Abstract：
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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov, NCT03350815.
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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov, NCT03350815.
摘要：
目的：研究强直性脊柱炎（AS）患者在第16周接受苏金单抗300与150mg治疗后，在第52周的临床反应。
方法：ASLeap（NCT03350815）是随机的，双盲,平行组，多中心,第四阶段试验。开放标签苏金单抗150mg（治疗期1）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)的患者被认为缓解不充分,并以1:1的比例随机分组,每4周接受苏金单抗300或150mg,直至第52周(治疗期2).主要疗效变量是在第52周以第16周为基线时ASDAS<1.3。通过直至第52周的治疗引起的不良事件的发生率来评估安全性。
结果：在第1期接受苏金单抗治疗的322例患者中，207例（64.3%）反应不充分。在治疗期2中，随机接受苏金单抗300mg（n=101）和150mg（n=105）的反应不足的患者比例相似（83.8％和84.3％，分别)。在第52周，8.8%和6.7%的患者接受苏金单抗300和150毫克，分别,达到ASDAS<1.3。到第52周，两组治疗引起的不良事件的发生率相似。没有观察到新的安全信号。
结论：在接受苏金单抗150mg治疗16周后未达到ASDAS<1.3的AS患者在第52周期间经历了相似的临床反应和安全性，而与剂量递增无关。
背景：ClinicalTrials.gov，NCT03350815。
方法：ASLeap（NCT03350815）是随机的，双盲,平行组，多中心,第四阶段试验。开放标签苏金单抗150mg（治疗期1）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)的患者被认为缓解不充分,并以1:1的比例随机分组,每4周接受苏金单抗300或150mg,直至第52周(治疗期2).主要疗效变量是在第52周以第16周为基线时ASDAS<1.3。通过直至第52周的治疗引起的不良事件的发生率来评估安全性。
结果：在第1期接受苏金单抗治疗的322例患者中，207例（64.3%）反应不充分。在治疗期2中，随机接受苏金单抗300mg（n=101）和150mg（n=105）的反应不足的患者比例相似（83.8％和84.3％，分别)。在第52周，8.8%和6.7%的患者接受苏金单抗300和150毫克，分别,达到ASDAS<1.3。到第52周，两组治疗引起的不良事件的发生率相似。没有观察到新的安全信号。
结论：在接受苏金单抗150mg治疗16周后未达到ASDAS<1.3的AS患者在第52周期间经历了相似的临床反应和安全性，而与剂量递增无关。
背景：ClinicalTrials.gov，NCT03350815。
