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
Oregon Health & Science University, Portland, OR, USA.
Altoona Center for Clinical Research, Duncansville, PA, USA.
Rheumatology (Oxford). 2025 Apr 1;64(4):1864-1872. doi: 10.1093/rheumatology/keae432.
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.
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.
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.
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.
ClinicalTrials.gov, http://clinicaltrials.gov, NCT03350815.
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。
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。
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。
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。
ClinicalTrials.gov，http://clinicaltrials.gov，NCT03350815 。
