Bimekizumab Treatment in Patients with Active Psoriatic Arthritis and Inadequate Response to Tumor Necrosis Factor Inhibitors: 16-Week Efficacy and Safety from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study

Joseph Merola¹, Robert Landewé², Iain B McInnes³, Philip J Mease⁴, Christopher Ritchlin⁵, Yoshiya Tanaka⁶, Akihiko Asahina⁷, Frank Behrens⁸, Dafna Gladman⁹, Laure Gossec¹⁰, Richard Warren¹¹, Barbara Ink¹², Deepak Assudani¹², Rajan Bajracharya¹², Jason Coarse¹³ and Laura Coates¹⁴, ¹Harvard Medical School, Brigham and Women's Hospital, Boston, MA, ²Amsterdam University Medical Center, Meerssen, Netherlands, ³Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, Scotland, United Kingdom, ⁴Swedish Medical Center/Providence St. Joseph Health, Seattle, WA, ⁵Allergy, Immunology and Rheumatology Division, University of Rochester Medical School, Canandaigua, NY, ⁶University of Occupational and Environmental Health, Kitakyusyu Fukuoka, Japan, ⁷Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan, ⁸Rheumatology University Hospital & Fraunhofer Institute Translational Medicine and Pharmacology, Goethe-University Frankfurt, Frankfurt Am Main, Germany, ⁹Toronto Western Hospital, Schroeder Arthritis Institute, Toronto, ON, Canada, ¹⁰Sorbonne Université, Paris, France, ¹¹The University of Manchester, Manchester, United Kingdom, ¹²UCB Pharma, Slough, United Kingdom, ¹³UCB Pharma, Raleigh, NC, USA, Raleigh, NC, ¹⁴Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK, Oxford, England, United Kingdom

Meeting: ACR Convergence 2022

Keywords: American College of Rheumatology Criteria, clinical trial, Interleukins, Psoriatic arthritis, spondyloarthritis

Session Information

Date: Sunday, November 13, 2022

Title: Abstracts: Spondyloarthritis Including PsA – Treatment II: PsA

Session Type: Abstract Session

Session Time: 3:00PM-4:30PM

Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. The phase 3 BE COMPLETE study assessed the efficacy and safety of BKZ vs placebo (PBO) in patients (pts) with active PsA and inadequate response to TNF inhibitor (TNFi).

Methods: BE COMPLETE (NCT03896581) comprised a 16-week (wk) double-blind, PBO-controlled period. Pts were eligible if they had a diagnosis of adult-onset, active PsA meeting the Classification Criteria for PsA with duration ≥6 months, ≥3 tender and swollen joints, ≥1 active psoriatic lesion and/or documented history of psoriasis, and inadequate response or intolerance to 1–2 prior TNFi. Pts were randomized 2:1 to subcutaneous BKZ 160 mg every 4 wks (Q4W) or PBO. Primary endpoint: ≥50% improvement in ACR response criteria (ACR50) at Wk 16. Missing data for binary endpoints were imputed as non-response; missing continuous efficacy variables used multiple imputation.

Results: A total of 388/400 (97.0%) pts completed Wk 16 (263/267 [98.5%] BKZ; 125/133 [94.0%] PBO). Baseline (BL) characteristics were comparable between groups. Mean age: 50.5 years; BMI: 29.8 kg/m²; time since diagnosis: 9.5 years; 47.5% male. Mean tender and swollen joint counts were 18.7 and 9.9, respectively; 66.0% had psoriasis affecting ≥3% body surface area (BSA).

At Wk 16, BKZ demonstrated significant improvements vs PBO for the primary endpoint (ACR50: 116 [43.4%] BKZ vs 9 [6.8%] PBO; p< 0.001; Table). Improvement in ACR50 response compared with PBO was observed in the BKZ group as early as Wk 4. Over half of pts with psoriasis affecting ≥3% BSA at BL achieved complete skin clearance at Wk 16 with BKZ (Psoriasis Area and Severity Index [PASI]100: 103/176 [58.5%] BKZ vs 4/88 [4.5%] PBO; Table). BKZ treatment also resulted in greater percentages of pts achieving minimal disease activity (MDA: 118 [44.2%] BKZ vs 8 [6.0%] PBO; p< 0.001) and nail psoriasis resolution compared to PBO (Figure). Further, BKZ demonstrated superiority vs PBO for improvements in physical function, including Health Assessment Questionnaire Disability Index and Short-Form 36-Item Health Survey Physical Component Summary (Table).

To Wk 16, 107/267 (40.1%) pts on BKZ had ≥1 treatment-emergent adverse event (TEAE) vs 44/132 (33.3%) pts on PBO (safety set). Most frequent TEAEs on BKZ were nasopharyngitis (BKZ: 3.7%; PBO: 0.8%), oral candidiasis (2.6%; 0%), and upper respiratory tract infection (2.2%; 1.5%). Two pts on BKZ discontinued due to a TEAE (BKZ: 0.7%; PBO: 0%). Incidence of serious TEAEs was low (BKZ: 1.9%; PBO: 0%); none led to discontinuation. All reported Candida infections were oral; all were mild to moderate, none were systemic. One case of oral candidiasis led to discontinuation. No cases of IBD, major adverse cardiac events, uveitis, serious hypersensitivity, or deaths were reported.

Conclusion: Dual inhibition of IL-17F in addition to IL-17A with BKZ in pts with active PsA and inadequate response to TNFi resulted in clinically meaningful and statistically significant improvements in efficacy outcomes vs PBO. BKZ was well tolerated; no new safety signals were observed.^1,2

References: 1. Ritchlin CT. Lancet 2020;395(10222):427–40; 2. Coates LC. Ann Rheum Dis 2021;80:779–80(POS1022).

Disclosures: J. Merola, AbbVie, Biogen, BMS, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sun Pharma, UCB Pharma, Arena, Avotres, EMD, LEO Pharma, Merck, Regeneron, Sanofi; R. Landewé, Abbott, Amgen, AstraZeneca, BMS, GSK, Novartis, Merck, Pfizer, Schering-Plough, UCB Pharma; I. McInnes, Bristol-Myers Squibb (BMS), Janssen, Novartis, UCB, Pfizer, AbbVie, Celgene, AstraZeneca, Boehringer Ingelheim, EveloBio, LEO, Lilly; P. Mease, AbbVie, Amgen, Janssen, Novartis, Pfizer Inc, UCB, Sun Pharma, Eli Lilly, Bristol-Myers Squibb(BMS), Celgene, Genentech; C. Ritchlin, UCB, AbbVie, Eli Lilly, Pfizer Inc, Novartis, Janssen, Bristol-Myers Squibb; Y. Tanaka, Lilly, AbbVie, Bristol Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Pfizer, Mitsubishi Tanabe, GlaxoSmithKline, Asahi Kasei, Takeda, Astellas, Janssen, Novartis, Sanofi, UCB, YL Biologics, MSD, Ono, Taisho Toyama, Celltrion, Gilead, Boehringer-Ingelheim, Corrona, Kowa, Amgen, AstraZeneca, AstraZeneca, Eli Lilly; A. Asahina, AbbVie, Eisai, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Pharma, Sun Pharma, Taiho Pharma, Torii Pharmaceutical, UCB Pharma, Celgene; F. Behrens, AbbVie, Boehringer Ingelheim, Celgene, Chugai, Eli Lilly, Genzyme, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, Bristol-Myers Squibb(BMS), Galapagos, Gilead, UCB, Affibody, MoonLake, GlaxoSmithKlein(GSK); D. Gladman, AbbVie, Amgen, Eli Lilly, Janssen, Gilead, Novartis, Pfizer, Bristol-Myers Squibb(BMS), Galapagos, UCB Pharma, Celgene; L. Gossec, Amgen, Lilly, Pfizer, Sandoz, UCB Pharma, AbbVie, Bristol Myers Squibb, Gilead, Janssen, Novartis, Samsung Bioepis, Sanofi-Aventis, Galapagos, GlaxoSmithKlein (GSK), Celltrion, MSD; R. Warren, AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, UCB Pharma, DiCE, Union; B. Ink, UCB Pharma, GlaxoSmithKlein(GSK); D. Assudani, UCB Pharma; R. Bajracharya, UCB Pharma; J. Coarse, UCB Pharma; L. Coates, AbbVie, Amgen, Boehringer-Ingelheim, Bristol-Myers Squibb (BMS), Eli Lilly, Gilead, Galapagos, Janssen, Medac, Novartis, Pfizer, UCB, Celgene, Biogen, Moonlake, GlaxoSmithKlein (GSK).

To cite this abstract in AMA style:

Merola J, Landewé R, McInnes I, Mease P, Ritchlin C, Tanaka Y, Asahina A, Behrens F, Gladman D, Gossec L, Warren R, Ink B, Assudani D, Bajracharya R, Coarse J, Coates L. Bimekizumab Treatment in Patients with Active Psoriatic Arthritis and Inadequate Response to Tumor Necrosis Factor Inhibitors: 16-Week Efficacy and Safety from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/bimekizumab-treatment-in-patients-with-active-psoriatic-arthritis-and-inadequate-response-to-tumor-necrosis-factor-inhibitors-16-week-efficacy-and-safety-from-a-phase-3-randomized-double-blind-pla/. Accessed .

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