多中心、随机、开放标签、平行组研究评估依奇珠单抗与阿达木单抗在生物疾病修正抗风湿药物初治的银屑病关节炎患者中的疗效和安全性：第 52 周的最终结果。

Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52.

机构信息

Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria

Providence St Joseph Health, Rentton, Washington, USA.

出版信息

Ann Rheum Dis. 2020 Oct;79(10):1310-1319. doi: 10.1136/annrheumdis-2020-217372. Epub 2020 Jul 13.

OBJECTIVES

SPIRIT head-to-head (H2H) is a 52-week (Wk) trial comparing ixekizumab (IXE) with adalimumab (ADA) for simultaneous American College of Rheumatology (ACR)50 and Psoriasis Area and Severity Index (PASI)100 responses in 566 patients (distributed evenly across both groups) with psoriatic arthritis (PsA). IXE was superior to ADA for this primary end point at Wk24. We aimed to determine the final efficacy and safety results through Wk52 including a prespecified subgroup analysis of concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARD) use.

METHODS

SPIRIT-H2H is a Wk52 multicentre, open-label, blinded-assessor study comparing IXE and ADA in bionaïve patients with PsA. Patients were randomised 1:1 to IXE or ADA with stratification by concomitant csDMARD use and presence of moderate-to-severe plaque psoriasis. Prespecified end points at Wk24 and Wk52 included musculoskeletal, psoriasis, quality-of life outcomes, subgroup analyses and safety.

RESULTS

A significantly higher proportion of patients treated with IXE versus ADA simultaneously achieved ACR50 and PASI100 (39% vs 26%, p<0.001), PASI100 (64% vs 41%, p<0.001) at Wk52. Efficacy of IXE and ADA was similar at Wk52 for ACR50 (49.8% vs 49.8%, p=0.924), treat-to-target outcomes, enthesitis and dactylitis resolution. Responses to IXE were consistent irrespective of concomitant csDMARD use. Significantly more patients on IXE monotherapy versus ADA monotherapy had simultaneous ACR50 and PASI100 (38% vs 19%, p=0.007), and PASI100 responses (66% vs 35%, p<0.001) at Wk52. There were no new safety findings for IXE or ADA.

CONCLUSIONS

IXE provided significantly greater simultaneous joint and skin improvement than ADA through Wk52 in bionaïve patients with PsA. IXE showed better efficacy on psoriasis and performed at least as well as ADA on musculoskeletal manifestations. IXE efficacy was consistent irrespective of concomitant csDMARD use.

TRIAL REGISTRATION NUMBER

NCT03151551.

目的

SPIRIT 头对头（H2H）试验是一项 52 周（Wk）的试验，比较了 ixekizumab（IXE）与阿达木单抗（ADA）在 566 例同时满足美国风湿病学会（ACR）50 和银屑病面积和严重程度指数（PASI）100 缓解的银屑病关节炎（PsA）患者中的疗效。在第 24 周时，IXE 在这个主要终点上优于 ADA。我们旨在通过第 52 周（包括同时使用常规合成疾病修饰抗风湿药物（csDMARDs）的预设亚组分析）确定最终的疗效和安全性结果。

方法

SPIRIT-H2H 是一项在 bionaïve 银屑病关节炎患者中比较 IXE 和 ADA 的第 52 周、多中心、开放性、盲法评估研究。患者按 1:1 随机分配至 IXE 或 ADA 治疗，并根据同时使用 csDMARDs 和中重度斑块状银屑病进行分层。第 24 周和第 52 周的预设终点包括肌肉骨骼、银屑病、生活质量结局、亚组分析和安全性。

结果

与 ADA 相比，接受 IXE 治疗的患者同时达到 ACR50 和 PASI100 的比例显著更高（39% vs 26%，p<0.001），第 52 周时达到 PASI100 的比例也显著更高（64% vs 41%，p<0.001）。第 52 周时，IXE 和 ADA 治疗的 ACR50（49.8% vs 49.8%，p=0.924）、治疗目标结局、附着点炎和指（趾）炎缓解的疗效相似。无论同时使用 csDMARDs 如何，IXE 的疗效均一致。与 ADA 单药治疗相比，接受 IXE 单药治疗的患者同时达到 ACR50 和 PASI100 的比例显著更高（38% vs 19%，p=0.007），第 52 周时达到 PASI100 的比例也显著更高（66% vs 35%，p<0.001）。IXE 和 ADA 均未出现新的安全性发现。