Fremanezumab for the Preventive Treatment of Migraine: Subgroup Analysis by Number of Prior Preventive Treatments with Inadequate Response. (September 2021)

• Record Type: Journal Article
• Authors: Pazdera, Ladislav; Cohen, Joshua M; Ning, Xiaoping; Campos, Verena Ramirez; Yang, Ronghua; Pozo-Rosich, Patricia
• Is Part Of: Cephalalgia. Volume 41:Number 10(2021)
• Page Start: 1075
• Page End: 1088
• Publication Date: 2021-09
• Subjects: Chronic migraine -- episodic migraine -- treatment failure -- CGRP; Headache -- Periodicals; 616.8491
• DOI: 10.1177/03331024211008401
• Languages: English
• ISSNs: 0333-1024

Abstract

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.