Bimekizumab Efficacy and Safety Through 4 Years in Moderate to Severe Plaque Psoriasis: Long-Term Results from a Phase 3 Study and Open-Label Extension

Diamant Thaçi¹, Luis Puig², Joseph F. Merola³, Denis Jullien⁴, Antonio Costanzo⁵, Maggie Wang⁶, Delphine Deherder⁷, José M. López Pinto⁸ and Mark Lebwohl⁹, ¹Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Schleswig-Holstein, Germany, ²Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain, ³UT Southwestern Medical Center, Dallas, TX, ⁴Department of Dermatology, Hôpital Edouard Herriot, Hospices Civils de Lyon, University of Lyon, Lyon, France, ⁵Department of Dermatology, Humanitas Clinical and Research Centre, IRCCS, Rozzano, Milan, Italy, ⁶UCB Pharma, Morrisville, NC, ⁷UCB Pharma, Braine-l'Alleud, Belgium, ⁸UCB Pharma, Madrid, Spain, ⁹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY

Meeting: ACR Convergence 2024

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

Session Information

Date: Monday, November 18, 2024

Title: SpA Including PsA – Treatment Poster III

Session Type: Poster Session C

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

Background/Purpose: Clinical improvements through Week 152, with no unexpected safety findings, were previously reported with bimekizumab (BKZ) in the BE SURE phase 3 trial and BE BRIGHT open-label extension.^1,2Here, we evaluate long-term efficacy of BKZ, as measured by complete (100% improvement from baseline in Psoriasis Area and Severity Index [PASI 100]) or near-complete skin clearance (PASI 90), in addition to safety of BKZ, through 4 years of treatment.

Methods: In BE SURE (NCT03412747), patients with moderate to severe plaque psoriasis were randomized 1:1:1 to either BKZ 320 mg every 4 weeks (Q4W) to Week 16 then Q8W to Week 56 (BKZ Q4W/Q8W), BKZ Q4W to Week 56 (Q4W/Q4W), or adalimumab (ADA) 40 mg Q2W to Week 24 then BKZ Q4W to Week 56 (ADA/BKZ).¹

At Week 56, patients could enroll in BE BRIGHT (NCT03598790) to receive open-label BKZ Q4W or Q8W;³ all received BKZ Q8W from Week 104 or next scheduled visit.

Efficacy data are reported through Week 200 by initial randomization group. Patients discontinuing 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) occurring whilst receiving BKZ (incidence/100 patient-years [PY]) are reported through Weeks 0–200.

Results: In BE SURE, 478 patients were randomized to BKZ Q4W/Q8W (N=161), BKZ Q4W/Q4W (N=158), and ADA/BKZ (N=159).¹ At Week 200, PASI 90 was achieved by 83.2% of BKZ Q4W/Q8W-randomized, 82.4% BKZ Q4W/Q4W-randomized, and 87.6% ADA/BKZ-randomized patients. PASI 100 was achieved by 58.5%, 61.9%, and 69.5%, respectively.

Week 0–200 serious TEAE rate with BKZ was low (4.9/100 PY). Five deaths occurred (zero treatment-related). The most common TEAEs were: nasopharyngitis (12.3/100 PY), oral candidiasis (8.3/100 PY), and upper respiratory tract infection (6.0/100 PY). Most (99.2%) oral candidiasis events were mild or moderate; none led to discontinuation.

Conclusion: Through 4 years, clinical improvements with BKZ were maintained and BKZ was well-tolerated with no unexpected safety findings.^1,2

References: 1. Thaçi D. Br J Dermatol 2023;188:22–31; 2. Thaçi D. Presented at EADV 2022, P1572; 3. Strober B. Br J Dermatol 2023;188:749–59.

Previously presented at AAD 2024.

Disclosures: 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, 1, 2, 12, Investigator, Galapagos, 1, 2, 12, Investigator, Galderma, 1, 2, 12, Investigator, Janssen-Cilag, 1, 2, 12, Investigator, Kyowa Kirin, 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 Pharma, 1, 2, 12, Investigator; L. Puig: AbbVie, 2, 5, 6, Almirall, 2, 5, 6, Amgen, 2, 5, 6, Baxalta, 2, 5, 6, Biogen, 2, 5, 6, Boehringer Ingelheim, 2, 5, 6, Bristol Myers Squibb, 2, 5, 6, Celgene, 2, 5, 6, Eli Lilly, 2, 5, 6, Gebro, 2, 5, 6, Janssen, 2, 5, 6, JS BIOCAD, 2, 5, 6, LEO Pharma, 2, 5, 6, Merck-Serono, 2, 5, 6, MSD, 2, 5, 6, Mylan, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Regeneron, 2, 5, 6, Roche, 2, 5, 6, Samsung-Bioepis, 2, 5, 6, Sandoz, 2, 5, 6, Sanofi-Genzyme, 2, 5, 6, UCB, 2, 5, 6; J. Merola: AbbVie, 2, 12, Investigator, Amgen, 2, 12, Investigator, Biogen, 2, 12, Investigator, Bristol Myers Squibb, 2, 12, Investigator, Dermavant, 2, 12, Investigator, Janssen, 2, 12, Investigator, LEO Pharma, 2, 12, Investigator, Lilly, 2, 12, Investigator, Novartis, 2, 12, Investigator, Pfizer, 2, 12, Investigator, Regeneron, 2, 12, Investigator, Sanofi, 2, 12, Investigator, Sun Pharma, 2, 12, Investigator, UCB, 2, 12, Investigator; D. Jullien: AbbVie, 2, 4, 6, 12, Travel/accommodations expenses covered or reimbursed, Almirall, 2, 4, Amgen, 2, 4, 12, Travel/accommodations expenses covered or reimbursed, Biogen, 2, 4, 12, Travel/accommodations expenses covered or reimbursed, Boehringer Ingelheim, 2, 4, Bristol Myers Squibb, 2, 4, Celgene, 2, 4, 6, 12, Travel/accommodations expenses covered or reimbursed, Eli Lilly, 2, 4, 6, 12, Travel/accommodations expenses covered or reimbursed, Fresenius Kabi, 2, 4, 12, Travel/accommodations expenses covered or reimbursed, Janssen, 2, 4, 6, 12, Travel/accommodations expenses covered or reimbursed, LEO Pharma, 2, 4, 6, 12, Travel/accommodations expenses covered or reimbursed, MEDAC, 2, 4, 6, 12, Travel/accommodations expenses covered or reimbursed, MSD, 2, 4, 12, Travel/accommodations expenses covered or reimbursed, Novartis, 2, 4, 6, 12, Travel/accommodations expenses covered or reimbursed, Pfizer, 2, 4, 6, 12, Travel/accommodations expenses covered or reimbursed, Sanofi, 2, 4, 12, Travel/accommodations expenses covered or reimbursed, UCB Pharma, 2, 4, 12, Travel/accommodations expenses covered or reimbursed; A. Costanzo: AbbVie, 1, 6, 12, Investigator, Almirall, 1, 6, 12, Investigator, Amgen, 1, 6, 12, Investigator, Boehringer Ingelheim, 1, 6, 12, Investigator, Celgene, 1, 6, 12, Investigator, Eli Lilly, 1, 6, 12, Investigator, Galderma, 1, 6, 12, Investigator, Janssen, 1, 6, 12, Investigator, LEO Pharma, 1, 6, 12, Investigator, Novartis, 1, 6, 12, Investigator, Pfizer, 1, 6, 12, Investigator, Regeneron, 1, 6, 12, Investigator, Sandoz, 1, 6, 12, Investigator, Sanofi, 1, 6, 12, Investigator, UCB Pharma, 1, 6, 12, Investigator; M. Wang: UCB Pharma, 3, 12, Shareholder; D. Deherder: UCB Pharma, 3, 12, Shareholder; J. López Pinto: UCB Pharma, 3, 12, Shareholder; M. Lebwohl: AbbVie, 5, Almirall, 2, AltruBio Inc., 2, Amgen, 5, AnaptysBio, 2, Arcutis, 2, 5, AstraZeneca, 2, Avotres, 2, 5, Boehringer Ingelheim, 2, 5, Brickell Biotech, 2, Bristol Myers Squibb, 2, Cara Therapeutics, 5, Castle Biosciences, 2, Celltrion, 2, CorEvitas, 2, Dermavant Sciences, 2, 5, Eli Lilly, 5, EPI, 2, Evommune Inc., 2, Facilitation of International Dermatology Education, 2, Forte Biosciences, 2, Foundation for Research and Education in Dermatology, 2, Galderma, 2, Genentech, 2, Incyte, 2, 5, Inozyme, 5, Janssen, 5, LEO Pharma, 2, LLC, 5, Meiji Seika Pharma, 2, Mindera, 2, Mount Sinai, 3, Ortho Dermatologics, 5, Pfizer, 2, Sanofi-Regeneron, 5, Seanergy, 2, Strata, 2, Trevi, 2, UCB Pharma, 5, Verrica, 2.

To cite this abstract in AMA style:

Thaçi D, Puig L, Merola J, Jullien D, Costanzo A, Wang M, Deherder D, López Pinto J, Lebwohl M. Bimekizumab Efficacy and Safety Through 4 Years in Moderate to Severe Plaque Psoriasis: Long-Term Results from a Phase 3 Study and Open-Label Extension [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/bimekizumab-efficacy-and-safety-through-4-years-in-moderate-to-severe-plaque-psoriasis-long-term-results-from-a-phase-3-study-and-open-label-extension/. Accessed .

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