背景:Atogepant是一种口服降钙素基因相关肽受体拮抗剂,被批准用于成人偏头痛的预防性治疗。这些分析评估了在12或52周的治疗中对atogepant有持续反应的临床试验参与者的比例。
方法:这些是对ADVANCE的事后分析,12周,双盲,atogepant10、30和60mg每日一次的随机试验与安慰剂用于间歇性偏头痛的预防性治疗,以及一项单独的开放标签长期安全性(LTS)试验,在52周内每天一次使用60mgatogepant。使用60mg剂量的atogepant来检测安全性问题。初始反应定义为≥50%,≥75%,或在LTS试验的第1个月或第1个季度的MMD较基线减少100%。计算了在随后的每个月(对于ADVANCE)或每个季度(对于LTS)继续经历超过每个响应定义阈值的响应的参与者的比例。
结果:提前,第2个月和第3个月的持续反应率随剂量而变化,如下:初始反应≥50%后的70.8-81.1%,47.3-61.9%的初始反应≥75%后,在最初的100%反应后,为34.8-41.7%。在第1个月期间经历初始≥75%或100%反应的人中,超过79%的人在第2个月和第3个月期间继续经历至少50%的反应。在LTS审判期间,在最初≥50%的反应后,第2、3和4季度的持续反应率为84.7%,初始反应≥75%后72.6%,在最初的100%反应后,为37.8%。在第1季度经历了初始≥75%或100%反应的人中,超过90%的人在第2、3和4季度继续经历了至少50%的反应。
结论:超过70%的参与者在接受atogepant治疗时出现初始反应,在继续治疗时出现持续反应。
背景:ClinicalTrials.gov:NCT03777059(提交时间:2018年12月13日);NCT03700320(提交时间:2018年9月25日)。
BACKGROUND: Atogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the preventive treatment of migraine in adults. These analyses evaluated the proportions of clinical trial participants who experienced sustained responses to atogepant over 12 or 52 weeks of treatment.
METHODS: These were post hoc analyses of ADVANCE, a 12-week, double-blind, randomized trial of atogepant 10, 30, and 60 mg once daily vs. placebo for the preventive treatment of episodic migraine, and a separate open-label long-term safety (LTS) trial of atogepant 60 mg once daily over 52 weeks. The 60 mg dose of atogepant was used to detect safety issues. An initial response was defined as ≥50%, ≥75%, or 100% reduction from baseline in MMDs in month 1 for ADVANCE or quarter 1 for the LTS trial. The proportions of participants who continued to experience a response above each response-defining threshold through each subsequent month (for ADVANCE) or each quarter (for LTS) were calculated.
RESULTS: In ADVANCE, sustained response rates during months 2 and 3 varied with dose and were as follows: 70.8-81.1% following an initial ≥50% response, 47.3-61.9% following an initial ≥75% response, and 34.8-41.7% following an initial 100% response. Of those who experienced an initial ≥75% or 100% response during month 1, more than 79% continued to experience at least a 50% response during both months 2 and 3. During the LTS trial, sustained response rates through quarters 2, 3, and 4 were 84.7% following an initial ≥50% response, 72.6% following an initial ≥75% response, and 37.8% following an initial 100% response. Of those who experienced an initial ≥75% or 100% response during quarter 1, more than 90% continued to experience at least a 50% response through quarters 2, 3, and 4.
CONCLUSIONS: Over 70% of participants who experienced an initial response with atogepant treatment had a sustained response with continued treatment.
BACKGROUND: ClinicalTrials.gov: NCT03777059 (submitted: December 13, 2018); NCT03700320 (submitted: September 25, 2018).