Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials.

IF 3.5 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2024-11-22 DOI:10.1007/s13555-024-01295-w

Joseph F Merola, Alice B Gottlieb, Andreas Pinter, Boni Elewski, Melinda Gooderham, Richard B Warren, Stefano Piaserico, Krista Wixted, Nancy Cross, Nicola Tilt, Susanne Wiegratz, Ulrich Mrowietz

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引用次数: 0

Abstract

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.

Clinicaltrials:

Gov trial registration numbers: NCT03370133, NCT03410992, NCT03412747, NCT03598790, NCT03536884.

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Bimekizumab 在高发区的疗效：来自 3/3b 期随机对照试验的头皮、指甲和掌跖银屑病 2 年汇总分析。

导言：头皮、指甲、手掌和足底等高发部位的银屑病会严重影响患者的生活质量。在此，我们通过对五项 3/3b 期试验的事后分析，评估了比美单抗治疗中度至重度斑块状银屑病患者的两年疗效：这些试验包括：BE VIVID、BE READY、BE SURE、正在进行的开放标签扩展（OLE）BE BRIGHT 和 BE RADIANT（包括双盲治疗期和第一年的 OLE）。通过头皮研究者总体评估（IGA）、掌跖研究者总体评估（IGA）和改良的指甲银屑病严重程度指数（mNAPSI）来报告高发区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为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：共有1107名患者随机接受了bimekizumab治疗，并进入了OLEs。821名患者基线时头皮IGA≥3分，377名患者mNAPSI>10分，193名患者掌跖IGA≥3分。随机接受比美单抗治疗的基线头皮IGA≥3的患者很快就能实现头皮完全清除，从第一年（86.4%）到第二年（85.9%）都能保持较高的应答率。基线 mNAPSI > 10 的患者的指甲清除率从第一年的 63.4% 增加到第二年的 68.5%。基线掌跖 IGA ≥ 3 的患者的掌跖清除率从第一年（88.3%）持续到第二年（89.8%）。在每4周（Q4W）/每8周（Q8W）接受320毫克比美单抗初始/维持剂量治疗的374名患者中，也出现了类似的趋势：结论：在这些为期两年的汇总分析中，bimekizumab显示出对高发区银屑病的持续疗效：Gov 试验注册号：NCT03370133、NCT03410992、NCT03412747、NCT03598790、NCT03536884。

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.