Objective To investigate the clinical response at week 52 in patients with 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 [AS Disease Activity Score (ASDAS) <1.3] at both week 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 (TEAEs) 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 TEAEs 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, http://clinicaltrials.gov, NCT03350815.

中文翻译：

---

在治疗 16 周后强直性脊柱炎患者未达到非活动性疾病的苏金单抗剂量递增研究


目的 探讨第 16 周对 150 mg 反应不足后接受苏金单抗 300 mg 与 150 mg 治疗的 AS 患者在第 52 周时的临床反应。方法 ASLeap （NCT03350815） 是一项随机、双盲、平行组、多中心、4 期试验。在开放标签苏金单抗 150 mg 16 周（治疗期 1）后，在第 12 周和第 16 周均未达到非活动性疾病 [AS 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）。主要疗效变量是第 52 周时 ASDAS <1.3 的实现，第 16 周为基线。通过第 52 周治疗中出现的不良事件 （TEAE） 的发生率来评估安全性。结果 在治疗期 1 接受苏金单抗治疗的 322 例患者中，207 例 （64.3%） 反应不足。在治疗期 2 中随机分配至苏金单抗 300 mg （n = 101） 和 150 mg （n = 105） 的反应不足的患者完成研究的比例相似 （分别为 83.8% 和 84.3%）。在第 52 周时，接受苏金单抗 300 和 150 mg 治疗的患者中，分别为 8.8% 和 6.7% 达到 ASDAS <1.3。到第 52 周，两组的 TEAE 发生率相似。未观察到新的安全信号。结论 接受苏金单抗 150 mg 16 周后未达到 ASDAS <1.3 的 AS 患者在第 52 周时经历了相似的临床反应和安全性，无论剂量是否增加。试验注册 ClinicalTrials.gov、http://clinicaltrials.gov NCT03350815。