Bimekizumab Efficacy And Safety Through 5 Years In Patients With Moderate To Severe Plaque Psoriasis In The US And Canada

Andrew Blauvelt¹, Saakshi Khattri², Phoebe Rich³, Ronald Vender⁴, Kenneth B. Gordon⁵, Balint Szilagyi⁶, Heather Herr⁷, Bertram Knapp⁶, Delphine Deherder⁸, Sarah Kavanagh⁹ and Kim Papp¹⁰, ¹Blauvelt Consulting, LLC, Portland, OR, ²The Mount Sinai Hospital, New York, NY, ³Oregon Dermatology and Research Center, Portland, OR, ⁴Dermatrials Research Inc., Hamilton, ON, Canada, ⁵Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, ⁶UCB, Monheim am Rhein, Germany, ⁷UCB, Smyrna, GA, ⁸UCB, Braine-l'Alleud, Belgium, ⁹UCB, Morrisville, NC, ¹⁰Probity Medical Research and Alliance Clinical Trials, Waterloo, and Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada

Meeting: ACR Convergence 2025

Keywords: Biologicals, clinical trial, Dermatology, immunology, skin

Session Information

Date: Tuesday, October 28, 2025

Title: (2338–2376) Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster III

Session Type: Poster Session C

Session Time: 10:30AM-12:30PM

Background/Purpose: Given the chronic nature of psoriasis, and the loss of response observed with biologic therapies over time, it is crucial to establish the long-term efficacy and safety of biologic therapies for psoriasis. Here, we evaluate the efficacy and safety of bimekizumab (BKZ) treatment through 5 years in patients with moderate to severe plaque psoriasis from the US and Canada.

Methods: A US/Canadian patient subgroup completing the BE VIVID (NCT03370133)/BE SURE (NCT03412747)/BE READY (NCT03410992) phase 3 trials and their open-label extension (OLE), BE BRIGHT (NCT03598790; 4 years’ total treatment) could enter a second 48-week extension (OLE2), in which they received BKZ 320 mg every 4 weeks (Q4W) or Q8W depending on Investigator’s Global Assessment (IGA) response at entry.1–4 Included patients received BKZ continuously from feeder study baseline to OLE2 entry; patients receiving BKZ Q4W to Week 16 then Q8W thereafter (BKZ Q4W/Q8W; approved dosing regimen) were also analyzed.5Five-year efficacy data are reported (244 weeks’ total treatment). Patients discontinuing treatment due to lack of efficacy/treatment‑related adverse events were considered non-responders; multiple imputation was used for other missing data (modified non‑responder imputation). Treatment-emergent adverse events (TEAEs) are reported through 5 years (Weeks 0–244) using exposure-adjusted incidence rates/100 patient-years [PY]).

Results: In total, 153 US/Canadian patients were analyzed; 52 received BKZ Q4W/Q8W.At Year 1 (Week 52) and Year 5 (Week 244), 75.2% and 67.7% patients treated with BKZ achieved 100% improvement from baseline in Psoriasis Area and Severity Index (PASI 100), respectively (BKZ Q4W/Q8W: 78.8% and 76.9%). At Year 1 and Year 5, 92.8% and 84.9% achieved PASI 90 (BKZ Q4W/Q8W: 96.2% and 88.5%).Over 5 years, serious TEAEs (3.6/100 PY) and discontinuations due to TEAEs (0.3/100 PY) were low; zero deaths occurred. Most common TEAEs were nasopharyngitis (9.7/100 PY), oral candidiasis (7.6/100 PY), and corona virus infection (6.1/100 PY). The vast majority (99.3%) of oral candidiasis events were mild/moderate; none led to discontinuation. Safety results were generally similar in BKZ Q4W/Q8W patients.

Conclusion: BKZ demonstrated high rates of clinical response, which were durable over 5 years, in patients from the US and Canada with moderate to severe plaque psoriasis. BKZ was well-tolerated in this patient subgroup, with no unexpected safety findings.References: 1. Reich K. Lancet 2021;397:487–98; 2. Warren RB. N Engl J Med 2021;385:130–41; 3. Gordon KB. Lancet 2021;397:475–86; 4. Strober B. Br J Dermatol 2023;188:749–59; 5. Bimekizumab Summary of Product Characteristics. 2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdf [Accessed April 2025].Previously presented at AAD 2025.

Disclosures: A. Blauvelt: AbbVie, 1, Acelyrin, 12, Clinical study investigator, Almirall, 1, 12, Clinical study investigator, Alumis, 1, 12, Clinical study investigator, Amgen, 1, 12, Clinical study investigator, Anaptysbio, 1, Apogee, 1, Arcutis, 1, 12, Clinical study investigator, Boehringer Ingelheim, 1, 12, Clinical study investigator, Bristol Myers Squibb, 1, Celltrion, 1, Corvus, 1, Dermavant, 1, 12, Clinical study investigator, Eli Lilly and Company, 1, 6, 12, Clinical study investigator, Galderma, 1, 12, Clinical study investigator, GlaxoSmithKline, 1, Immunovant, 1, Incyte, 1, 12, Clinical study investigator, IQVIA, 1, Janssen, 1, 12, Clinical study investigator, Leo, 1, 12, Clinical study investigator, Lipidio, 1, 11, Merck, 1, 12, Clinical study investigator, Novartis, 1, 12, Clinical study investigator, Oruka, 1, 11, Paragon, 1, Pfizer, 1, 12, Clinical study investigator, Regeneron, 1, 12, Clinical study investigator, Sanofi, 1, 12, Clinical study investigator, Spherix Global Insights, 1, Sun Pharma, 1, 12, Clinical study investigator, Syncona, 1, Takeda, 1, 12, Clinical study investigator, UCB, 1, 6, Union, 1; S. Khattri: AbbVie, 1, 2, 5, 6, Acelyrin, 5, Bristol Myers Squibb, 5, Eli Lilly and Company, 1, 2, 6, Incyte, 5, Janssen, 1, 2, 6, LEO Pharma, 1, 2, 6, Regeneron, 1, 2, 6, UCB, 1, 2, 6; P. Rich: AbbVie, 12, Principal Investigator/clinical trials, Amgen, 12, Principal Investigator/clinical trials, Arcutis, 12, Principal Investigator/clinical trials, Bristol Myers Squibb, 2, 12, Principal Investigator/clinical trials, Dermavant, 12, Principal Investigator/clinical trials, Eli Lilly and Company, 12, Principal Investigator/clinical trials, Janssen, 12, Principal Investigator/clinical trials, Sun Pharma, 12, Principal Investigator/clinical trials, UCB, 12, Principal Investigator/clinical trials; R. Vender: AbbVie, 2, 5, 6, Actelion, 2, 6, Amgen, 2, 5, 6, Bausch Health, 2, 6, Celgene, 2, 6, Centocor, 5, Cipher, 2, 6, Dermavant, 5, Dermira, 5, Eli Lilly and Company, 2, 5, 6, Galderma, 2, 5, 6, GSK, 2, 5, 6, Janssen, 2, 6, LEO Pharma, 2, 5, 6, Merck, 2, 5, 6, Novartis, 2, 5, 6, Palladin, 2, Pfizer, 2, 5, 6, Regeneron, 5, Takeda, 5, UCB, 2, 5, 6; K. Gordon: AbbVie, 2, 5, Almirall, 2, Amgen, 2, Boehringer Ingelheim, 2, Bristol Myers Squibb, 2, 5, Celgene, 2, 5, Dermira, 2, Eli Lilly and Company, 2, 5, Janssen, 2, 5, Novartis, 2, 5, Pfizer, 2, Sun Pharma, 2, UCB, 2, 5; B. Szilagyi: UCB, 3, 12, Shareholder; H. Herr: UCB, 3, 12, Shareholder; B. Knapp: UCB, 3, 12, Shareholder; D. Deherder: UCB, 3, 12, Shareholder; S. Kavanagh: Aclipse Therapeutics, 2, Aliada Therapeutics, 2, Allay Therapeutics, 2, Autobahn Therapeutics, 2, Cognition Therapeutics, 2, Colorado Prevention Center, 2, Karuna Therapeutics, 2, Kisbee Therapeutics, 2, LB Pharmaceuticals, 2, Nesos, 2, Novartis, 2, Onward Medical, 2, PharPoint Research, 2, Summit Analytical, 2, Therini Bio, 2, Tonix Pharmaceuticals, 2, Tornado Therapeutics, 2, UCB, 2, 3, Whitsell Innovations, 2, Worldwide Clinical Trials, 2, Zosano Pharma, 2; K. Papp: AbbVie, 1, 2, 4, 5, 6, 12, Investigator, Acelyrin, 1, 2, 4, 5, 6, 12, Investigator, Akros, 1, 2, 4, 5, 6, 12, Investigator, Alumis, 1, 2, 4, 5, 6, 12, Investigator, Amgen, 1, 2, 4, 5, 6, 12, Investigator, Arcutis, 1, 2, 4, 5, 6, 12, Investigator, Bausch Health/Valeant, 1, 2, 4, 5, 6, 12, Investigator, Boehringer-Ingelheim, 1, 2, 4, 5, 12, Investigator, Bristol-Myers Squibb(BMS), 1, 2, 4, 5, 12, Investigator, Can-Fite Biopharma, 1, 2, 4, 5, 12, Investigator, Celltrion, 1, 2, 4, 5, 12, Investigator, Concert Pharmaceuticals, 1, 2, 4, 5, 12, Investigator, Dermavant, 1, 2, 4, 5, 6, 12, Investigator, Dermira, 1, 2, 4, 5, 6, 12, Investigator, Dice Pharmaceuticals, 1, 2, 4, 5, 6, 12, Investigator, Dice Therapeutics, 1, 2, 4, 5, 6, 12, Investigator, Eli Lilly and Company, 1, 2, 4, 5, 6, 12, Investigator, Evelo Biosciences, 1, 2, 4, 5, 6, 12, Investigator, Forbion, 1, 2, 4, 5, 6, 12, Investigator, Galderma, 1, 2, 4, 5, 6, 12, Investigator, Horizon Therapeutics, 1, 2, 4, 5, 6, 12, Investigator, Incyte, 1, 2, 4, 5, 12, Investigator, Janssen, 1, 2, 4, 5, 6, 12, Investigator, Kymab, 1, 2, 4, 5, 6, 12, Investigator, Kyowa Hakko Kirin, 1, 2, 4, 5, 6, 12, Investigator, LEO Pharma, 1, 2, 4, 5, 6, 12, Investigator, Meiji Seika Pharma, 1, 2, 4, 5, 6, 12, Investigator, Mitsubishi Pharma, 1, 2, 4, 5, 6, 12, Investigator, Nimbus Therapeutics, 1, 2, 4, 5, 6, 12, Investigator, Novartis, 1, 2, 4, 5, 6, 12, Investigator, Pfizer, 1, 2, 4, 5, 6, 12, Investigator, Reistone, 1, 2, 4, 5, 6, 12, Investigator, Sandoz, 1, 2, 4, 5, 6, 12, Investigator, Sanofi-Aventis/Genzyme, 1, 2, 4, 5, 6, 12, Investigator, Sun Pharma, 1, 2, 4, 5, 6, 12, Investigator, Takeda, 1, 2, 4, 5, 6, 12, Investigator, Tarsus Pharmaceuticals, 1, 2, 4, 5, 6, 12, Investigator, UCB, 1, 2, 4, 5, 6, 12, Investigator, Zai Lab, 1, 2, 4, 5, 6, 12, Investigator.

To cite this abstract in AMA style:

Blauvelt A, Khattri S, Rich P, Vender R, Gordon K, Szilagyi B, Herr H, Knapp B, Deherder D, Kavanagh S, Papp K. Bimekizumab Efficacy And Safety Through 5 Years In Patients With Moderate To Severe Plaque Psoriasis In The US And Canada [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/bimekizumab-efficacy-and-safety-through-5-years-in-patients-with-moderate-to-severe-plaque-psoriasis-in-the-us-and-canada/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/bimekizumab-efficacy-and-safety-through-5-years-in-patients-with-moderate-to-severe-plaque-psoriasis-in-the-us-and-canada/