Vestra Clinics, Rychnov nad Kněžnou, Czech Republic.
Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.
Cephalalgia. 2021 Sep;41(10):1075-1088. doi: 10.1177/03331024211008401. Epub 2021 May 14.
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.
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.
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 0.001). No significant treatment-by-subgroup interactions were observed for any outcome ( interaction > 0.20 for all). Adverse events were comparable for placebo and fremanezumab.
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. NCT03308968.
评估每月或每季度依洛尤单抗治疗慢性偏头痛或发作性偏头痛患者的疗效，这些患者对 2、3 或 4 种偏头痛预防性药物治疗反应不足。
这是一项对慢性偏头痛或发作性偏头痛且对 2 至 4 种偏头痛预防性药物治疗反应不足的患者进行的随机、双盲、安慰剂对照、3b 期试验的探索性分析，这些患者按照 1:1:1 的比例随机（1:1:1）分配至依洛尤单抗（每月或每季度）或安慰剂组。在这项探索性分析中，根据先前预防性药物治疗反应不足的药物种类，评估了 12 周双盲治疗期间每月平均偏头痛天数的变化以及不良事件。
总体而言，分别有 414、265 和 153 名患者对 2、3 和 4 种预防性药物治疗反应不足。与安慰剂相比，有记录的 2 种预防性药物治疗反应不足（最小二乘均数差值与安慰剂相比[95%置信区间]：每季度-2.9[-3.83，-1.98]；每月-3.7[-4.63，-2.75]）、3 种预防性药物治疗反应不足（每季度-3.3[-4.65，-1.95]；每月-3.0[-4.25，-1.66]）和 4 种预防性药物治疗反应不足（每季度-5.3[-7.38，-3.22]；每月-5.4[-7.35，-3.48]）的患者中，依洛尤单抗与安慰剂相比，每月偏头痛天数的改善更为显著（所有 P 值均＜0.001）。在任何结果中，未观察到治疗与亚组之间的显著交互作用（所有交互作用＞0.20）。依洛尤单抗和安慰剂的不良事件相当。
与安慰剂相比，依洛尤单抗在偏头痛预防性药物治疗反应不足的患者中观察到了显著的疗效改善，即使在先前对 4 种不同类别的偏头痛预防性药物治疗反应不足的患者中也是如此。NCT03308968。
