Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study
Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study
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DOI：
10.1177/0333102419835459
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发表时间：
2019-06-01
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：
Goadsby, Peter J.;Paemeleire, Koen;Mikol, Daniel D.
背景：在一项针对发作性偏头痛的关键临床试验中，Erenumab是有效且耐受性良好的，该试验包括对先前预防措施天真的受试者和失败的受试者。在这篇文章中，我们评估了厄伦单抗(70 mg或140 mg)与安慰剂的疗效和安全性，对象是先前预防治疗失败的患者(S)：1或2个先前失败的偏头痛预防类别，以及从未失败的患者。方法预先指定的亚组分析评估了每月偏头痛天数从基线到4-6个月(盲法研究阶段的主要终点)的变化，每月偏头痛天数减少50%和75%的成就，以及急性偏头痛专用药物治疗天数与基线的变化。结果两种剂量的厄伦单抗治疗4-6个月后每月偏头痛天数显著减少(与安慰剂[95%CI]相比，治疗差异：70 mg为-0.9[-1.5，-0.3]，140 mg为-1.3[-1.9，-0.7]；1既往未用药类别亚组：70 mg为-2.0[-2.8，-1.2]，140 mg为-2.5[-3.4，-1.7]；2既往用药失败亚组：70 mg为-1.3[-2.6，0.0]，140 mg为-2.7[-4.0，-1.4])。在每月急性偏头痛特定用药天数终点观察到类似的结果，在实现每月偏头痛天数减少50%和75%方面也观察到类似的结果。对于每月减少50%的偏头痛日终点，未治疗失败组的安慰剂有效率为32.6%，1次治疗失败组为17.5%，2次治疗失败组为11.1%。结论Erenumab对先前预防治疗失败的发作期偏头痛患者具有一致的疗效，且跨亚组耐受性良好。数据表明，既往治疗失败的患者安慰剂应答率较低。
Background Erenumab was effective and well tolerated in a pivotal clinical trial of episodic migraine that included subjects both naive to, and those who had failed, previous preventives. Here we evaluated the efficacy and safety of erenumab (70mg or 140mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s): 1 or 2 prior failed migraine preventive categories, and in patients who had never failed.Methods Prespecified subgroup analyses evaluated change from baseline to months 4-6 (the primary endpoint of the blinded study phase) in monthly migraine days, achievement of 50% and 75% reduction in monthly migraine days, and change from baseline in acute migraine-specific medication days. Adverse events were also evaluated.Results Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days at months 4-6 (treatment difference versus placebo [95% CI], never failed subgroup: -0.9 [-1.5, -0.3] for 70mg and -1.3 [-1.9, -0.7] for 140mg; 1 prior failed medication categories subgroup: -2.0 [-2.8, -1.2] for 70mg and -2.5 [-3.4, -1.7] for 140mg; 2 prior failed medication categories subgroup: -1.3 [-2.6, 0.0] for 70mg and -2.7 [-4.0, -1.4] for 140mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of 50% and 75% reduction in monthly migraine days. For the 50% reduction in monthly migraine day endpoint, placebo response in the no prior treatment failed group was 32.6%, in the 1 failed treatment 17.5%, and in the 2 failed treatments 11.1%.Conclusion Erenumab showed consistent efficacy in episodic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups. The data suggest prior patients with prior treatment failures have lower placebo response rates.