Background Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A.

Objectives Assess BKZ efficacy and safety vs PBO in bDMARD-naïve pts with active PsA to Wk 24 of BE OPTIMAL.

Methods BE OPTIMAL (NCT03895203) comprises 16 wks double-blind PBO-controlled and 36 wks treatment-blind. Pts were ≥18 yrs, bDMARD-naïve, with adult-onset, active PsA, ≥3 tender and ≥3 swollen joints. Pts randomised 3:2:1, subcutaneous BKZ 160 mg Q4W:PBO:adalimumab (ADA; reference arm) 40 mg Q2W. From Wk 16, PBO pts received BKZ 160 mg Q4W. Primary endpoint: ACR50 at Wk 16.

Results 821/852 (96.4%) pts completed Wk 16 and 806 (94.6%) Wk 24. Mean age 48.7 yrs, BMI 29.2 kg/m²; since diagnosis: 5.9 yrs; 46.8% male. BL characteristics comparable across arms. Primary endpoint met (Wk 16 ACR50: 43.9% BKZ vs 10.0% PBO, p<0.001; ADA: 45.7%; Figure 1). All ranked secondary endpoints met at Wk 16 (Table 1). As early as Wk 2, ACR20 was higher in BKZ vs PBO (27.1% vs 7.8%, nominal p<0.001; ADA: 33.6%). Outcomes continued to improve at Wk 24 (Table 1). To Wk 16, pts with ≥1 TEAE, BKZ: 59.9%; PBO: 49.5%; ADA: 59.3%. SAE rate low (1.6%; 1.1%; 1.4%). Most frequent (≥5%) AEs for all arms: nasopharyngitis (9.3%; 4.6%; 5.0%), URTI (4.9%; 6.4%; 2.1%), increased ALT (0.7%; 0.7%; 5.0%). Candida infections: 2.6%, 0.7%, 0%; no systemic candidiasis. 2 malignancies (BKZ: basal cell carcinoma; PBO: breast cancer stage 1); no MACE, uveitis, IBD or deaths.

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Conclusion Dual inhibition of IL-17A and IL-17F with BKZ in bDMARD-naïve pts with active PsA resulted in rapid, clinically relevant improvements in musculoskeletal and skin outcomes vs PBO. No new safety signals observed.^1,2

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

Disclosure of Interests Iain McInnes Consultant of: AbbVie, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, and UCB Pharma, Grant/research support from: BMS, Boehringer Ingelheim, Celgene, Janssen, UCB Pharma, Laura Coates Consultant of: AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Domain, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer, and UCB Pharma, Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer, and UCB Pharma, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB Pharma, Robert B.M. Landewé Consultant of: Abbott, Ablynx, Amgen, AstraZeneca, BMS, Centocor, GSK, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, and Wyeth, Speakers bureau: Abbott, Amgen, BMS, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB Pharma, and Wyeth, Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB Pharma, and Wyeth, Philip J Mease Consultant of: AbbVie, Amgen, BMS, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma, Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Amgen, BMS, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma, Christopher T. Ritchlin Consultant of: AbbVie, Amgen, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, Amgen and UCB Pharma, Yoshiya Tanaka Consultant of: AbbVie, Ayumi, Daiichi-Sankyo, Eli Lilly, GSK, Sanofi, and Taisho, Speakers bureau: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer-Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, Mitsubishi-Tanabe, and YL Biologics, Grant/research support from: AbbVie, Asahi-Kasei, Boehringer-Ingelheim, Chugai, Corrona, Daiichi-Sankyo, Eisai, Kowa, Mitsubishi-Tanabe, and Takeda, Akihiko Asahina Grant/research support from: AbbVie, Amgen, Eisai, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Pfizer, Sun Pharma, Taiho Pharma, Torii Pharmaceutical, and UCB Pharma, Laure Gossec Consultant of: AbbVie, Amgen, BMS, Celltrion, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer and UCB Pharma, Grant/research support from: Amgen, Galapagos, Lilly, Pfizer, Sandoz and UCB Pharma, Alice B Gottlieb Consultant of: Amgen, AnaptsysBio, Avotres Therapeutics, Boehringer Ingelheim, BMS, Dermavant, Eli Lilly, Incyte, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and XBiotech, Grant/research support from: Boehringer Ingelheim, Janssen, Novartis, Sun Pharma, UCB Pharma, and XBiotech: all funds go to Mount Sinai Medical School, Richard B. Warren Consultant of: AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB Pharma, Paid instructor for: Astellas, DiCE, GSK, and Union, Grant/research support from: AbbVie, Almirall, Janssen, LEO Pharma, Novartis, and UCB Pharma, Barbara Ink Shareholder of: GSK, UCB Pharma, Employee of: UCB Pharma, Deepak Assudani Shareholder of: UCB Pharma, Employee of: UCB Pharma, Jason Coarse Shareholder of: UCB Pharma, Employee of: UCB Pharma, Rajan Bajracharya Shareholder of: UCB Pharma, Employee of: UCB Pharma, Joseph F. Merola Consultant of: AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB Pharma, Paid instructor for: Amgen, Abbvie, Biogen, BMS, Dermavant, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB Pharma