银屑病关节炎患者使用比美单抗的安全性和有效性：两项 3 期研究的两年结果

IF 2.9 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2024-10-01 Epub Date: 2024-08-31 DOI:10.1007/s40744-024-00708-8

Philip J Mease, Joseph F Merola, Yoshiya Tanaka, Laure Gossec, Iain B McInnes, Christopher T Ritchlin, Robert B M Landewé, Akihiko Asahina, Barbara Ink, Andrea Heinrichs, Rajan Bajracharya, Vishvesh Shende, Jason Coarse, Laura C Coates

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引用次数: 0

摘要

导言银屑病关节炎（PsA）是一种需要长期治疗的慢性炎症性疾病。Bimekizumab是一种单克隆IgG1抗体，除抑制IL-17A外，还能选择性抑制白细胞介素（IL）-17F，对PsA患者具有耐受性和长达1年的持续临床疗效。在此，我们报告了 bimekizumab 长达 2 年的长期安全性和有效性：BE OPTIMAL（生物改变病情抗风湿药[bDMARD]-naïve）和BE COMPLETE（之前对肿瘤坏死因子抑制剂[TNFi-IR]反应不充分/不耐受）评估了PsA患者皮下注射bimekizumab 160 mg，每4周一次。BE OPTIMAL包括一个参照组（阿达木单抗40毫克，每2周1次）；患者在第52周转为使用bimekizumab，治疗之间无冲洗。BE OPTIMAL 第 52 周和 BE COMPLETE 第 16 周完成者有资格参加 BE VITAL 开放标签扩展。疗效结果报告至第 104/100 周（BE OPTIMAL/BE COMPLETE）：共有 710/852 (83.3%) bDMARD-naïve 和 322/400 (80.5%) TNFi-IR 患者完成了第 104/100 周的治疗。截至104周，在BE OPTIMAL和BE COMPLETE中接受bimekizumab治疗的患者的治疗突发不良事件发生率（暴露调整发生率/100患者年）分别为179.9（95% CI 166.9, 193.7）和100.3（89.2, ‍112.4）。从第52周到第104周/100周，所有患者达到疗效结果（美国风湿病学会[ACR]反应标准比基线改善≥50%，皮损面积和严重程度指数[PASI]、最小疾病活动度[MDA]比基线改善100%）的比例均保持不变：比美单抗在长达2年的治疗中耐受性良好，未发现新的安全性信号。在bDMARD无效和TNFi-IR活动性PsA患者中观察到了长达2年的持续临床疗效。从阿达木单抗转用比美珠单抗的患者皮肤和指甲症状得到进一步改善，关节症状也有持续疗效：试验注册：be optimal（NCT03895203）、be complete（NCT03896581）、be vital（NCT04009499）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies.

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Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies.

Introduction: Psoriatic arthritis (PsA) is a chronic inflammatory disease requiring long-term treatment. Bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated tolerability and sustained clinical efficacy for up to 1 year for patients with PsA. Here, we report the longer-‍term safety and efficacy of bimekizumab up to 2 years.

Methods: BE OPTIMAL (biologic disease-modifying antirheumatic drug [bDMARD]-naïve) and BE COMPLETE (prior inadequate response/intolerance to tumor necrosis factor inhibitors [TNFi-IR]) assessed subcutaneous bimekizumab 160 mg every 4 weeks in patients with PsA. BE OPTIMAL included a reference arm (adalimumab 40 mg every 2 weeks); patients switched to bimekizumab at week 52 with no washout between treatments. BE OPTIMAL week 52 and BE COMPLETE week 16 completers were eligible for the BE VITAL open-label extension. Efficacy outcomes are reported to week 104/100 (BE OPTIMAL/BE COMPLETE).

Results: A total of 710/852 (83.3%) bDMARD-naïve and 322/400 (80.5%) TNFi-IR patients completed week 104/100. Up to 104 weeks, patients treated with bimekizumab in BE OPTIMAL and BE COMPLETE had treatment-emergent adverse event incidence rates (exposure-adjusted incidence rate/100 patient-years) of 179.9 (95% CI 166.9, 193.7) and 100.3 (89.2, ‍112.4), respectively. The proportion of patients achieving efficacy outcomes (≥ 50% improvement from baseline in American College of Rheumatology [ACR] response criteria, 100% improvement from baseline in Psorisis Area and Severity Index [PASI], minimal disease activity [MDA]) was sustained in all patients from week 52 to week 104/100.

Conclusions: Bimekizumab was well tolerated for up to 2 years of treatment and no new safety signals were observed. Sustained clinical efficacy was observed up to 2 years in bDMARD-naïve and TNFi-IR patients with active PsA. Patients switching from adalimumab to bimekizumab demonstrated further improvement in skin and nail symptoms, and sustained efficacy in joint symptoms.

Trial registration: BE OPTIMAL (NCT03895203), BE COMPLETE (NCT03896581), BE VITAL (NCT04009499).

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来源期刊

Rheumatology and Therapy RHEUMATOLOGY-

CiteScore

6.00

自引率

5.30%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Rheumatology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of rheumatologic therapies. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. Areas of focus include, but are not limited to, rheumatoid arthritis, gout, gouty arthritis, psoriatic arthritis, osteoarthritis, juvenile idiopathic/rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, Pompe’s disease, inflammatory joint conditions, musculoskeletal conditions, systemic sclerosis, and fibromyalgia. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial protocols, communications and letters. 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