Oregon Medical Research Center, Portland, Oregon.
Probity Medical Research and K. Papp Clinical Research, Waterloo, and University of Toronto, Toronto, Ontario.
J Am Acad Dermatol. 2020 Nov;83(5):1367-1374. doi: 10.1016/j.jaad.2020.05.105. Epub 2020 May 29.
BACKGROUND: Dual neutralization of both interleukin 17A and 17F with the monoclonal antibody bimekizumab may have greater efficacy in psoriasis than neutralization of interleukin 17A alone. OBJECTIVE: To provide longer-term efficacy and safety data for bimekizumab from a phase 2b extension study in patients with moderate to severe psoriasis (BE ABLE 2). METHODS: After the 12-week initial study (BE ABLE 1), patients who had a 90% improvement in Psoriasis Area and Severity Index (PASI 90) at week 12 received bimekizumab 64, 160, or 320 mg for an additional 48 weeks (60 weeks in total). The primary objective was safety. RESULTS: Across all dose groups (N = 217), initial PASI 90 responders generally maintained high levels of efficacy through week 60: PASI 90, 80% to 100%; 100% improvement in PASI, 69% to 83%; Investigator's Global Assessment score 0 or 1, 78% to 100% (all nonresponder imputation). Incidence of serious treatment-emergent adverse events was 15/217 (6.9%). No cases of inflammatory bowel disease, major adverse cardiovascular events, or suicidal ideation or behavior were reported. LIMITATIONS: Low numbers in the bimekizumab 64 mg group (n = 15). The majority of 60-week data reported here are primarily for the week 12 PASI 90 responders only. CONCLUSION: Bimekizumab response rates were maintained through week 60. A substantial proportion of patients achieved complete skin clearance. Bimekizumab was generally well tolerated.
背景:与单克隆抗体 bimekizumab 双重中和白细胞介素 17A 和 17F 可能比单独中和白细胞介素 17A 对银屑病更有效。
目的:提供来自中度至重度银屑病(BE ABLE 2)的 2b 期扩展研究中 bimekizumab 的更长时间疗效和安全性数据。
方法:在为期 12 周的初始研究(BE ABLE 1)之后,在第 12 周达到银屑病面积和严重程度指数(PASI 90)改善 90%的患者接受 bimekizumab 64、160 或 320 mg 治疗,再持续 48 周(总共 60 周)。主要目的是安全性。
结果:在所有剂量组(N=217)中,最初达到 PASI 90 的应答者通常在第 60 周时保持较高的疗效水平:PASI 90,80%至 100%;PASI 100%改善,69%至 83%;研究者全球评估评分 0 或 1,78%至 100%(所有非应答者推断)。严重治疗突发不良事件的发生率为 15/217(6.9%)。没有报告炎症性肠病、主要不良心血管事件或自杀意念或行为的病例。
局限性:bimekizumab 64 mg 组人数较少(n=15)。这里报告的 60 周数据主要是针对第 12 周 PASI 90 应答者。
结论:bimekizumab 的应答率在第 60 周保持不变。很大一部分患者达到了完全的皮肤清除。bimekizumab 通常具有良好的耐受性。
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