This article is available to subscribers. Subscribe now. Already have an account? Sign in

Original ArticleFree Preview

Bimekizumab versus Adalimumab in Plaque Psoriasis

List of authors.
  • Richard B. Warren, M.D., Ph.D.,
  • Andrew Blauvelt, M.D.,
  • Jerry Bagel, M.D.,
  • Kim A. Papp, M.D., Ph.D.,
  • Paul Yamauchi, M.D., Ph.D.,
  • April Armstrong, M.D., M.P.H.,
  • Richard G. Langley, M.D.,
  • Veerle Vanvoorden, M.Sc.,
  • Dirk De Cuyper, M.D.,
  • Christopher Cioffi, Ph.D.,
  • Luke Peterson, M.S.,
  • Nancy Cross, M.D.,
  • and Kristian Reich, M.D., Ph.D.

Abstract

Background

Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin-17A and interleukin-17F. The efficacy and safety of bimekizumab as compared with the tumor necrosis factor inhibitor adalimumab in patients with moderate-to-severe plaque psoriasis have not been extensively examined.

Methods

Download a PDF of the Research Summary.

We randomly assigned patients with moderate-to-severe plaque psoriasis in a 1:1:1 ratio to receive subcutaneous bimekizumab at a dose of 320 mg every 4 weeks for 56 weeks; bimekizumab at a dose of 320 mg every 4 weeks for 16 weeks, then every 8 weeks for weeks 16 to 56; or subcutaneous adalimumab at a dose of 40 mg every 2 weeks for 24 weeks, followed by bimekizumab at a dose of 320 mg every 4 weeks to week 56. The primary end points were a 90% or greater reduction from baseline in the Psoriasis Area and Severity Index (PASI) score (PASI 90 response; PASI scores range from 0 to 72, with higher scores indicating worse disease) and an Investigators Global Assessment (IGA) score of 0 or 1, signifying clear or almost clear skin (scores range from 0 [clear skin] to 4 [severe disease]), at week 16. The analysis of the primary end points tested noninferiority at a margin of ?10 percentage points and then tested for superiority.

Results

A total of 614 patients were screened, and 478 were enrolled; 158 patients were assigned to receive bimekizumab every 4 weeks, 161 to receive bimekizumab every 4 weeks and then every 8 weeks, and 159 to receive adalimumab. The mean age of the patients was 44.9 years; the mean PASI score at baseline was 19.8. At week 16, a total of 275 of 319 patients (86.2%) who received bimekizumab (both dose groups combined) and 75 of 159 (47.2%) who received adalimumab had a PASI 90 response (adjusted risk difference, 39.3 percentage points; 95% confidence interval [CI], 30.9 to 47.7; P<0.001 for noninferiority and superiority). A total of 272 of 319 patients (85.3%) who received bimekizumab and 91 of 159 (57.2%) who received adalimumab had an IGA score of 0 or 1 (adjusted risk difference, 28.2 percentage points; 95% CI, 19.7 to 36.7; P<0.001 for noninferiority and superiority). The most common adverse events with bimekizumab were upper respiratory tract infections, oral candidiasis (predominantly mild or moderate as recorded by the investigator), hypertension, and diarrhea.

Conclusions

In this 56-week trial, bimekizumab was noninferior and superior to adalimumab through 16 weeks in reducing symptoms and signs of plaque psoriasis but was associated with a higher frequency of oral candidiasis and diarrhea. Longer and larger trials are required to determine the efficacy and safety of bimekizumab as compared with other agents in the treatment of plaque psoriasis. (Funded by UCB Pharma; BE SURE ClinicalTrials.gov number, NCT03412747.)

Digital Object ThumbnailQUICK TAKE VIDEO SUMMARY
Bimekizumab versus Adalimumab in Plaque Psoriasis
?02:38

Funding and Disclosures

Supported by UCB Pharma. Dr. Warren is supported by the Manchester National Institute for Health Research Biomedical Research Centre.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Dr. Warren reports receiving grant support and consulting fees from AbbVie, Almirall, Bristol-Myers Squibb, Eli Lilly, Janssen, LEO Pharma, Novartis, and UCB Pharma, consulting fees from Amgen, Arena Pharmaceuticals, Avillion, Boehringer Ingelheim, Celgene, Pfizer, Sanofi, Astellas, GlaxoSmithKline, Biogen, DiCE Molecules, Sun Pharma, and Union Therapeutics, and grant support from Medac; Dr. Blauvelt, receiving research funding and consulting fees from AbbVie, Amgen, Arcutis Biotherapeutics, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant Sciences, Eli Lilly, Evommune, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron Pharmaceuticals, Sun Pharma, and UCB Pharma and consulting fees from Aligos Therapeutics, Almirall, Arena Pharmaceuticals, Forte Biosciences, Galderma, Rapt Therapeutics, and Sanofi Genzyme; Dr. Bagel, receiving grant support from Arcutis Biotherapeutics, Boehringer Ingelheim, Corrona, Dermavant Sciences, Dermira, Glenmark Pharmaceuticals, Kadmon, LEO Pharma, Lycera, Menlo Therapeutics, Pfizer, Regeneron Pharmaceuticals, Taro Pharmaceutical Industries, and Ortho Dermatologics, grant support, consulting fees, and lecture fees from AbbVie, Celgene, Eli Lilly, Janssen Biotech, and Novartis, and grant support and consulting fees from Amgen, Bristol-Myers Squibb, Sun Pharmaceutical Industries, and UCB Pharma; Dr. Papp, receiving grant support, consulting fees, fees for serving on a speakers bureau, steering committee fees, and advisory board fees, all paid to his institution, and honoraria from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Merck (Merck Sharp & Dohme), Novartis, Pfizer, Sanofi Genzyme, and Bausch Health, grant support and consulting fees, all paid to his institution, and honoraria from Akros Pharma, Coherus BioSciences, Mitsubishi Pharma, Takeda, and PRCL Research, grant support, paid to his institution, from Anacor Pharmaceuticals, GlaxoSmithKline, MedImmune, Gilead Sciences, and Moberg Pharma, grant support and consulting fees, all paid to his institution, from Arcutis Biotherapeutics, Baxalta, Can-Fite BioPharma, Dermira, Genentech, Meiji Seika Pharma, Roche, Evelo Biosciences, Galapagos, Avillion, and DiCE Molecules, grant support, consulting fees, fees for serving on a speakers bureau, and advisory board fees from Astellas, grant support, consulting fees, steering committee fees, and advisory board fees, all paid to his institution, and honoraria from Boehringer Ingelheim and Regeneron Pharmaceuticals, grant support, consulting fees, and advisory board fees, all paid to his institution, from Bristol-Myers Squibb, Dow Pharma, and Dermavant Sciences, grant support, consulting fees, fees for serving on a speakers bureau, and advisory board fees, all paid to his institution, and honoraria from Galderma, grant support, consulting fees, fees for serving on a speakers bureau, and advisory board fees, all paid to his institution, and honoraria from Kyowa Hakko Kirin, grant support, consulting fees, and fees for serving on a speakers bureau, all paid to his institution, from LEO Pharma and Incyte, grant support, consulting fees, and steering committee fees, all paid to his institution, and honoraria from Merck Serono, grant support, consulting fees, and advisory board fees, all paid to his institution, and honoraria from UCB Pharma, and grant support and advisory board fees, all paid to his institution, from Sun Pharma; Dr. Yamauchi, receiving lecture fees, consulting fees, and investigator fees from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, and UCB Pharma; Dr. Armstrong, receiving grant support, advisory fees, and lecture fees from AbbVie and Regeneron Pharmaceuticals, grant support and advisory fees from Bristol-Myers Squibb, Dermavant Sciences, Dermira, Eli Lilly, LEO Pharma, Novartis, and UCB Pharma, advisory fees from Janssen, Modernizing Medicine, Ortho Dermatologics, Sanofi Genzyme, Sun Pharma, and Pfizer, grant support from Kyowa Kirin and Galderma, and fees for serving on a data and safety monitoring board from Boehringer Ingelheim and Parexel; Dr. Langley, receiving grant support, advisory board fees, investigator fees, and lecture fees from AbbVie, Amgen, Centocor, Eli Lilly, Janssen, LEO Pharma, Novartis, UCB Pharma, and Celgene and grant support, advisory board fees, and investigator fees from Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Merck; Ms. Vanvoorden, Drs. De Cuyper and Cioffi, Mr. Peterson, and Dr. Cross, being employed by and owning shares in UCB Pharma; and Dr. Reich, receiving grant support, consulting fees, and lecture fees from AbbVie, Almirall, Biogen Idec, Celgene, Eli Lilly, Janssen-Cilag, LEO Pharma, Medac, Merck Sharp & Dohme, Novartis, and Sanofi, grant support and consulting fees from Affibody, Boehringer Ingelheim, Covagen, Forward Pharma, Galderma, Kyowa Kirin, Ocean Pharma, Pfizer, Sun Pharma, Takeda, UCB Pharma, and Bristol-Myers Squibb, consulting fees from Amgen, GlaxoSmithKline, Samsung Bioepis, and XenoPort, lecture fees from Valeant Pharmaceuticals and Sandoz, and grant support from Fresenius Medical Care, Galapagos, Miltenyi Biotec, and XBiotech. No other potential conflict of interest relevant to this article was reported.

This article was published on April 23, 2021, at NEJM.org.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

We thank the patients and their caregivers in addition to all the investigators and their teams who contributed to this trial; Susanne Wiegratz, M.Sc., of UCB Pharma (Monheim, Germany) for publication coordination; Natalie Nunez Gomez, M.D., of UCB Pharma (Brussels) for critical review; and Ruth Moulson, M.P.H., of Costello Medical (London) for medical writing and editorial assistance with an earlier version of the manuscript, in accordance with Good Publication Practice 3 guidelines (http://www.ismpp.org/gpp3).

Author Affiliations

From the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester National Institute for Health Research Biomedical Research Centre, University of Manchester, Manchester, United Kingdom (R.B.W.); Oregon Medical Research Center, Portland (A.B.); Psoriasis Treatment Center of Central New Jersey, East Windsor (J.B.); Probity Medical Research and K. Papp Clinical Research, Waterloo, ON (K.A.P.), and Dalhousie University, Halifax, NS (R.G.L.) both in Canada; Dermatology Institute and Skin Care Center, Santa Monica, CA (P.Y.); the Division of Dermatology, David Geffen School of Medicine at University of California, Los Angeles (P.Y.), and the Department of Dermatology, Keck School of Medicine, University of Southern California (A.A.) both in Los Angeles; UCB Pharma, Brussels (V.V., D.D.C.); UCB Pharma, Raleigh, NC (C.C., L.P., N.C.); and the Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center HamburgCEppendorf, Hamburg, Germany (K.R.).

Address reprint requests to Dr. Warren at the Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester National Institute for Health Research Biomedical Research Centre, University of Manchester, Manchester M13 9PL, United Kingdom, or at .

Print Subscriber? Activate your online access.