Bimekizumab Safety and Tolerability in Moderate to Severe Plaque Psoriasis: Pooled Analysis from Up to 4 Years of Treatment in 5 Phase 3/3b Clinical Trials

SKIN The Journal of Cutaneous Medicine Pub Date : 2024-07-23 DOI:10.25251/skin.8.supp.404

Kenneth B Gordon, Diamant Thaçi, Melinda Gooderham, Yukari Okubo, B. Strober, Luke Peterson, D. Deherder, José M. López Pinto, Paolo Gisondi

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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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Bimekizumab 对中度至重度斑块状银屑病的安全性和耐受性：5项3/3b期临床试验长达4年治疗的汇总分析

简介银屑病是一种需要长期治疗的慢性疾病，因此评估治疗的长期安全性非常重要。我们报告了双美珠单抗（BKZ）治疗中重度斑块状银屑病患者的首个四年（yr）安全性数据。研究方法汇总了 5 项试验的数据：1-5 患者每 4 周（周）（Q4W）或每 8 周（Q8W）接受一次 BKZ 320 毫克治疗；所有患者均从第 64 周（BE RADIANT）/第 48 周（BE BRIGHT）或下一次预定就诊开始接受 Q8W 治疗。治疗突发不良事件（TEAEs）以暴露调整发生率（EAIRs）/100 患者年（PY）表示，针对所有接受≥1 次 BKZ 剂量治疗的患者，并分别评估治疗第 1 年/第 2 年/第 3 年/第 4 年（Wks0-52/52-104/104-156/156-208）的情况。结果：BKZ总暴露量为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]）。总体而言，发生 TEAE 的 EAIR 为 170.5/100PY（Yr1、Yr2、Yr3、Yr4：230.9/100PY、137.7/100PY、107.1/100PY、99.9/100PY），严重 TEAE 为 5.5/100PY（6.5/100PY、5.9/100PY、5.8/100PY；5.6/100PY），导致停药的 TEAEs 为 2.9/100PY（4.6/100PY、2.3/100PY、2.3/100PY、1.1/100PY）。最常见的 TEAE 为鼻咽炎 12.7/100PY（25.8/100PY、13.2/100PY、5.4/100PY、5.9/100PY）、口腔念珠菌病 8.9/100PY（18.9/100PY、10.7/100PY、6.8/100PY、5.4/100PY）和上呼吸道感染 5.7/100PY（10.4/100PY、5.7/100PY、3.7/100PY、3.9/100PY）。总的来说，BKZ Q8W 与 Q4W（115.4/100PY vs 224.4/100PY）相比，发生的 TEAEs 更少，包括口腔念珠菌病（6.5/100PY vs 16.7/100PY）。结论BKZ在斑块状银屑病患者中表现出良好的耐受性和持续4年的安全性。TEAEs的EAIRs保持一致/随着BKZ暴露时间的延长而降低；没有发现新的安全性问题。

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SKIN The Journal of Cutaneous Medicine

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