Bimekizumab Maintained Efficacy Responses in Patients With Active Psoriatic Arthritis: Up to 2-Year Results From Two Phase 3 Studies (Update).

Abstract

Aims: To report proportion of Week (Wk) 16 responders maintaining response in joint/skin/composite efficacy outcomes to 2 years in bimekizumab (BKZ)-treated patients with psoriatic arthritis (PsA). Method(s): BE OPTIMAL (biologic DMARD [bDMARD]-naive; NCT03895203)/BE COMPLETE (TNF inhibitor inadequate response/ intolerance [TNFi-IR]; NCT03896581) assessed BKZ 160 mg every 4wks (Q4W; placebo-controlled to Wk16). BE OPTIMAL Wk52/BE COMPLETE Wk16 completers could enter BE VITAL (open-label extension; NCT04009499). Efficacy reported for BKZ-randomized patients at baseline; safety reported for all BKZ-treated patients. Maintenance of response: proportion of Wk16 responders who were Wk104/100 responders (BE OPTIMAL/BE COMPLETE). Efficacy outcomes reported to Wk104/100 BE OPTIMAL/BE COMPLETE: ACR20/50/70, PASI75/90/100, ACR50 + PASI100, SJC = 0, Minimal/Very Low Disease Activity (MDA/VLDA). Missing data: non-responder imputation. Result(s): 83.3% (359/431) bDMARD-naive completed Wk104; 80.5% (215/267) TNFi-IR completed Wk100. High proportions of Wk16 ACR50/PASI100/ACR50 + PASI100/ SJC = 0/MDA responders maintained Wk104/100 responses. ACR50 Wk16 responders: 43.9% (n = 189) bDMARD-naive, 43.1% (n = 115) TNFi-IR; of these patients, 79.4% (150/189) bDMARD-naive, 75.7% (87/115) TNFi-IR maintained Wk104/100 response. PASI100 Wk16 responders among patients with baseline psoriasis >=3% body surface area (BSA): 47.5% (103/217) bDMARD-naive, 58.5% (103/176) TNFi-IR; of these, 70.9% (73/103) bDMARD-naive, 80.6% (83/103) TNFi-IR maintained Wk104/100 response. ACR50 + PASI100 Wk16 responders among patients with baseline psoriasis >=3% BSA: 27.6% (60/217) bDMARD-naive, 33.5% (59/176) TNFi-IR; of these, 70.0% (42/60) bDMARD-naive, 72.9% (43/59) TNFi-IR maintained Wk104/100 response. SJC = 0 Wk16 responders: 47.8% (n = 206) bDMARD-naive, 45.7% (n = 122) TNFi-IR; of these, 75.2% (155/206) bDMARD-naive, 73.8% (90/122) TNFi-IR maintained Wk104/100 response. MDA Wk16 responders: 45.0% (n = 194) bDMARD-naive, 43.8% (n = 117) TNFi-IR; of these, 75.8% (147/194) bDMARD-naive, 74.4% (87/117) TNFi-IR maintained Wk104/100 response. Similar Wk104/100 results observed for other joint/skin/composite efficacy outcomes. Wk104 exposure-adjusted incidence rates/100 patient-years for >=1 treatment-emergent adverse event: 179.9 (bDMARD-naive); 100.3 (TNFi-IR). Conclusion(s): BKZ demonstrated robust maintenance of response at 2 years in bDMARD-naive and TNFi-IR patients with PsA who were Wk16 responders. Safety profile was consistent with previous reports. Funding(s): UCB.