Bimekizumab 3-Year Efficacy In Patients With Psoriasis And Risk Factors For Progression To Psoriatic Arthritis Or Screening Positive For Psoriatic Arthritis: Long-Term Results From Five Phase 3/3b Trials

Richard G. Langley¹, Joseph F Merola², Diamant Thaçi³, Emi Nishida⁴, Bruce Strober⁵, Richard B. Warren⁶, José M. López Pinto⁷, Christina Crater⁸, Sarah Kavanagh⁸ and Paolo Gisondi⁹, ¹Dalhousie University, Halifax, NS, Canada, ²Department of Dermatology and Department of Medicine, UT Southwestern Medical Center, Dallas, TX, ³Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, ⁴Nagoya City West Medical Center, Nagoya, Japan, ⁵Department of Dermatology, Yale University, New Haven, and Central Connecticut Dermatology Research, Cromwell, CT, ⁶Dermatology Centre, Northern Care Alliance, NHS Foundation Trust & Division of Musculoskeletal and Dermatological Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom, ⁷UCB, Madrid, Spain, ⁸UCB, Morrisville, NC, ⁹Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy

Meeting: ACR Convergence 2025

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

Session Information

Date: Sunday, October 26, 2025

Title: (0554–0592) Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster I

Session Type: Poster Session A

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

Background/Purpose: Psoriatic arthritis (PsA) affects up to one-third of patients with psoriasis;1 early identification and intervention for patients with psoriasis and risk factors (RFs) for progression to PsA, or those screening PsA-positive, may reduce progression.1

Methods: Data were pooled from the BE VIVID (NCT03370133), BE SURE (NCT03412747), and BE READY (NCT03410992) phase 3 trials, their open-label extension (OLE) BE BRIGHT (NCT03598790), and the BE RADIANT phase 3b trial (NCT03536884; including its OLE).2–6 Included patients received bimekizumab (BKZ) 320 mg every 4 weeks (Q4W) to Week 16, then Q4W or Q8W, and entered the OLE (BKZ Total). Data are also reported for the subset of patients who received BKZ Q4W to Week 16 then Q8W continuously (Q4W/Q8W). Achievement of 100% improvement from baseline in Psoriasis Area and Severity Index (PASI 100) was evaluated through Year 3 (OLE Week 96) in patients with baseline nail involvement (modified Nail Psoriasis Severity Index [mNAPSI] >10), and in patients screening PsA-positive at baseline (Psoriatic Arthritis Screening and Evaluation [PASE] ≥47). Patients with ≥3 RFs, including mNAPSI >10, scalp Investigator’s Global Assessment ≥3, PASI ≥20, and BMI >30 kg/m2, were also analyzed. 7–10 Modified non-responder imputation was used: patients discontinuing due to lack of efficacy or treatment-related adverse events were considered non-responders; multiple imputation was used for other missing data.

Results: Among 1,107 BKZ Total patients, 377, 189, and 320 had mNAPSI >10, PASE ≥47, or ≥3 RFs, respectively. Among Q4W/Q8W patients (N&#3f374), 129, 53, and 99 had mNAPSI >10, PASE ≥47, or ≥3 RFs, respectively. At Week 16, 61.8%, 68.8%, and 59.7% of BKZ Total patients with mNAPSI >10, PASE ≥47, or ≥3 RFs achieved PASI 100, respectively, consistent with the overall BKZ Total population (65.5%). At Year 3, 68.6%, 63.5%, and 66.9% achieved PASI 100, generally consistent with 70.2% overall.Responses were similar in Q4W/Q8W patients with mNAPSI >10/PASE ≥47/≥3 RFs at Week 16 (72.1%/69.8%/66.7%) and Year 3 (73.8%/66.3%/70.4%), consistent with Q4W/Q8W patients overall (Week 16/Year 3: 71.5%/74.0%).

Conclusion: Rates of complete skin clearance were high through Year 3 in BKZ-treated patients with psoriasis and PsA RFs at baseline, and those screening PsA-positive at baseline, consistent with the overall BKZ-treated group. These patients may benefit from highly effective psoriasis treatment, to help prevent progression in the long term.References: 1. Zabotti A. Ann Rheum Dis 2023;82:1162–70; 2. Reich K. Lancet 2021;397:487–98; 3. Warren RB. N Engl J Med 2021;385:130–41; 4. Gordon KB. Lancet 2021;397:475–86; 5. Strober Bl. Br J Dermatol 2023;188:749–59; 6. Strober B. J Am Acad Dermatol 2023;486–95; 7. Husni ME. J Am Acad Dermatol 2007;57:581–7; 8. Yan D. Dermatol Ther (Heidelb) 2018;8:593–604; 9. Iragorri N. Rheumatology (Oxford) 2019;692–707; 10. Green A. Br J Dermatol 2020;182:714–20.Previously presented at AAD 2025.

Disclosures: R. Langley: AbbVie, 1, 6, 12, Principal investigator, Amgen, 1, 6, 12, Principal investigator, Boehringer-Ingelheim, 1, 12, Principal investigator, Celgene, 1, 6, 12, Principal Investigator, Eli Lilly and Company, 1, 6, 12, Principal Investigator, LEO Pharma, 1, 6, 12, Principal Investigator, Merck, 1, 6, 12, Principal Investigator, Novartis, 1, 6, 12, Principal Investigator, Pfizer, 1, 6, 12, Principal Investigator, UCB, 1, 12, Principal Investigator; J. Merola: AbbVie, 2, Amgen, 2, 5, AstraZeneca, 2, 5, Biogen, 2, 5, Boehringer Ingelheim, 2, 5, Bristol Myers Squibb, 2, 5, Dermavant, 2, 5, Eli Lilly and Company, 2, 5, Incyte, 2, Janssen, 2, 5, LEO Pharma, 2, MoonLake Immunotherapeutics, 2, 5, Novartis, 2, Pfizer, 2, Sanofi-Regeneron, 2, 5, Sun Pharma, 5, UCB, 2, 5; 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, 1, 2, 12, Investigator, Celltrion, 1, 2, 12, Investigator, Eli Lilly and Company, 1, 2, 12, Investigator, Fresenius-Kabi, 2, 5, Galderma, 1, 2, 12, Investigator, Johnson & Johnson, 1, 2, 12, Investigator, Kyowa Kirin, 1, 2, 12, Investigator, L’Oreal, 1, 2, 12, Investigator, LEO Pharma, 1, 2, 5, 12, Investigator, New Bridge, 1, 2, 12, Investigator, Novartis, 1, 2, 12, Investigator, Pfizer, 1, 2, 12, Investigator, Regeneron, 1, 2, 12, Investigator, Samsung, 1, 2, 12, Investigator, Sanofi, 1, 2, 12, Investigator, Sun-Pharma, 1, 2, 5, Target-RWE, 1, 2, 12, Investigator, UCB, 1, 2, 12, Investigator, Vichy, 1, 2, 12, Investigator; E. Nishida: AbbVie, 2, Amgen, 2, Boehringer Ingelheim, 2, Bristol Myers Squibb, 2, Daiichi Sankyo, 2, Eli Lilly and Company, 2, Janssen, 2, Kyowa Kirin, 2, LEO Pharma, 2, Maruho, 2, Novartis, 2, Pfizer, 2, Regeneron, 2, Sanofi, 2, Sun Pharma, 2, Taiho, 2, Torii, 2, UCB, 2; B. Strober: AbbVie, 2, 6, Almirall, 2, 6, Alumis, 2, 6, Amgen, 2, 6, Arcutis, 2, 6, Boehringer-Ingelheim, 2, 6, Bristol-Myers Squibb, 2, 6, Capital One, 2, 6, Connect Biopharma, 11, CorEvitas, 2, CorEvitas Psoriasis Registry, 12, Scientific Co-Director (Consulting fee) and Investgator, Dermavant, 2, 6, Eli Lilly and Company, 2, 6, Incyte, 6, Janssen, 2, 6, Journal of Psoriasis and Psoriatic Arthritis, 12, Editor-in-Chief (honorarium), LEO Pharma, 2, 6, Maruho, 2, 6, Meiji Seika Pharma, 2, 6, Mindera Health, 11, Novartis, 2, 6, Oruka, 2, 6, Pfizer, 2, 6, Protagonist, 2, 6, Rapt, 2, 6, Regeneron, 2, 6, Sanofi-Genzyme, 2, 6, Sun Pharma, 2, 6, 12, Investigator, Takeda, 2, 6, UCB, 2, 6, Union Therapeutics, 2, 6; R. Warren: AbbVie, 2, 5, 6, Almirall, 2, 5, 6, Amgen, 2, 5, Arena, 2, Astellas, 2, Avillion, 2, Biogen, 2, Boehringer Ingelheim, 2, Bristol Myers Squibb, 2, 6, Celgene, 2, 5, DICE Therapeutics, 2, Eli Lilly and Company, 2, 5, 6, GSK, 2, Janssen, 2, 5, 6, LEO Pharma, 2, 5, Meiji Pharma, 2, Novartis, 2, 5, 6, Pfizer, 2, 5, RAPT Therapeutics, 2, Sanofi, 2, Sun Pharma, 2, UCB, 2, 5, Union, 2; J. López Pinto: UCB, 3, 12, Shareholder; C. Crater: 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; P. Gisondi: AbbVie, 2, Abiogen, 2, Almirall, 2, Celgene, 2, Eli Lilly and Company, 2, Janssen, 2, LEO Pharma, 2, Merck, 2, MSD, 2, Novartis, 2, Otsuka, 2, Pfizer, 2, Pierre Fabre, 2, Sanofi, 2, UCB, 2.

To cite this abstract in AMA style:

Langley R, Merola J, Thaçi D, Nishida E, Strober B, Warren R, López Pinto J, Crater C, Kavanagh S, Gisondi P. Bimekizumab 3-Year Efficacy In Patients With Psoriasis And Risk Factors For Progression To Psoriatic Arthritis Or Screening Positive For Psoriatic Arthritis: Long-Term Results From Five Phase 3/3b Trials [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/bimekizumab-3-year-efficacy-in-patients-with-psoriasis-and-risk-factors-for-progression-to-psoriatic-arthritis-or-screening-positive-for-psoriatic-arthritis-long-term-results-from-five-phase-3-3b-tri/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/bimekizumab-3-year-efficacy-in-patients-with-psoriasis-and-risk-factors-for-progression-to-psoriatic-arthritis-or-screening-positive-for-psoriatic-arthritis-long-term-results-from-five-phase-3-3b-tri/