Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A. This study compared the efficacy and safety of bimekizumab with placebo over 16 weeks in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α (TNFα) inhibitors. BE COMPLETE was a phase 3, multicentre, randomised, double-blind, placebo-controlled trial conducted across 92 sites (including hospitals, clinics, and research centres) in 11 countries (Australia, Canada, Czech Republic, Germany, Hungary, Italy, Japan, Poland, Russia, the UK, and the USA). Eligible patients were aged 18 years or older with adult-onset psoriatic arthritis (meeting the Classification Criteria for Psoriatic Arthritis for at least 6 months before screening) with a history of inadequate response or intolerance to treatment with one or two TNFα inhibitors for either psoriatic arthritis or psoriasis. We stratified patients with active psoriatic arthritis by region and previous TNFα inhibitor use. Patients were randomly assigned (2:1) to receive subcutaneous bimekizumab 160 mg every 4 weeks or placebo by an interactive-voice and web-response system on the basis of a predetermined randomisation schedule. The primary endpoint was the proportion of patients with 50% or greater improvement in American College of Rheumatology criteria (ACR50) at week 16 (non-responder imputation). Efficacy analyses were done in the randomised population. The safety analysis set comprised patients who received one or more doses of study treatment. This trial was registered at , , and is completed. Between March 28, 2019, and Feb 14, 2022, 556 patients were screened and 400 patients were randomly assigned to bimekizumab 160 mg every 4 weeks (n=267) or placebo (n=133). The primary and all hierarchical secondary endpoints were met at week 16. 116 (43%) of 267 patients receiving bimekizumab reached ACR50, compared with nine (7%) of 133 patients receiving placebo (adjusted odds ratio [OR] 11·1 [95% CI 5·4–23·0], p<0·0001). 121 (69%) of 176 patients with psoriasis affecting at least 3% body surface area at baseline who received bimekizumab reached 90% or greater improvement in the Psoriasis Area and Severity Index (PASI90), compared with six (7%) of 88 patients who received placebo (adjusted OR 30·2 [12·4–73·9], p<0·0001). Treatment-emergent adverse events up to week 16 were reported in 108 (40%) of 267 patients receiving bimekizumab and 44 (33%) of 132 patients receiving placebo. There were no new safety signals and no deaths. Bimekizumab treatment led to superior improvements in joint and skin efficacy outcomes at week 16 compared with placebo in patients with psoriatic arthritis and inadequate response or intolerance to TNFα inhibitors. The safety profile of bimekizumab was consistent with previous phase 3 studies in patients with plaque psoriasis, and studies of IL-17A inhibitors. UCB Pharma.

中文翻译：

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Bimekizumab 治疗活动性银屑病关节炎且既往对肿瘤坏死因子-α 抑制剂反应不足或不耐受的患者：一项随机、双盲、安慰剂对照 3 期试验（已完成）

Bimekizumab 是一种单克隆 IgG1 抗体，可选择性抑制白细胞介素 (IL)-17F 和 IL-17A。这项研究比较了 bimekizumab 与安慰剂在 16 周内对患有活动性银屑病关节炎且既往对肿瘤坏死因子-α (TNFα) 抑制剂反应不足或不耐受的患者的疗效和安全性。BE COMPLETE 是一项 3 期、多中心、随机、双盲、安慰剂对照试验，在 11 个国家（澳大利亚、加拿大、捷克共和国、德国、匈牙利、意大利、日本、波兰、俄罗斯、英国和美国）。符合条件的患者年龄为 18 岁或以上，患有成人发病的银屑病关节炎（筛选前至少 6 个月符合银屑病关节炎分类标准），且对一种或两种 TNFα 抑制剂治疗银屑病关节炎的反应不足或不耐受或牛皮癣。我们按地区和既往使用 TNFα 抑制剂的情况对活动性银屑病关节炎患者进行分层。根据预定的随机化时间表，通过交互式语音和网络响应系统将患者随机分配 (2:1) 接受皮下注射 bimekizumab 160 mg 每 4 周或安慰剂。主要终点是第 16 周时美国风湿病学会标准 (ACR50) 改善 50% 或以上的患者比例（无反应者插补）。在随机人群中进行疗效分析。安全性分析组包括接受一剂或多剂研究治疗的患者。该试验已于 、 、 注册，并已完成。2019年3月28日至2022年2月14日期间，对556名患者进行了筛查，其中400名患者被随机分配至每4周一次160mg的bimekizumab治疗组（n=267）或安慰剂组（n=133）。主要终点和所有分级次要终点均在第 16 周达到。267 名接受 bimekizumab 治疗的患者中有 116 名 (43%) 达到了 ACR50，而接受安慰剂的 133 名患者中有 9 名 (7%) 达到了 ACR50（调整后的比值比 [OR] 11·1 [95 % CI 5·4–23·0]，p<0·0001）。在接受 bimekizumab 治疗的 176 名基线时体表面积至少为 3% 的银屑病患者中，有 121 名 (69%) 的银屑病面积和严重程度指数 (PASI90) 达到 90% 或更高改善，而 88 名患者中有 6 名 (7%)接受安慰剂的患者（调整后 OR 30·2 [12·4–73·9]，p<0·0001）。截至第 16 周，接受 Bimekizumab 的 267 名患者中有 108 名（40%）报告了治疗引起的不良事件，接受安慰剂的 132 名患者中有 44 名（33%）报告了治疗引起的不良事件。没有新的安全信号，也没有死亡。对于对 TNFα 抑制剂反应不足或不耐受的银屑病关节炎患者，与安慰剂相比，Bimekizumab 治疗在第 16 周时可显着改善关节和皮肤疗效。bimekizumab 的安全性与之前针对斑块型银屑病患者的 3 期研究以及 IL-17A 抑制剂的研究一致。UCB 制药公司。