Abstract
Introduction: Psoriasis is a chronic condition requiring long-term management; evaluating long-term safety of treatments is important. We report the first 4-year (yr) safety data for bimekizumab (BKZ) in patients with moderate to severe plaque psoriasis. Methods: Data were pooled from 5 trials: BE SURE/BE VIVID/BE READY, their open-label extension (OLE) BE BRIGHT (4‑yr data; cut-off 14Nov2022), and BE RADIANT (3‑yr data; cut‑off 6May2022).1-5 Patients received BKZ 320mg every 4 weeks (wks)(Q4W) or Q8W; all received Q8W from Wk64 (BE RADIANT)/OLE Wk48 (BE BRIGHT) or next scheduled visit. Treatment-emergent adverse events (TEAEs) are presented as exposure-adjusted incidence rates (EAIRs)/100 patient‑yrs (PY) for all patients who received ≥1 BKZ dose, and evaluated separately for Yr1/Yr2/Yr3/Yr4 (Wks0-52/52-104/104-156/156-208) of treatment. Results: Total BKZ exposure was 6,324.3PY (N=2,186) (Yr1: 2,053.3PY [n=2,186]; Yr2: 1,904.3PY [n=2,013]; Yr3: 1,521.1PY [n=1,803]; Yr4: 819.5PY [n=1,309]). Overall, TEAEs occurred at an EAIR of 170.5/100PY (Yr1, Yr2, Yr3, Yr4: 230.9/100PY, 137.7/100PY, 107.1/100PY, 99.9/100PY), serious TEAEs at 5.5/100PY (6.5/100PY, 5.9/100PY, 5.8/100PY; 5.6/100PY), and TEAEs leading to discontinuation at 2.9/100PY (4.6/100PY, 2.3/100PY, 2.3/100PY, 1.1/100PY). The most common TEAEs were nasopharyngitis at 12.7/100PY (25.8/100PY, 13.2/100PY, 5.4/100PY, 5.9/100PY), oral candidiasis at 8.9/100PY (18.9/100PY, 10.7/100PY, 6.8/100PY, 5.4/100PY), and upper respiratory tract infection at 5.7/100PY (10.4/100PY, 5.7/100PY, 3.7/100PY, 3.9/100PY). Throughout, fewer TEAEs occurred with BKZ Q8W vs Q4W (115.4/100PY vs 224.4/100PY), including for oral candidiasis (6.5/100PY vs 16.7/100PY). Conclusions: BKZ demonstrated good tolerability and a consistent safety profile over 4 yrs in patients with plaque psoriasis. EAIRs of TEAEs remained consistent/decreased with longer BKZ exposure; no new safety findings were identified.
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