国际临床研究表明，白细胞介素17A抑制剂Ixekizumab对活动性放射性脊柱关节炎（r-axSpA）的治疗具有疗效且耐受性良好。本III期研究旨在评估Ixekizumab治疗中国活动性r-axSpA患者的疗效和安全性。成年活动性r-axSpA患者对生物疾病修饰抗风湿药（bDMARDs）尚无经验或对一种肿瘤坏死因子抑制剂反应不足/无耐受性者被随机分配（1:1），双盲，接受Ixekizumab80mg每4周（IXEQ4W; 起始剂量160mg）或安慰剂治疗16周。接受安慰剂治疗的患者之后转换至IXEQ4W剂量，接受IXEQ4W的患者继续治疗，直至第52周。主要终点是在第16周时，bDMARD无经验患者中达到ASAS40（SpondyloArthritis International Society评估40）反应的比例。总计147名患者被随机分配接受安慰剂（n = 73）或IXEQ4W（n = 74）治疗。在第16周，IXEQ4W组有更多的bDMARD无经验患者达到ASAS40（n = 66; 40.9%），而安慰剂组只有少数患者达到ASAS40（n = 64, 7.8%; p < 0.001）。在总体研究人群中，第16周时IXEQ4W组（37.8%）达到ASAS40的患者也比安慰剂组（8.2%; p < 0.001）更多，这一差异早在第1周即可观察到。IXEQ4W治疗组在第16周的所有关键次要终点上均有显著改善，与安慰剂相比。在继续接受IXEQ4W的患者中，疗效在第52周得到持续，而转至IXEQ4W治疗的患者在第16周至第52周也有临床改善。Ixekizumab的安全性与先前的描述一致。感染和注射部位反应是最常见的特殊事件报道。Ixekizumab治疗对于中国患者的活动性r-axSpA在第16周显示出迅速和显著的临床症状改善，该疗效在第52周保持，并且未出现新的安全信号。ClinicalTrials.gov识别号：NCT04285229.©2023年。作者在独家许可下授权给施普林格自然瑞士出版集团。

Ixekizumab, an interleukin-17A inhibitor, was efficacious and well tolerated for the treatment of active radiographic axial spondyloarthritis (r-axSpA) in international clinical studies. This phase III study aimed to determine the efficacy and safety of ixekizumab for treating Chinese patients with active r-axSpA.Adults with active r-axSpA naïve to biologic disease-modifying antirheumatic drugs (bDMARDs), or with an inadequate response/intolerance to one tumor necrosis factor inhibitor, were randomized (1:1), double-blind, to receive ixekizumab 80 mg every 4 weeks (IXEQ4W; starting dose 160 mg), or placebo, for 16 weeks. Patients receiving placebo were then switched to IXEQ4W, and those receiving IXEQ4W continued, until week 52. The primary endpoint was the proportion of bDMARD-naïve patients achieving an Assessment of SpondyloArthritis International Society 40 (ASAS40) response at week 16.In total, 147 patients were randomized to receive placebo (n = 73) or IXEQ4W (n = 74). At week 16, more bDMARD-naive patients achieved ASAS40 in the IXEQ4W group (n = 66; 40.9%) than the placebo group (n = 64, 7.8%; p < 0.001). In the overall study population, ASAS40 was also achieved by more patients in the IXEQ4W group (37.8%) than the placebo group (8.2%; p < 0.001) at week 16, with a significant difference observed as early as week 1. There were significant improvements in all key secondary endpoints at week 16 with IXEQ4W versus placebo. Efficacy was sustained at week 52 in patients who continued IXEQ4W and there were also clinical improvements from weeks 16 to 52 in patients switched to IXEQ4W. The safety profile of ixekizumab was consistent with that described previously. Infections and injection-site reactions were the most frequently reported events of special interest.IXEQ4W was associated with rapid and significant improvements in the signs and symptoms of active r-axSpA in Chinese patients at week 16 that were sustained at week 52, with no new safety signals.ClinicalTrials.gov identifier: NCT04285229.© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.