Objective To investigate the clinical response at week 52 in patients with ankylosing spondylitis (AS) who received secukinumab 300 vs 150 mg after inadequate response to 150 mg at week 16. Methods ASLeap (NCT03350815) was a randomized, double-blind, parallel-group, multicentre, phase 4 trial. After 16 weeks of open-label secukinumab 150 mg (Treatment Period 1), patients who did not achieve inactive disease (Ankylosing Spondylitis Disease Activity Score [ASDAS] <1.3) at both Weeks 12 and 16 were considered to have an inadequate response and were randomized 1:1 to receive secukinumab 300 or 150 mg every 4 weeks until week 52 (Treatment Period 2). The primary efficacy variable was achievement of ASDAS <1.3 at week 52 using week 16 as baseline. Safety was evaluated by the incidence of treatment-emergent adverse events through week 52. Results Of 322 patients treated with secukinumab in Treatment Period 1, 207 (64.3%) had inadequate response. Similar proportions of patients with inadequate response randomized to secukinumab 300 mg (n = 101) and 150 mg (n = 105) in Treatment Period 2 completed the study (83.8% and 84.3%, respectively). At week 52, 8.8% and 6.7% of patients receiving secukinumab 300 and 150 mg, respectively, achieved ASDAS <1.3. The incidence of treatment-emergent adverse events was similar in both groups through week 52. No new safety signals were observed. Conclusion Patients with AS who did not achieve ASDAS <1.3 after receiving secukinumab 150 mg for 16 weeks experienced similar clinical response and safety through week 52 regardless of dose escalation. Trial registration ClinicalTrials.gov, NCT03350815

中文翻译：

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一项针对治疗 16 周后未达到疾病静止状态的强直性脊柱炎患者的苏金单抗剂量递增研究


目的 调查强直性脊柱炎 (AS) 患者在第 16 周对 150 mg 苏金单抗反应不足后，接受 300 mg 苏金单抗与 150 mg 苏金单抗治疗后第 52 周的临床反应。方法 ASLeap (NCT03350815) 是一个随机、双盲、平行组，多中心，第 4 期试验。开放标签苏金单抗 150 mg（治疗期 1）治疗 16 周后，在第 12 周和第 16 周均未达到非活动性疾病（强直性脊柱炎疾病活动评分 [ASDAS]<1.3）的患者被认为反应不足并以 1:1 的比例随机接受苏金单抗 300 或 150 mg 每 4 周一次，直至第 52 周（治疗期 2）。主要功效变量是在第 52 周时达到 ASDAS <1.3（以第 16 周为基线）。通过第 52 周期间治疗中出现的不良事件的发生率来评估安全性。 结果 在第 1 治疗期接受苏金单抗治疗的 322 名患者中，207 名 (64.3%) 反应不足。在第 2 期治疗中，随机接受苏金单抗 300 mg (n = 101) 和 150 mg (n = 105) 治疗反应不足的患者完成研究的比例相似（分别为 83.8% 和 84.3%）。第 52 周时，接受苏金单抗 300 毫克和 150 毫克的患者分别有 8.8% 和 6.7% 达到 ASDAS <1.3。截至第 52 周，两组治疗中出现的不良事件发生率相似。没有观察到新的安全信号。结论 在接受 150 mg 苏金单抗 16 周后未达到 ASDAS <1.3 的 AS 患者在第 52 周经历了相似的临床反应和安全性，无论剂量如何增加。试验注册 ClinicalTrials.gov，NCT03350815