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Poor Use of ICD-10 Rheumatology Codes Suggests New Approach Needed for ICD-11 Adoption
Inflammatory arthritis codes increased 30-fold in the transition from the ninth to the 10th revision of the International Classification of Diseases (ICD-9 and -10), yet few were used in clinical practice, according to new research.
Most of the new codes for inflammatory arthritis in ICD-10 were rarely used, if at all, from 2015 to 2021.
“About 10-20 codes were comprising the majority of usage for inflammatory arthritis patients in ICD-10,” first author Justin Zhu, a researcher and medical student at Yale University in New Haven, Connecticut, told this news organization. “The other 380 or 400 codes just weren’t seeing a lot of use.”
The findings show the difficulties of transitioning to a new system, he added, and emphasize the need for additional training to improve adoption of ICD-11. The new coding system launched globally in January 2022, but it is not clear when it will be implemented in the United States.
ICD-10 was launched in the United States in 2015, with the goal of enabling greater specificity in identifying health conditions. For example, the new coding system allowed users to include information on laterality and anatomic location for the first time. The total number of codes increased from 14,500 with ICD-9 to 70,000 with ICD-10, with the number of inflammatory arthritis diagnosis codes growing from 14 to 425.
To see how these ICD-10 codes were utilized compared with ICD-9, Zhu and colleagues used national multi-insurance administrative claims data to find inflammatory arthritis diagnostic codes for over 5.1 million patients. About half were coded in ICD-9, while the remaining half were coded in ICD-10. Mr. Zhu and colleagues defined “higher-usage codes” as those that were used more than 1% of the time.
The findings were published in a research letter in JAMA Network Open on April 18.
For ICD-9, four of the available 14 codes (28.6%) were higher-usage codes. In contrast, only nine of the 425 ICD-10 codes (2.1%) were frequently used. Though ICD-10 allowed for increased granularity in diagnosis, data showed that nonspecific codes were most popular. Of the 20 most used ICD-10 arthritis codes, 65% contained “unspecified or other specified” in its wording.
The researchers also found that there was no significant change in these higher-usage codes throughout the study period from 2015 to 2021, suggesting there was not a detectable learning curve in ICD-10 usage among physicians and coders. They also found that clinician specialty did not change code usage patterns.
“The percentage of codes used was not better for rheumatologists (who might be expected to be more refined users of such codes) than primary care clinicians,” Mr. Zhu and colleagues wrote.
Moving to ICD-11 Brings Challenges as Well as Opportunities
Mr. Zhu noted that the study highlights the challenges of adopting new technological systems into daily practice, which can inform the eventual transition to ICD-11.
“There is this need to emphasize training as well as just invest more in improving adoption of ICD-11,” he said.
Michael Pine, MD, MBA, of MJP Healthcare Innovations, LLC in Evanston, Illinois, added that ICD-11 needs to be more user-friendly to be useful in practice. While ICD-10 allowed for greater granularity in coding, it did not result in “usable granularity, in terms of the things doctors really want to communicate,” he told this news organization.
And the transition to ICD-11 could pose greater challenges; rather than ICD-10’s taxonomy system, ICD-11 is formatted as an ontology.
“Although ICD-11 retains some precoordinated codes that convey multifaceted compound concepts, its structure and syntax also provide for post-coordination, a new feature to the ICD that supports the customized combination of concepts and modifier codes to capture previously inaccessible clinical nuance,” he wrote in a coauthored invited commentary.
This added clinical nuance, however, will potentially make coding more complex, he said. One solution is to automate coding, such that clinicians could input information in a natural clinical format that makes sense to them, which would then be translated into ICD-11 code by a program. (This would then be translated back to the user in the natural clinical format to ensure accuracy.)
This type of process would limit how much any one person would need to know about ICD-11 to code diagnoses effectively, while also taking full advantage of the increasing specificity of the new coding system, he said.
Such a program does not yet exist but could be possible with intensive investment in the transition to ICD-11.
The findings of this study serve as a cautionary tale for future transitions to new systems without considering the importance of user experience and usability, Dr. Pine noted. If the United States takes an approach for the adoption of ICD-11 that is similar to that used for ICD-10, it is likely to be “just another overhyped transition” that will make users unwilling to adopt any new system moving forward out of frustration.
But if the United States takes a different, innovative approach, the opposite could be true.
“In short, the US must decide whether it is time to invest considerable resources and effort into a 21st-century information system that could overcome such hindrances as asymmetric information for decision-making, faulty risk adjustment in performance evaluations and payment formulas, and burdens imposed by current coding and documentation practices,” the commentary reads.
“It will allow us to make the best of what computers do and the best of what clinicians do,” Dr. Pine added, “and get them to work together in ways which would not have been conceivable 50 years ago.”
No information on study funding was provided. Mr. Zhu and Dr. Pine did not disclose any competing interests.
A version of this article appeared on Medscape.com.
Inflammatory arthritis codes increased 30-fold in the transition from the ninth to the 10th revision of the International Classification of Diseases (ICD-9 and -10), yet few were used in clinical practice, according to new research.
Most of the new codes for inflammatory arthritis in ICD-10 were rarely used, if at all, from 2015 to 2021.
“About 10-20 codes were comprising the majority of usage for inflammatory arthritis patients in ICD-10,” first author Justin Zhu, a researcher and medical student at Yale University in New Haven, Connecticut, told this news organization. “The other 380 or 400 codes just weren’t seeing a lot of use.”
The findings show the difficulties of transitioning to a new system, he added, and emphasize the need for additional training to improve adoption of ICD-11. The new coding system launched globally in January 2022, but it is not clear when it will be implemented in the United States.
ICD-10 was launched in the United States in 2015, with the goal of enabling greater specificity in identifying health conditions. For example, the new coding system allowed users to include information on laterality and anatomic location for the first time. The total number of codes increased from 14,500 with ICD-9 to 70,000 with ICD-10, with the number of inflammatory arthritis diagnosis codes growing from 14 to 425.
To see how these ICD-10 codes were utilized compared with ICD-9, Zhu and colleagues used national multi-insurance administrative claims data to find inflammatory arthritis diagnostic codes for over 5.1 million patients. About half were coded in ICD-9, while the remaining half were coded in ICD-10. Mr. Zhu and colleagues defined “higher-usage codes” as those that were used more than 1% of the time.
The findings were published in a research letter in JAMA Network Open on April 18.
For ICD-9, four of the available 14 codes (28.6%) were higher-usage codes. In contrast, only nine of the 425 ICD-10 codes (2.1%) were frequently used. Though ICD-10 allowed for increased granularity in diagnosis, data showed that nonspecific codes were most popular. Of the 20 most used ICD-10 arthritis codes, 65% contained “unspecified or other specified” in its wording.
The researchers also found that there was no significant change in these higher-usage codes throughout the study period from 2015 to 2021, suggesting there was not a detectable learning curve in ICD-10 usage among physicians and coders. They also found that clinician specialty did not change code usage patterns.
“The percentage of codes used was not better for rheumatologists (who might be expected to be more refined users of such codes) than primary care clinicians,” Mr. Zhu and colleagues wrote.
Moving to ICD-11 Brings Challenges as Well as Opportunities
Mr. Zhu noted that the study highlights the challenges of adopting new technological systems into daily practice, which can inform the eventual transition to ICD-11.
“There is this need to emphasize training as well as just invest more in improving adoption of ICD-11,” he said.
Michael Pine, MD, MBA, of MJP Healthcare Innovations, LLC in Evanston, Illinois, added that ICD-11 needs to be more user-friendly to be useful in practice. While ICD-10 allowed for greater granularity in coding, it did not result in “usable granularity, in terms of the things doctors really want to communicate,” he told this news organization.
And the transition to ICD-11 could pose greater challenges; rather than ICD-10’s taxonomy system, ICD-11 is formatted as an ontology.
“Although ICD-11 retains some precoordinated codes that convey multifaceted compound concepts, its structure and syntax also provide for post-coordination, a new feature to the ICD that supports the customized combination of concepts and modifier codes to capture previously inaccessible clinical nuance,” he wrote in a coauthored invited commentary.
This added clinical nuance, however, will potentially make coding more complex, he said. One solution is to automate coding, such that clinicians could input information in a natural clinical format that makes sense to them, which would then be translated into ICD-11 code by a program. (This would then be translated back to the user in the natural clinical format to ensure accuracy.)
This type of process would limit how much any one person would need to know about ICD-11 to code diagnoses effectively, while also taking full advantage of the increasing specificity of the new coding system, he said.
Such a program does not yet exist but could be possible with intensive investment in the transition to ICD-11.
The findings of this study serve as a cautionary tale for future transitions to new systems without considering the importance of user experience and usability, Dr. Pine noted. If the United States takes an approach for the adoption of ICD-11 that is similar to that used for ICD-10, it is likely to be “just another overhyped transition” that will make users unwilling to adopt any new system moving forward out of frustration.
But if the United States takes a different, innovative approach, the opposite could be true.
“In short, the US must decide whether it is time to invest considerable resources and effort into a 21st-century information system that could overcome such hindrances as asymmetric information for decision-making, faulty risk adjustment in performance evaluations and payment formulas, and burdens imposed by current coding and documentation practices,” the commentary reads.
“It will allow us to make the best of what computers do and the best of what clinicians do,” Dr. Pine added, “and get them to work together in ways which would not have been conceivable 50 years ago.”
No information on study funding was provided. Mr. Zhu and Dr. Pine did not disclose any competing interests.
A version of this article appeared on Medscape.com.
Inflammatory arthritis codes increased 30-fold in the transition from the ninth to the 10th revision of the International Classification of Diseases (ICD-9 and -10), yet few were used in clinical practice, according to new research.
Most of the new codes for inflammatory arthritis in ICD-10 were rarely used, if at all, from 2015 to 2021.
“About 10-20 codes were comprising the majority of usage for inflammatory arthritis patients in ICD-10,” first author Justin Zhu, a researcher and medical student at Yale University in New Haven, Connecticut, told this news organization. “The other 380 or 400 codes just weren’t seeing a lot of use.”
The findings show the difficulties of transitioning to a new system, he added, and emphasize the need for additional training to improve adoption of ICD-11. The new coding system launched globally in January 2022, but it is not clear when it will be implemented in the United States.
ICD-10 was launched in the United States in 2015, with the goal of enabling greater specificity in identifying health conditions. For example, the new coding system allowed users to include information on laterality and anatomic location for the first time. The total number of codes increased from 14,500 with ICD-9 to 70,000 with ICD-10, with the number of inflammatory arthritis diagnosis codes growing from 14 to 425.
To see how these ICD-10 codes were utilized compared with ICD-9, Zhu and colleagues used national multi-insurance administrative claims data to find inflammatory arthritis diagnostic codes for over 5.1 million patients. About half were coded in ICD-9, while the remaining half were coded in ICD-10. Mr. Zhu and colleagues defined “higher-usage codes” as those that were used more than 1% of the time.
The findings were published in a research letter in JAMA Network Open on April 18.
For ICD-9, four of the available 14 codes (28.6%) were higher-usage codes. In contrast, only nine of the 425 ICD-10 codes (2.1%) were frequently used. Though ICD-10 allowed for increased granularity in diagnosis, data showed that nonspecific codes were most popular. Of the 20 most used ICD-10 arthritis codes, 65% contained “unspecified or other specified” in its wording.
The researchers also found that there was no significant change in these higher-usage codes throughout the study period from 2015 to 2021, suggesting there was not a detectable learning curve in ICD-10 usage among physicians and coders. They also found that clinician specialty did not change code usage patterns.
“The percentage of codes used was not better for rheumatologists (who might be expected to be more refined users of such codes) than primary care clinicians,” Mr. Zhu and colleagues wrote.
Moving to ICD-11 Brings Challenges as Well as Opportunities
Mr. Zhu noted that the study highlights the challenges of adopting new technological systems into daily practice, which can inform the eventual transition to ICD-11.
“There is this need to emphasize training as well as just invest more in improving adoption of ICD-11,” he said.
Michael Pine, MD, MBA, of MJP Healthcare Innovations, LLC in Evanston, Illinois, added that ICD-11 needs to be more user-friendly to be useful in practice. While ICD-10 allowed for greater granularity in coding, it did not result in “usable granularity, in terms of the things doctors really want to communicate,” he told this news organization.
And the transition to ICD-11 could pose greater challenges; rather than ICD-10’s taxonomy system, ICD-11 is formatted as an ontology.
“Although ICD-11 retains some precoordinated codes that convey multifaceted compound concepts, its structure and syntax also provide for post-coordination, a new feature to the ICD that supports the customized combination of concepts and modifier codes to capture previously inaccessible clinical nuance,” he wrote in a coauthored invited commentary.
This added clinical nuance, however, will potentially make coding more complex, he said. One solution is to automate coding, such that clinicians could input information in a natural clinical format that makes sense to them, which would then be translated into ICD-11 code by a program. (This would then be translated back to the user in the natural clinical format to ensure accuracy.)
This type of process would limit how much any one person would need to know about ICD-11 to code diagnoses effectively, while also taking full advantage of the increasing specificity of the new coding system, he said.
Such a program does not yet exist but could be possible with intensive investment in the transition to ICD-11.
The findings of this study serve as a cautionary tale for future transitions to new systems without considering the importance of user experience and usability, Dr. Pine noted. If the United States takes an approach for the adoption of ICD-11 that is similar to that used for ICD-10, it is likely to be “just another overhyped transition” that will make users unwilling to adopt any new system moving forward out of frustration.
But if the United States takes a different, innovative approach, the opposite could be true.
“In short, the US must decide whether it is time to invest considerable resources and effort into a 21st-century information system that could overcome such hindrances as asymmetric information for decision-making, faulty risk adjustment in performance evaluations and payment formulas, and burdens imposed by current coding and documentation practices,” the commentary reads.
“It will allow us to make the best of what computers do and the best of what clinicians do,” Dr. Pine added, “and get them to work together in ways which would not have been conceivable 50 years ago.”
No information on study funding was provided. Mr. Zhu and Dr. Pine did not disclose any competing interests.
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>Inflammatory arthritis codes increased 30-fold in the transition from the ninth to the 10th revision of the International Classification of Diseases (ICD-9 and </metaDescription> <articlePDF/> <teaserImage>301203</teaserImage> <teaser>Inflammatory arthritis codes increased from 14 to 425 from ICD-9 to ICD-10, yet only nine codes were commonly used in practice from 2015 to 2021.</teaser> <title>Poor Use of ICD-10 Rheumatology Codes Suggests New Approach Needed for ICD-11 Adoption</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>rn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">26</term> <term>21</term> </publications> <sections> <term canonical="true">27970</term> <term>39313</term> </sections> <topics> <term canonical="true">289</term> <term>282</term> <term>183</term> <term>299</term> <term>290</term> <term>38029</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012895.jpg</altRep> <description role="drol:caption">Justin Zhu</description> <description role="drol:credit">Yale University</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012896.jpg</altRep> <description role="drol:caption">Dr. Michael Pine</description> <description role="drol:credit"/> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Poor Use of ICD-10 Rheumatology Codes Suggests New Approach Needed for ICD-11 Adoption</title> <deck/> </itemMeta> <itemContent> <p>Inflammatory arthritis codes increased 30-fold in the transition from the ninth to the 10th revision of the International Classification of Diseases (ICD-9 and -10), yet few were used in clinical practice, according to new research.</p> <p>Most of the new codes for inflammatory arthritis in ICD-10 were rarely used, if at all, from 2015 to 2021.<br/><br/>“About 10-20 codes were comprising the majority of usage for inflammatory arthritis patients in ICD-10,” first author Justin Zhu, a researcher and medical student at Yale University in New Haven, Connecticut, told this news organization. “The other 380 or 400 codes just weren’t seeing a lot of use.”<br/><br/>[[{"fid":"301203","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Justin Zhu, a researcher and medical student at Yale University in New Haven, Connecticut","field_file_image_credit[und][0][value]":"Yale University","field_file_image_caption[und][0][value]":"Justin Zhu"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]The findings show the difficulties of transitioning to a new system, he added, and emphasize the need for additional training to improve adoption of ICD-11. The new coding system launched globally in January 2022, but it is not clear when it will be implemented in the United States.<br/><br/>ICD-10 was launched in the United States in 2015, with the goal of enabling greater specificity in identifying health conditions. For example, the new coding system allowed users to include information on laterality and anatomic location for the first time. The total number of codes increased from 14,500 with ICD-9 to 70,000 with ICD-10, with the number of inflammatory arthritis diagnosis codes growing from 14 to 425.<br/><br/>To see how these ICD-10 codes were utilized compared with ICD-9, Zhu and colleagues used national multi-insurance administrative claims data to find inflammatory arthritis diagnostic codes for over 5.1 million patients. About half were coded in ICD-9, while the remaining half were coded in ICD-10. Mr. Zhu and colleagues defined “higher-usage codes” as those that were used more than 1% of the time.<br/><br/>The findings were published in a <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2817816">research letter</a></span> in <em>JAMA Network Open</em> on April 18.<br/><br/>For ICD-9, four of the available 14 codes (28.6%) were higher-usage codes. In contrast, only nine of the 425 ICD-10 codes (2.1%) were frequently used. Though ICD-10 allowed for increased granularity in diagnosis, data showed that nonspecific codes were most popular. Of the 20 most used ICD-10 arthritis codes, 65% contained “unspecified or other specified” in its wording.<br/><br/>The researchers also found that there was no significant change in these higher-usage codes throughout the study period from 2015 to 2021, suggesting there was not a detectable learning curve in ICD-10 usage among physicians and coders. They also found that clinician specialty did not change code usage patterns.<br/><br/>“The percentage of codes used was not better for rheumatologists (who might be expected to be more refined users of such codes) than primary care clinicians,” Mr. Zhu and colleagues wrote.<br/><br/></p> <h2>Moving to ICD-11 Brings Challenges as Well as Opportunities</h2> <p>Mr. Zhu noted that the study highlights the challenges of adopting new technological systems into daily practice, which can inform the eventual transition to ICD-11.</p> <p>“There is this need to emphasize training as well as just invest more in improving adoption of ICD-11,” he said.<br/><br/>Michael Pine, MD, MBA, of MJP Healthcare Innovations, LLC in Evanston, Illinois, added that ICD-11 needs to be more user-friendly to be useful in practice. While ICD-10 allowed for greater granularity in coding, it did not result in “usable granularity, in terms of the things doctors really want to communicate,” he told this news organization.<br/><br/>And the transition to ICD-11 could pose greater challenges; rather than ICD-10’s taxonomy system, ICD-11 is formatted as an ontology.[[{"fid":"301204","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. Michael Pine, of MJP Healthcare Innovations, LLC in Evanston, Illinois","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Michael Pine"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]]<br/><br/>“Although ICD-11 retains some precoordinated codes that convey multifaceted compound concepts, its structure and syntax also provide for post-coordination, a new feature to the ICD that supports the customized combination of concepts and modifier codes to capture previously inaccessible clinical nuance,” he wrote in a coauthored <span class="Hyperlink"><a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2817818">invited commentary</a></span>.<br/><br/>This added clinical nuance, however, will potentially make coding more complex, he said. One solution is to automate coding, such that clinicians could input information in a natural clinical format that makes sense to them, which would then be translated into ICD-11 code by a program. (This would then be translated back to the user in the natural clinical format to ensure accuracy.)<br/><br/>This type of process would limit how much any one person would need to know about ICD-11 to code diagnoses effectively, while also taking full advantage of the increasing specificity of the new coding system, he said.<br/><br/>Such a program does not yet exist but could be possible with intensive investment in the transition to ICD-11.<br/><br/>The findings of this study serve as a cautionary tale for future transitions to new systems without considering the importance of user experience and usability, Dr. Pine noted. If the United States takes an approach for the adoption of ICD-11 that is similar to that used for ICD-10, it is likely to be “just another overhyped transition” that will make users unwilling to adopt any new system moving forward out of frustration.<br/><br/>But if the United States takes a different, innovative approach, the opposite could be true.<br/><br/>“In short, the US must decide whether it is time to invest considerable resources and effort into a 21st-century information system that could overcome such hindrances as asymmetric information for decision-making, faulty risk adjustment in performance evaluations and payment formulas, and burdens imposed by current coding and documentation practices,” the commentary reads.<br/><br/>“It will allow us to make the best of what computers do and the best of what clinicians do,” Dr. Pine added, “and get them to work together in ways which would not have been conceivable 50 years ago.”<br/><br/>No information on study funding was provided. Mr. Zhu and Dr. Pine did not disclose any competing interests.<br/><br/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/rheumatology-data-reflect-poor-adoption-icd-10-2024a100085t?src=">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
FROM JAMA NETWORK OPEN
Commentary: Comparisons Among PsA Therapies, May 2024
Bimekizumab is a novel biologic therapy that inhibits interleukin (IL)–17A and IL-17F and is efficacious in the treatment of psoriasis, PsA, and axial spondyloarthritis. In the absence of a formal head-to-head study, matching-adjusted indirect comparison is a method to evaluate comparative effectiveness. Warren and colleagues ran a study that included biological DMARD-naive patients and patients with inadequate response to tumor necrosis factor inhibitors (TNFi-IR) with PsA who received bimekizumab (160 mg every 4 weeks; 431 and 267 patients, respectively) and guselkumab (100 mg every 4 weeks or every 8 weeks; 495 and 189 patients, respectively). They demonstrate that in biological DMARD-naive patients, bimekizumab was associated with a greater likelihood of achieving ≥70% improvement in American College of Rheumatology (ACR) response and minimal disease activity outcome at week 52 compared with guselkumab. Similar outcomes were observed in the TNFi-IR subgroup. Thus, bimekizumab may be more effective than guselkumab in PsA. Formal head-to-head studies comparing bimekizumab vs guselkumab are required.
With the availability of multiple targeted therapies for PsA, choosing the most effective and safe drug for a patient is difficult, especially in the absence of many head-to-head clinical trials. To help address this problem, Lin and Ren conducted a network meta-analysis of head-to-head active comparison studies in PsA. They included 17 studies in their analysis and demonstrated that Janus kinase inhibitors had the highest probability of achieving ACR 20/50/70 response. Treatment with IL-17A inhibitors was more likely than TNFi therapy to lead to resolution of enthesitis and dactylitis and achieving combined ACR 50 and Psoriasis Area Severity Index 100 response. Patients receiving phosphodiesterase 4 inhibitors were least likely to have adverse events. They conclude that when both efficacy and safety are considered, IL-17A inhibitors may be the better agent for initial therapy for PsA. IL-17A inhibitors are indeed safe and efficacious in PsA; more direct head-to-head comparisons as well as strategy trials are required to determine choice of first and subsequent therapy in PsA.
Infections are the most important adverse effects of targeted therapies. The risk for infection in PsA in real-world settings is not well known. In a cohort study that included 12,071 patients with PsA from the French national health insurance database who were new users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab pegol, infliximab, secukinumab, ixekizumab, ustekinumab, and tofacitinib), Bastard and colleagues demonstrated that the incidence of serious infections in users of targeted therapies was 17.0 per 1000 person-years. Compared with new users of adalimumab, the risk for serious infections was significantly lower in new users of etanercept (weighted hazard ratio [wHR] 0.72; 95% CI 0.53-0.97) and ustekinumab (wHR 0.57; 95% CI 0.35-0.93). Thus, the overall risk for serious infections is low, with etanercept and ustekinumab being safer treatment options than adalimumab.
Bimekizumab is a novel biologic therapy that inhibits interleukin (IL)–17A and IL-17F and is efficacious in the treatment of psoriasis, PsA, and axial spondyloarthritis. In the absence of a formal head-to-head study, matching-adjusted indirect comparison is a method to evaluate comparative effectiveness. Warren and colleagues ran a study that included biological DMARD-naive patients and patients with inadequate response to tumor necrosis factor inhibitors (TNFi-IR) with PsA who received bimekizumab (160 mg every 4 weeks; 431 and 267 patients, respectively) and guselkumab (100 mg every 4 weeks or every 8 weeks; 495 and 189 patients, respectively). They demonstrate that in biological DMARD-naive patients, bimekizumab was associated with a greater likelihood of achieving ≥70% improvement in American College of Rheumatology (ACR) response and minimal disease activity outcome at week 52 compared with guselkumab. Similar outcomes were observed in the TNFi-IR subgroup. Thus, bimekizumab may be more effective than guselkumab in PsA. Formal head-to-head studies comparing bimekizumab vs guselkumab are required.
With the availability of multiple targeted therapies for PsA, choosing the most effective and safe drug for a patient is difficult, especially in the absence of many head-to-head clinical trials. To help address this problem, Lin and Ren conducted a network meta-analysis of head-to-head active comparison studies in PsA. They included 17 studies in their analysis and demonstrated that Janus kinase inhibitors had the highest probability of achieving ACR 20/50/70 response. Treatment with IL-17A inhibitors was more likely than TNFi therapy to lead to resolution of enthesitis and dactylitis and achieving combined ACR 50 and Psoriasis Area Severity Index 100 response. Patients receiving phosphodiesterase 4 inhibitors were least likely to have adverse events. They conclude that when both efficacy and safety are considered, IL-17A inhibitors may be the better agent for initial therapy for PsA. IL-17A inhibitors are indeed safe and efficacious in PsA; more direct head-to-head comparisons as well as strategy trials are required to determine choice of first and subsequent therapy in PsA.
Infections are the most important adverse effects of targeted therapies. The risk for infection in PsA in real-world settings is not well known. In a cohort study that included 12,071 patients with PsA from the French national health insurance database who were new users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab pegol, infliximab, secukinumab, ixekizumab, ustekinumab, and tofacitinib), Bastard and colleagues demonstrated that the incidence of serious infections in users of targeted therapies was 17.0 per 1000 person-years. Compared with new users of adalimumab, the risk for serious infections was significantly lower in new users of etanercept (weighted hazard ratio [wHR] 0.72; 95% CI 0.53-0.97) and ustekinumab (wHR 0.57; 95% CI 0.35-0.93). Thus, the overall risk for serious infections is low, with etanercept and ustekinumab being safer treatment options than adalimumab.
Bimekizumab is a novel biologic therapy that inhibits interleukin (IL)–17A and IL-17F and is efficacious in the treatment of psoriasis, PsA, and axial spondyloarthritis. In the absence of a formal head-to-head study, matching-adjusted indirect comparison is a method to evaluate comparative effectiveness. Warren and colleagues ran a study that included biological DMARD-naive patients and patients with inadequate response to tumor necrosis factor inhibitors (TNFi-IR) with PsA who received bimekizumab (160 mg every 4 weeks; 431 and 267 patients, respectively) and guselkumab (100 mg every 4 weeks or every 8 weeks; 495 and 189 patients, respectively). They demonstrate that in biological DMARD-naive patients, bimekizumab was associated with a greater likelihood of achieving ≥70% improvement in American College of Rheumatology (ACR) response and minimal disease activity outcome at week 52 compared with guselkumab. Similar outcomes were observed in the TNFi-IR subgroup. Thus, bimekizumab may be more effective than guselkumab in PsA. Formal head-to-head studies comparing bimekizumab vs guselkumab are required.
With the availability of multiple targeted therapies for PsA, choosing the most effective and safe drug for a patient is difficult, especially in the absence of many head-to-head clinical trials. To help address this problem, Lin and Ren conducted a network meta-analysis of head-to-head active comparison studies in PsA. They included 17 studies in their analysis and demonstrated that Janus kinase inhibitors had the highest probability of achieving ACR 20/50/70 response. Treatment with IL-17A inhibitors was more likely than TNFi therapy to lead to resolution of enthesitis and dactylitis and achieving combined ACR 50 and Psoriasis Area Severity Index 100 response. Patients receiving phosphodiesterase 4 inhibitors were least likely to have adverse events. They conclude that when both efficacy and safety are considered, IL-17A inhibitors may be the better agent for initial therapy for PsA. IL-17A inhibitors are indeed safe and efficacious in PsA; more direct head-to-head comparisons as well as strategy trials are required to determine choice of first and subsequent therapy in PsA.
Infections are the most important adverse effects of targeted therapies. The risk for infection in PsA in real-world settings is not well known. In a cohort study that included 12,071 patients with PsA from the French national health insurance database who were new users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab pegol, infliximab, secukinumab, ixekizumab, ustekinumab, and tofacitinib), Bastard and colleagues demonstrated that the incidence of serious infections in users of targeted therapies was 17.0 per 1000 person-years. Compared with new users of adalimumab, the risk for serious infections was significantly lower in new users of etanercept (weighted hazard ratio [wHR] 0.72; 95% CI 0.53-0.97) and ustekinumab (wHR 0.57; 95% CI 0.35-0.93). Thus, the overall risk for serious infections is low, with etanercept and ustekinumab being safer treatment options than adalimumab.
Combined Pediatric Derm-Rheum Clinics Supported by Survey Respondents
TOPLINE:
.
METHODOLOGY:
- Combined pediatric dermatology-rheumatology clinics can improve patient outcomes and experiences, particularly for pediatric autoimmune conditions presenting with both cutaneous and systemic manifestations.
- The researchers surveyed 208 pediatric dermatologists working in combined pediatric dermatology-rheumatology clinics.
- A total of 13 member responses were recorded from three countries: 10 from the United States, two from Mexico, and one from Canada.
TAKEAWAY:
- Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.
- Patient satisfaction was favorable, and patients and families endorsed the combined clinic approach.
- Barriers to clinic establishment included differences in the pace between dermatology and rheumatology clinic flow, the need to generate more relative value units, resistance from colleagues, and limited time.
- Areas that needed improvement included more time for patient visits, dedicated research assistants, new patient referrals, additional patient rooms, resources for research, and patient care infrastructure.
IN PRACTICE:
The insights from this survey “will hopefully inspire further development of these combined clinics,” the authors wrote.
SOURCE:
The investigation, led by Olga S. Cherepakhin, BS, University of Washington, Seattle, Washington, was published in Pediatric Dermatology.
LIMITATIONS:
Limitations included the subjective nature, lack of some information, selection bias, and small number of respondents, and the survey reflected the perspective of the pediatric dermatologists only.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. One author reported full-time employment at Janssen R&D, and the other authors had no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- Combined pediatric dermatology-rheumatology clinics can improve patient outcomes and experiences, particularly for pediatric autoimmune conditions presenting with both cutaneous and systemic manifestations.
- The researchers surveyed 208 pediatric dermatologists working in combined pediatric dermatology-rheumatology clinics.
- A total of 13 member responses were recorded from three countries: 10 from the United States, two from Mexico, and one from Canada.
TAKEAWAY:
- Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.
- Patient satisfaction was favorable, and patients and families endorsed the combined clinic approach.
- Barriers to clinic establishment included differences in the pace between dermatology and rheumatology clinic flow, the need to generate more relative value units, resistance from colleagues, and limited time.
- Areas that needed improvement included more time for patient visits, dedicated research assistants, new patient referrals, additional patient rooms, resources for research, and patient care infrastructure.
IN PRACTICE:
The insights from this survey “will hopefully inspire further development of these combined clinics,” the authors wrote.
SOURCE:
The investigation, led by Olga S. Cherepakhin, BS, University of Washington, Seattle, Washington, was published in Pediatric Dermatology.
LIMITATIONS:
Limitations included the subjective nature, lack of some information, selection bias, and small number of respondents, and the survey reflected the perspective of the pediatric dermatologists only.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. One author reported full-time employment at Janssen R&D, and the other authors had no disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- Combined pediatric dermatology-rheumatology clinics can improve patient outcomes and experiences, particularly for pediatric autoimmune conditions presenting with both cutaneous and systemic manifestations.
- The researchers surveyed 208 pediatric dermatologists working in combined pediatric dermatology-rheumatology clinics.
- A total of 13 member responses were recorded from three countries: 10 from the United States, two from Mexico, and one from Canada.
TAKEAWAY:
- Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.
- Patient satisfaction was favorable, and patients and families endorsed the combined clinic approach.
- Barriers to clinic establishment included differences in the pace between dermatology and rheumatology clinic flow, the need to generate more relative value units, resistance from colleagues, and limited time.
- Areas that needed improvement included more time for patient visits, dedicated research assistants, new patient referrals, additional patient rooms, resources for research, and patient care infrastructure.
IN PRACTICE:
The insights from this survey “will hopefully inspire further development of these combined clinics,” the authors wrote.
SOURCE:
The investigation, led by Olga S. Cherepakhin, BS, University of Washington, Seattle, Washington, was published in Pediatric Dermatology.
LIMITATIONS:
Limitations included the subjective nature, lack of some information, selection bias, and small number of respondents, and the survey reflected the perspective of the pediatric dermatologists only.
DISCLOSURES:
The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. One author reported full-time employment at Janssen R&D, and the other authors had no disclosures.
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>Combined pediatric dermatology-rheumatology clinics can improve patient care and patient satisfaction, a survey of dermatologists suggested</metaDescription> <articlePDF/> <teaserImage/> <teaser>Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.</teaser> <title>Combined Pediatric Derm-Rheum Clinics Supported by Survey Respondents</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>skin</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> <publicationData> <publicationCode>pn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>rn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> <term>15</term> <term>21</term> <term>25</term> <term>26</term> </publications> <sections> <term canonical="true">39313</term> <term>27970</term> </sections> <topics> <term canonical="true">271</term> <term>281</term> <term>29134</term> <term>282</term> <term>203</term> <term>290</term> <term>176</term> <term>299</term> <term>241</term> <term>38029</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Combined Pediatric Derm-Rheum Clinics Supported by Survey Respondents</title> <deck/> </itemMeta> <itemContent> <h2>TOPLINE:</h2> <p><span class="tag metaDescription">Combined pediatric dermatology-rheumatology clinics can improve patient care and patient satisfaction, a survey of dermatologists suggested</span>.</p> <h2>METHODOLOGY:</h2> <ul class="body"> <li>Combined pediatric dermatology-rheumatology clinics can improve patient outcomes and experiences, particularly for pediatric autoimmune conditions presenting with both cutaneous and systemic manifestations.</li> <li>The researchers surveyed 208 pediatric dermatologists working in combined pediatric dermatology-rheumatology clinics.</li> <li>A total of 13 member responses were recorded from three countries: 10 from the United States, two from Mexico, and one from Canada.</li> </ul> <h2>TAKEAWAY:</h2> <ul class="body"> <li>Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.</li> <li>Patient satisfaction was favorable, and patients and families endorsed the combined clinic approach.</li> <li>Barriers to clinic establishment included differences in the pace between dermatology and rheumatology clinic flow, the need to generate more relative value units, resistance from colleagues, and limited time.</li> <li>Areas that needed improvement included more time for patient visits, dedicated research assistants, new patient referrals, additional patient rooms, resources for research, and patient care infrastructure.</li> </ul> <h2>IN PRACTICE:</h2> <p>The insights from this survey “will hopefully inspire further development of these combined clinics,” the authors wrote.</p> <h2>SOURCE:</h2> <p>The investigation, led by Olga S. Cherepakhin, BS, University of Washington, Seattle, Washington, was <span class="Hyperlink"><a href="https://onlinelibrary.wiley.com/doi/10.1111/pde.15588">published</a></span> in <em>Pediatric Dermatology</em>.</p> <h2>LIMITATIONS:</h2> <p>Limitations included the subjective nature, lack of some information, selection bias, and small number of respondents, and the survey reflected the perspective of the pediatric dermatologists only.</p> <h2>DISCLOSURES:</h2> <p>The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. One author reported full-time employment at Janssen R&D, and the other authors had no disclosures.<span class="end"/></p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/survey-highlights-benefits-pediatric-derm-rheum-clinics-2024a1000756">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Second Ustekinumab Biosimilar Gets FDA Approval
The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.
This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release.
“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release.
The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis.
The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.
Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.
This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release.
“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release.
The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis.
The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.
Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years or older.
This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals.
Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a press release.
“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release.
The first ustekinumab biosimilar, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active Crohn’s disease and ulcerative colitis. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis.
The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.
Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson.
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 US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe plaque psoriasis and p</metaDescription> <articlePDF/> <teaserImage/> <teaser>The biosimilar is expected to be marketed in the United States on or after February 21, 2025.</teaser> <title>Second Ustekinumab Biosimilar Gets FDA Approval</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>2</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>rn</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>skin</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>GIHOLD</publicationCode> <pubIssueName>January 2014</pubIssueName> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> <journalTitle/> <journalFullTitle/> <copyrightStatement/> </publicationData> </publications_g> <publications> <term canonical="true">26</term> <term>13</term> <term>21</term> <term>15</term> </publications> <sections> <term canonical="true">27979</term> <term>39313</term> </sections> <topics> <term canonical="true">282</term> <term>281</term> <term>290</term> <term>203</term> <term>213</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Second Ustekinumab Biosimilar Gets FDA Approval</title> <deck/> </itemMeta> <itemContent> <p>The US Food and Drug Administration (FDA) has approved the biosimilar ustekinumab-aekn (Selarsdi) for the treatment of moderate to severe <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/1108072-overview">plaque psoriasis</a></span> and <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/2196539-overview">psoriatic arthritis</a></span> in adults and pediatric patients aged 6 years or older.</p> <p>This is the second ustekinumab biosimilar approved by the regulatory agency and is the second biosimilar approval in the United States for the Icelandic pharmaceutical company Alvotech in partnership with Teva Pharmaceuticals. <br/><br/>Ustekinumab (Stelara) is a human monoclonal antibody targeting interleukin (IL)–12 and IL-23. The drug, manufactured by Johnson & Johnson, totaled nearly $7 billion in sales in 2023 alone, according a <span class="Hyperlink"><a href="https://www.tevapharm.com/news-and-media/latest-news/alvotech-and-teva-announce-u.s.-fda-approval-of-selarsdi-ustekinumab-aekn-biosimilar-to-stelara-ust/">press release</a></span>. <br/><br/>“Bringing Selarsdi to market in the US early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs,” the chairman and CEO of Alvotech said in the release. <br/><br/>The <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/997961">first ustekinumab biosimilar</a></span>, ustekinumab-auub (Wezlana), was approved by the FDA in on October 31, 2023 and is interchangeable with the reference product. This allows pharmacists to substitute the biosimilar for the reference product without involving the prescribing clinician (according to state law). Besides psoriasis and psoriatic arthritis, ustekinumab-auub was also approved for treating moderate to severely active <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/172940-overview">Crohn’s disease</a></span> and <span class="Hyperlink"><a href="https://emedicine.medscape.com/article/183084-overview">ulcerative colitis</a></span>. Ustekinumab-aekn does not have an interchangeability designation and was not approved for Crohn’s disease or ulcerative colitis. <br/><br/>The approval of ustekinumab-aekn was based on two clinical studies. A randomized, double blind, multicenter, 52-week study of 581 patients with moderate to severe plaque psoriasis demonstrated that the biosimilar was as effective as the reference product, with equivalent safety and immunogenicity profiles. A phase 1, randomized, double-blind, single-dose, parallel-group, three-arm study also compared the pharmacokinetic profile of the biosimilar to ustekinumab in 294 healthy adults.<br/><br/>Ustekinumab-aekn is expected to be marketed in the United States on or after February 21, 2025 per a settlement and license agreement with Johnson & Johnson.<span class="end"/> </p> <p> <em>A version of this article appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/fda-approves-second-ustekinumab-biosimilar-2024a10007ge?src=">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>
Clinical Characteristics of Severe PsA
Key clinical point: Patients with psoriatic arthritis (PsA) who had severe vs non-severe disease according to the modified Composite Psoriatic Disease Activity Index (mCPDAI) showed higher disease activity, experienced more pain, and had higher disease impact both at baseline and during follow-up.
Major finding: At baseline, 36.1% of patients had severe PsA as assessed by mCPDAI. A significantly higher disease activity, disease impact, number of tender or swollen joints, and pain and reduced function were observed in patients with severe vs non-severe disease at baseline and follow-up (all P < .01). Male sex and severity of skin involvement at baseline were the factors associated with the severe PsA at last follow-up (both P ≤ .01).
Study details: This retrospective analysis of a longitudinal study included 177 patients with peripheral PsA who were followed for at least 1 year.
Disclosures: This study did not receive any funding or sponsorship. Ennio Lubrano and Fabio Perrotta declared being members of the editorial board of Rheumatology and Therapy. Silvia Scriffignano declared no conflicts of interest.
Source: Lubrano E, Scriffignano S, Perrotta FM. Clinical characteristics of "severe" peripheral psoriatic arthritis: A retrospective analysis of a longitudinal cohort. Rheumatol Ther. 2024 (Apr 9). doi: 10.1007/s40744-024-00667-0 Source
Key clinical point: Patients with psoriatic arthritis (PsA) who had severe vs non-severe disease according to the modified Composite Psoriatic Disease Activity Index (mCPDAI) showed higher disease activity, experienced more pain, and had higher disease impact both at baseline and during follow-up.
Major finding: At baseline, 36.1% of patients had severe PsA as assessed by mCPDAI. A significantly higher disease activity, disease impact, number of tender or swollen joints, and pain and reduced function were observed in patients with severe vs non-severe disease at baseline and follow-up (all P < .01). Male sex and severity of skin involvement at baseline were the factors associated with the severe PsA at last follow-up (both P ≤ .01).
Study details: This retrospective analysis of a longitudinal study included 177 patients with peripheral PsA who were followed for at least 1 year.
Disclosures: This study did not receive any funding or sponsorship. Ennio Lubrano and Fabio Perrotta declared being members of the editorial board of Rheumatology and Therapy. Silvia Scriffignano declared no conflicts of interest.
Source: Lubrano E, Scriffignano S, Perrotta FM. Clinical characteristics of "severe" peripheral psoriatic arthritis: A retrospective analysis of a longitudinal cohort. Rheumatol Ther. 2024 (Apr 9). doi: 10.1007/s40744-024-00667-0 Source
Key clinical point: Patients with psoriatic arthritis (PsA) who had severe vs non-severe disease according to the modified Composite Psoriatic Disease Activity Index (mCPDAI) showed higher disease activity, experienced more pain, and had higher disease impact both at baseline and during follow-up.
Major finding: At baseline, 36.1% of patients had severe PsA as assessed by mCPDAI. A significantly higher disease activity, disease impact, number of tender or swollen joints, and pain and reduced function were observed in patients with severe vs non-severe disease at baseline and follow-up (all P < .01). Male sex and severity of skin involvement at baseline were the factors associated with the severe PsA at last follow-up (both P ≤ .01).
Study details: This retrospective analysis of a longitudinal study included 177 patients with peripheral PsA who were followed for at least 1 year.
Disclosures: This study did not receive any funding or sponsorship. Ennio Lubrano and Fabio Perrotta declared being members of the editorial board of Rheumatology and Therapy. Silvia Scriffignano declared no conflicts of interest.
Source: Lubrano E, Scriffignano S, Perrotta FM. Clinical characteristics of "severe" peripheral psoriatic arthritis: A retrospective analysis of a longitudinal cohort. Rheumatol Ther. 2024 (Apr 9). doi: 10.1007/s40744-024-00667-0 Source
Meta-Analysis Identifies IL17A Inhibitor as a Better Treatment Option in Biologic-Naive Patients with PsA
Key clinical point: Treatment with an interleukin-17A inhibitor (IL-17Ai) may be desirable in biologic-naive patients with psoriatic arthritis (PsA) as it proved to be more effective and safer compared with other biologics.
Major finding: A higher number of patients achieved the composite endpoint of ≥50% improvement in American College of Rheumatology and 100% improvement in Psoriasis Area Severity Index (pooled risk ratio [RR] 1.56; 95% CI 1.29-1.88; P < .001) and enthesitis resolution (pooled RR 1.22; 95% CI 1.02-1.47) with IL17Ai vs TNFi. The probability of adverse events was the lowest with phosphodiesterase-4 inhibitor (PDE4i) followed by IL-17Ai.
Study details: Findings are from a network meta-analysis of 17 studies including biologic-naive patients with PsA treated with IL inhibitor, TNFi, PDE4i, and Janus kinase inhibitors.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lin J, Ren Y. Different biologics for biological-naïve patients with psoriatic arthritis: A systematic review and network meta-analysis. Front Pharmacol. 2024;15:1279525 (Mar 12). doi: 10.3389/fphar.2024.1279525 Source
Key clinical point: Treatment with an interleukin-17A inhibitor (IL-17Ai) may be desirable in biologic-naive patients with psoriatic arthritis (PsA) as it proved to be more effective and safer compared with other biologics.
Major finding: A higher number of patients achieved the composite endpoint of ≥50% improvement in American College of Rheumatology and 100% improvement in Psoriasis Area Severity Index (pooled risk ratio [RR] 1.56; 95% CI 1.29-1.88; P < .001) and enthesitis resolution (pooled RR 1.22; 95% CI 1.02-1.47) with IL17Ai vs TNFi. The probability of adverse events was the lowest with phosphodiesterase-4 inhibitor (PDE4i) followed by IL-17Ai.
Study details: Findings are from a network meta-analysis of 17 studies including biologic-naive patients with PsA treated with IL inhibitor, TNFi, PDE4i, and Janus kinase inhibitors.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lin J, Ren Y. Different biologics for biological-naïve patients with psoriatic arthritis: A systematic review and network meta-analysis. Front Pharmacol. 2024;15:1279525 (Mar 12). doi: 10.3389/fphar.2024.1279525 Source
Key clinical point: Treatment with an interleukin-17A inhibitor (IL-17Ai) may be desirable in biologic-naive patients with psoriatic arthritis (PsA) as it proved to be more effective and safer compared with other biologics.
Major finding: A higher number of patients achieved the composite endpoint of ≥50% improvement in American College of Rheumatology and 100% improvement in Psoriasis Area Severity Index (pooled risk ratio [RR] 1.56; 95% CI 1.29-1.88; P < .001) and enthesitis resolution (pooled RR 1.22; 95% CI 1.02-1.47) with IL17Ai vs TNFi. The probability of adverse events was the lowest with phosphodiesterase-4 inhibitor (PDE4i) followed by IL-17Ai.
Study details: Findings are from a network meta-analysis of 17 studies including biologic-naive patients with PsA treated with IL inhibitor, TNFi, PDE4i, and Janus kinase inhibitors.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Lin J, Ren Y. Different biologics for biological-naïve patients with psoriatic arthritis: A systematic review and network meta-analysis. Front Pharmacol. 2024;15:1279525 (Mar 12). doi: 10.3389/fphar.2024.1279525 Source
Real World Study Confirms Efficacy of Risankizumab in PsA
Key clinical point: Risankizumab led to considerable improvements in skin- and joint-associated clinical outcomes in patients with psoriatic arthritis (PsA) who were followed-up for >28 weeks.
Major finding: Of the 31 patients with clinical disease activity index for PsA > 4 at baseline, 11 patients achieved remission at a follow-up visit between 28 and 40 weeks (P < .004). Risankizumab also led to a significant reduction in the mean psoriasis area severity index score between weeks 28 and 40 vs baseline (0.3 vs 8.4; P < .001).
Study details: Findings are from a prospective, multicenter real-world study including 40 patients with PsA who were treated with 150 mg risankizumab at week 0 and week 4 and every 12 weeks subsequently.
Disclosures: This study did not receive any funding. Five authors declared receiving consulting fees or honoraria from or having other ties with various sources. The other authors declared no conflicts of interest.
Source: Graceffa D, Zangrilli A, Caldarola G, et al. Effectiveness of risankizumab for the treatment of psoriatic arthritis: A multicenter, real-world study. Int J Dermatol. 2024 (Apr 7). doi: 10.1111/ijd.17156 Source
Key clinical point: Risankizumab led to considerable improvements in skin- and joint-associated clinical outcomes in patients with psoriatic arthritis (PsA) who were followed-up for >28 weeks.
Major finding: Of the 31 patients with clinical disease activity index for PsA > 4 at baseline, 11 patients achieved remission at a follow-up visit between 28 and 40 weeks (P < .004). Risankizumab also led to a significant reduction in the mean psoriasis area severity index score between weeks 28 and 40 vs baseline (0.3 vs 8.4; P < .001).
Study details: Findings are from a prospective, multicenter real-world study including 40 patients with PsA who were treated with 150 mg risankizumab at week 0 and week 4 and every 12 weeks subsequently.
Disclosures: This study did not receive any funding. Five authors declared receiving consulting fees or honoraria from or having other ties with various sources. The other authors declared no conflicts of interest.
Source: Graceffa D, Zangrilli A, Caldarola G, et al. Effectiveness of risankizumab for the treatment of psoriatic arthritis: A multicenter, real-world study. Int J Dermatol. 2024 (Apr 7). doi: 10.1111/ijd.17156 Source
Key clinical point: Risankizumab led to considerable improvements in skin- and joint-associated clinical outcomes in patients with psoriatic arthritis (PsA) who were followed-up for >28 weeks.
Major finding: Of the 31 patients with clinical disease activity index for PsA > 4 at baseline, 11 patients achieved remission at a follow-up visit between 28 and 40 weeks (P < .004). Risankizumab also led to a significant reduction in the mean psoriasis area severity index score between weeks 28 and 40 vs baseline (0.3 vs 8.4; P < .001).
Study details: Findings are from a prospective, multicenter real-world study including 40 patients with PsA who were treated with 150 mg risankizumab at week 0 and week 4 and every 12 weeks subsequently.
Disclosures: This study did not receive any funding. Five authors declared receiving consulting fees or honoraria from or having other ties with various sources. The other authors declared no conflicts of interest.
Source: Graceffa D, Zangrilli A, Caldarola G, et al. Effectiveness of risankizumab for the treatment of psoriatic arthritis: A multicenter, real-world study. Int J Dermatol. 2024 (Apr 7). doi: 10.1111/ijd.17156 Source
Bone Erosions Highly Prevalent in Early, Untreated PsA
Key clinical point: A quarter of patients with early psoriatic arthritis who were naive to disease-modifying antirheumatic drugs (DMARD) reported bone erosions, with a decreased prevalence being observed in patients with shorter duration of PsA symptoms (<8 months).
Major finding: Overall, 4655 hand and feet joints were assessed in 122 patients, of whom 24.6% patients had bone erosions at baseline, with higher Disease Activity features observed in patients who did vs did not have bone erosions (P < .05). Prevalence of erosion was less in patients who had a <8 months vs >24 months of PsA symptoms (17.5% vs 24.3%).
Study details: This study included 122 newly diagnosed, DMARD-naive patients with early PsA from the Leeds Spondyloarthropathy Register for Research and Observation cohort who were assessed for bone erosions using conventional radiography or ultrasound.
Disclosures: This study was supported by the UK National Institute for Health Research Leeds Biomedical Research Centre. Sayam R. Dubash received support from Leeds Cares charity. The other authors declared no conflicts of interest.
Source: Hen O, Di Matteo A, Dubash SR, et al. High prevalence of radiographic erosions in early, untreated PsA: Results from the SpARRO cohort. RMD Open. 2024;10:e003841 (Apr 5). doi: 10.1136/rmdopen-2023-003841 Source
Key clinical point: A quarter of patients with early psoriatic arthritis who were naive to disease-modifying antirheumatic drugs (DMARD) reported bone erosions, with a decreased prevalence being observed in patients with shorter duration of PsA symptoms (<8 months).
Major finding: Overall, 4655 hand and feet joints were assessed in 122 patients, of whom 24.6% patients had bone erosions at baseline, with higher Disease Activity features observed in patients who did vs did not have bone erosions (P < .05). Prevalence of erosion was less in patients who had a <8 months vs >24 months of PsA symptoms (17.5% vs 24.3%).
Study details: This study included 122 newly diagnosed, DMARD-naive patients with early PsA from the Leeds Spondyloarthropathy Register for Research and Observation cohort who were assessed for bone erosions using conventional radiography or ultrasound.
Disclosures: This study was supported by the UK National Institute for Health Research Leeds Biomedical Research Centre. Sayam R. Dubash received support from Leeds Cares charity. The other authors declared no conflicts of interest.
Source: Hen O, Di Matteo A, Dubash SR, et al. High prevalence of radiographic erosions in early, untreated PsA: Results from the SpARRO cohort. RMD Open. 2024;10:e003841 (Apr 5). doi: 10.1136/rmdopen-2023-003841 Source
Key clinical point: A quarter of patients with early psoriatic arthritis who were naive to disease-modifying antirheumatic drugs (DMARD) reported bone erosions, with a decreased prevalence being observed in patients with shorter duration of PsA symptoms (<8 months).
Major finding: Overall, 4655 hand and feet joints were assessed in 122 patients, of whom 24.6% patients had bone erosions at baseline, with higher Disease Activity features observed in patients who did vs did not have bone erosions (P < .05). Prevalence of erosion was less in patients who had a <8 months vs >24 months of PsA symptoms (17.5% vs 24.3%).
Study details: This study included 122 newly diagnosed, DMARD-naive patients with early PsA from the Leeds Spondyloarthropathy Register for Research and Observation cohort who were assessed for bone erosions using conventional radiography or ultrasound.
Disclosures: This study was supported by the UK National Institute for Health Research Leeds Biomedical Research Centre. Sayam R. Dubash received support from Leeds Cares charity. The other authors declared no conflicts of interest.
Source: Hen O, Di Matteo A, Dubash SR, et al. High prevalence of radiographic erosions in early, untreated PsA: Results from the SpARRO cohort. RMD Open. 2024;10:e003841 (Apr 5). doi: 10.1136/rmdopen-2023-003841 Source
Deucravacitinib Improves Patient-Reported Outcomes in PsA
Key clinical point: Deucravacitinib improved patient-reported outcomes (PRO) for physical and social functioning, mental health, fatigue, and pain in patients with active psoriatic arthritis (PsA).
Major finding: At week 16, 6 mg deucravacitinib vs placebo led to significant changes in functional ability as assessed by the Health Assessment Questionnaire-Disability Index (−0.26; 95% CI −0.42 to −0.10) and the 36-Item Short-Form Health Survey physical component summary (3.3; 95% CI 0.9 to 5.7), with similar outcomes for 12 mg deucravacitinib. Improvements were also noted in mental health and quality of life at week 16 with deucravacitinib vs placebo.
Study details: Findings are from a phase 2, double-blind trial that included 203 patients with active PsA who were randomly assigned (1:1:1) to receive 6 mg deucravacitinib daily (n = 70), 12 mg deucravacitinib daily (n = 67), or placebo (n = 66) for 16 weeks.
Disclosures: This study was sponsored by Bristol Myers Squibb. The authors declared no conflicts of interest.
Source: Strand V, Gossec L, Coates LC, et al. Improvements in patient-reported outcomes after treatment with deucravacitinib in patients with psoriatic arthritis: Results from a randomized phase 2 trial. Arthritis Care Res (Hoboken). 2024 (Mar 26). doi: 10.1002/acr.25333 Source
Key clinical point: Deucravacitinib improved patient-reported outcomes (PRO) for physical and social functioning, mental health, fatigue, and pain in patients with active psoriatic arthritis (PsA).
Major finding: At week 16, 6 mg deucravacitinib vs placebo led to significant changes in functional ability as assessed by the Health Assessment Questionnaire-Disability Index (−0.26; 95% CI −0.42 to −0.10) and the 36-Item Short-Form Health Survey physical component summary (3.3; 95% CI 0.9 to 5.7), with similar outcomes for 12 mg deucravacitinib. Improvements were also noted in mental health and quality of life at week 16 with deucravacitinib vs placebo.
Study details: Findings are from a phase 2, double-blind trial that included 203 patients with active PsA who were randomly assigned (1:1:1) to receive 6 mg deucravacitinib daily (n = 70), 12 mg deucravacitinib daily (n = 67), or placebo (n = 66) for 16 weeks.
Disclosures: This study was sponsored by Bristol Myers Squibb. The authors declared no conflicts of interest.
Source: Strand V, Gossec L, Coates LC, et al. Improvements in patient-reported outcomes after treatment with deucravacitinib in patients with psoriatic arthritis: Results from a randomized phase 2 trial. Arthritis Care Res (Hoboken). 2024 (Mar 26). doi: 10.1002/acr.25333 Source
Key clinical point: Deucravacitinib improved patient-reported outcomes (PRO) for physical and social functioning, mental health, fatigue, and pain in patients with active psoriatic arthritis (PsA).
Major finding: At week 16, 6 mg deucravacitinib vs placebo led to significant changes in functional ability as assessed by the Health Assessment Questionnaire-Disability Index (−0.26; 95% CI −0.42 to −0.10) and the 36-Item Short-Form Health Survey physical component summary (3.3; 95% CI 0.9 to 5.7), with similar outcomes for 12 mg deucravacitinib. Improvements were also noted in mental health and quality of life at week 16 with deucravacitinib vs placebo.
Study details: Findings are from a phase 2, double-blind trial that included 203 patients with active PsA who were randomly assigned (1:1:1) to receive 6 mg deucravacitinib daily (n = 70), 12 mg deucravacitinib daily (n = 67), or placebo (n = 66) for 16 weeks.
Disclosures: This study was sponsored by Bristol Myers Squibb. The authors declared no conflicts of interest.
Source: Strand V, Gossec L, Coates LC, et al. Improvements in patient-reported outcomes after treatment with deucravacitinib in patients with psoriatic arthritis: Results from a randomized phase 2 trial. Arthritis Care Res (Hoboken). 2024 (Mar 26). doi: 10.1002/acr.25333 Source
Enthesitis or Dactylitis Remission Associated with Improved Patient-Reported Outcomes in PsA
Key clinical point: Among biologic-naive, guselkumab-treated patients with psoriatic arthritis (PsA), enthesitis resolution (ER) was associated with dactylitis resolution (DR), and those achieving ER or DR showed improvements in patient-reported outcomes.
Major finding: At weeks 24, 52, and 100, guselkumab-treated patients who achieved DR were more likely to achieve ER, and vice versa (all P < .05). At week 24, a higher proportion of patients who did vs did not achieve ER reported minimal pain (30%-45% vs 11%-21%; all P < .001), with similar pain outcomes in patients who did vs did not achieve DR.
Study details: This post hoc analysis included 739 biologic-naive patients with PsA who were randomly assigned to receive guselkumab (100 mg every 4 or 8 weeks) or placebo with crossover to guselkumab (100 mg every 4 weeks) at week 24, of whom 68.6% and 44.9% of patients had enthesitis and dactylitis, respectively.
Disclosures: This study was supported by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owning Johnson and Johnson stock or stock options. The other authors declared receiving consulting fees from or having other ties with various sources, including Janssen.
Source: Rahman P, McInnes IB, Deodhar A, et al. Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis. Clin Rheumatol. 2024;43:1591-1604 (Mar 12). doi: 10.1007/s10067-024-06921-8 Source
Key clinical point: Among biologic-naive, guselkumab-treated patients with psoriatic arthritis (PsA), enthesitis resolution (ER) was associated with dactylitis resolution (DR), and those achieving ER or DR showed improvements in patient-reported outcomes.
Major finding: At weeks 24, 52, and 100, guselkumab-treated patients who achieved DR were more likely to achieve ER, and vice versa (all P < .05). At week 24, a higher proportion of patients who did vs did not achieve ER reported minimal pain (30%-45% vs 11%-21%; all P < .001), with similar pain outcomes in patients who did vs did not achieve DR.
Study details: This post hoc analysis included 739 biologic-naive patients with PsA who were randomly assigned to receive guselkumab (100 mg every 4 or 8 weeks) or placebo with crossover to guselkumab (100 mg every 4 weeks) at week 24, of whom 68.6% and 44.9% of patients had enthesitis and dactylitis, respectively.
Disclosures: This study was supported by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owning Johnson and Johnson stock or stock options. The other authors declared receiving consulting fees from or having other ties with various sources, including Janssen.
Source: Rahman P, McInnes IB, Deodhar A, et al. Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis. Clin Rheumatol. 2024;43:1591-1604 (Mar 12). doi: 10.1007/s10067-024-06921-8 Source
Key clinical point: Among biologic-naive, guselkumab-treated patients with psoriatic arthritis (PsA), enthesitis resolution (ER) was associated with dactylitis resolution (DR), and those achieving ER or DR showed improvements in patient-reported outcomes.
Major finding: At weeks 24, 52, and 100, guselkumab-treated patients who achieved DR were more likely to achieve ER, and vice versa (all P < .05). At week 24, a higher proportion of patients who did vs did not achieve ER reported minimal pain (30%-45% vs 11%-21%; all P < .001), with similar pain outcomes in patients who did vs did not achieve DR.
Study details: This post hoc analysis included 739 biologic-naive patients with PsA who were randomly assigned to receive guselkumab (100 mg every 4 or 8 weeks) or placebo with crossover to guselkumab (100 mg every 4 weeks) at week 24, of whom 68.6% and 44.9% of patients had enthesitis and dactylitis, respectively.
Disclosures: This study was supported by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owning Johnson and Johnson stock or stock options. The other authors declared receiving consulting fees from or having other ties with various sources, including Janssen.
Source: Rahman P, McInnes IB, Deodhar A, et al. Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis. Clin Rheumatol. 2024;43:1591-1604 (Mar 12). doi: 10.1007/s10067-024-06921-8 Source