1441: Bimekizumab Maintenance of Response and Safety in Patients with Moderate to Severe Plaque Psoriasis: Results from the Open-label Extension Period (Weeks 48–144) of the BE RADIANT Phase 3b Trial

Bruce Strober¹, Luis Puig², Andrew Blauvelt³, Diamant Thaçi⁴, Boni Elewski⁵, Maggie Wang⁶, Veerle Vanvoorden⁷, Delphine Deherder⁸, fabienne Staelens⁸, Susanne Wiegratz⁹, Joseph F. Merola¹⁰ and Carle Paul¹¹, ¹Yale University, New Haven, CT, ²Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain, ³Oregon Medical Research Center, Portland, OR, ⁴Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, ⁵Department of Dermatology, University Hospitals of Cleveland, Case Western Reserve University, Cleveland, OH, ⁶UCB Pharma, Morrisville, NC, ⁷UCB Pharma, Brussels, Belgium, ⁸UCB Pharma, Braine-l’Alleud, Belgium, ⁹UCB Pharma, Monheim am Rhein, Germany, ¹⁰Brigham and Women's Hospital and Harvard Medical School, Boston, MA, ¹¹Toulouse University and CHU, Toulouse, France

Background/Purpose: Clinical improvements through Week (Wk)96, with no unexpected safety findings, have previously been reported with bimekizumab (BKZ) in the BE RADIANT phase 3b trial in patients with moderate to severe plaque psoriasis.[1,2] Here, we evaluate the efficacy of BKZ, as measured by complete or near complete skin clearance using the Psoriasis Area and Severity Index (PASI), over 144 weeks, and assess long-term safety of BKZ treatment.

Methods: Patients with moderate to severe plaque psoriasis received BKZ (320mg every 4 wks [Q4W] through Wk16, then Q4W or Q8W) or secukinumab (SEC; 300mg weekly to Wk4, then Q4W) through Wk48, then BKZ (Q4W or Q8W; all received Q8W from Wk64/next scheduled visit). Wks48–144 (open-label extension [OLE]) overlapped with the COVID‑19 pandemic. Wk48–144 efficacy data are reported for patients treated with BKZ or SEC to Wk48 who entered the OLE, receiving BKZ Q4W or Q8W. Patients discontinuing due to lack of efficacy/treatment‑related adverse events (AEs) were considered non‑responders; multiple imputation was used for other missing data (modified non-responder imputation [mNRI]). Wk48–144 safety data (incidence/100 patient-years [PY]) are grouped for patients receiving ≥1 BKZ dose in this period.

Results: 336/373 BKZ-randomized and 318/370 SEC-randomized patients entered the OLE. Among these, 74.9% BKZ vs 52.8% SEC (Wk48) and 68.8% BKZ/BKZ vs 69.1% SEC/BKZ (Wk144) achieved PASI100 (100% improvement from baseline in PASI); 94.3% vs 83.9% (Wk48) and 89.8% vs 87.0% (Wk144) achieved PASI≤2. Wk48–144 serious AE rate with BKZ was low (5.4/100PY).Four deaths (two from coronavirus infection [unvaccinated patients]) occurred; none treatment-related. The most common AEs were: nasopharyngitis (8.4/100PY); oral candidiasis (7.1/100PY); coronavirus infection (5.1/100PY). Most (98.3%) oral candidiasis events were mild/moderate; three led to discontinuation.

Conclusion: Clinical improvements with BKZ were maintained through Wk144; outcomes improved for SEC-treated patients after switching to BKZ (Wk48–144). AEs were consistent with BKZ's safety profile.[1–3]

Funding: This study was funded by UCB Pharma. Medical writing provided by Costello Medical and funded by UCB Pharma. References: 1. Strober B et al. Presented at AAD 2022, poster 34321; 2.Reich K et al. N Engl J Med 2021;
385(2):142–52, NCT03536884; 3.Gordon KB et al. JAMA Dermatol 2022;158(7):735–44.
Abstract previously submitted to AAD 2023.


B. Strober: AbbVie, 6, 6, Alamar, 6, Almirall, 6, Alumis, 6, Amgen, 6, Arcutis, 6, 6, Arena, 6, Aristea, 6, Asana, 6, Boehringer Ingelheim, 6, Bristol Myers Squibb, 12, Consultancy honoraria, Connect Biopharma, 6, 11, CorEvitas, 6, CorEvitas Psoriasis Registry, 12, Scientific Co-Director (consulting fee), 12, Investigator, Dermavant, 6, 6, Dermira, 12, Investigator, Eli Lilly, 6, 6, Evelo Biosciences, 6, Immunic Therapeutics, 6, Incyte, 6, Janssen, 6, 6, Journal of Psoriasis and Psoriatic Arthritis, 6, Leo, 6, Maruho, 6, Meiji Seika Pharma, 6, Mindera Health, 6, 11, Novartis, 6, Pfizer, 6, Protagonist, 6, Regeneron, 6, 6, Sanofi-Genzyme, 6, 6, Sun Pharma, 6, UCB Pharma, 6, Union Therapeutics, 6, Ventyxbio, 6, vTv Therapeutics, 6; L. Puig: AbbVie, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Almirall, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Amgen, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Baxalta, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Biogen, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Boehringer Ingelheim, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Celgene, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Eli Lilly, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Gebro, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Janssen, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, JS BIOCAD, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, LEO Pharma, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Merck-Serono, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, MSD, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Mylan, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Novartis, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Pfizer, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Regeneron, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Roche, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Samsung-Bioepis, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Sandoz, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, Sanofi-Genzyme, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:, UCB Pharma, 12, Received consultancy/speaker’s honoraria from and/or participated in trials sponsored by:; A. Blauvelt: AbbVie/Abbott, 5, 6, Abcentra, 6, Acelyrin, 12, Clinical study investigator, Aclaris, 6, Affibody, 6, Aligos, 6, Allakos, 12, Clinical study investigator, Almirall, 6, Alumis, 6, Amgen, 5, 6, Anaptysbio, 6, Apogee, 6, Arcutis, 5, 6, Arena, 6, Aslan, 6, Athenex, 5, 6, 12, Clinical study investigator, Bluefin, 6, Boehringer-Ingelheim, 5, 6, Bristol-Myers Squibb(BMS), 5, 6, Cara Therapeutics, 6, Concert, 12, Clinical study investigator, CTI Biopharma, 6, Dermavant, 5, 6, EcoR1, 6, Eli Lilly, 5, 6, Escient, 6, Evelo, 6, Evommune, 6, Forte, 6, Galderma, 5, 6, Highlightll Pharma, 6, Incyte, 5, 6, InnoventBio, 6, Janssen, 5, 6, Landos, 6, Leo, 5, 6, Merck/MSD, 5, 6, Novartis, 5, 6, Pfizer, 5, 6, Rani, 6, Rapt, 6, Regeneron, 5, 6, Sanofi Genzyme, 6, Spherix Global Insights, 6, Sun Pharma, 5, 6, TLL Pharmaceutical, 6, TrialSpark, 6, UCB, 5, 5, 6, 6, Union, 6, Ventyx, 6, Vibliome, 6, Xencor, 6; D. Thaçi: AbbVie, 1, 2, 5, 12, Investigator, Almirall, 1, 2, 12, Investigator, Amgen, 1, 2, 12, Investigator, Boehringer-Ingelheim, 1, 2, 12, Investigator, Bristol-Myers Squibb(BMS), 1, 2, 12, Investigator, Celltrion, 1, 2, 12, Investigator, Eli Lilly, 1, 2, 12, Investigator, Galapagos, 1, 2, 12, Investigator, Galderma, 1, 2, 5, 12, Investigator, Janssen-Cilag, 1, 2, 12, Investigator, LEO Pharma, 1, 2, 5, 12, Investigator, Novartis, 1, 2, 5, 12, Investigator, Pfizer, 1, 2, 12, Investigator, Regeneron, 1, 2, 12, Investigator, Samsung, 1, 2, 12, Investigator, Sandoz, 1, 2, 12, Investigator, Sanofi, 1, 2, 12, Investigator, Target-Solution, 1, 2, 12, Investigator, UCB, 1, 2, 12, Investigator; B. Elewski: AbbVie/Abbott, 12, Received research support as funding to Case Western Reserve University from:, AnaptysBio, 12, Received research support as funding to Case Western Reserve University from:, Arcutis, 2, Boehringer Ingelheim, 2, 12, Received research support as funding to Case Western Reserve University from:, Bristol Myers Squibb, 2, 12, Received research support as funding to Case Western Reserve University from:, Celgene, 2, 12, Received research support as funding to Case Western Reserve University from:, Eli Lilly, 2, 12, Received research support as funding to Case Western Reserve University from:, Incyte, 12, Received research support as funding to Case Western Reserve University from:, LEO Pharma, 2, 12, Received research support as funding to Case Western Reserve University from:, Menlo, 2, 12, Received research support as funding to Case Western Reserve University from:, Novartis, 2, 12, Received research support as funding to Case Western Reserve University from:, Pfizer, 2, 12, Received research support as funding to Case Western Reserve University from:, Regeneron, 12, Received research support as funding to Case Western Reserve University from:, Sun Pharma, 2, 12, Received research support as funding to Case Western Reserve University from:, UCB Pharma, 2, Valeant, 2, 12, Received research support as funding to Case Western Reserve University from:, Vanda, 12, Received research support as funding to Case Western Reserve University from:, Verrica, 2; M. Wang: UCB Pharma, 3, 11; V. Vanvoorden: UCB Pharma, 3, 11; D. Deherder: UCB Pharma, 3, 11; f. Staelens: UCB Pharma, 3, 11; S. Wiegratz: UCB Pharma, 3, 11; J. Merola: AbbVie, 12, Consultant and/or investigator, Amgen, 2, Biogen, 12, Consultant and/or investigator, Bristol Myers Squibb, 2, Dermavant, 12, Consultant and/or investigator, Eli Lilly, 12, Consultant and/or investigator, Janssen, 12, Consultant and/or investigator, LEO Pharma, 12, Consultant and/or investigator, Novartis, 12, Consultant and/or investigator, Pfizer, 12, Consultant and/or investigator, Regeneron, 12, Consultant and/or investigator, Sanofi, 12, Consultant and/or investigator, Sun Pharmaceuticals, 12, Consultant and/or investigator, UCB Pharma, 12, Consultant and/or investigator; C. Paul: AbbVie, 2, 5, Almirall, 2, 5, Amgen, 2, 5, Boehringer-Ingelheim, 2, 5, Celgene, 2, 5, Eli Lilly, 2, 5, GlaxoSmithKlein(GSK), 2, 5, Janssen, 2, 5, Leo Pharma, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, Pierre Fabre, 2, 5, Sanofi Regeneron, 2, 5, UCB, 2, 5.