一项针对强直性脊柱炎患者的司库奇尤单抗剂量递增研究，这些患者在治疗16周后未达到疾病非活动状态。
A secukinumab dose-escalation study in patients with ankylosing spondylitis not achieving inactive disease after 16 weeks of treatment.
作者信息
Deodhar Atul, Kivitz Alan J, Magrey Marina, Walsh Jessica A, Mease Philip J, Greenwald Maria, Kianifard Farid, Elam Chelsea, Bommidi Gopi M, Winseck Adam, Gensler Lianne S
机构信息
Oregon Health & Science University, Portland, OR, USA.
Altoona Center for Clinical Research, Duncansville, PA, USA.
出版信息
Rheumatology (Oxford). 2025 Apr 1;64(4):1864-1872. doi: 10.1093/rheumatology/keae432.
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.
目的
在对司库奇尤单抗150mg治疗16周反应不足的强直性脊柱炎（AS）患者中，研究第52周时接受300mg与150mg司库奇尤单抗治疗的临床反应。
方法
ASLeap（NCT03350815）是一项随机、双盲、平行组、多中心4期试验。在150mg司库奇尤单抗开放标签治疗16周（治疗期1）后，在第12周和16周均未达到疾病非活动状态[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，并按1:1随机分组，每4周接受300mg或150mg司库奇尤单抗治疗，直至第52周（治疗期2）。主要疗效变量是以第16周为基线，在第52周时ASDAS<1.3。通过第52周治疗期间出现的不良事件（TEAE）发生率评估安全性。
结果
在治疗期1接受司库奇尤单抗治疗的322例患者中，207例（64.3%）反应不足。在治疗期2，随机接受300mg司库奇尤单抗（n = 101）和150mg司库奇尤单抗（n = 105）治疗的反应不足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300mg和150mg司库奇尤单抗治疗的患者分别有8.8%和6.7%达到ASDAS<1.3。两组至第52周时TEAE的发生率相似。未观察到新 的安全信号。
结论
接受150mg司库奇尤单抗治疗16周后未达到ASDAS<1.3的AS患者，无论剂量是否增加，在第52周时临床反应和安全性相似。
试验注册
ClinicalTrials.gov，http://clinicaltrials.gov，NCT03350815 。
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