Objective

To evaluate the efficacy of monthly or quarterly fremanezumab in patients with chronic migraine or episodic migraine and documented inadequate response to 2, 3, or 4 classes of prior migraine preventive medications.

Methods

This is an exploratory analysis of a randomized, double-blind, placebo-controlled, phase 3b trial for patients with chronic migraine or episodic migraine and inadequate response to 2 to 4 prior migraine preventive medication classes randomized (1:1:1) to fremanezumab (quarterly or monthly) or placebo. In this exploratory analysis, changes from baseline in the monthly average number of migraine days during 12 weeks of double-blind treatment and adverse events were evaluated for predefined subgroups of patients by number of prior preventive medication classes with inadequate response.

Results

Overall, 414, 265, and 153 patients had inadequate response to 2, 3, and 4 preventive medication classes, respectively. Changes from baseline in monthly average migraine days during 12 weeks were significantly greater with fremanezumab compared with placebo for patients with documented inadequate response to 2 classes (least-squares mean difference vs placebo [95% confidence interval]: quarterly, –2.9 [–3.83, –1.98]; monthly, –3.7 [–4.63, –2.75]), 3 classes (quarterly, –3.3 [–4.65, –1.95]; monthly, –3.0 [–4.25, –1.66]), and 4 classes (quarterly, –5.3 [–7.38, –3.22]; monthly, –5.4 [–7.35, –3.48]) of migraine preventive medications (all p < 0.001). No significant treatment-by-subgroup interactions were observed for any outcome (p interaction > 0.20 for all). Adverse events were comparable for placebo and fremanezumab.

Conclusion

Significant improvements in efficacy were observed with fremanezumab compared with placebo, even in patients who had previously experienced inadequate response to 4 different classes of migraine preventive medications.

ClinicalTrials.gov identifier: NCT03308968.

中文翻译：

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Fremanezumab 用于偏头痛的预防性治疗：按先前未充分反应的预防性治疗次数进行的亚组分析

客观的

评估每月或每季度 fremanezumab 在慢性偏头痛或发作性偏头痛患者中的疗效，并记录对 2、3 或 4 类先前偏头痛预防药物的反应不足。

方法

这是一项随机、双盲、安慰剂对照、3b 期试验的探索性分析，针对慢性偏头痛或发作性偏头痛且对 2 至 4 种随机 (1:1:1) 随机分配至 fremanezumab 的先前偏头痛预防药物类别反应不足的患者（每季度或每月）或安慰剂。在这项探索性分析中，根据先前反应不足的预防性药物类别的数量，对预先确定的患者亚组在 12 周双盲治疗期间偏头痛的月平均天数和不良事件相对于基线的变化进行了评估。

结果

总体而言，分别有 414、265 和 153 名患者对 2、3 和 4 种预防性药物类别的反应不足。对于记录对 2 类反应不足的患者，fremanezumab 与安慰剂相比，12 周期间每月平均偏头痛天数相对于基线的变化显着更大（最小二乘均差与安慰剂 [95% 置信区间]：季度，–2.9 [–3.83 , –1.98]; 每月, –3.7 [–4.63, –2.75]), 3 个班级 (季度, –3.3 [–4.65, –1.95]; 每月, –3.0 [–4.25, –1.66]), 和 4 个班级 (每季度，–5.3 [–7.38，–3.22]；每月，–5.4 [–7.35，–3.48]）偏头痛预防药物（所有p <  0.001）。对于任何结果均未观察到显着的亚组治疗相互作用（p相互作用 > 0.20 所有）。安慰剂和 fremanezumab 的不良事件具有可比性。

结论

与安慰剂相比，观察到 fremanezumab 的疗效显着提高，即使在以前对 4 种不同类别的偏头痛预防药物反应不足的患者中也是如此。

ClinicalTrials.gov 标识符： NCT03308968。