Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from a Phase 3, Randomized, Placebo-Controlled, Active Reference Study

Christopher Ritchlin¹, Laura Coates², Iain McInnes³, Philip J. Mease⁴, Joseph Merola⁵, Yoshiya Tanaka⁶, Akihiko Asahina⁷, Laure Gossec⁸, Alice Gottlieb⁹, Diamant Thaci¹⁰, Barbara Ink¹¹, Deepak Assudani¹¹, Rajan Bajracharya¹¹, Vish Shende¹¹, Jason Coarse¹² and Robert Landewé¹³, ¹University of Rochester Medical Center, Rochester, NY, ²Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, United Kingdom, ³College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom, ⁴Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, ⁵Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, ⁶University of Occupational and Environmental Health Japan, Kitakyushu, Japan, ⁷Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan, ⁸Sorbonne Universités, UPMC Univ Paris 06, GRC-UPMC 08 (EEMOIS); AP-HP, Hôpital Pitié Salpêtrière, Rheumatology Department, Paris, France, Paris, France, ⁹Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, ¹⁰Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany, ¹¹UCB Pharma, Slough, United Kingdom, ¹²UCB Pharma, Raleigh, NC, ¹³Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, and Zuyderland MC, Heerlen, Netherlands

Meeting: ACR Convergence 2022

Date of first publication: October 18, 2022

Keywords: American College of Rheumatology Criteria, clinical trial, Dermatology, Late-Breaking 2022, Psoriatic arthritis, spondyloarthritis

Session Information

Date: Monday, November 14, 2022

Title: Late-Breaking Abstracts (L01–L06)

Session Type: Late-Breaking Abstract Session

Session Time: 9:00AM-10:30AM

Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A. BKZ treatment has demonstrated superior efficacy in joints and skin versus placebo (PBO) at Week (Wk) 16 in the phase 3 BE OPTIMAL study in biologic DMARD (bDMARD)-naïve patients (pts) with active PsA.¹ Wk 52 efficacy and safety data are presented here.

Methods: BE OPTIMAL (NCT03895203) comprised 16 wks double-blind, PBO-controlled, and 36 wks treatment-blind. bDMARD-naïve pts were eligible if they had adult-onset, active PsA meeting the Classification Criteria for PsA for ≥6 months, ≥3 tender and ≥3 swollen joints, and ≥1 active psoriatic lesion and/or history of psoriasis. Pts were randomized 3:2:1 subcutaneous BKZ 160 mg every 4 wks:PBO:reference arm (adalimumab [ADA] 40 mg every 2 wks). From Wk 16, PBO pts received BKZ 160 mg Q4W (PBO/BKZ). Missing data imputed using non-responder imputation (discrete) or multiple imputation (continuous).

Results: 821/852 (96.4%) pts completed Wk 16; 761 (89.3%) completed Wk 52. Baseline (BL) characteristics were generally balanced between groups (randomized set): mean age 48.7 years; BMI 29.2 kg/m²; time since diagnosis 5.9 years; 46.8% male; 49.9% had psoriasis affecting ≥3% body surface area (BSA).

At Wk 52, pts achieving ACR50: 53.0% PBO/BKZ, 54.5% BKZ, 50.0% ADA; pts with BL psoriasis (≥3% BSA) achieving complete skin clearance (Psoriasis Area and Severity Index [PASI]100): 65.0% PBO/BKZ, 60.8% BKZ, 48.5% ADA; pts achieving minimal disease activity: 53.7% PBO/BKZ, 55.0% BKZ, 52.9% ADA (Figure 1). Clinical joint and skin efficacy responses continued to increase or were sustained from Wk 16 to Wk 52 on BKZ; pts who switched to BKZ at Wk 16 demonstrated improvements in efficacy outcomes to Wk 52 (Table).

Overall radiographic progression was minimal to Wk 52. At Wk 52, pts with no radiographic progression (van der Heijde modified Total Sharp Score change from baseline ≤0.5): 87.3% PBO/BKZ, 89.3% BKZ, 94.1% ADA (radiographic set; observed case). Cumulative probability of radiographic progression is presented in Figure 2.

To Wk 52, 555/702 (79.1%) pts had ≥1 treatment-emergent adverse event (TEAE) while receiving BKZ; 113/140 (80.7%) on ADA. The three most frequent TEAEs on BKZ: nasopharyngitis (BKZ: 12.0% pts; ADA 8.6% pts), upper respiratory tract infection (BKZ: 7.1%; ADA: 5.7%), and urinary tract infection (BKZ: 6.1%; ADA: 3.6%). Pts who discontinued the study due to a TEAE: 21 (3.0%) BKZ; 7 (5.0%) ADA. Candida infections (high level term) reported in 7.7% BKZ, 0.7% ADA pts. All were mild/moderate; none systemic. 1 case of oral candidiasis led to discontinuation. To Wk 52, 3 BKZ‑treated pts had malignancies excluding non-melanoma skin cancers, 4 had adjudicated major adverse cardiac events, and 2 had definite IBD (ulcerative colitis); 1 death reported (motorcycle accident). No uveitis events were reported.

Conclusion: BKZ treatment demonstrated clinically meaningful improvements in efficacy outcomes in bDMARD-naïve pts with active PsA at Wk 16, which were sustained or continued to improve to Wk 52. BKZ was well tolerated; no new safety signals observed.²

References:
1. McInnes IB. Ann Rheum Dis 2022;81:206–7; 2. Coates LC. Arthritis & Rheum 2022;10.1002/art.42280.

Disclosures: C. Ritchlin, AbbVie, Amgen, UCB Pharma, Eli Lilly, Gilead, Janssen, Novartis, Pfizer; L. Coates, AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, UCB Pharma, Bristol-Myers Squibb(BMS), Boehringer Ingelheim, Domain, Galapagos, Moonlake, GlaxoSmithKlein(GSK), Medac; I. McInnes, AbbVie, AstraZeneca, Bristol-Myers Squibb(BMS), Boehringer Ingelheim, Cabaletta, Causeway Therapeutics, Celgene, Eli Lilly, Evelo, Janssen, Moonlake, Novartis, UCB Pharma; P. Mease, AbbVie, Amgen, Bristol-Myers Squibb(BMS), Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma, UCB Pharma, Acelyrin, Aclaris, Boehringer Ingelheim, Galapagos, GlaxoSmithKlein(GSK), Moonlake; J. Merola, AbbVie, Amgen, Bayer, Bristol-Myers Squibb(BMS), Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma; Y. Tanaka, AstraZeneca, AbbVie, Bristol-Myers Squibb(BMS), Boehringer Ingelheim, Chugai, Daiichi-Sankyo, Eisai, Lilly, Gilead, GlaxoSmithKlein(GSK), Mitsubishi Tanabe, Pfizer, Asahi-Kasei, Takeda; A. Asahina, AbbVie, Amgen, Bristol-Myers Squibb(BMS), Boehringer Ingelheim, Eisai, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Pfizer, Sun Pharma, Taiho Pharma, Torii Pharmaceutical, UCB Pharma; L. Gossec, Amgen, Eli Lilly, Galapagos, Pfizer, Sandoz, UCB Pharma, AbbVie, Bristol-Myers Squibb(BMS), Celltrion, Gilead, GlaxoSmithKlein(GSK), Janssen, Novartis; A. Gottlieb, Amgen, AnaptysBio, Avotres Therapeutics, Bristol-Myers Squibb(BMS), Boehringer Ingelheim, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, XBiotech, Ortho Dermatologics; D. Thaci, AbbVie, Almirall, Amgen, Biogen, Bristol-Myers Squibb(BMS), Celltrion, Eli Lilly, Galapagos, Galderma, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, UCB Pharma; B. Ink, UCB Pharma, AbbVie, GlaxoSmithKlein(GSK); D. Assudani, UCB Pharma; R. Bajracharya, UCB Pharma; V. Shende, UCB Pharma; J. Coarse, UCB Pharma; R. Landewé, AbbVie, AstraZeneca, Bristol-Myers Squibb(BMS), Eli Lilly, Novartis, Pfizer, UCB Pharma, Rheumatology Consultancy BV.

To cite this abstract in AMA style:

Ritchlin C, Coates L, McInnes I, Mease P, Merola J, Tanaka Y, Asahina A, Gossec L, Gottlieb A, Thaci D, Ink B, Assudani D, Bajracharya R, Shende V, Coarse J, Landewé R. Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from a Phase 3, Randomized, Placebo-Controlled, Active Reference Study [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9). https://acrabstracts.org/abstract/bimekizumab-treatment-in-biologic-dmard-naive-patients-with-active-psoriatic-arthritis-52-week-efficacy-and-safety-results-from-a-phase-3-randomized-placebo-controlled-active-reference-study/. Accessed .

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