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May 2024 – ICYMI

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Gastroenterology

January 2024

Hirano I, et al; ASCENT WORKING GROUP. Ascending to New Heights for Novel Therapeutics for Eosinophilic Esophagitis. Gastroenterology. 2024 Jan;166(1):1-10. doi: 10.1053/j.gastro.2023.09.004. Epub 2023 Sep 9. PMID: 37690772; PMCID: PMC10872872.

Åkerström JH, et al. Antireflux Surgery Versus Antireflux Medication and Risk of Esophageal Adenocarcinoma in Patients With Barrett’s Esophagus. Gastroenterology. 2024 Jan;166(1):132-138.e3. doi: 10.1053/j.gastro.2023.08.050. Epub 2023 Sep 9. PMID: 37690771.

Barnes EL, et al; AGA Clinical Guidelines Committee. AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders. Gastroenterology. 2024 Jan;166(1):59-85. doi: 10.1053/j.gastro.2023.10.015. PMID: 38128971.

February 2024

Yoo HW, et al. Helicobacter pylori Treatment and Gastric Cancer Risk After Endoscopic Resection of Dysplasia: A Nationwide Cohort Study. Gastroenterology. 2024 Feb;166(2):313-322.e3. doi: 10.1053/j.gastro.2023.10.013. Epub 2023 Oct 18. PMID: 37863270.

Yang J, et al. High Soluble Fiber Promotes Colorectal Tumorigenesis Through Modulating Gut Microbiota and Metabolites in Mice. Gastroenterology. 2024 Feb;166(2):323-337.e7. doi: 10.1053/j.gastro.2023.10.012. Epub 2023 Oct 18. PMID: 37858797.

Young E, et al. Texture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Feb;166(2):338-340.e3. doi: 10.1053/j.gastro.2023.10.008. Epub 2023 Oct 14. PMID: 37839498.

Clinical Gastroenterology and Hepatology

January 2024

Overbeek KA, et al; Dutch Familial Pancreatic Cancer Surveillance Study work group. Intraductal Papillary Mucinous Neoplasms in High-Risk Individuals: Incidence, Growth Rate, and Malignancy Risk. Clin Gastroenterol Hepatol. 2024 Jan;22(1):62-71.e7. doi: 10.1016/j.cgh.2023.03.035. Epub 2023 Apr 7. PMID: 37031711.

Reddy CA, et al. Achalasia is Strongly Associated With Eosinophilic Esophagitis and Other Allergic Disorders. Clin Gastroenterol Hepatol. 2024 Jan;22(1):34-41.e2. doi: 10.1016/j.cgh.2023.06.013. Epub 2023 Jun 28. PMID: 37391057; PMCID: PMC10753026.

Thiruvengadam NR, et al. The Clinical Impact and Cost-Effectiveness of Surveillance of Incidentally Detected Gastric Intestinal Metaplasia: A Microsimulation Analysis. Clin Gastroenterol Hepatol. 2024 Jan;22(1):51-61. doi: 10.1016/j.cgh.2023.05.028. Epub 2023 Jun 9. Erratum in: Clin Gastroenterol Hepatol. 2024 Jan 19;: PMID: 37302442.

February 2024

Goodoory VC, et al. Systematic Review and Meta-analysis: Efficacy of Mesalamine in Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):243-251.e5. doi: 10.1016/j.cgh.2023.02.014. Epub 2023 Feb 27. PMID: 36858143.

Brenner DM, et al. Development and Current State of Digital Therapeutics for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):222-234. doi: 10.1016/j.cgh.2023.09.013. Epub 2023 Sep 22. PMID: 37743035.

Techniques and Innovations in Gastrointestinal Endoscopy

January 2024

Ramirez PR, et al. Gaps and Improvement Opportunities in Post-Colonoscopy Communication. Tech Innov Gastrointest Endosc. 2024 Jan;26(1):90-92. doi: 10.1016/j.tige.2023.10.001. Epub 2023 Oct 22.

Gonzaga ER, et al. Gastric Peroral Endoscopic Myotomy (G-POEM) for the Management of Gastroparesis. Tech Innov Gastrointest Endosc. 2024 Jan; 26(1): 46-55. doi: 10.1016/j.tige.2023.09.002. Epub 2023 Oct 13.

Wang D, et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2024 Jan;26(1): 30-37. doi: 10.1016/j.tige.2023.10.003. Epub 2023 Nov 8.

Gastro Hep Advances

January 2024

Adeniran E, et al. Intense and Sustained Alcohol Consumption Associated With Acute Pancreatitis Warrants Early Intervention. Gastro Hep Advances. 2024 Jan;3(1):61-63. doi: 10.1016/j.gastha.2023.08.017. Epub 2023 Sep 2.

Alkhouri N, et al. A Novel Prescription Digital Therapeutic Option for the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease. Gastro Hep Advances. 2024 Jan;3(1): 9-16. doi: 10.1016/j.gastha.2023.08.019. Epub 2023 Oct 1.

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GLP-1s May Increase Post-Endoscopy Aspiration Pneumonia Risk

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Carolyn Crist

The use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may lead to an increased risk for aspiration pneumonia after endoscopic procedures, according to a new large population-based study.

In June 2023, the American Society of Anesthesiologists (ASA) recommended holding GLP-1 RAs before an endoscopic or surgical procedure to reduce the risk for complications associated with anesthesia and delayed stomach emptying.

In response, the American Gastroenterological Association (AGA) published a rapid clinical practice update in November 2023 that found insufficient evidence to support patients stopping the medications before endoscopic procedures.

“It is known that GLP-1 RAs significantly reduce the motility of the stomach and small bowel. As more and more patients are being started on GLP-1 RAs at higher doses and longer half-life, the question became whether the current recommended fasting durations are enough to reasonably assume the stomach is empty prior to procedures that require sedation,” said senior author Ali Rezaie, MD, medical director of the GI Motility Program at Cedars-Sinai Medical Center in Los Angeles.

“We wanted to see if these medications in fact increased the chance of aspiration before the ASA suggestion went into effect,” he said. “However, this is not an easy task, as aspiration is a rare event and a large sample size is needed to confidently answer that question. That is why we evaluated nearly 1 million cases.”

The study was published online in Gastroenterology.

Analyzing GLP-1 RA Use

Dr. Rezaie and colleagues conducted a population-based, retrospective cohort study of the TriNetX dataset, which includes 114 million deidentified individual health records from 80 healthcare organizations. The research team analyzed nearly 1 million records for adult patients between ages 21 and 70 who underwent upper and lower endoscopies between January 2018 and December 2020.

The researchers defined GLP-1 RA users as those who had the medication for more than 6 months and two or more refills within 6 months before the procedure. They adjusted for 59 factors that could affect gut motility or aspiration risks, such as obesity, numerous chronic diseases, and dozens of medications. The primary outcome was aspiration pneumonia within a month after the procedure.

Among 963,184 patients who underwent endoscopy, 46,935 (4.9%) were considered GLP-1 RA users. Among those, 20,099 GLP-1 RA users met the inclusion criteria and had their results compared with non-GLP-1 RA users.

After propensity score matching for the 59 potential confounders, GLP-1 RA use had a higher incidence rate of aspiration pneumonia (0.83% vs 0.63%) and was associated with a significantly higher risk for aspiration pneumonia, with a hazard ratio (HR) of 1.33.

An even higher risk was seen among patients with propofol-assisted endoscopies (HR, 1.49) but not among those without propofol (HR, 1.31).

In a subgroup analysis based on endoscopy type, an elevated risk was observed among patients who underwent upper endoscopy (HR, 1.82) and combined upper and lower endoscopy (HR, 2.26) but not lower endoscopy (HR, 0.56).

“The results were not necessarily surprising given the mechanism of action of GLP-1 RAs. However, for the first time, this was shown with a clinically relevant outcome, such as aspiration pneumonia,” Dr. Rezaie said. “Aspiration during sedation can have devastating consequences, and the 0.2% difference in risk of aspiration can have a significant effect on healthcare as well.”

More than 20 million endoscopies are performed across the United States annually. Based on the assumption that about 3% of those patients are taking GLP-1 RAs, about 1200 aspiration cases per year can be prevented by raising awareness, he said.

Considering Next Steps

The varying risk profiles observed with separate sedation and endoscopy types point to a need for more tailored guidance in managing GLP-1 RA use before a procedure, the study authors wrote.

Although holding the medications before endoscopy may disrupt diabetes management, the potential increased risk for aspiration could justify a change in practice, particularly for upper endoscopy and propofol-associated procedures, they added.

At the same time, additional studies are needed to understand the optimal drug withholding windows before endoscopies and other procedures, they concluded.

“We will need more data on what is the optimal duration of holding GLP-1 RAs,” Dr. Rezaie said. “But given our data and current ASA guidance, stopping these medications prior to elective procedures is the safe thing to do.”

For now, AGA guidance remains the same as offered in the November 2023 update, suggesting an individual approach for each patient on a GLP-1 RA rather than a “blanket statement” on how to manage all patients taking these medications.

“Overall, I believe that this study is important, but we require more high-level data to inform clinical decision-making regarding patients using GLP-1 receptor agonists prior to gastrointestinal endoscopy,” said Andrew Y. Wang, MD, AGAF, chief of gastroenterology and hepatology and director of interventional endoscopy at the University of Virginia in Charlottesville.

Dr. Wang, who wasn’t involved with this study, coauthored the AGA rapid clinical practice update. He and colleagues advised continuing with a procedure as planned for patients on GLP-1 RAs who followed standard preprocedure fasting instructions and didn’t have nausea, vomiting, dyspepsia, or abdominal distention.

Among patients with symptoms that suggest retained gastric contents, rapid sequence intubation may be considered, though it may not be possible in ambulatory or office-based endoscopy settings, Dr. Wang and colleagues wrote. As another option in lieu of stopping GLP-1 RAs, patients can be placed on a liquid diet for 1 day before the procedure.

“While this study found a signal suggesting that patients using GLP-1 RAs had an increased risk of aspiration pneumonia within 1 month following upper endoscopy or combined upper and lower endoscopy, it does not inform us if having patients stop GLP-1 RAs before endoscopic procedures — especially for a single dose — will mitigate this potential risk,” Dr. Wang said.

“It was also interesting that these investigators found that patients taking GLP-1 RAs who underwent lower endoscopy alone were not at increased risk for aspiration pneumonia,” Dr. Wang noted.

The authors didn’t report a funding source and disclosed no potential conflicts. Dr. Wang reported no relevant disclosures.

A version of this article appeared on Medscape.com.

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The use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may lead to an increased risk for aspiration pneumonia after endoscopic procedures, according to a new large population-based study.

Analyzing GLP-1 RA Use

Considering Next Steps

The varying risk profiles observed with separate sedation and endoscopy types point to a need for more tailored guidance in managing GLP-1 RA use before a procedure, the study authors wrote.

A version of this article appeared on Medscape.com.

The use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may lead to an increased risk for aspiration pneumonia after endoscopic procedures, according to a new large population-based study.

Analyzing GLP-1 RA Use

Considering Next Steps

The varying risk profiles observed with separate sedation and endoscopy types point to a need for more tailored guidance in managing GLP-1 RA use before a procedure, the study authors wrote.

A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>The use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may lead to an increased risk for aspiration pneumonia after endoscopic procedures</metaDescription> <articlePDF/> <teaserImage>301173</teaserImage> <teaser>Additional studies are needed to understand the optimal drug withholding windows before endoscopies and other procedures.</teaser> <title>GLP-1s May Increase Post-Endoscopy Aspiration Pneumonia Risk</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>gih</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>chph</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">17</term> <term>21</term> <term>15</term> <term>6</term> </publications> <sections> <term canonical="true">69</term> <term>39313</term> <term>27970</term> </sections> <topics> <term canonical="true">39702</term> <term>347</term> <term>213</term> <term>284</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012882.jpg</altRep> <description role="drol:caption">Dr. Ali Rezaie</description> <description role="drol:credit">Cedars-Sinai Medical Center</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24010452.jpg</altRep> <description role="drol:caption">Dr. Andrew Y. Wang</description> <description role="drol:credit"/> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>GLP-1s May Increase Post-Endoscopy Aspiration Pneumonia Risk</title> <deck/> </itemMeta> <itemContent> The use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may lead to an increased risk for aspiration pneumonia after endoscopic procedures, according to a new large population-based study. In June 2023, the American Society of Anesthesiologists (ASA) <a href="https://www.asahq.org/about-asa/newsroom/news-releases/2023/06/american-society-of-anesthesiologists-consensus-based-guidance-on-preoperative">recommended</a> holding GLP-1 RAs before an endoscopic or surgical procedure to reduce the risk for complications associated with anesthesia and delayed stomach emptying. In response, the American Gastroenterological Association (AGA) <a href="https://doi.org/10.1016/j.cgh.2023.11.002">published</a> a rapid clinical practice update in November 2023 that found insufficient evidence to support patients stopping the medications before endoscopic procedures. “It is known that GLP-1 RAs significantly reduce the motility of the stomach and small bowel. As more and more patients are being started on GLP-1 RAs at higher doses and longer half-life, the question became whether the current recommended fasting durations are enough to reasonably assume the stomach is empty prior to procedures that require sedation,” said senior author Ali Rezaie, MD, medical director of the GI Motility Program at Cedars-Sinai Medical Center in Los Angeles. “We wanted to see if these medications in fact increased the chance of aspiration before the ASA suggestion went into effect,” he said. “However, this is not an easy task, as aspiration is a rare event and a large sample size is needed to confidently answer that question. That is why we evaluated nearly 1 million cases.” The study was <a href="https://www.gastrojournal.org/article/S0016-5085(24)00298-1/abstract">published online</a> in Gastroenterology. <h2>Analyzing GLP-1 RA Use</h2> Dr. Rezaie and colleagues conducted a population-based, retrospective cohort study of the TriNetX dataset, which includes 114 million deidentified individual health records from 80 healthcare organizations. The research team analyzed nearly 1 million records for adult patients between ages 21 and 70 who underwent upper and lower endoscopies between January 2018 and December 2020.[[{"fid":"301173","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. Ali Rezaie, medical director of the GI Motility Program at Cedars-Sinai Medical Center in Los Angeles","field_file_image_credit[und][0][value]":"Cedars-Sinai Medical Center","field_file_image_caption[und][0][value]":"Dr. Ali Rezaie"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]] The researchers defined GLP-1 RA users as those who had the medication for more than 6 months and two or more refills within 6 months before the procedure. They adjusted for 59 factors that could affect gut motility or aspiration risks, such as obesity, numerous chronic diseases, and dozens of medications. The primary outcome was aspiration pneumonia within a month after the procedure. Among 963,184 patients who underwent endoscopy, 46,935 (4.9%) were considered GLP-1 RA users. Among those, 20,099 GLP-1 RA users met the inclusion criteria and had their results compared with non-GLP-1 RA users. After propensity score matching for the 59 potential confounders, GLP-1 RA use had a higher incidence rate of aspiration pneumonia (0.83% vs 0.63%) and was associated with a significantly higher risk for aspiration pneumonia, with a hazard ratio (HR) of 1.33. An even higher risk was seen among patients with propofol-assisted endoscopies (HR, 1.49) but not among those without propofol (HR, 1.31). In a subgroup analysis based on endoscopy type, an elevated risk was observed among patients who underwent upper endoscopy (HR, 1.82) and combined upper and lower endoscopy (HR, 2.26) but not lower endoscopy (HR, 0.56). “The results were not necessarily surprising given the mechanism of action of GLP-1 RAs. However, for the first time, this was shown with a clinically relevant outcome, such as aspiration pneumonia,” Dr. Rezaie said. “Aspiration during sedation can have devastating consequences, and the 0.2% difference in risk of aspiration can have a significant effect on healthcare as well.” <a href="https://www.niddk.nih.gov/about-niddk/strategic-plans-reports/burden-of-digestive-diseases-in-united-states/indications-outcomes-gastrointestinal-endoscopy">More than 20 million endoscopies</a> are performed across the United States annually. Based on the assumption that about 3% of those patients are taking GLP-1 RAs, about 1200 aspiration cases per year can be prevented by raising awareness, he said. <h2>Considering Next Steps</h2> The varying risk profiles observed with separate sedation and endoscopy types point to a need for more tailored guidance in managing GLP-1 RA use before a procedure, the study authors wrote. Although holding the medications before endoscopy may disrupt diabetes management, the potential increased risk for aspiration could justify a change in practice, particularly for upper endoscopy and propofol-associated procedures, they added. At the same time, additional studies are needed to understand the optimal drug withholding windows before endoscopies and other procedures, they concluded. “We will need more data on what is the optimal duration of holding GLP-1 RAs,” Dr. Rezaie said. “But given our data and current ASA guidance, stopping these medications prior to elective procedures is the safe thing to do.” For now, AGA guidance remains the same as offered in the November 2023 update, suggesting an individual approach for each patient on a GLP-1 RA rather than a “blanket statement” on how to manage all patients taking these medications. “Overall, I believe that this study is important, but we require more high-level data to inform clinical decision-making regarding patients using GLP-1 receptor agonists prior to gastrointestinal endoscopy,” said Andrew Y. Wang, MD, AGAF, chief of gastroenterology and hepatology and director of interventional endoscopy at the University of Virginia in Charlottesville. Dr. Wang, who wasn’t involved with this study, coauthored the AGA rapid clinical practice update. He and colleagues advised continuing with a procedure as planned for patients on GLP-1 RAs who followed standard preprocedure fasting instructions and didn’t have nausea, vomiting, dyspepsia, or abdominal distention.[[{"fid":"282039","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Andrew Y. Wang of the University of Virginia, Charlottesville","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Andrew Y. Wang"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]] Among patients with symptoms that suggest retained gastric contents, rapid sequence intubation may be considered, though it may not be possible in ambulatory or office-based endoscopy settings, Dr. Wang and colleagues wrote. As another option in lieu of stopping GLP-1 RAs, patients can be placed on a liquid diet for 1 day before the procedure. “While this study found a signal suggesting that patients using GLP-1 RAs had an increased risk of aspiration pneumonia within 1 month following upper endoscopy or combined upper and lower endoscopy, it does not inform us if having patients stop GLP-1 RAs before endoscopic procedures — especially for a single dose — will mitigate this potential risk,” Dr. Wang said. “It was also interesting that these investigators found that patients taking GLP-1 RAs who underwent lower endoscopy alone were not at increased risk for aspiration pneumonia,” Dr. Wang noted. The authors didn’t report a funding source and disclosed no potential conflicts. Dr. Wang reported no relevant disclosures. A version of this article appeared on <a href="https://www.medscape.com/viewarticle/glp-1s-may-increase-post-endoscopy-aspiration-pneumonia-risk-2024a10007hv">Medscape.com</a>. </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>

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AGA Defines Diagnostic, Treatment Approach to Cannabinoid Hyperemesis Syndrome

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Thu, 04/11/2024 - 13:11

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Will Pass

A new American Gastroenterological Association (AGA) clinical practice update shines a light on cannabinoid hyperemesis syndrome (CHS).

CHS, which is triggered by chronic cannabis usage and manifests with GI and autonomic symptoms, is on the rise in the United States, yet underdiagnosis remains a challenge and clinical data are scarce, reported lead update panelist Alberto Rubio Tapia, MD, of Cleveland Clinic, Cleveland, Ohio, and colleagues.

“Although cannabis use has been reported for many decades, some of its unique adverse effects of nausea, vomiting, and abdominal pain, termed CHS, were noted relatively recently,” the panelists wrote in Gastroenterology. “The objective of this article was to help practitioners define the appropriate approach to the diagnosis and management of CHS.”

According to the update, the typical CHS patient is male with a years-long history of daily or near-daily cannabis use. Paradoxically, while cannabis use drives this condition, some patients with CHS report that cannabis use relieves their symptoms.The update describes CHS as a subtype of cyclical vomiting syndrome (CVS), and offers diagnostic criteria for CHS, reproduced below verbatim:

Clinical features: stereotypical episodic vomiting resembling CVS in terms of onset, with frequency 3 or more times annually;
Cannabis use patterns: duration of cannabis use more than 1 year before symptom onset; frequency more than 4 times per week, on average;
Cannabis cessation: resolution of symptoms after a period of abstinence from cannabis use for at least 6 months, or at least equal to the total duration of 3 typical vomiting cycles in that patient.

As CHS is a subtype of CVS, the update also provides an outline and management guide for this broader condition, which is characterized by four phases: inter-episodic, prodromal, emetic, and recovery.

During the inter-episodic phase, patients will have minimal or no symptoms, although almost one third will describe dyspepsia or nausea. Prophylactic medications in this period include tricyclics, mitochondrial supplements like CoQ10 and vitamin B12, NK1 antagonists, and anticonvulsants.

The prodromal phase is characterized by abdominal pain and nausea with a duration of 30-90 minutes. During this time patients may have autonomic symptoms like sweating and feeling hot or cold. Psychological symptoms may include feelings of panic and being “out of control.” Abortive medications are appropriate during this period, according to the update, like triptans and antiemetics.

Next comes the emetic phase, in which patients exhibit “relentless vomiting,” retching, abdominal pain, neurological symptoms and extreme thirst. Because an empty stomach may provide relief, inducing emesis may be considered, along with rest in a quiet dark room and supportive care.

Finally, the vomiting subsides during the recovery phase, when it is possible to restart oral intake and resume normal activities.

While this framework may be useful when managing patients with CHS, intervention should be centered around cannabis cessation, according to the update.

“For long-term management, counseling to achieve marijuana cessation and tricyclic antidepressants, such as amitriptyline, are the mainstay of therapy,” Dr. Rubio Tapia and colleagues wrote.

Advising patients to stop cannabis “cold turkey” is not recommended, they added, as this may bring on withdrawal symptoms, and it tends to be ineffective in this population, which has a high recidivism rate.

“Co-management with a psychologist or psychiatrist may be helpful for patients who have a lack of response to standard therapies or extensive psychiatric comorbidity,” the panelists wrote. “Anxiety and depression are very common associated conditions.”

Dr. Rubio Tapia and colleagues concluded with a call for more research.

“Further understanding of CHS pathophysiology and evidence-based therapies are urgently needed,” they wrote.

This update was commissioned and approved by the AGA. The update panelists disclosed relationships with Evoke Pharma, RedHill Biopharma, Takeda, and others.

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A new American Gastroenterological Association (AGA) clinical practice update shines a light on cannabinoid hyperemesis syndrome (CHS).

Clinical features: stereotypical episodic vomiting resembling CVS in terms of onset, with frequency 3 or more times annually;
Cannabis use patterns: duration of cannabis use more than 1 year before symptom onset; frequency more than 4 times per week, on average;
Cannabis cessation: resolution of symptoms after a period of abstinence from cannabis use for at least 6 months, or at least equal to the total duration of 3 typical vomiting cycles in that patient.

A new American Gastroenterological Association (AGA) clinical practice update shines a light on cannabinoid hyperemesis syndrome (CHS).

Clinical features: stereotypical episodic vomiting resembling CVS in terms of onset, with frequency 3 or more times annually;
Cannabis use patterns: duration of cannabis use more than 1 year before symptom onset; frequency more than 4 times per week, on average;
Cannabis cessation: resolution of symptoms after a period of abstinence from cannabis use for at least 6 months, or at least equal to the total duration of 3 typical vomiting cycles in that patient.

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AGA Clinical Practice Update Describes High-Quality Upper Endoscopy

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American Gastroenterological Association (AGA) has published a clinical practice update detailing best practices for performing a high-quality upper endoscopy exam.

The update, authored by Satish Nagula, MD, of Icahn School of Medicine at Mount Sinai, New York, NY, and colleagues, includes nine pieces of best practice advice that address procedure optimization, evaluation of suspected premalignancy, and postprocedure follow-up evaluation.

“Deﬁning what constitutes a high-quality esophagogastroduodenoscopy (EGD) poses somewhat of a challenge because the spectrum of indications and the breadth of benign and (pre)malignant disease pathology in the upper GI tract is very broad,” the update panelists wrote in Clinical Gastroenterology and Hepatology. “Standardizing the measures deﬁning a high-quality upper endoscopic examination is one of the ﬁrst steps for assessing quality.”

Preprocedure Recommendations

Dr. Nagula and colleagues first emphasized that EGD should be performed for an appropriate indication, citing a recent meta-analysis that found 21.7% of upper endoscopy procedures were performed for an inappropriate indication. Of note, diagnostic yields were 42% higher in procedures performed for an appropriate indication.

After ensuring an appropriate indication, the update also encourages clinicians to inform patients of the various benefits, risks, and alternatives of the procedure prior to providing consent.

Intraprocedure Recommendations

During the procedure, endoscopists should take several steps to ensure optimal visualization of tissues, according to the update.

First, a high-definition (HD) white-light endoscopy system should be employed.

“Although HD imaging is a standard feature of newer-generation endoscopes, legacy standard-deﬁnition scopes remain in use,” Dr. Nagula and colleagues noted. “Moreover, to provide true HD image resolution, each component of the system (eg, the endoscope video chip, the processor, the monitor, and transmission cables) must be HD compatible.”

This HD-compatible system should be coupled with image-enhancing technology to further improve lesion detection. In Barrett’s esophagus, the panelists noted, image enhancement can improve lesion detection as much as 20%.

They predicted that AI-assisted software may boost detection rates even higher: “Computer-aided detection and computer-aided diagnosis systems for upper endoscopy are still in the early phases of development but do show similar promise for improving the detection and characterization of upper GI tract neoplasia.”

Beyond selection of best available technologies, the update encourages more fundamental strategies to improve visualization, including mucosal cleansing and insufflation, with sufficient time spent inspecting the foregut mucosa via anterograde and retroflexed views.

Where appropriate, standardized biopsy protocols should be followed to evaluate and manage foregut conditions.

Postprocedure Recommendations

After the procedure, endoscopists should offer patients management recommendations based on the endoscopic findings and, if necessary, notify them that more recommendations may be forthcoming based on histopathology results, according to the update.

Similarly, endoscopists should follow established surveillance intervals for future procedures, with modifications made as needed, based on histopathology findings.

Document, Document, Document

Throughout the update, Dr. Nagula and colleagues repeatedly emphasize the importance of documentation, from preprocedural discussions with patients through planned surveillance schedules.

However, the recommendations are clear about “weighing the practical implications” of “onerous” documentation, particularly photodocumentation requirements. For instance, the authors note that “there are some scenarios in which more rigorous photodocumentation standards during upper endoscopy should be considered, such as patients with risk factors for neoplasia,” but at the very least “photodocumentation of any suspicious abnormalities, ideally with annotations, is strongly advised.”

Moving Toward Quality Standardization for Upper Endoscopy

“These best practice advice statements are intended to improve measurable clinical, patient-reported, and economic healthcare outcomes and are not meant to put an additional burden on endoscopists,” the panelists wrote. “Ideally, future research will set threshold indicators of adherence to these best practices that optimally are associated with these aforementioned objective outcomes.”

This update was commissioned and approved by AGA. The update panelists disclosed relationships with Covidien LP, Fujiﬁlm USA, Mahana Therapeutics, and others.

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American Gastroenterological Association (AGA) has published a clinical practice update detailing best practices for performing a high-quality upper endoscopy exam.

Preprocedure Recommendations

After ensuring an appropriate indication, the update also encourages clinicians to inform patients of the various benefits, risks, and alternatives of the procedure prior to providing consent.

Intraprocedure Recommendations

During the procedure, endoscopists should take several steps to ensure optimal visualization of tissues, according to the update.

Postprocedure Recommendations

Similarly, endoscopists should follow established surveillance intervals for future procedures, with modifications made as needed, based on histopathology findings.

Document, Document, Document

Throughout the update, Dr. Nagula and colleagues repeatedly emphasize the importance of documentation, from preprocedural discussions with patients through planned surveillance schedules.

Moving Toward Quality Standardization for Upper Endoscopy

This update was commissioned and approved by AGA. The update panelists disclosed relationships with Covidien LP, Fujiﬁlm USA, Mahana Therapeutics, and others.

American Gastroenterological Association (AGA) has published a clinical practice update detailing best practices for performing a high-quality upper endoscopy exam.

Preprocedure Recommendations

After ensuring an appropriate indication, the update also encourages clinicians to inform patients of the various benefits, risks, and alternatives of the procedure prior to providing consent.

Intraprocedure Recommendations

During the procedure, endoscopists should take several steps to ensure optimal visualization of tissues, according to the update.

Postprocedure Recommendations

Similarly, endoscopists should follow established surveillance intervals for future procedures, with modifications made as needed, based on histopathology findings.

Document, Document, Document

Throughout the update, Dr. Nagula and colleagues repeatedly emphasize the importance of documentation, from preprocedural discussions with patients through planned surveillance schedules.

Moving Toward Quality Standardization for Upper Endoscopy

This update was commissioned and approved by AGA. The update panelists disclosed relationships with Covidien LP, Fujiﬁlm USA, Mahana Therapeutics, and others.

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Global Rates of H. Pylori, Gastric Cancer, Dropping Together

Laying the Groundwork for Effective Gastric Cancer Prevention Strategies

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The global prevalence of Helicobacter pylori (H. pylori) infection in adults has fallen more than 15% over the past three decades, and gastric cancer incidence appears to be falling in turn, according to investigators.

These findings suggest that decreasing H. pylori prevalence does indeed reduce rates of gastric cancer, although large-scale clinical trials are needed to solidify confidence in this apparent relationship, reported lead author Yi Chun Chen, PhD, of National Taiwan University, Taipei, and colleagues.

“Eradication of H. pylori infection heals chronic active gastritis and peptic ulcer disease and reduces the risk of peptic ulcer bleeding in aspirin users and the risk of gastric cancer in infected individuals,” the investigators wrote in Gastroenterology. “However, whether reduction of the prevalence of H. pylori is associated with a reduction of the incidence of gastric cancer at the population level remains uncertain.”

According to several previous meta-analyses, the global rate of H. pylori infection has been in a downtrend, but Dr. Chen and colleagues pointed out several limitations of these publications, including scarcity of recent data, insufficiently representative data, inconsistent diagnostic methods, and lack of adjustment for socioeconomic status.

“We therefore conducted this comprehensive systematic review and meta-analysis, including healthy individuals recruited in hospital-based studies, to provide an updated global prevalence and the secular trend of H. pylori infection,” the investigators wrote, noting that they leveraged meta-regression analysis to “identify factors affecting heterogeneity of the prevalence,” and concurrently evaluated the corresponding global incidence of gastric cancer.

Their dataset, which included 1,748 articles from 111 countries, suggested that the global rate of H. pylori is indeed in a downtrend.

From a crude global prevalence of 52.6% prior to 1990, the rate of H. pylori decreased to 43.9% among adults in 2015-2022, but was “still as high as” 35.1% among children and adolescents in the same 2015-2022 period. Multivariate regression analysis showed that prevalence decreased significantly, by 15.9%, among adults, but not in children and adolescents.

“The signiﬁcant reduction of H. pylori prevalence in adults can be explained by the improvement of socioeconomic status, cleaner water supply, better sanitation and hygiene status, and widening of indication for eradication therapy,” Dr. Chen and colleagues wrote. “The higher prevalence in adults than in children/adolescents is explained by the cohort effect because most H. pylori infection is acquired in childhood.”

Global incidence of gastric cancer among both male and female individuals declined approximately in parallel with decreasing prevalence of H. pylori. Rates of gastric cancer decreased most in high-incidence countries such as Brazil, Japan, and China.

“These studies collectively provide evidence for the causal association of H. pylori infection and gastric cancer and that elimination of this bacterium can prevent the development of gastric cancer,” the investigators wrote.

Still, more work is needed.

“Future prospective studies should be conducted to confirm whether public health interventions or mass screening and eradication of H. pylori infection to reduce its prevalence may reduce the incidence of gastric cancer at population level,” Dr. Chen and colleagues concluded. “Besides, it is also important to consider the potential adverse consequences of H. pylori eradication, such as emergence of antibiotic resistance. The beneﬁt-to-harm ratio and cost-effectiveness should also be taken into account.”

The study was funded by the National Taiwan University Hospital, the Taiwan Ministry of Science and Technology, the Taiwan Ministry of Health and Welfare, and others. The investigators disclosed no conflicts of interest.

Body

Chen et al.’s study establishes a connection between the global decline in H. pylori infection rates and the decrease in gastric cancer cases, analyzing data from 1,748 articles across 111 countries. It highlights a significant drop in adult H. pylori prevalence from 52.6% before 1990 to 43.9% between 2015 and 2022, crediting improvements in socioeconomic conditions, water quality, and sanitation, along with targeted eradication efforts. This emphasizes the critical role of public health measures in reducing H. pylori infections and, consequently, gastric cancer risks, showcasing the success of eradication campaigns and widespread screening.

Nevertheless, the research advises caution regarding the widespread elimination of H. pylori due to the risk of antibiotic resistance. It advocates for a measured evaluation of the pros and cons, as well as the cost-effectiveness of such interventions. The authors call for additional large-scale clinical trials to verify these results and improve public health tactics.[[{"fid":"300656","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Li-Ju Chen, PhD, of the German Cancer Research Center, Heidelberg, Germany","field_file_image_credit[und][0][value]":"Dr. Chen","field_file_image_caption[und][0][value]":"Dr. Li-Ju Chen"},"type":"media","field_deltas":{"1":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Li-Ju Chen, PhD, of the German Cancer Research Center, Heidelberg, Germany","field_file_image_credit[und][0][value]":"Dr. Chen","field_file_image_caption[und][0][value]":"Dr. Li-Ju Chen"},"2":{"format":"medstat_image_flush_right","field_file_image_caption[und][0][value]":"%3Cp%3EDr.%20Li-Ju%20Chen%3C%2Fp%3E","field_file_image_caption[und][0][format]":"filtered_html","field_file_image_credit[und][0][value]":""}},"attributes":{"alt":"Li-Ju Chen, PhD, of the German Cancer Research Center, Heidelberg, Germany","class":"media-element file-medstat-image-flush-left","data-delta":"1"}}]]

The findings indicate that precise public health actions can greatly influence disease prevention, underlining the necessity of well-informed policies backed by ongoing clinical research and trials. Such an informed approach is essential to confirm that the advantages of eradication surpass the potential dangers, particularly considering the growing concern over antibiotic resistance. This study lays the groundwork for effective gastric cancer prevention strategies and emphasizes the ongoing need for research to shape sound public health policies and actions.

Li-Ju Chen, PhD, is a postdoctoral researcher in the Division of Clinical Epidemiology and Aging Research at the German Cancer Research Center, Heidelberg, Germany. She declared no conflicts of interest in regard to this review.

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Dupilumab for Eosinophilic Esophagitis: How Is it Improving Treatment?

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Marilynn Larkin

The US Food and Drug Administration approvals of dupilumab (Dupixent, Regeneron/Sanofi) for adults and children with eosinophilic esophagitis (EoE) affirmed the safety and efficacy of the drug, which is the first product indicated specifically for treatment of this disease.

The recent expanded approval for its use in kids aged 1 year and older imply that clinicians can prescribe it for just about any patient with the immune disorder.

But is dupilumab right for everyone?

What the Trials Said

Dupilumab, given by injection, is a recombinant human immunoglobulin-G4 monoclonal antibody that inhibits interleukin 4 (IL-4) and IL-13 signaling.

The first approval for EoE, on May 22, 2022, for adults and children aged 12 years and older weighing at least 40 kg, was based on data from 321 participants in the first two parts of a three-part phase 3 trial involving patients with EoE despite 8 weeks of high-dose proton pump inhibitor (PPI) therapy and with substantial symptom burden.

At 24 weeks, histologic remission occurred in 60% of patients in Part A of the trial and 59% in Part B who received a weekly 300-mg dose of dupilumab compared with 5% and 6% taking placebo. Additionally, Part A and B participants taking the drug weekly experienced a 69% and 64% reduction in disease symptoms, respectively, vs 32% and 41% for placebo. The drug also outperformed placebo in reducing patients’ esophageal eosinophilic counts and abnormal endoscopic findings.

The second approval, on January 25, 2024, for children aged 1 year and older weighing at least 15 kg, was based on data from a two-part, placebo-controlled trial involving 102 children, ages 1-11 years, with EoE. The study involved a 16-week treatment period and a 36-week extended period during which eligible children from the dupilumab group continued to receive their weight-based dose level and those who were on placebo switched to active treatment. The trial showed that a greater proportion of children taking the drug achieved histological remission.

A Major Advance but Temper Expectations

Dupilumab is a “major advance for EoE that has to find its place but should be looked at with optimism and what I call tempered expectations,” Philip Katz, MD, AGAF, professor of medicine in the gastroenterology division at Weill Cornell Medicine, New York City, said in an interview. “I’ve been using it since The New England Journal of Medicine paper was published about a year and a half ago , and as a slow adopter, I like it.”

Dr. Katz and his colleagues have been prescribing dupilumab mainly for patients who haven’t responded to other medications, mainly PPIs and steroids.

“We start people on it without stopping anything else,” Dr. Katz said. “Then, as symptoms evolve and people have a positive response, we stop the other medications. For example, in one patient who did very well on the drug, we stopped his steroids and now, we’re weaning him off his PPI. It’s a process. This is not a disease where you can rush people.”

The tempered approach is in part because of payer issues, he noted.

“It’s very difficult to get it reimbursed in the US if you haven’t tried something else first,” Dr. Katz said. “And because it’s still relatively new in this field, standard treatment is still used frequently.”

Although Dr. Katz has had “incredible success” with dupilumab so far, “nothing should be considered a miracle drug,” he said. “A couple of people have had injection reactions, and one person couldn’t tolerate the drug. So, while it seems to have an excellent response rate, it’s not 100%. Like any new drug, it will have to find its true success rate.”

Taking a Step-Up Approach

Like Dr. Katz, Evan Dellon, MD, MPH, AGAF, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina at Chapel Hill, North Carolina, is enthusiastic about dupilumab.

“It’s a boon to the field, and now, some real-world data are coming out and looking very much like the clinical trial data, which are reassuring,” said Dr. Dellon, a coauthor of The New England Journal of Medicine paper.

It’s been a “game changer,” particularly for people who weren’t doing well with their current treatments, he said. “In my practice, I’ve been seeing a lowish response rate for PPIs, and about 30%-40% not responding to topical steroids, since we don’t have a standard formulation for that. The diet elimination therapy is effective if people can do it well and adhere to it. But there’s a group of people who don’t respond, and probably, a larger group who can’t really do that treatment long term. So, the drug has been fantastic for those patients.”

Although the drug is approved for patients aged 1 year and older with no caveats, “it’s not the right medicine for every patient,” he said. “Patients in the clinical trials had EoE for 5 years, many of them were treatment refractory, and just under half had dilations and strictures,” he said. “They represent a certain group of patients.”

Dr. Dellon is taking a “step-up approach” to EoE treatment, first trying the standard interventions — PPIs, steroids, and an elimination diet — that many patients do respond to.

For new patients who choose medication therapy, he prescribes PPIs and then topical steroids and then steps up to dupilumab for patients who aren’t responding or who have a strong preference for starting the drug early.

In addition to EoE, the drug is approved for certain patients with atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. As such, Dr. Dellon said that he will try dupilumab early on in patients with multiple atopic conditions, such as asthma, eczema, or nasal disease.

“Even if their EoE is not that severe, those patients can still benefit from a more streamlined systemic therapy,” he said.

Challenges and Questions Still Remain

Not surprisingly, both Dr. Katz and Dr. Dellon pointed to dupilumab’s cost and the related challenge of convincing insurance companies to cover the drug as major challenges to more widespread use. The lack of long-term data also poses a challenge.

Side effects, which often stand in the way of the use of a new drug, are not an issue, for the most part, at least in the short term, according to Dr. Dellon. The most common side effects are discomfort, redness at the injection site, and pain related to the injection.

“Keeping the medication out of the refrigerator for a bit to bring it up to room temperature can help, as can doing the injection in the lower abdomen,” he said. “Otherwise, it’s well tolerated, with no side effects that are unique to EoE.”

Data from the third part of the clinical trial, which followed patients from weeks 24-52 of treatment, indicated that improvements in histological, symptomatic, endoscopic, and molecular features of EoE among patients taking weekly dupilumab continued or improved.

In my practice, “my observations have been that people are maintaining their responses,” said Dr. Dellon, a coauthor of the paper on the study’s third part.

However, one critical question is whether the dose intensity and/or frequency can be decreased over time without reducing the response rate.

“Hopefully, we’ll start getting data on that in the next year or two,” Dr. Dellon said. “It’s hard to do that yet because the drug has only been out for a year or year and a half, and people are just getting to that year of the initial dosing.”

Another question is how to use the drug in people who are different from the clinical trial population, such as those who have been responding to other therapies but want to switch, and people who are newly diagnosed but who have severe disease. Can the drug be used earlier in these populations?

Dr. Dellon would like to see a study that utilizes the new EoE index of severity metric to focus specifically on dupilumab use in patients with severe disease.

Early findings from his recent real-world study of 46 patients with severe disease who would not have qualified for the clinical trials found histologic, endoscopic, and symptom improvement in 91% of patients with refractory and fibrostenotic EoE after 6 months of dupilumab treatment.

While women tend to be well represented in the clinical trial, the drug needs to be tested in a more diverse population, Dr. Dellon noted. Research is underway looking at dupilumab effectiveness in people with different race/ethnicities.

EoE is more common among White people but that may be the result of a “detection issue,” he said. “When clinicians see a Black or Hispanic patient with dysphagia, for example, they may not be thinking of EoE. And there are also some data suggesting that EoE presents slightly differently in non-White populations, which again could decrease the suspicion for it. This is an area we need to learn more about.”

Don’t ‘Abandon’ Current Interventions

“We’ve got an exciting drug that is going to help a lot of people with a complex disease,” Dr. Katz said. “But we should not forget that there are other interventions that have been successful, and quite frankly, they don’t need to be abandoned.”

“Learn about the drug if you’ve never used it,” he advised. “Read the studies so you understand who the patients were as a baseline for where you’re going to use it. Be prepared to do the appropriate paperwork requirements to get approvals from insurers. And look for more literature because it’s coming.”

“Overall, dupilumab has really changed care in people with moderate to severe disease who are not responding or are intolerant to the other treatments,” Dr. Dellon said. “That’s the natural place for the medication to go at this point.”

Dr. Katz is a consultant to Phathom Pharma, Sebela Pharma, Medpace (not active), and Medtronic.

Dr. Dellon received research funding from Adare/Ellodi, Allakos, Arena/Pfizer, AstraZeneca, Eupraxia, Ferring, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, Revolo, and Shire/Takeda. He served as a consultant to Abbott, AbbVie, Adare/Ellodi, Aimmune, Akesobio, Alfasigma, ALK, Allakos, Amgen, Aqilion, Arena/Pfizer, Aslan, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Eli Lilly, EsoCap, Eupraxia, Dr. Falk Pharma, Ferring, GSK, Gossamer Bio, Holoclara, Invea, Knightpoint, Landos, LucidDx, Morphic, Nexstone Immunology/Uniquity, Nutricia, Parexel/Calyx, Phathom, Regeneron, Revolo, Robarts/Alimentiv, Salix, Sanofi, Shire/Takeda, Target RWE, and Upstream Bio. He also received educational grants from Allakos, Aqilion, Holoclara, and Invea.

A version of this article appeared on Medscape.com.

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What the Trials Said

Dupilumab, given by injection, is a recombinant human immunoglobulin-G4 monoclonal antibody that inhibits interleukin 4 (IL-4) and IL-13 signaling.

A Major Advance but Temper Expectations

Taking a Step-Up Approach

Challenges and Questions Still Remain

Don’t ‘Abandon’ Current Interventions

A version of this article appeared on Medscape.com.

What the Trials Said

Dupilumab, given by injection, is a recombinant human immunoglobulin-G4 monoclonal antibody that inhibits interleukin 4 (IL-4) and IL-13 signaling.

A Major Advance but Temper Expectations

Taking a Step-Up Approach

Challenges and Questions Still Remain

Don’t ‘Abandon’ Current Interventions

A version of this article appeared on Medscape.com.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Dupilumab is a “major advance for EoE that has to find its place but should be looked at with optimism and what I call tempered expectations</metaDescription> <articlePDF/> <teaserImage/> <teaser>Dupilumab has “really changed care in people with moderate to severe disease who are not responding or are intolerant to the other treatments,” said Dr. Evan Dellon.</teaser> <title>Dupilumab for Eosinophilic Esophagitis: How Is it Improving Treatment?</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>gih</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">17</term> <term>15</term> <term>21</term> </publications> <sections> <term canonical="true">39313</term> <term>27980</term> </sections> <topics> <term canonical="true">347</term> <term>213</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Dupilumab for Eosinophilic Esophagitis: How Is it Improving Treatment?</title> <deck/> </itemMeta> <itemContent> The US Food and Drug Administration approvals of dupilumab (Dupixent, Regeneron/Sanofi) <a href="https://www.medscape.com/viewarticle/974374">for adults and children</a> with eosinophilic esophagitis (EoE) affirmed the safety and efficacy of the drug, which is the first product indicated specifically for treatment of this disease. The <a href="https://www.medscape.com/viewarticle/fda-expands-dupilumab-eoe-younger-children-2024a10001v6">recent expanded approval</a> for its use in kids aged 1 year and older imply that clinicians can prescribe it for just about any patient with the immune disorder. But is dupilumab right for everyone? <h2>What the Trials Said</h2> Dupilumab, given by injection, is a recombinant human immunoglobulin-G4 monoclonal antibody that inhibits interleukin 4 (IL-4) and IL-13 signaling. The first approval for EoE, on May 22, 2022, for adults and children aged 12 years and older weighing at least 40 kg, was based on data from 321 participants in the first two parts of a three-part <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2205982">phase 3 trial</a> involving patients with EoE despite 8 weeks of high-dose proton pump inhibitor (PPI) therapy and with substantial symptom burden. At 24 weeks, histologic remission occurred in 60% of patients in Part A of the trial and 59% in Part B who received a weekly 300-mg dose of dupilumab compared with 5% and 6% taking placebo. Additionally, Part A and B participants taking the drug weekly experienced a 69% and 64% reduction in disease symptoms, respectively, vs 32% and 41% for placebo. The drug also outperformed placebo in reducing patients’ esophageal eosinophilic counts and abnormal endoscopic findings. The second approval, on January 25, 2024, for children aged 1 year and older weighing at least 15 kg, was based on data from a two-part, placebo-controlled trial involving 102 children, ages 1-11 years, with EoE. The study involved a 16-week treatment period and a 36-week extended period during which eligible children from the dupilumab group continued to receive their weight-based dose level and those who were on placebo switched to active treatment. The trial showed that a greater proportion of children taking the drug achieved histological remission. <h2>A Major Advance but Temper Expectations</h2> Dupilumab is a “major advance for EoE that has to find its place but should be looked at with optimism and what I call tempered expectations,” Philip Katz, MD, AGAF, professor of medicine in the gastroenterology division at Weill Cornell Medicine, New York City, said in an interview. “I’ve been using it since <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2205982">The New England Journal of Medicine</a> paper was published about a year and a half ago , and as a slow adopter, I like it.” Dr. Katz and his colleagues have been prescribing dupilumab mainly for patients who haven’t responded to other medications, mainly PPIs and steroids. “We start people on it without stopping anything else,” Dr. Katz said. “Then, as symptoms evolve and people have a positive response, we stop the other medications. For example, in one patient who did very well on the drug, we stopped his steroids and now, we’re weaning him off his PPI. It’s a process. This is not a disease where you can rush people.” The tempered approach is in part because of payer issues, he noted. “It’s very difficult to get it reimbursed in the US if you haven’t tried something else first,” Dr. Katz said. “And because it’s still relatively new in this field, standard treatment is still used frequently.” Although Dr. Katz has had “incredible success” with dupilumab so far, “nothing should be considered a miracle drug,” he said. “A couple of people have had injection reactions, and one person couldn’t tolerate the drug. So, while it seems to have an excellent response rate, it’s not 100%. Like any new drug, it will have to find its true success rate.” <h2>Taking a Step-Up Approach</h2> Like Dr. Katz, Evan Dellon, MD, MPH, AGAF, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina at Chapel Hill, North Carolina, is enthusiastic about dupilumab. “It’s a boon to the field, and now, some real-world data are coming out and looking very much like the clinical trial data, which are reassuring,” said Dr. Dellon, a coauthor of The New England Journal of Medicine paper. It’s been a “game changer,” particularly for people who weren’t doing well with their current treatments, he said. “In my practice, I’ve been seeing a lowish response rate for PPIs, and about 30%-40% not responding to topical steroids, since we don’t have a standard formulation for that. The diet elimination therapy is effective if people can do it well and adhere to it. But there’s a group of people who don’t respond, and probably, a larger group who can’t really do that treatment long term. So, the drug has been fantastic for those patients.” Although the drug is approved for patients aged 1 year and older with no caveats, “it’s not the right medicine for every patient,” he said. “Patients in the clinical trials had EoE for 5 years, many of them were treatment refractory, and just under half had dilations and strictures,” he said. “They represent a certain group of patients.” Dr. Dellon is taking a “step-up approach” to EoE treatment, first trying the standard interventions — PPIs, steroids, and an elimination diet — that many patients do respond to. For new patients who choose medication therapy, he prescribes PPIs and then topical steroids and then steps up to dupilumab for patients who aren’t responding or who have a strong preference for starting the drug early. In addition to EoE, the drug is approved for certain patients with atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis. As such, Dr. Dellon said that he will try dupilumab early on in patients with multiple atopic conditions, such as asthma, eczema, or nasal disease. “Even if their EoE is not that severe, those patients can still benefit from a more streamlined systemic therapy,” he said. <h2>Challenges and Questions Still Remain</h2> Not surprisingly, both Dr. Katz and Dr. Dellon pointed to dupilumab’s cost and the related challenge of convincing insurance companies to cover the drug as major challenges to more widespread use. The lack of long-term data also poses a challenge. Side effects, which often stand in the way of the use of a new drug, are not an issue, for the most part, at least in the short term, according to Dr. Dellon. The most common side effects are discomfort, redness at the injection site, and pain related to the injection. “Keeping the medication out of the refrigerator for a bit to bring it up to room temperature can help, as can doing the injection in the lower abdomen,” he said. “Otherwise, it’s well tolerated, with no side effects that are unique to EoE.” Data from the <a href="https://www.thelancet.com/journals/langas/article/PIIS2468-1253(23)00204-2/fulltext">third part of the clinical trial</a>, which followed patients from weeks 24-52 of treatment, indicated that improvements in histological, symptomatic, endoscopic, and molecular features of EoE among patients taking weekly dupilumab continued or improved. In my practice, “my observations have been that people are maintaining their responses,” said Dr. Dellon, a coauthor of the paper on the study’s third part. However, one critical question is whether the dose intensity and/or frequency can be decreased over time without reducing the response rate. “Hopefully, we’ll start getting data on that in the next year or two,” Dr. Dellon said. “It’s hard to do that yet because the drug has only been out for a year or year and a half, and people are just getting to that year of the initial dosing.” Another question is how to use the drug in people who are different from the clinical trial population, such as those who have been responding to other therapies but want to switch, and people who are newly diagnosed but who have severe disease. Can the drug be used earlier in these populations? Dr. Dellon would like to see a study that utilizes the new EoE <a href="https://www.gastrojournal.org/article/S0016-5085(22)00287-6/fulltext">index of severity</a> metric to focus specifically on dupilumab use in patients with severe disease. Early findings from his recent <a href="https://doi.org/10.1016/j.cgh.2023.08.015">real-world study</a> of 46 patients with severe disease who would not have qualified for the clinical trials found histologic, endoscopic, and symptom improvement in 91% of patients with refractory and fibrostenotic EoE after 6 months of dupilumab treatment. While women tend to be well represented in the clinical trial, the drug needs to be tested in a more diverse population, Dr. Dellon noted. Research is underway looking at dupilumab effectiveness in people with different race/ethnicities. EoE is more common among White people but that may be the result of a “detection issue,” he said. “When clinicians see a Black or Hispanic patient with dysphagia, for example, they may not be thinking of EoE. And there are also some data suggesting that EoE presents slightly differently in <a href="https://www.cghjournal.org/article/S1542-3565(15)01193-3/fulltext">non-White populations</a>, which again could decrease the suspicion for it. This is an area we need to learn more about.” <h2>Don’t ‘Abandon’ Current Interventions</h2> “We’ve got an exciting drug that is going to help a lot of people with a complex disease,” Dr. Katz said. “But we should not forget that there are other interventions that have been successful, and quite frankly, they don’t need to be abandoned.” “Learn about the drug if you’ve never used it,” he advised. “Read the studies so you understand who the patients were as a baseline for where you’re going to use it. Be prepared to do the appropriate paperwork requirements to get approvals from insurers. And look for more literature because it’s coming.” “Overall, dupilumab has really changed care in people with moderate to severe disease who are not responding or are intolerant to the other treatments,” Dr. Dellon said. “That’s the natural place for the medication to go at this point.” Dr. Katz is a consultant to Phathom Pharma, Sebela Pharma, Medpace (not active), and Medtronic. Dr. Dellon received research funding from Adare/Ellodi, Allakos, Arena/Pfizer, AstraZeneca, Eupraxia, Ferring, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, Revolo, and Shire/Takeda. He served as a consultant to Abbott, AbbVie, Adare/Ellodi, Aimmune, Akesobio, Alfasigma, ALK, Allakos, Amgen, Aqilion, Arena/Pfizer, Aslan, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Eli Lilly, EsoCap, Eupraxia, Dr. Falk Pharma, Ferring, GSK, Gossamer Bio, Holoclara, Invea, Knightpoint, Landos, LucidDx, Morphic, Nexstone Immunology/Uniquity, Nutricia, Parexel/Calyx, Phathom, Regeneron, Revolo, Robarts/Alimentiv, Salix, Sanofi, Shire/Takeda, Target RWE, and Upstream Bio. He also received educational grants from Allakos, Aqilion, Holoclara, and Invea. A version of this article appeared on <a href="https://www.medscape.com/viewarticle/dupilumab-eosinophilic-esophagitis-how-it-improving-2024a10003gs">Medscape.com</a>. </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>

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The Paradox of Achalasia Symptoms

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In contrast to most diseases, as achalasia progresses, the symptoms improve. Specifically, reduction of symptoms of dysphagia lulls the gastroenterologist into thinking their patients are doing well.

This improvement in dysphagia is likely due to two mechanisms. The first is that as the esophagus dilates, there is a greater capacity for food accumulation before sensation occurs. Whether this is completely a volume issue or whether there is a contribution from increased esophageal body distensibility is unclear. Similarly, as achalasia results from inflammation and destruction of the motor neurons of the myenteric plexus, sensory neurons are also damaged. As a result, the patient’s ability to sense food retention lessens. To some degree, this explains the phenomenon of patients presenting with megaesophagus; after years of initially diminishing or stable symptoms managed with patient accommodation, patients present with end-stage disease manifested by a food-impacted esophagus, nocturnal aspiration, and weight loss.

This aspect of the natural history of achalasia has led esophagologists to follow patients with achalasia after treatment at regular intervals with objective examinations such as timed esophagography to mitigate against this worsening yet symptomatically stable course.

Dr. Katzka is based in the Division of Digestive and Liver Diseases, Columbia University Medical Center, New York. He receives research support from Medtronic and is an associate editor for GI & Hepatology News. Previously published in Gastro Hep Advances. 2024 Jan 19. doi: 10.1016/j.gastha.2024.01.006.

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Commentary: PPI Dosing, Biomarkers, and Eating Behaviors in Patients With EoE, March 2024

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This study provides compelling evidence that a twice-daily dosing regimen of moderate-dose proton pump inhibitors (PPIs) is superior to a once-daily regimen for inducing histologic remission in eosinophilic esophagitis (EoE). This finding suggests a significant paradigm shift in EoE management, challenging the current standard treatment guideline that recommends a PPI trial of 20-40 mg twice daily. The limited data on various dosing regimens for EoE treatment underscores the importance of this research. Dr Muftah and colleagues from Brigham and Women's Hospital have conducted a novel retrospective cohort study to address the question: Does a twice-daily PPI dose induce a higher remission rate in EoE than a once-daily regimen does regardless of the total daily dose?

The study enrolled adult patients with newly-diagnosed treatment-naive EoE at a tertiary care center, dividing participants into four groups on the basis of their treatment regimen: once-daily standard dose (20 mg omeprazole), once-daily moderate dose (40 mg), twice-daily moderate dose (20 mg), and twice-daily high dose (40 mg). Patients underwent endoscopy 8-12 weeks after initiating PPI treatment, with the primary outcome being the histologic response to PPI, defined as fewer than 15 eosinophils/high power field in repeat esophageal biopsies.

Out of 305 patients (54.6% men, mean age 44.7 ± 16.7 years), 42.3% achieved a histologic response to PPI treatment. Patients receiving the standard PPI dose (20 mg omeprazole once daily) vs those on twice-daily moderate and high doses showed significantly higher histologic response rates (52.8% vs 11.8%, P < .0001; and 54.3% vs 11.8%, P < .0001; respectively). Multivariable analysis revealed that twice-daily moderate and high doses were significantly more effective (adjusted odds ration [aOR] 6.75; CI 2.53-18.0, P = .0008; and aOR 12.8, CI 4.69-34.8, P < .001; respectively).

However, the study's retrospective design limits its ability to establish causality and may introduce selection bias. In addition, the lack of specified adjustments for PPI dosing based on diet and lifestyle factors across the cohort could influence treatment response and outcomes. Last, as a single-center study, the results may not generalize across diverse patient populations, particularly those with different demographics or disease severities.

This research heralds a shift toward a more effective treatment strategy in EoE management, suggesting that a twice-daily PPI regimen may be more beneficial than once-daily dosing is for inducing histologic remission, especially in patients inadequately responding to once-daily PPI treatment. It advocates for a personalized treatment approach, considering factors such as symptom severity, previous PPI response, and potential for adherence to a twice-daily regimen.

Distinguishing between inflammatory bowel disease (IBD)–induced eosinophilia and EoE poses a significant challenge for clinicians. Given that the incidence of EoE is 3-5 times higher in patients with IBD compared with the general population, there is a pressing need for new biomarkers to differentiate between these two conditions. In response to this need, Dr Butzke and colleagues at Nemours Children's Health in Wilmington, Delaware, conducted a retrospective study to evaluate the roles of Major Basic Protein (MBP) and interleukin (IL)-13 in distinguishing these diseases. The study included participants who underwent esophagogastroduodenoscopy with esophageal biopsies for IBD workup or suspicion of EoE. It comprised 27 patients with EoE-IBD, 39 with EoE, 29 with IBD eosinophilia, 30 with IBD only, and 30 control patients. The biopsies were stained with MBP and IL-13 antibodies, and the results (percent staining/total tissue area), demographic, and clinical findings were compared among the groups.

The study revealed that MBP staining levels among patients with EoE-IBD were 3.8 units, which is significantly lower than those in the EoE group at 52.8 units and higher than those with IBD eosinophilia at 0.2 units (P < .001). IL-13 expression was significantly higher only compared with the IBD and control groups and not with EoE-IBD or IBD eosinophilia. MBP predicted EoE with 100% sensitivity and 99% specificity, whereas IL-13 demonstrated 83% sensitivity and 90% specificity using a cutoff point from the cohort of patients without EoE-IBD. Based on the MBP cutoff point of 3.49 units that distinguished between EoE and non-EoE cases, 100% of patients with EoE were MBP-positive compared with 3% of patients with IBD-associated eosinophilia (P < .05).

To implement this new biomarker into clinical practice, guidelines for interpreting MBP staining results should be developed and established, including defining cutoff points for positive and negative results. However, this study faces several limitations, such as not evaluating the differences in MBP results based on EoE-IBD type and disease activity. The retrospective nature of the study and its small sample size limit its power. In addition, the study did not assess how different treatments and disease activity affect MBP levels nor did it address the lack of longitudinal evaluation in assessing MBP levels.

Despite these limitations, the study presents a compelling case for the use of MBP as a biomarker to distinguish true EoE from EoE-IBD. This differentiation is crucial because it can guide therapeutic approaches, influencing medication choices and dietary interventions. MBP shows promise as an excellent biomarker for distinguishing true EoE from eosinophilia caused by IBD. When combined with endoscopic and histologic changes, MBP can assist with the diagnosis of EoE in IBD patients, thereby reducing the possibility of misdiagnosis.

Being diagnosed with EoE poses a challenging and life-altering experience for patients and their families. They face numerous challenges, from undergoing diagnostic procedures and treatments to adapting daily diets. Limited information is available on the eating habits of patients diagnosed with EoE. In this study, Dr Kennedy and colleagues explored how a diagnosis of EoE affects eating behaviors among pediatric patients.

The researchers conducted a prospective study involving 27 patients diagnosed with EoE and compared their eating behaviors to those of 25 healthy control participants. The participants were evaluated on the basis of their responses to four food textures (puree, soft solid, chewable, and hard solid), focusing on the number of chews per bite, sips of fluid per food, and consumption time.

The study found that, on average, patients with EoE (63.5% boys, mean age 11 years) required more chews per bite across several food textures (soft solid P = .031; chewable P = .047; and hard solid P = .037) and demonstrated increased consumption time for soft solid (P = .002), chewable (P = .005), and hard solid foods (P = .034) compared to healthy controls. In addition, endoscopic reference scores positively correlated with consumption time (r = 0.53; P = .008) and the number of chews (r = 0.45; P = .027) for chewable foods as well as with the number of chews (r = 0.44; P = .043) for hard solid foods. Increased consumption time also correlated with increased eosinophil counts (r = 0.42; P = .050) and decreased esophageal distensibility (r = -0.82; P < .0001).

Though these findings open promising avenues for the noninvasive assessment and personalized management of EoE, further research with larger, longitudinal studies is essential to validate these behaviors as reliable clinical biomarkers. Increasing the sample size would enhance the study's power and broaden the generalizability of its findings to a wider pediatric EoE population. The study's cross-sectional nature limits the ability to assess how eating behaviors change over time with treatment or disease progression.

This study underscores the potential of eating behaviors as clinical markers for pediatric patients with EoE, enabling early identification through increased chewing and consumption times, especially with harder textures. Such markers could prompt diagnostic evaluations in settings where endoscopy and biopsy are gold standards for diagnosing EoE. Moreover, eating patterns could assist in monitoring disease activity and progression, offering a noninvasive means of assessing disease status and response to therapy, thus allowing for more frequent assessments of disease status without the need for invasive procedures. Understanding these behaviors allows healthcare providers to tailor dietary advice and interventions, potentially enhancing treatment compliance and improving the quality of life for pediatric patients with EoE.

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Real-World Dupilumab Wins in Treating Refractory EoE

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Severe, refractory, and fibrostenotic eosinophilic esophagitis (EoE) responded well in the everyday clinical setting to the monoclonal antibody dupilumab (Dupixent). Most patients achieved histologic, endoscopic, and symptom improvement with a median of 6 months’ treatment with the interleukin 4 and 13 blocker, and esophageal stricture diameter improved as well, according to a single-center retrospective study in Clinical Gastroenterology and Hepatology.

“Dupilumab has real-world efficacy for a severe EoE population, most of whom would not have qualified for prior clinical trials,” concluded gastroenterologists Christopher J. Lee, MD (lead author), and Evan S. Dellon, MD, MPH, AGAF, of the Center for Esophageal Diseases and Swallowing, at the University of North Carolina School of Medicine in Chapel Hill.

These real-world findings aligned with data from the group’s phase 3 clinical trial.

In addition, several case reports or series have highlighted the real-world efficacy of dupilumab, with a particular focus on pediatric patients and those with other atopic diseases.

“Despite nonresponse to prior treatments, these patients can likely expect to see results similar to what was seen in the clinical trial,” Dr. Dellon said in an interview. “However, it would be good to have similar confirmatory data from other centers, and I’m sure those data will be forthcoming as more EoE patients are treated with dupilumab.”

The placement of dupilumab in the EoE treatment algorithm is still actively being investigated. “While the phase 3 study led to [Food and Drug Administration] approval, it had strict inclusion and exclusion criteria, and some populations were ineligible,” he added. “In particular, the very severe EoE patients who either had a very narrow esophagus where the scope wouldn’t pass, or who had severe strictures and symptoms requiring esophageal dilation and who couldn’t go 6 to 12 months without dilation, couldn’t be enrolled. So the efficacy of dupilumab in this more severe group was not known.”

The group hypothesized that dupilumab would be effective in this population but did not know if the efficacy would be similar to that in the clinical trial. “The overall response rates, which were very similar to what were seen in the phase 3 trial, were surprising,“ Dr. Dellon said.”The other surprising finding was the increase in esophageal caliber, as measured by the size achieved with esophageal dilation.”

The study

The investigators identified 46 patients treated with dupilumab for refractory fibrostenotic EoE at the university’s medical center. All had failed or lost response to one or more standard therapies such as proton pump inhibitors, topical glucocorticosteroids, and a food elimination diet.

Previous treatments also included systemic steroids, cromolyn, ketotifen, montelukast, and 6-mercaptopurine, all with minimal response. Some 85% of patients had undergone an average of 9.0+ 7.0 pre-dupilumab dilations.

The biologic was initially prescribed off-label before FDA approval. Patients received it at a dose of 300 mg subcutaneously either fortnightly (n = 16) or weekly (n = 30), depending on insurance approval and timing of prescription. Length of treatment varied based on the time from prescription to first post-treatment evaluative endoscopy.

Patients showed endoscopic, histologic, and symptomatic improvement on dupilumab compared with both the worst and the pre-dupilumab esophagogastroduodenoscopies.

Among the specific findings:

Peak eosinophil counts significantly decreased.
Post-dupilumab histologic response rates were 80% and 57% for fewer than 15 eosinophils per high-power field, and 6 or fewer eosinophils per high-power field, respectively.
The Endoscopic Reference Score decreased from 5.01 to 1.89 (P < .001 for all).
Pre-dilation esophageal diameter increased from 13.9 to 16.0 mm (P < .001), although the proportion of strictures was stable.
Global symptom improvement was reported in 91% of patients (P < .001).

Commenting on the study but not involved in it, David A. Katzka, MD, professor of medicine at Columbia University in New York City, said the findings would be of immediate use to practicing gastroenterologists.

“It’s necessary to do clinical trials, but real-world data make the clinician feel more comfortable in prescribing. Interestingly, I am seeing dupilumab being recommended not just for refractory disease but also as first-line therapy,” he said.

Dr. Dellon noted that the incidence and prevalence of EoE are rising rapidly in the US and around the world. “This increase is outpacing growing recognition of the disease,” he said. “Most likely, environmental factors are driving this change.” He called for studies to determine the long-term efficacy of dupilumab for this severe subgroup — and the potential benefit of moving dupilumab earlier into the treatment algorithm.

The latter is a controversial question, noted Dr. Katzka. “For patients with other indications such as asthma or eczema, dupilumab is the ideal medication,” he said. And it can be a first-line therapy if there are contraindications to alternatives or if compliance will be better with a once-weekly injection as opposed to a twice-daily medication or a food elimination diet. But overall, our more established therapies should be considered first.”

Dr. Katzka emphasized the need to further define EoE phenotypes in order to personalize therapy. “There’s likely a group of patients who should go straight to dupilumab, perhaps those marked by factors such as severity, progression, young age, or other atopic disorders. But we have yet to definitively identify this group.”

The authors reported no specific funding for this analysis. Dr. Dellon reported research funding and/or consulting fees from multiple pharmaceutical companies, including Regeneron/Sanofi, the developers of dupilumab. Dr. Lee had no competing interests to disclose. Dr. Katzka reported consulting for Medtronic, and is an associate editor for GI & Hepatology News.

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Peak eosinophil counts significantly decreased.
Post-dupilumab histologic response rates were 80% and 57% for fewer than 15 eosinophils per high-power field, and 6 or fewer eosinophils per high-power field, respectively.
The Endoscopic Reference Score decreased from 5.01 to 1.89 (P < .001 for all).
Pre-dilation esophageal diameter increased from 13.9 to 16.0 mm (P < .001), although the proportion of strictures was stable.
Global symptom improvement was reported in 91% of patients (P < .001).

The study

Peak eosinophil counts significantly decreased.
Post-dupilumab histologic response rates were 80% and 57% for fewer than 15 eosinophils per high-power field, and 6 or fewer eosinophils per high-power field, respectively.
The Endoscopic Reference Score decreased from 5.01 to 1.89 (P < .001 for all).
Pre-dilation esophageal diameter increased from 13.9 to 16.0 mm (P < .001), although the proportion of strictures was stable.
Global symptom improvement was reported in 91% of patients (P < .001).

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167027</fileName> <TBEID>0C04EAB8.SIG</TBEID> <TBUniqueIdentifier>MD_0C04EAB8</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname>Dupilumab for EoE</storyname> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240223T132514</QCDate> <firstPublished>20240223T133702</firstPublished> <LastPublished>20240223T133702</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240223T133702</CMSDate> <articleSource>FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY</articleSource> <facebookInfo/> <meetingNumber/> <byline>DianaSwift dianaswift@rogers.com</byline> <bylineText>DIANA SWIFT</bylineText> <bylineFull>DIANA SWIFT</bylineFull> <bylineTitleText>MDedge News</bylineTitleText> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Severe, refractory, and fibrostenotic eosinophilic esophagitis (EoE) responded well in the everyday clinical setting to the monoclonal antibody dupilumab (Dupix</metaDescription> <articlePDF/> <teaserImage>287671</teaserImage> <teaser>Patients showed endoscopic, histologic, and symptomatic improvement on dupilumab.</teaser> <title>Real-World Dupilumab Wins in Treating Refractory EoE</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>gih</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">17</term> <term>21</term> <term>15</term> </publications> <sections> <term canonical="true">69</term> <term>39313</term> <term>27970</term> </sections> <topics> <term canonical="true">347</term> <term>213</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24010f0e.jpg</altRep> <description role="drol:caption">Dr. Evan S. Dellon</description> <description role="drol:credit"/> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/240126a1.jpg</altRep> <description role="drol:caption">Dr. David A. Katzka</description> <description role="drol:credit"/> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Real-World Dupilumab Wins in Treating Refractory EoE</title> <deck/> </itemMeta> <itemContent> Severe, refractory, and fibrostenotic eosinophilic esophagitis (EoE) responded well in the everyday clinical setting to the monoclonal antibody dupilumab (Dupixent). Most patients achieved histologic, endoscopic, and symptom improvement with a median of 6 months’ treatment with the interleukin 4 and 13 blocker, and esophageal stricture diameter improved as well, according to a <a href="https://www.cghjournal.org/article/S1542-3565(23)00665-1/fulltext">single-center retrospective study</a> in Clinical Gastroenterology and Hepatology. “Dupilumab has real-world efficacy for a severe EoE population, most of whom would not have qualified for prior clinical trials,” concluded gastroenterologists Christopher J. Lee, MD (lead author), and Evan S. Dellon, MD, MPH, AGAF, of the Center for Esophageal Diseases and Swallowing, at the University of North Carolina School of Medicine in Chapel Hill. These real-world findings aligned with data from the group’s <a href="https://www.nejm.org/doi/10.1056/NEJMoa2205982">phase 3 clinical trial</a>. In addition, several case reports or series have <a href="https://journals.lww.com/jpgnr/fulltext/2022/05000/real_world_experience_with_dupilumab_in.5.aspx">highlighted the real-world efficacy</a> of dupilumab, with a particular focus on pediatric patients and those with other atopic diseases. “Despite nonresponse to prior treatments, these patients can likely expect to see results similar to what was seen in the clinical trial,” Dr. Dellon said in an interview. “However, it would be good to have similar confirmatory data from other centers, and I’m sure those data will be forthcoming as more EoE patients are treated with dupilumab.”[[{"fid":"287671","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Evan D. Dellon, MD, of University of North Carolina, Chapel Hill","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Evan S. Dellon"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]] The placement of dupilumab in the EoE treatment algorithm is still actively being investigated. “While the phase 3 study led to [Food and Drug Administration] approval, it had strict inclusion and exclusion criteria, and some populations were ineligible,” he added. “In particular, the very severe EoE patients who either had a very narrow esophagus where the scope wouldn’t pass, or who had severe strictures and symptoms requiring esophageal dilation and who couldn’t go 6 to 12 months without dilation, couldn’t be enrolled. So the efficacy of dupilumab in this more severe group was not known.” The group hypothesized that dupilumab would be effective in this population but did not know if the efficacy would be similar to that in the clinical trial. “The overall response rates, which were very similar to what were seen in the phase 3 trial, were surprising,“ Dr. Dellon said.”The other surprising finding was the increase in esophageal caliber, as measured by the size achieved with esophageal dilation.” <h2>The study</h2> The investigators identified 46 patients treated with dupilumab for refractory fibrostenotic EoE at the university’s medical center. All had failed or lost response to one or more standard therapies such as proton pump inhibitors, topical glucocorticosteroids, and a food elimination diet. Previous treatments also included systemic steroids, cromolyn, ketotifen, montelukast, and 6-mercaptopurine, all with minimal response. Some 85% of patients had undergone an average of 9.0+ 7.0 pre-dupilumab dilations. The biologic was initially prescribed off-label before FDA approval. Patients received it at a dose of 300 mg subcutaneously either fortnightly (n = 16) or weekly (n = 30), depending on insurance approval and timing of prescription. Length of treatment varied based on the time from prescription to first post-treatment evaluative endoscopy. Patients showed endoscopic, histologic, and symptomatic improvement on dupilumab compared with both the worst and the pre-dupilumab esophagogastroduodenoscopies. Among the specific findings: <ul class="body"> <li>Peak eosinophil counts significantly decreased.</li> <li>Post-dupilumab histologic response rates were 80% and 57% for fewer than 15 eosinophils per high-power field, and 6 or fewer eosinophils per high-power field, respectively. </li> <li>The <a href="https://www.cghjournal.org/article/S1542-3565(15)01302-6/fulltext">Endoscopic Reference Score</a> decreased from 5.01 to 1.89 (P < .001 for all).</li> <li>Pre-dilation esophageal diameter increased from 13.9 to 16.0 mm (P < .001), although the proportion of strictures was stable.</li> <li>Global symptom improvement was reported in 91% of patients (P < .001).</li> </ul> Commenting on the study but not involved in it, David A. Katzka, MD, professor of medicine at Columbia University in New York City, said the findings would be of immediate use to practicing gastroenterologists. [[{"fid":"300366","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. David A. Katzka, Columbia University, New York","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. David A. Katzka"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]“It’s necessary to do clinical trials, but real-world data make the clinician feel more comfortable in prescribing. Interestingly, I am seeing dupilumab being recommended not just for refractory disease but also as first-line therapy,” he said. Dr. Dellon noted that the incidence and prevalence of EoE <a href="https://link.springer.com/article/10.1007/s11882-022-01042-1">are rising rapidly</a> in the US and around the world. “This increase is outpacing growing recognition of the disease,” he said. “Most likely, environmental factors are driving this change.” He called for studies to determine the long-term efficacy of dupilumab for this severe subgroup — and the potential benefit of moving dupilumab earlier into the treatment algorithm. The latter is a controversial question, noted Dr. Katzka. “For patients with other indications such as asthma or eczema, dupilumab is the ideal medication,” he said. And it can be a first-line therapy if there are contraindications to alternatives or if compliance will be better with a once-weekly injection as opposed to a twice-daily medication or a food elimination diet. But overall, our more established therapies should be considered first.” Dr. Katzka emphasized the need to further define EoE phenotypes in order to personalize therapy. “There’s likely a group of patients who should go straight to dupilumab, perhaps those marked by factors such as severity, progression, young age, or other atopic disorders. But we have yet to definitively identify this group.” The authors reported no specific funding for this analysis. Dr. Dellon reported research funding and/or consulting fees from multiple pharmaceutical companies, including Regeneron/Sanofi, the developers of dupilumab. Dr. Lee had no competing interests to disclose. Dr. Katzka reported consulting for Medtronic, and is an associate editor for GI & Hepatology News. </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>

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Determinants of Topical Corticosteroid Effectiveness in Eosinophilic Esophagitis in Real‐World Practice

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Key clinical point: Reduced symptom severity and use of budesonide orodispersible tablets and high topical corticosteroid (tC) doses (eg, fluticasone propionate metered dose ≥ 1 mg/day from inhalation devices) are all independent predictors of tC effectiveness in patients with eosinophilic esophagitis (EoE) in the real‐world setting.

Major finding: Corticosteroid treatment proved to be the most important determining factor in achieving clinico-histological remission, with budesonide orodispersible tablets presenting the highest efficacy (adjusted odds ratio [aOR], 18.9; P < .001). High tC doses (aOR, 4.3; P = .03) and lower symptom scores (aOR, 0.9; P = .01) were also significant predictors of tC effectiveness.

Study details: This real-world cross‐sectional analysis of the multicenter EoE CONNECT registry assessed the data on 1456 prescriptions of tC monotherapy used in 866 patients with EoE.

Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.

Source: Laserna‐Mendieta EJ, Navarro P, Casabona-Francés S, et al. Swallowed topical corticosteroids for eosinophilic esophagitis: Utilization and real‐world efficacy from the EoE CONNECT registry. United European Gastroenterol J. Published online January 29, 2024. Source

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Read more about Determinants of Topical Corticosteroid Effectiveness in Eosinophilic Esophagitis in Real‐World Practice

Study details: This real-world cross‐sectional analysis of the multicenter EoE CONNECT registry assessed the data on 1456 prescriptions of tC monotherapy used in 866 patients with EoE.

Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.

Study details: This real-world cross‐sectional analysis of the multicenter EoE CONNECT registry assessed the data on 1456 prescriptions of tC monotherapy used in 866 patients with EoE.

Disclosures: This study did not receive any specific funding. The authors declared no conflicts of interest.

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