Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: A Phase 2, Double-blind, Placebo-Controlled Randomized Clinical Trial
العنوان: | Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: A Phase 2, Double-blind, Placebo-Controlled Randomized Clinical Trial |
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المؤلفون: | Christopher Sayed, Seth B Forman, Christos C. Zouboulis, Lucian Ionescu, Dominique Baeten, George Schmieder, Sophie Glatt, Seth D Seegobin, Jamie Weisman, Stevan Shaw, R. Rolleri, Gregor B.E. Jemec |
المساهمون: | Clinical Immunology and Rheumatology, AII - Inflammatory diseases |
المصدر: | JAMA dermatology, 157(11), 1279-1288. American Medical Association JAMA Dermatol |
سنة النشر: | 2021 |
مصطلحات موضوعية: | Adult, medicine.medical_specialty, Bimekizumab, Dermatology, Placebo, Antibodies, Monoclonal, Humanized, Severity of Illness Index, Drug Administration Schedule, law.invention, Randomized controlled trial, Double-Blind Method, law, Internal medicine, medicine, Adalimumab, Humans, Hidradenitis suppurativa, Abscess, Adverse effect, business.industry, Infant, Correction, Bayes Theorem, Dermatology Life Quality Index, medicine.disease, Hidradenitis Suppurativa, Treatment Outcome, Female, business, medicine.drug |
الوصف: | Importance Hidradenitis suppurativa (HS) is a chronic inflammatory disease with a high burden for patients and limited existing therapeutic options. Objective To evaluate the efficacy and safety of bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin 17A and 17F in individuals with moderate to severe HS. Design, Setting, and Participants This phase 2, double-blind, placebo-controlled randomized clinical trial with an active reference arm was performed from September 22, 2017, to February 21, 2019. The study included a 2- to 4-week screening period, a 12-week treatment period, and a 20-week safety follow-up. Of 167 participants screened at multiple centers, 90 were enrolled. Eligible participants were 18 to 70 years of age with a diagnosis of moderate to severe HS 12 months or more before baseline. Interventions Participants with HS were randomized 2:1:1 to receive bimekizumab (640 mg at week 0, 320 mg every 2 weeks), placebo, or reference arm adalimumab (160 mg at week 0, 80 mg at week 2, and 40 mg every week for weeks 4-10). Main Outcomes and Measures The prespecified primary efficacy variable was the proportion of participants with a 50% or greater reduction from baseline in the total abscess and inflammatory nodule count with no increase in abscess or draining fistula count (Hidradenitis Suppurativa Clinical Response [HiSCR] at week 12. Exploratory variables included proportion achieving a modified HiSCR with 75% reduction of HiSCR criteria (HiSCR75) or a modified HiSCR with 90% reduction of HiSCR criteria (HiSCR90), change in Patient’s Global Assessment of Pain, and Dermatology Life Quality Index total scores. Results Eighty-eight participants received at least 1 dose of study medication (61 [69%] female; median age, 36 years; range, 18-69 years). Seventy-three participants completed the study, including safety follow-up. Bimekizumab demonstrated a higher HiSCR rate vs placebo at week 12 (57.3% vs 26.1%; posterior probability of superiority equaled 0.998, calculated using bayesian analysis). Bimekizumab demonstrated greater clinical improvements compared with placebo. Improvements in the International Hidradenitis Suppurativa Severity Score (IHS4) were seen at week 12 with bimekizumab (mean [SD] IHS4, 16.0 [18.0]) compared with placebo (mean [SD] IHS4, 40.2 [32.6]). More bimekizumab-treated participants achieved positive results on stringent outcome measures compared with placebo. At week 12, 46% of bimekizumab-treated participants achieved HiSCR75and 32% achieved HiSCR90, whereas 10% of placebo-treated participants achieved HiSCR75and none achieved HiSCR90; in adalimumab-treated participants, 35% achieved HiSCR75and 15% achieved HiSCR90. One participant withdrew because of adverse events. Serious adverse events occurred in 2 of 46 bimekizumab-treated participants (4%), 2 of 21 placebo-treated participants (10%), and 1 of 21 adalimumab-treated participants (5%). Conclusions and Relevance In this phase 2 randomized clinical trial, bimekizumab demonstrated clinically meaningful improvements across all outcome measures, including stringent outcomes. Bimekizumab’s safety profile was consistent with studies of other indications, supporting further evaluation in participants with HS. Trial Registration ClinicalTrials.gov Identifier:NCT03248531 |
اللغة: | English |
تدمد: | 2168-6068 |
URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0b4c1d0ed65479af00e672e072431b06 https://pure.amc.nl/en/publications/efficacy-and-safety-of-bimekizumab-in-moderate-to-severe-hidradenitis-suppurativa-a-phase-2-doubleblind-placebocontrolled-randomized-clinical-trial(3a0da2c2-2eb5-44a6-8d23-19510f4b019b).html |
حقوق: | OPEN |
رقم الأكسشن: | edsair.doi.dedup.....0b4c1d0ed65479af00e672e072431b06 |
قاعدة البيانات: | OpenAIRE |
تدمد: | 21686068 |
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