Objectives To compare efficacy and safety of ixekizumab (IXE) to adalimumab (ADA) in biological disease-modifying antirheumatic drug-naïve patients with both active psoriatic arthritis (PsA) and skin disease and inadequate response to conventional synthetic disease-modifying antirheumatic drug (csDMARDs). Methods Patients with active PsA were randomised (1:1) to approved dosing of IXE or ADA in an open-label, head-to-head, blinded assessor clinical trial. The primary objective was to evaluate whether IXE was superior to ADA at week 24 for simultaneous achievement of a ≥50% improvement from baseline in the American College of Rheumatology criteria (ACR50) and a 100% improvement from baseline in the Psoriasis Area and Severity Index (PASI100). Major secondary objectives, also at week 24, were to evaluate whether IXE was: (1) non-inferior to ADA for achievement of ACR50 and (2) superior to ADA for PASI100 response. Additional PsA, skin, treat-to-target and quality-of-life outcome measures were assessed at week 24. Results The primary efficacy endpoint was met (IXE: 36%, ADA: 28%; p=0.036). IXE was non-inferior for ACR50 response (IXE: 51%, ADA: 47%; treatment difference: 3.9%) and superior for PASI100 response (IXE: 60%, ADA: 47%; p=0.001). IXE had greater response versus ADA in additional PsA, skin, nail, treat-to-target and quality-of-life outcomes. Serious adverse events were reported in 8.5% (ADA) and 3.5% (IXE) of patients. Conclusions IXE was superior to ADA in achievement of simultaneous improvement of joint and skin disease (ACR50 and PASI100) in patients with PsA and inadequate response to csDMARDs. Safety and tolerability for both biologicals were aligned with established safety profiles.

中文翻译：

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ixekizumab 和阿达木单抗在未接受生物学治疗的活动性银屑病关节炎患者中的疗效和安全性的头对头比较：一项随机、开放标签、盲法评估试验的 24 周结果

目的 比较 ixekizumab (IXE) 与阿达木单抗 (ADA) 在患有活动性银屑病关节炎 (PsA) 和皮肤病且对常规合成疾病缓解抗风湿药 (csDMARDs) 反应不足的生物疾病缓解性抗风湿药初治患者中的疗效和安全性）。方法 在一项开放标签、头对头、盲法评估者临床试验中，患有活动性 PsA 的患者随机 (1:1) 接受 IXE 或 ADA 的批准剂量。主要目标是评估 IXE 在第 24 周是否优于 ADA，以同时实现美国风湿病学会标准 (ACR50) 的基线改善≥50% 和银屑病面积和严重程度指数的基线改善 100% (PASI100)。同样在第 24 周的主要次要目标是评估 IXE 是否：(1) 在达到 ACR50 方面不劣于 ADA 和 (2) 在 PASI100 反应方面优于 ADA。在第 24 周评估了额外的 PsA、皮肤、治疗目标和生活质量结果指标。结果 达到主要疗效终点（IXE：36%，ADA：28%；p=0.036）。IXE 对 ACR50 反应（IXE：51%，ADA：47%；治疗差异：3.9%）不劣于 PASI100 反应（IXE：60%，ADA：47%；p=0.001）。在额外的 PsA、皮肤、指甲、治疗目标和生活质量结果方面，IXE 比 ADA 有更大的反应。8.5% (ADA) 和 3.5% (IXE) 的患者报告了严重的不良事件。结论 IXE 在同时改善 PsA 和 csDMARDs 反应不足患者的关节和皮肤疾病（ACR50 和 PASI100）方面优于 ADA。