study suggest.

Among more than 156,000 hospitalized patients with ARDS, 16.8% of whom also had a diagnosis of PH, the presence of PH was associated with about a 50% higher risk for in-hospital mortality and a 37% higher risk for longer hospital stays. In addition, the presence of PH was associated with nearly $20,000 of higher hospital expenditures, reported Kaushik Kumar, MBBS, at the annual meeting of the American College of Chest Physicians (CHEST).

“Clinicians should be vigilant in identifying and managing pulmonary hypertension in ARDS patients,” Dr. Kumar, a resident in internal medicine at Medstar Health, Baltimore, said in an oral abstract presentation.

He added that PH has the potential to serve as an indicator of disease severity for patients with ARDS.
 

National database

PH is a frequent complication of ARDS, likely related to a combination of pulmonary vasoconstriction, thromboembolism, and interstitial edema, he said.

To test their hypothesis that the presence of PH in patients with ARDS is associated with worse outcomes, Dr. Kumar and colleagues drew on the National Inpatient Sample database for information on adults aged 18 years and older who had been diagnosed with ARDS with or without PH.

They identified a total of 156,687 patients of whom 26,324 (16.8%) also had been diagnosed with PH. Among the cohort with PH, there were higher proportions of older patients, women, and patients with multiple comorbidities.

The in-hospital mortality rate was 36.8% among patients with PH, compared with 24.6% among those without. The mean length of stay was also longer among patients with PH, at 12 days versus 10 days.

In an unadjusted analysis, mean total hospital charges for patients with ARDS and PH were $210,165, versus $160,683 for patients with ARDS who did not have PH.

In an analysis in which the investigators controlled for age, sex, index admission length of stay, insurance status, and comorbidities, in-hospital mortality for patients with PH remained significantly higher, with an odds ratio of 1.52 (P < .001). PH was also significantly associated with longer length of stay (odds ratio, 1.37; P < .001) and higher total hospital costs, with a mean difference of $19,406.

Dr. Kumar said that the findings underscore the importance of a tailored approach to managing patients with ARDS, especially in the presence of PH.

The investigators plan further studies to assess the role of PH-targeted therapies, to examine the role of sepsis and right ventricular failure and to explore the long-term impact of PH among ARDS survivors, including effects with respect to pulmonary function, quality of life, and long-term morbidity.
 

Potential to inform practice

A pulmonologist who was not involved in the study said in an interview that the findings of the trial suggest that PH may have a greater influence on mortality than is currently understood and that further investigations into this association could change practice in the future.

“I think it would be very important for us to understand if that is going to change our outlook on how ARDS is managed. It’s possible that some of the interventions that we give people who don’t have pulmonary hypertension, for example, increasing the airway pressure in order to minimize oxygenation, may have a detrimental effect on the pulmonary vasculature,” said Timothy Morris, MD, medical director of the pulmonary and exercise lab and professor of medicine at the University of California, San Diego.

“I think it’s a little bit premature to say that this should guide management now, but it’s certainly an interesting question that may end up changing practice in the future,” said Dr. Morris, who was moderator of the session in which Dr. Kumar presented the data.

The study was supported by the Agency for Healthcare Research and Quality and Medstar Health Research Institute. Dr. Kumar and Dr. Morris have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

HONOLULU – Patients with acute respiratory distress syndrome (ARDS) and coexisting pulmonary hypertension (PH) are significantly more likely to have longer and more costly hospital stays and to die in-hospital than patients with ARDS without PH, results of a retrospective study suggest.

Among more than 156,000 hospitalized patients with ARDS, 16.8% of whom also had a diagnosis of PH, the presence of PH was associated with about a 50% higher risk for in-hospital mortality and a 37% higher risk for longer hospital stays. In addition, the presence of PH was associated with nearly $20,000 of higher hospital expenditures, reported Kaushik Kumar, MBBS, at the annual meeting of the American College of Chest Physicians (CHEST).

“Clinicians should be vigilant in identifying and managing pulmonary hypertension in ARDS patients,” Dr. Kumar, a resident in internal medicine at Medstar Health, Baltimore, said in an oral abstract presentation.

He added that PH has the potential to serve as an indicator of disease severity for patients with ARDS.
 

National database

PH is a frequent complication of ARDS, likely related to a combination of pulmonary vasoconstriction, thromboembolism, and interstitial edema, he said.

To test their hypothesis that the presence of PH in patients with ARDS is associated with worse outcomes, Dr. Kumar and colleagues drew on the National Inpatient Sample database for information on adults aged 18 years and older who had been diagnosed with ARDS with or without PH.

They identified a total of 156,687 patients of whom 26,324 (16.8%) also had been diagnosed with PH. Among the cohort with PH, there were higher proportions of older patients, women, and patients with multiple comorbidities.

The in-hospital mortality rate was 36.8% among patients with PH, compared with 24.6% among those without. The mean length of stay was also longer among patients with PH, at 12 days versus 10 days.

In an unadjusted analysis, mean total hospital charges for patients with ARDS and PH were $210,165, versus $160,683 for patients with ARDS who did not have PH.

In an analysis in which the investigators controlled for age, sex, index admission length of stay, insurance status, and comorbidities, in-hospital mortality for patients with PH remained significantly higher, with an odds ratio of 1.52 (P < .001). PH was also significantly associated with longer length of stay (odds ratio, 1.37; P < .001) and higher total hospital costs, with a mean difference of $19,406.

Dr. Kumar said that the findings underscore the importance of a tailored approach to managing patients with ARDS, especially in the presence of PH.

The investigators plan further studies to assess the role of PH-targeted therapies, to examine the role of sepsis and right ventricular failure and to explore the long-term impact of PH among ARDS survivors, including effects with respect to pulmonary function, quality of life, and long-term morbidity.
 

Potential to inform practice

A pulmonologist who was not involved in the study said in an interview that the findings of the trial suggest that PH may have a greater influence on mortality than is currently understood and that further investigations into this association could change practice in the future.

“I think it would be very important for us to understand if that is going to change our outlook on how ARDS is managed. It’s possible that some of the interventions that we give people who don’t have pulmonary hypertension, for example, increasing the airway pressure in order to minimize oxygenation, may have a detrimental effect on the pulmonary vasculature,” said Timothy Morris, MD, medical director of the pulmonary and exercise lab and professor of medicine at the University of California, San Diego.

“I think it’s a little bit premature to say that this should guide management now, but it’s certainly an interesting question that may end up changing practice in the future,” said Dr. Morris, who was moderator of the session in which Dr. Kumar presented the data.

The study was supported by the Agency for Healthcare Research and Quality and Medstar Health Research Institute. Dr. Kumar and Dr. Morris have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

HONOLULU – Patients with acute respiratory distress syndrome (ARDS) and coexisting pulmonary hypertension (PH) are significantly more likely to have longer and more costly hospital stays and to die in-hospital than patients with ARDS without PH, results of a retrospective study suggest.

Among more than 156,000 hospitalized patients with ARDS, 16.8% of whom also had a diagnosis of PH, the presence of PH was associated with about a 50% higher risk for in-hospital mortality and a 37% higher risk for longer hospital stays. In addition, the presence of PH was associated with nearly $20,000 of higher hospital expenditures, reported Kaushik Kumar, MBBS, at the annual meeting of the American College of Chest Physicians (CHEST).

“Clinicians should be vigilant in identifying and managing pulmonary hypertension in ARDS patients,” Dr. Kumar, a resident in internal medicine at Medstar Health, Baltimore, said in an oral abstract presentation.

He added that PH has the potential to serve as an indicator of disease severity for patients with ARDS.
 

National database

PH is a frequent complication of ARDS, likely related to a combination of pulmonary vasoconstriction, thromboembolism, and interstitial edema, he said.

To test their hypothesis that the presence of PH in patients with ARDS is associated with worse outcomes, Dr. Kumar and colleagues drew on the National Inpatient Sample database for information on adults aged 18 years and older who had been diagnosed with ARDS with or without PH.

They identified a total of 156,687 patients of whom 26,324 (16.8%) also had been diagnosed with PH. Among the cohort with PH, there were higher proportions of older patients, women, and patients with multiple comorbidities.

The in-hospital mortality rate was 36.8% among patients with PH, compared with 24.6% among those without. The mean length of stay was also longer among patients with PH, at 12 days versus 10 days.

In an unadjusted analysis, mean total hospital charges for patients with ARDS and PH were $210,165, versus $160,683 for patients with ARDS who did not have PH.

In an analysis in which the investigators controlled for age, sex, index admission length of stay, insurance status, and comorbidities, in-hospital mortality for patients with PH remained significantly higher, with an odds ratio of 1.52 (P < .001). PH was also significantly associated with longer length of stay (odds ratio, 1.37; P < .001) and higher total hospital costs, with a mean difference of $19,406.

Dr. Kumar said that the findings underscore the importance of a tailored approach to managing patients with ARDS, especially in the presence of PH.

The investigators plan further studies to assess the role of PH-targeted therapies, to examine the role of sepsis and right ventricular failure and to explore the long-term impact of PH among ARDS survivors, including effects with respect to pulmonary function, quality of life, and long-term morbidity.
 

Potential to inform practice

A pulmonologist who was not involved in the study said in an interview that the findings of the trial suggest that PH may have a greater influence on mortality than is currently understood and that further investigations into this association could change practice in the future.

“I think it would be very important for us to understand if that is going to change our outlook on how ARDS is managed. It’s possible that some of the interventions that we give people who don’t have pulmonary hypertension, for example, increasing the airway pressure in order to minimize oxygenation, may have a detrimental effect on the pulmonary vasculature,” said Timothy Morris, MD, medical director of the pulmonary and exercise lab and professor of medicine at the University of California, San Diego.

“I think it’s a little bit premature to say that this should guide management now, but it’s certainly an interesting question that may end up changing practice in the future,” said Dr. Morris, who was moderator of the session in which Dr. Kumar presented the data.

The study was supported by the Agency for Healthcare Research and Quality and Medstar Health Research Institute. Dr. Kumar and Dr. Morris have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In a real-world study of asthma patients, treatment with biologics following an exacerbation was associated with better health care utilization outcomes.

The data fill a gap, according to Sushan Gupta, MD, who presented the results at the annual meeting of the American College of Chest Physicians. “There’s some ample real-world data that shows that biologics reduce the incidence of asthma exacerbation, but the data regarding what happens after an exacerbation is still lacking, especially real-world data,” said Dr. Gupta, who is a resident at Carle Foundation Hospital in Champaign, Ill.

The findings were encouraging. “Patients with severe asthma on biologics fare well even after an exacerbation event, which includes a reduced incidence of hospitalization, ICU admission, and need for mechanical ventilation. We did not have any patient in the biologic group that required intubation, so that is pretty significant as compared to other patients who did not receive biologics,” said Dr. Gupta.

The results weren’t surprising, but underscore the benefits of biologics, according to Brittany Duchene, MD, who moderated the session where the results were presented. “I think it reinforced that they’re really good drugs,” said Dr. Duchene, who is a pulmonary critical care physician at Northeastern Vermont Regional Hospital, St. Johnsbury.

Although the study was retrospective, it suggests that the threshold for initiating biologics could potentially be lowered for patients with uncontrolled asthma despite adequate use of inhalers, according to Dr. Gupta. “Should that threshold be lower, and would that improve the overall morbidity and eventually the health care cost of utilization? Our study does not prove any of those data, but moving forward that data will also come out.”

Dr. Duchene noted that the accumulating scientific and clinical data for biologics is “really, really strong.” She also speculated that biologics could be used increasingly in the acute setting, which she admitted is a controversial topic. “I think there’s going to be a lot more push to early initiation, and you can see from the [new] study that it decreased a lot of hospitalizations.”

Dr. Gupta emphasized the need for prospective studies, and Dr. Duchene agreed that any such change would need to be patient centric, considering the diversity of available biologics. “It depends what their true issue is. The broader the biologic [mechanism of action], probably the more success you’ll have. I’ve found there’s not a pure allergic or a pure eosinophilic asthma patient. They’re usually more a combination.”

Some key questions remain about biologics treatment, especially in the long term. These include when a patient should be switched from one biologic to another, and whether biologic treatment should be continued over the patient’s lifetime and potential long-term side effects. “I think that data is still evolving and will come to us with time,” said Dr. Gupta.

The researchers analyzed retrospective data from 316 asthma patients treated with biologics and 9,645 treated with nonbiologic therapy between February 2018 and February 2023 at a tertiary care teaching hospital in the Midwest. There was a higher proportion of females in the biologics (69.7%) and nonbiologics groups (63.8%, P = .032), but there was no significant difference in the proportion of Whites in the biologics and nonbiologics groups (78.2% vs. 74.3%, P = .103).

The lack of a difference in racial groups was a surprise, according to Dr. Duchene, especially since other studies have noted disparities in biologic therapy among asthma patients.

Among the biologics group, 0.9% were hospitalized during the study period, compared with 6.5% of the nonbiologics group (P = .00006). They also had fewer ICU visits (0.3% vs. 1.8%; P = .04).

Dr. Gupta’s team attempted to subdivide the data by individual biologic, but there was no statistical significance in outcomes between biologics, perhaps because of the relatively small sample size.

Dr. Gupta noted that his group’s results are generally similar to other studies, including a U.S. study that found a decrease in exacerbation rates after staring or switching biologics and a slightly higher prevalence of biologics use among White patients (77% of biologic users versus 71% of nonbiologics users). A study in southwestern England found fewer ED visits and hospitalizations among patients on biologics.

Dr. Gupta and Dr. Duchene have no relevant financial disclosures.
 

In a real-world study of asthma patients, treatment with biologics following an exacerbation was associated with better health care utilization outcomes.

The data fill a gap, according to Sushan Gupta, MD, who presented the results at the annual meeting of the American College of Chest Physicians. “There’s some ample real-world data that shows that biologics reduce the incidence of asthma exacerbation, but the data regarding what happens after an exacerbation is still lacking, especially real-world data,” said Dr. Gupta, who is a resident at Carle Foundation Hospital in Champaign, Ill.

The findings were encouraging. “Patients with severe asthma on biologics fare well even after an exacerbation event, which includes a reduced incidence of hospitalization, ICU admission, and need for mechanical ventilation. We did not have any patient in the biologic group that required intubation, so that is pretty significant as compared to other patients who did not receive biologics,” said Dr. Gupta.

The results weren’t surprising, but underscore the benefits of biologics, according to Brittany Duchene, MD, who moderated the session where the results were presented. “I think it reinforced that they’re really good drugs,” said Dr. Duchene, who is a pulmonary critical care physician at Northeastern Vermont Regional Hospital, St. Johnsbury.

Although the study was retrospective, it suggests that the threshold for initiating biologics could potentially be lowered for patients with uncontrolled asthma despite adequate use of inhalers, according to Dr. Gupta. “Should that threshold be lower, and would that improve the overall morbidity and eventually the health care cost of utilization? Our study does not prove any of those data, but moving forward that data will also come out.”

Dr. Duchene noted that the accumulating scientific and clinical data for biologics is “really, really strong.” She also speculated that biologics could be used increasingly in the acute setting, which she admitted is a controversial topic. “I think there’s going to be a lot more push to early initiation, and you can see from the [new] study that it decreased a lot of hospitalizations.”

Dr. Gupta emphasized the need for prospective studies, and Dr. Duchene agreed that any such change would need to be patient centric, considering the diversity of available biologics. “It depends what their true issue is. The broader the biologic [mechanism of action], probably the more success you’ll have. I’ve found there’s not a pure allergic or a pure eosinophilic asthma patient. They’re usually more a combination.”

Some key questions remain about biologics treatment, especially in the long term. These include when a patient should be switched from one biologic to another, and whether biologic treatment should be continued over the patient’s lifetime and potential long-term side effects. “I think that data is still evolving and will come to us with time,” said Dr. Gupta.

The researchers analyzed retrospective data from 316 asthma patients treated with biologics and 9,645 treated with nonbiologic therapy between February 2018 and February 2023 at a tertiary care teaching hospital in the Midwest. There was a higher proportion of females in the biologics (69.7%) and nonbiologics groups (63.8%, P = .032), but there was no significant difference in the proportion of Whites in the biologics and nonbiologics groups (78.2% vs. 74.3%, P = .103).

The lack of a difference in racial groups was a surprise, according to Dr. Duchene, especially since other studies have noted disparities in biologic therapy among asthma patients.

Among the biologics group, 0.9% were hospitalized during the study period, compared with 6.5% of the nonbiologics group (P = .00006). They also had fewer ICU visits (0.3% vs. 1.8%; P = .04).

Dr. Gupta’s team attempted to subdivide the data by individual biologic, but there was no statistical significance in outcomes between biologics, perhaps because of the relatively small sample size.

Dr. Gupta noted that his group’s results are generally similar to other studies, including a U.S. study that found a decrease in exacerbation rates after staring or switching biologics and a slightly higher prevalence of biologics use among White patients (77% of biologic users versus 71% of nonbiologics users). A study in southwestern England found fewer ED visits and hospitalizations among patients on biologics.

Dr. Gupta and Dr. Duchene have no relevant financial disclosures.
 

In a real-world study of asthma patients, treatment with biologics following an exacerbation was associated with better health care utilization outcomes.

The data fill a gap, according to Sushan Gupta, MD, who presented the results at the annual meeting of the American College of Chest Physicians. “There’s some ample real-world data that shows that biologics reduce the incidence of asthma exacerbation, but the data regarding what happens after an exacerbation is still lacking, especially real-world data,” said Dr. Gupta, who is a resident at Carle Foundation Hospital in Champaign, Ill.

The findings were encouraging. “Patients with severe asthma on biologics fare well even after an exacerbation event, which includes a reduced incidence of hospitalization, ICU admission, and need for mechanical ventilation. We did not have any patient in the biologic group that required intubation, so that is pretty significant as compared to other patients who did not receive biologics,” said Dr. Gupta.

The results weren’t surprising, but underscore the benefits of biologics, according to Brittany Duchene, MD, who moderated the session where the results were presented. “I think it reinforced that they’re really good drugs,” said Dr. Duchene, who is a pulmonary critical care physician at Northeastern Vermont Regional Hospital, St. Johnsbury.

Although the study was retrospective, it suggests that the threshold for initiating biologics could potentially be lowered for patients with uncontrolled asthma despite adequate use of inhalers, according to Dr. Gupta. “Should that threshold be lower, and would that improve the overall morbidity and eventually the health care cost of utilization? Our study does not prove any of those data, but moving forward that data will also come out.”

Dr. Duchene noted that the accumulating scientific and clinical data for biologics is “really, really strong.” She also speculated that biologics could be used increasingly in the acute setting, which she admitted is a controversial topic. “I think there’s going to be a lot more push to early initiation, and you can see from the [new] study that it decreased a lot of hospitalizations.”

Dr. Gupta emphasized the need for prospective studies, and Dr. Duchene agreed that any such change would need to be patient centric, considering the diversity of available biologics. “It depends what their true issue is. The broader the biologic [mechanism of action], probably the more success you’ll have. I’ve found there’s not a pure allergic or a pure eosinophilic asthma patient. They’re usually more a combination.”

Some key questions remain about biologics treatment, especially in the long term. These include when a patient should be switched from one biologic to another, and whether biologic treatment should be continued over the patient’s lifetime and potential long-term side effects. “I think that data is still evolving and will come to us with time,” said Dr. Gupta.

The researchers analyzed retrospective data from 316 asthma patients treated with biologics and 9,645 treated with nonbiologic therapy between February 2018 and February 2023 at a tertiary care teaching hospital in the Midwest. There was a higher proportion of females in the biologics (69.7%) and nonbiologics groups (63.8%, P = .032), but there was no significant difference in the proportion of Whites in the biologics and nonbiologics groups (78.2% vs. 74.3%, P = .103).

The lack of a difference in racial groups was a surprise, according to Dr. Duchene, especially since other studies have noted disparities in biologic therapy among asthma patients.

Among the biologics group, 0.9% were hospitalized during the study period, compared with 6.5% of the nonbiologics group (P = .00006). They also had fewer ICU visits (0.3% vs. 1.8%; P = .04).

Dr. Gupta’s team attempted to subdivide the data by individual biologic, but there was no statistical significance in outcomes between biologics, perhaps because of the relatively small sample size.

Dr. Gupta noted that his group’s results are generally similar to other studies, including a U.S. study that found a decrease in exacerbation rates after staring or switching biologics and a slightly higher prevalence of biologics use among White patients (77% of biologic users versus 71% of nonbiologics users). A study in southwestern England found fewer ED visits and hospitalizations among patients on biologics.

Dr. Gupta and Dr. Duchene have no relevant financial disclosures.
 

HONOLULU – There’s new evidence to support a practice that many pulmonologists have been doing empirically anyway: namely, reducing the dose of the antifibrotic medication nintedanib (Ofev) for patients with idiopathic pulmonary fibrosis (IPF) who can’t tolerate the full 150-mg twice-daily dose.

An analysis of data from a large administrative claims database showed that there were no significant differences in either all-cause mortality or hospitalization rates between patients with IPF treated at the full 150-mg twice-daily dose and those treated with a reduced twice-daily dose of 100 mg nintedanib.

Although the results need to be confirmed by additional prospective and registry studies, they suggest that patients with IPF can still fare just as well with a reduced-dose nintedanib regimen, ideally with fewer gastrointestinal side effects such as diarrhea, reported Andrew Limper, MD, of the Mayo Clinic in Rochester, Minn.

“At least on this preliminary data you could ... rest assured,” Dr. Limper told his colleagues in an oral abstract session at the American College of Chest Physicians (CHEST) 2023 annual meeting.

“This is not definitive proof, I’m not making more out of this than it is, but we all put people on 100 mg twice daily because their guts don’t tolerate it; they live in the bathroom and they don’t want to live that way,” Dr. Limper said.
 

Hard to take

Nintedanib is approved in the United States for the treatment of IPF, chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated ILD. For IPF, the standard dose established in randomized clinical trials is 150 mg twice daily.

However, nintedanib is associated with a number of side effects, including hepatic and other gastrointestinal toxicities, arterial thromboembolic events, and proteinuria within the nephrotic range. As a result, clinicians often reduce the dose to 100 mg twice daily, but there is a lack of data to indicate whether it’s safe to do so or if efficacy will be compromised.

To see whether dose reductions might result in poorer outcomes for patients with IPF, Dr. Limper and colleagues analyzed data from the OptumLabs Data Warehouse, a large administrative claims database, to compare outcomes for patients treated with IPF at either the 150-mg or 100-mg twice-daily doses.

They used propensity-score matching to account for differences among individuals according to age, sex, race/ethnicity, residence, insurance type, additional medication use, oxygen use, smoking status, health care use, and comorbidities. The final cohort included 346 patients in each dosing group.

There was no difference between the dosing groups for the primary outcome of all-cause mortality at 18 months, with a nonsignificant hazard ratio of 0.65 (P = .313), and no significant difference over 24 months in risk of hospitalization, with a hazard ratio of 0.98 (P = .899).

“This is not randomized controlled data; I doubt that [nintedanib maker Boehringer Ingelheim] is ever going to do a 150 vs. 100 milligram head-to-head trial, but it does give us some ground to start to look at this,” Dr. Limper said.
 

Not so sure

Session comoderator Misbah Baqir, MBBS, also from the Mayo Clinic, told this news organization that she would need to see more data from prospective studies using endpoints other than mortality before she could be convinced that nintedanib dose reductions do not adversely affect efficacy. She was not involved in the study.

“I feel that the endpoint should be different, either it should be forced vital capacity change, quality of life, or something else. The problem with a database study is that you don’t have everything in it. You have to play with what you have, and you don’t have forced vital capacity. You have to go into the charts to get it,” she said.

It would be more helpful to objectively compare, for example, diarrhea episodes or other adverse events to see whether they were significantly reduced with the 100-mg dose, she added.

In an interview, Dr. Limper said that he and his colleagues plan to gather additional observational data including the newly available Medicare fee-for-service data set, registry data, and other sources.

“If we get all of that, and it really still looks compelling – and that’s an if – then I think that would be the foothold to go back to the manufacturer and say, ‘Hey, maybe you ought to think about doing a prospective trial to prove it with lung function and other endpoints such as 6-minute walks,’ ” he said.

The study was supported by a grant from Three Lakes Foundation. Dr. Limper and Dr. Baqir have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

HONOLULU – There’s new evidence to support a practice that many pulmonologists have been doing empirically anyway: namely, reducing the dose of the antifibrotic medication nintedanib (Ofev) for patients with idiopathic pulmonary fibrosis (IPF) who can’t tolerate the full 150-mg twice-daily dose.

An analysis of data from a large administrative claims database showed that there were no significant differences in either all-cause mortality or hospitalization rates between patients with IPF treated at the full 150-mg twice-daily dose and those treated with a reduced twice-daily dose of 100 mg nintedanib.

Although the results need to be confirmed by additional prospective and registry studies, they suggest that patients with IPF can still fare just as well with a reduced-dose nintedanib regimen, ideally with fewer gastrointestinal side effects such as diarrhea, reported Andrew Limper, MD, of the Mayo Clinic in Rochester, Minn.

“At least on this preliminary data you could ... rest assured,” Dr. Limper told his colleagues in an oral abstract session at the American College of Chest Physicians (CHEST) 2023 annual meeting.

“This is not definitive proof, I’m not making more out of this than it is, but we all put people on 100 mg twice daily because their guts don’t tolerate it; they live in the bathroom and they don’t want to live that way,” Dr. Limper said.
 

Hard to take

Nintedanib is approved in the United States for the treatment of IPF, chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated ILD. For IPF, the standard dose established in randomized clinical trials is 150 mg twice daily.

However, nintedanib is associated with a number of side effects, including hepatic and other gastrointestinal toxicities, arterial thromboembolic events, and proteinuria within the nephrotic range. As a result, clinicians often reduce the dose to 100 mg twice daily, but there is a lack of data to indicate whether it’s safe to do so or if efficacy will be compromised.

To see whether dose reductions might result in poorer outcomes for patients with IPF, Dr. Limper and colleagues analyzed data from the OptumLabs Data Warehouse, a large administrative claims database, to compare outcomes for patients treated with IPF at either the 150-mg or 100-mg twice-daily doses.

They used propensity-score matching to account for differences among individuals according to age, sex, race/ethnicity, residence, insurance type, additional medication use, oxygen use, smoking status, health care use, and comorbidities. The final cohort included 346 patients in each dosing group.

There was no difference between the dosing groups for the primary outcome of all-cause mortality at 18 months, with a nonsignificant hazard ratio of 0.65 (P = .313), and no significant difference over 24 months in risk of hospitalization, with a hazard ratio of 0.98 (P = .899).

“This is not randomized controlled data; I doubt that [nintedanib maker Boehringer Ingelheim] is ever going to do a 150 vs. 100 milligram head-to-head trial, but it does give us some ground to start to look at this,” Dr. Limper said.
 

Not so sure

Session comoderator Misbah Baqir, MBBS, also from the Mayo Clinic, told this news organization that she would need to see more data from prospective studies using endpoints other than mortality before she could be convinced that nintedanib dose reductions do not adversely affect efficacy. She was not involved in the study.

“I feel that the endpoint should be different, either it should be forced vital capacity change, quality of life, or something else. The problem with a database study is that you don’t have everything in it. You have to play with what you have, and you don’t have forced vital capacity. You have to go into the charts to get it,” she said.

It would be more helpful to objectively compare, for example, diarrhea episodes or other adverse events to see whether they were significantly reduced with the 100-mg dose, she added.

In an interview, Dr. Limper said that he and his colleagues plan to gather additional observational data including the newly available Medicare fee-for-service data set, registry data, and other sources.

“If we get all of that, and it really still looks compelling – and that’s an if – then I think that would be the foothold to go back to the manufacturer and say, ‘Hey, maybe you ought to think about doing a prospective trial to prove it with lung function and other endpoints such as 6-minute walks,’ ” he said.

The study was supported by a grant from Three Lakes Foundation. Dr. Limper and Dr. Baqir have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

HONOLULU – There’s new evidence to support a practice that many pulmonologists have been doing empirically anyway: namely, reducing the dose of the antifibrotic medication nintedanib (Ofev) for patients with idiopathic pulmonary fibrosis (IPF) who can’t tolerate the full 150-mg twice-daily dose.

An analysis of data from a large administrative claims database showed that there were no significant differences in either all-cause mortality or hospitalization rates between patients with IPF treated at the full 150-mg twice-daily dose and those treated with a reduced twice-daily dose of 100 mg nintedanib.

Although the results need to be confirmed by additional prospective and registry studies, they suggest that patients with IPF can still fare just as well with a reduced-dose nintedanib regimen, ideally with fewer gastrointestinal side effects such as diarrhea, reported Andrew Limper, MD, of the Mayo Clinic in Rochester, Minn.

“At least on this preliminary data you could ... rest assured,” Dr. Limper told his colleagues in an oral abstract session at the American College of Chest Physicians (CHEST) 2023 annual meeting.

“This is not definitive proof, I’m not making more out of this than it is, but we all put people on 100 mg twice daily because their guts don’t tolerate it; they live in the bathroom and they don’t want to live that way,” Dr. Limper said.
 

Hard to take

Nintedanib is approved in the United States for the treatment of IPF, chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated ILD. For IPF, the standard dose established in randomized clinical trials is 150 mg twice daily.

However, nintedanib is associated with a number of side effects, including hepatic and other gastrointestinal toxicities, arterial thromboembolic events, and proteinuria within the nephrotic range. As a result, clinicians often reduce the dose to 100 mg twice daily, but there is a lack of data to indicate whether it’s safe to do so or if efficacy will be compromised.

To see whether dose reductions might result in poorer outcomes for patients with IPF, Dr. Limper and colleagues analyzed data from the OptumLabs Data Warehouse, a large administrative claims database, to compare outcomes for patients treated with IPF at either the 150-mg or 100-mg twice-daily doses.

They used propensity-score matching to account for differences among individuals according to age, sex, race/ethnicity, residence, insurance type, additional medication use, oxygen use, smoking status, health care use, and comorbidities. The final cohort included 346 patients in each dosing group.

There was no difference between the dosing groups for the primary outcome of all-cause mortality at 18 months, with a nonsignificant hazard ratio of 0.65 (P = .313), and no significant difference over 24 months in risk of hospitalization, with a hazard ratio of 0.98 (P = .899).

“This is not randomized controlled data; I doubt that [nintedanib maker Boehringer Ingelheim] is ever going to do a 150 vs. 100 milligram head-to-head trial, but it does give us some ground to start to look at this,” Dr. Limper said.
 

Not so sure

Session comoderator Misbah Baqir, MBBS, also from the Mayo Clinic, told this news organization that she would need to see more data from prospective studies using endpoints other than mortality before she could be convinced that nintedanib dose reductions do not adversely affect efficacy. She was not involved in the study.

“I feel that the endpoint should be different, either it should be forced vital capacity change, quality of life, or something else. The problem with a database study is that you don’t have everything in it. You have to play with what you have, and you don’t have forced vital capacity. You have to go into the charts to get it,” she said.

It would be more helpful to objectively compare, for example, diarrhea episodes or other adverse events to see whether they were significantly reduced with the 100-mg dose, she added.

In an interview, Dr. Limper said that he and his colleagues plan to gather additional observational data including the newly available Medicare fee-for-service data set, registry data, and other sources.

“If we get all of that, and it really still looks compelling – and that’s an if – then I think that would be the foothold to go back to the manufacturer and say, ‘Hey, maybe you ought to think about doing a prospective trial to prove it with lung function and other endpoints such as 6-minute walks,’ ” he said.

The study was supported by a grant from Three Lakes Foundation. Dr. Limper and Dr. Baqir have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

HONOLULU – What we eat and what’s in the gut may influence lung health for better or worse, suggest new data from an ongoing study of lung function in New York City firefighters who were at the World Trade Center site on Sept. 11, 2001, and the days immediately following the 9/11 attacks.

Among NYC firefighters enrolled in the randomized FIREHOUSE (Food Intake Restriction for Health Outcome Support and Education) study who took part in a microbiome substudy, those who followed a low-calorie, Mediterranean-style diet had higher levels in stools samples at 6 months of Bacteroides ovatus, a bacterial species associated with protection against bowel inflammation.

In contrast, participants who followed a usual-care diet had elevated 6-month levels of a species associated with high-fat diets and inflammation, reported Rachel Lam, a predoctoral fellow in the Nolan Lab at NYU Langone Medical Center, at the annual meeting of the American College of Chest Physicians (CHEST).

“Overall, we found that in our validation cohort, Bacteroides ovatus was increased in the LoCalMed arm after 6 months, and this bacterial species is associated with fewer negative health effects,” she said.

Ms. Lam noted that in a murine model of high-fat diets, mice gavaged with Bacteroides ovatus had reductions in body mass index and decreased serum LDL cholesterol and triglyceride levels.
 

FIREHOUSE cohort

Senior author Anna Nolan, MD, whose lab members study predictors of lung function loss in a cohort of firefighters who were exposed to the particulate matter clouding the air of lower Manhattan on 9/11 and the ensuing days, told this news organization that the findings, while preliminary, support previous research findings on potential links between intestinal microbiota and lung function.

“It’s interesting that we saw this done in other models, like mouse models and such, where certain bacteria were viewed as healthy for the system, and if they were able to bring that bacteria out in larger amounts they saw anti-inflammatory effects, so we’re hoping to mirror that and also do a mouse model,” she said.

Dr. Nolan’s group has previously shown that markers for the metabolic syndrome, inflammation, and vascular injury detected in serum samples taken within 6 months of 9/11 were predictive for later abnormal lung function. In addition, their group has found that elevated serum levels of an LDL metabolite after intense World Trade Center dust exposure is a risk factor for future impaired lung function as measured by forced expiratory volume in 1 second (FEV₁).

In the FIREHOUSE trial, 89 patients were randomly assigned either to a technology-supported educational and behavioral intervention targeting calorie restriction for weight loss while following a low-calorie Mediterranean diet, or to usual care. The usual-care arm included participants who were informed about their weight, BMI, and other standard measures at annual visits and were given general advice about healthy eating, but were not assigned to a specific diet.

Participants in the LoCalMed group had significant decreases in BMI and increases in FEV₁, compared with those in the usual-care group. In addition, the LoCalMed group had improved vascular health, better dietary habits, decreases in fats and calories from sweets, and decreases in inflammation as measured by a lower white blood cell count.
 

Microbiome substudy

At CHEST 2023, Ms. Lam reported on microbiome pilot and validation substudies of FIREHOUSE.

The pilot study included five patients in each arm. The validation sample included 15 participants in the Mediterranean diet group and 16 in the usual-care diet group.

Each participant’s microbiome was assessed with genomic sequencing with sequences aligned to a bacterial database.  The number and diversity of bacterial species in each sample were determined with the Chao1 Index and Shannon Index, respectively.

There were no significant differences among the study groups in mean age, exposure at the World Trade Center site, or years of service.

Although bacterial diversity did not differ between the study arms either at baseline or at 6 months, in both groups it significantly decreased over time (P = .02 in the pilot, P < .0001 in the validation arm).

In the pilot study, there was an increase over 6 months in the usual care arm only of Bilophila wadsworthia, a species associated with high-fat diets and inflammation.

In the validation study, patients in the LoCalMed arm had significant reductions in Ruminococcaceae (P = .015) and increases in both Bacteroides ovatus (P = .03) and Alistipes shahii (P = .038), a recently identified species with uncertain protective or pathogenic potential.

In contrast, there were no significant increases in species in the usual-care group, but there were significant declines in several other bacterial species; Ms.Lam, however, did not say whether these changes had clinical significance. “Future studies will assess microbial association with clinical outcomes,” Ms. Lam said.
 

Confounding factors

Samuel Evans, MD, a pulmonologist at Straub Medical Center in Honolulu who moderated the oral abstract session where the data were presented, commented that the data are interesting but added that associations are difficult to determine given the heterogeneity of exposures that firefighters encounter.

“I think it’s interesting that clearly diet is influencing the type of bacteria in the biome in the gut, and perhaps some are favorable, and some are not favorable,” he told this news organization “We already know that the Mediterranean diet is associated with better health outcomes, so it makes sense, but can we tease out in the microbiome which bacteria are harmful and which are helpful.”

He noted that there are a lot of confounding factors and that “it’s hard to find the right signal when you have so many variables.”

The FIREHOUSE study is supported by the Centers for Disease Control and Prevention’s National Institute of Occupational Safety & Health and the National Heart, Lung, and Blood Institute. Ms. Lam, Dr. Nolan, and Dr. Evans report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

HONOLULU – What we eat and what’s in the gut may influence lung health for better or worse, suggest new data from an ongoing study of lung function in New York City firefighters who were at the World Trade Center site on Sept. 11, 2001, and the days immediately following the 9/11 attacks.

Among NYC firefighters enrolled in the randomized FIREHOUSE (Food Intake Restriction for Health Outcome Support and Education) study who took part in a microbiome substudy, those who followed a low-calorie, Mediterranean-style diet had higher levels in stools samples at 6 months of Bacteroides ovatus, a bacterial species associated with protection against bowel inflammation.

In contrast, participants who followed a usual-care diet had elevated 6-month levels of a species associated with high-fat diets and inflammation, reported Rachel Lam, a predoctoral fellow in the Nolan Lab at NYU Langone Medical Center, at the annual meeting of the American College of Chest Physicians (CHEST).

“Overall, we found that in our validation cohort, Bacteroides ovatus was increased in the LoCalMed arm after 6 months, and this bacterial species is associated with fewer negative health effects,” she said.

Ms. Lam noted that in a murine model of high-fat diets, mice gavaged with Bacteroides ovatus had reductions in body mass index and decreased serum LDL cholesterol and triglyceride levels.
 

FIREHOUSE cohort

Senior author Anna Nolan, MD, whose lab members study predictors of lung function loss in a cohort of firefighters who were exposed to the particulate matter clouding the air of lower Manhattan on 9/11 and the ensuing days, told this news organization that the findings, while preliminary, support previous research findings on potential links between intestinal microbiota and lung function.

“It’s interesting that we saw this done in other models, like mouse models and such, where certain bacteria were viewed as healthy for the system, and if they were able to bring that bacteria out in larger amounts they saw anti-inflammatory effects, so we’re hoping to mirror that and also do a mouse model,” she said.

Dr. Nolan’s group has previously shown that markers for the metabolic syndrome, inflammation, and vascular injury detected in serum samples taken within 6 months of 9/11 were predictive for later abnormal lung function. In addition, their group has found that elevated serum levels of an LDL metabolite after intense World Trade Center dust exposure is a risk factor for future impaired lung function as measured by forced expiratory volume in 1 second (FEV₁).

In the FIREHOUSE trial, 89 patients were randomly assigned either to a technology-supported educational and behavioral intervention targeting calorie restriction for weight loss while following a low-calorie Mediterranean diet, or to usual care. The usual-care arm included participants who were informed about their weight, BMI, and other standard measures at annual visits and were given general advice about healthy eating, but were not assigned to a specific diet.

Participants in the LoCalMed group had significant decreases in BMI and increases in FEV₁, compared with those in the usual-care group. In addition, the LoCalMed group had improved vascular health, better dietary habits, decreases in fats and calories from sweets, and decreases in inflammation as measured by a lower white blood cell count.
 

Microbiome substudy

At CHEST 2023, Ms. Lam reported on microbiome pilot and validation substudies of FIREHOUSE.

The pilot study included five patients in each arm. The validation sample included 15 participants in the Mediterranean diet group and 16 in the usual-care diet group.

Each participant’s microbiome was assessed with genomic sequencing with sequences aligned to a bacterial database.  The number and diversity of bacterial species in each sample were determined with the Chao1 Index and Shannon Index, respectively.

There were no significant differences among the study groups in mean age, exposure at the World Trade Center site, or years of service.

Although bacterial diversity did not differ between the study arms either at baseline or at 6 months, in both groups it significantly decreased over time (P = .02 in the pilot, P < .0001 in the validation arm).

In the pilot study, there was an increase over 6 months in the usual care arm only of Bilophila wadsworthia, a species associated with high-fat diets and inflammation.

In the validation study, patients in the LoCalMed arm had significant reductions in Ruminococcaceae (P = .015) and increases in both Bacteroides ovatus (P = .03) and Alistipes shahii (P = .038), a recently identified species with uncertain protective or pathogenic potential.

In contrast, there were no significant increases in species in the usual-care group, but there were significant declines in several other bacterial species; Ms.Lam, however, did not say whether these changes had clinical significance. “Future studies will assess microbial association with clinical outcomes,” Ms. Lam said.
 

Confounding factors

Samuel Evans, MD, a pulmonologist at Straub Medical Center in Honolulu who moderated the oral abstract session where the data were presented, commented that the data are interesting but added that associations are difficult to determine given the heterogeneity of exposures that firefighters encounter.

“I think it’s interesting that clearly diet is influencing the type of bacteria in the biome in the gut, and perhaps some are favorable, and some are not favorable,” he told this news organization “We already know that the Mediterranean diet is associated with better health outcomes, so it makes sense, but can we tease out in the microbiome which bacteria are harmful and which are helpful.”

He noted that there are a lot of confounding factors and that “it’s hard to find the right signal when you have so many variables.”

The FIREHOUSE study is supported by the Centers for Disease Control and Prevention’s National Institute of Occupational Safety & Health and the National Heart, Lung, and Blood Institute. Ms. Lam, Dr. Nolan, and Dr. Evans report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

HONOLULU – What we eat and what’s in the gut may influence lung health for better or worse, suggest new data from an ongoing study of lung function in New York City firefighters who were at the World Trade Center site on Sept. 11, 2001, and the days immediately following the 9/11 attacks.

Among NYC firefighters enrolled in the randomized FIREHOUSE (Food Intake Restriction for Health Outcome Support and Education) study who took part in a microbiome substudy, those who followed a low-calorie, Mediterranean-style diet had higher levels in stools samples at 6 months of Bacteroides ovatus, a bacterial species associated with protection against bowel inflammation.

In contrast, participants who followed a usual-care diet had elevated 6-month levels of a species associated with high-fat diets and inflammation, reported Rachel Lam, a predoctoral fellow in the Nolan Lab at NYU Langone Medical Center, at the annual meeting of the American College of Chest Physicians (CHEST).

“Overall, we found that in our validation cohort, Bacteroides ovatus was increased in the LoCalMed arm after 6 months, and this bacterial species is associated with fewer negative health effects,” she said.

Ms. Lam noted that in a murine model of high-fat diets, mice gavaged with Bacteroides ovatus had reductions in body mass index and decreased serum LDL cholesterol and triglyceride levels.
 

FIREHOUSE cohort

Senior author Anna Nolan, MD, whose lab members study predictors of lung function loss in a cohort of firefighters who were exposed to the particulate matter clouding the air of lower Manhattan on 9/11 and the ensuing days, told this news organization that the findings, while preliminary, support previous research findings on potential links between intestinal microbiota and lung function.

“It’s interesting that we saw this done in other models, like mouse models and such, where certain bacteria were viewed as healthy for the system, and if they were able to bring that bacteria out in larger amounts they saw anti-inflammatory effects, so we’re hoping to mirror that and also do a mouse model,” she said.

Dr. Nolan’s group has previously shown that markers for the metabolic syndrome, inflammation, and vascular injury detected in serum samples taken within 6 months of 9/11 were predictive for later abnormal lung function. In addition, their group has found that elevated serum levels of an LDL metabolite after intense World Trade Center dust exposure is a risk factor for future impaired lung function as measured by forced expiratory volume in 1 second (FEV₁).

In the FIREHOUSE trial, 89 patients were randomly assigned either to a technology-supported educational and behavioral intervention targeting calorie restriction for weight loss while following a low-calorie Mediterranean diet, or to usual care. The usual-care arm included participants who were informed about their weight, BMI, and other standard measures at annual visits and were given general advice about healthy eating, but were not assigned to a specific diet.

Participants in the LoCalMed group had significant decreases in BMI and increases in FEV₁, compared with those in the usual-care group. In addition, the LoCalMed group had improved vascular health, better dietary habits, decreases in fats and calories from sweets, and decreases in inflammation as measured by a lower white blood cell count.
 

Microbiome substudy

At CHEST 2023, Ms. Lam reported on microbiome pilot and validation substudies of FIREHOUSE.

The pilot study included five patients in each arm. The validation sample included 15 participants in the Mediterranean diet group and 16 in the usual-care diet group.

Each participant’s microbiome was assessed with genomic sequencing with sequences aligned to a bacterial database.  The number and diversity of bacterial species in each sample were determined with the Chao1 Index and Shannon Index, respectively.

There were no significant differences among the study groups in mean age, exposure at the World Trade Center site, or years of service.

Although bacterial diversity did not differ between the study arms either at baseline or at 6 months, in both groups it significantly decreased over time (P = .02 in the pilot, P < .0001 in the validation arm).

In the pilot study, there was an increase over 6 months in the usual care arm only of Bilophila wadsworthia, a species associated with high-fat diets and inflammation.

In the validation study, patients in the LoCalMed arm had significant reductions in Ruminococcaceae (P = .015) and increases in both Bacteroides ovatus (P = .03) and Alistipes shahii (P = .038), a recently identified species with uncertain protective or pathogenic potential.

In contrast, there were no significant increases in species in the usual-care group, but there were significant declines in several other bacterial species; Ms.Lam, however, did not say whether these changes had clinical significance. “Future studies will assess microbial association with clinical outcomes,” Ms. Lam said.
 

Confounding factors

Samuel Evans, MD, a pulmonologist at Straub Medical Center in Honolulu who moderated the oral abstract session where the data were presented, commented that the data are interesting but added that associations are difficult to determine given the heterogeneity of exposures that firefighters encounter.

“I think it’s interesting that clearly diet is influencing the type of bacteria in the biome in the gut, and perhaps some are favorable, and some are not favorable,” he told this news organization “We already know that the Mediterranean diet is associated with better health outcomes, so it makes sense, but can we tease out in the microbiome which bacteria are harmful and which are helpful.”

He noted that there are a lot of confounding factors and that “it’s hard to find the right signal when you have so many variables.”

The FIREHOUSE study is supported by the Centers for Disease Control and Prevention’s National Institute of Occupational Safety & Health and the National Heart, Lung, and Blood Institute. Ms. Lam, Dr. Nolan, and Dr. Evans report no relevant financial relationships.

A version of this article first appeared on Medscape.com.