比美吉珠单抗在高影响区域的疗效：3期/3b期随机对照试验中头皮、指甲和掌跖银屑病的2年汇总分析
Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials.
作者信息
Merola Joseph F, Gottlieb Alice B, Pinter Andreas, Elewski Boni, Gooderham Melinda, Warren Richard B, Piaserico Stefano, Wixted Krista, Cross Nancy, Tilt Nicola, Wiegratz Susanne, Mrowietz Ulrich
机构信息
Department of Dermatology and Department of Medicine, Division of Rheumatology, UT Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390, USA.
Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, NY, USA.
出版信息
Dermatol Ther (Heidelb). 2024 Dec;14(12):3291-3306. doi: 10.1007/s13555-024-01295-w. Epub 2024 Nov 22.
INTRODUCTION
Psoriasis in high-impact areas, including the scalp, nails, palms, and soles, can disproportionately impair patient quality of life. Here, we evaluate the 2-year efficacy of bimekizumab treatment in patients with moderate to severe plaque psoriasis in post hoc analyses of five phase 3/3b trials.
METHODS
High-impact area efficacy data were pooled through 2 years across five phase 3/3b trials: BE VIVID, BE READY, BE SURE, their ongoing open-label extension (OLE) BE BRIGHT, and BE RADIANT (including its double-blinded treatment period and the first year of its OLE). Complete clearance of psoriasis in high-impact areas is reported over 2 years using the scalp Investigator's Global Assessment (IGA), palmoplantar IGA, and modified Nail Psoriasis Severity Index (mNAPSI). Patients included in these analyses had baseline moderate to severe scalp or palmoplantar involvement (scalp or palmoplantar IGA score ≥ 3) or mNAPSI score > 10.
RESULTS
A total of 1107 patients were randomized to bimekizumab and entered the OLEs. Subsets of 821 patients had scalp IGA ≥ 3 at baseline, 377 had mNAPSI > 10, and 193 had palmoplantar IGA ≥ 3. Complete scalp clearance in patients with baseline scalp IGA ≥ 3 randomized to bimekizumab was achieved rapidly, with high responses sustained from first (86.4%) to second year (85.9%). Nail clearance responses in patients with baseline mNAPSI > 10 increased from 63.4% to 68.5% from first to second year. Palmoplantar clearance in patients with baseline palmoplantar IGA ≥ 3 was sustained from first (88.3%) to second year (89.8%). Similar trends were seen in the 374 patients who received bimekizumab 320 mg every 4 weeks (Q4W)/every 8 weeks (Q8W) initial/maintenance dosing.
CONCLUSION
In these analyses pooled across 2 years, bimekizumab showed sustained efficacy in psoriasis in high-impact areas.
GOV TRIAL REGISTRATION NUMBERS
NCT03370133, NCT03410992, NCT03412747, NCT03598790, NCT03536884.
引言
银屑病累及高影响区域，包括头皮、指甲、手掌和脚底，会对患者生活质量造成极大损害。在此，我们在五项3期/3b期试验的事后分析中评估了比美吉珠单抗治疗中度至重度斑块状银屑病患者的两年疗效。
方法
通过五项3期/3b期试验（BE VIVID、BE READY、BE SURE及其正在进行的开放标签扩展试验（OLE）BE BRIGHT以及BE RADIANT（包括其双盲治疗期及其OLE的第一年））汇总了两年内高影响区域的疗效数据。使用头皮研究者整体评估（IGA）、掌跖IGA和改良指甲银屑病严重程度指数（mNAPSI）报告高影响区域银屑病在两年内的完全清除情况。纳入这些分析的患者基线时存在中度至重度头皮或掌跖受累（头皮或掌跖IGA评分≥3）或mNAPSI评分>10。
结果
共有1107例患者随机接受比美吉珠单抗治疗并进入OLE试验。821例患者亚组基线时头皮IGA≥3，377例mNAPSI>10，193例掌跖IGA≥3。随机接受比美吉珠单抗治疗、基线头皮IGA≥3的患者头皮迅速实现完全清除，从第一年（86.4%）到第二年（85.9%）保持高缓解率。基线mNAPSI>10的患者指甲清除缓解率从第一年的63.4%升至第二年的68.5%。基线掌跖IGA≥3的患者掌跖清除率从第一年（88.3%）到第二年（89.8%）保持稳定。在每4周（Q4W）/每8周（Q8W）初始/维持给药接受比美吉珠单抗320mg的374例患者中也观察到类似趋势。
结论
在这些汇总的两年分析中，比美吉珠单抗在高影响区域的银屑病治疗中显示出持续疗效。
政府试验注册号
NCT03370133、NCT03410992、NCT03412747、NCT03598790、NCT03536884。
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