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，除了 IL-17A 之外，还能选择性抑制白细胞介素 (IL)-17F，已证明对 PsA 患者具有耐受性和长达 1 年的持续临床疗效。在这里，我们报告了 bimekizumab 长达 2 年的长期安全性和有效性。BE OPTIMAL（生物疾病缓解抗风湿药物 [bDMARD]-未使用过）和 BE COMPLETE（之前对肿瘤坏死因子抑制剂 [TNFi-] 反应不足/不耐受） IR]）评估了 PsA 患者每 4 周皮下注射 bimekizumab 160 mg。 BE OPTIMAL 包括参考组（阿达木单抗 40 毫克，每 2 周一次）；患者在第 52 周转用 bimekizumab，治疗之间没有清除。 BE OPTIMAL 第 52 周和 BE COMPLETE 第 16 周完成者有资格获得 BE VITAL 开放标签延期。疗效结果报告至第 104/100 周（最佳/完整）。共有 710/852 (83.3%) 未接受过 bDMARD 的患者和 322/400 (80.5%) TNFi-IR 患者完成了第 104/100 周。截至 104 周，在 BE OPTIMAL 和 BE COMPLETE 组中接受 bimekizumab 治疗的患者的治疗中出现的不良事件发生率（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, 193.7)。 ‍112.4），分别。达到疗效结果的患者比例（根据美国风湿病学会 [ACR] 反应标准，较基线改善≥50%，银屑病面积和严重程度指数 [PASI] 较基线改善 100%，最小疾病活动度 [MDA]）持续所有患者从第 52 周到第 104/100 周。Bimekizumab 在长达 2 年的治疗中耐受性良好，没有观察到新的安全信号。在未接受过 bDMARD 和 TNFi-IR 的活动性 PsA 患者中观察到了长达 2 年的持续临床疗效。从阿达木单抗转为 bimekizumab 的患者表现出皮肤和指甲症状的进一步改善，以及关节症状的持续疗效。BE OPTIMAL (NCT03895203)、BE COMPLETE (NCT03896581)、BE VITAL (NCT04009499)。© 2024。作者。

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.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).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.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.BE OPTIMAL (NCT03895203), BE COMPLETE (NCT03896581), BE VITAL (NCT04009499).© 2024. The Author(s).