Long-term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52-week, open-label extension study
Long-term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52-week, open-label extension study
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DOI：
10.1177/0333102420912726
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发表时间：
2020-03-26
期刊：
影响因子：
4.9
通讯作者：
Mikol, Daniel D.
中科院分区：
文献类型：
--
作者：
Tepper, Stewart J.;Ashina, Messoud;Mikol, Daniel D.
BackgroundThis study reports the long-term safety and efficacy of erenumab in chronic migraine patients.MethodsThis was a 52 week open-label extension study of a 12-week double-blind treatment phase study.在双盲治疗阶段，患者接受安慰剂或每月一次的erenumab 70 mg或140 mg。在开放标签治疗阶段，初始每月剂量为erenumab 70 mg。方案修订后，患者继续接受erenumab 70毫克，如果他们已经完成了他们的第28周的访问，否则，患者从70毫克切换到140毫克;如果在修订后入组，患者每月接受140毫克through.ResultsIn所有，451/609（74.1%）入组患者完成了研究。对于整个erenumab组，任何不良事件的经保险调整的患者发生率为126.3/100患者-年。总体而言，不良事件特征与双盲治疗期观察到的相似。与双盲治疗期相比，长期erenumab治疗的不良事件发生率没有增加，也没有观察到新的严重事件或治疗后出现的事件。在每月偏头痛日和偏头痛特定药物日，观察到双盲治疗期基线（约一半）的临床显著降低。在联合剂量组中，第52周每月偏头痛天数较双盲治疗期基线减少>= 50%、>= 75%和100%的患者分别为59.0%、33.2%和8.9%。在第40周和第52周，与70 mg相比，140 mg的获益在数值上更大。结论慢性偏头痛患者长期erenumab治疗的持续疗效得到证实，安全性结果与erenumab已知的安全性特征一致，双盲治疗期的不良事件发生率与安慰剂不良事件发生率相当。
BackgroundThis study reports the long-term safety and efficacy of erenumab in chronic migraine patients.MethodsThis was a 52-week open-label extension study of a 12-week double-blind treatment phase study. During the double-blind treatment phase, patients received placebo or once-monthly erenumab 70 mg or 140 mg. During the open-label treatment phase, the initial monthly dose was erenumab 70 mg. Following protocol amendment, patients continued to receive erenumab 70 mg if they had already completed their Week 28 visit, otherwise, patients switched from 70 mg to 140 mg; if enrolled after the amendment, patients received 140 mg monthly throughout.ResultsIn all, 451/609 (74.1%) enrolled patients completed the study. The exposure-adjusted patient incidence rate for any adverse event was 126.3/100 patient-years for the overall erenumab group. Overall, the adverse event profile was similar to that observed in the double-blind treatment phase. Adverse event incidence rates did not increase with long-term erenumab treatment compared with the double-blind treatment phase, and no new serious or treatment-emergent events were seen.Efficacy was sustained throughout the 52 weeks. Clinically significant reductions from double-blind treatment phase baseline (about half) were observed for monthly migraine days and migraine-specific medication days. Achievement of >= 50%, >= 75% and 100% reductions from the double-blind treatment phase baseline in monthly migraine days at Week 52 were reported by 59.0%, 33.2% and 8.9% of patients, respectively, for the combined dose group. A numerically greater benefit was observed with 140 mg compared with 70 mg at Weeks 40 and 52.ConclusionsSustained efficacy of long-term erenumab treatment in patients with chronic migraine is demonstrated, with safety results consistent with the known safety profile of erenumab and adverse event rates comparable to placebo adverse event rates in the double-blind treatment phase.