Abstract Details

Fremanezumab is a fully humanized monoclonal antibody (IgG2Δa) that selectively targets the calcitonin gene-related peptide (CGRP) and is approved for the preventive treatment of migraine in adults. Fremanezumab has been shown to be effective and well tolerated for preventive treatment of episodic and chronic migraine, including difficult-to-treat migraine, in the HALO CM, HALO EM, and FOCUS studies.

This pooled analysis of data from 3 randomized, double-blind, placebo-controlled phase 3 trials (HALO chronic migraine [CM], HALO episodic migraine [EM], and FOCUS) evaluated changes in heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP).

Across all 3 studies, participants were randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab, or matched monthly placebo for 12 weeks of double-blind treatment. In this pooled analysis, changes from baseline in HR, SBP, and DBP at the end of the double-blind treatment period were summarized descriptively.

Across the phase 3 studies, 1,897 participants received fremanezumab (quarterly, n=943; monthly, n=954) and 945 received placebo. At the end of 12 weeks of double-blind treatment, mean (SE) changes from baseline were small and similar across both fremanezumab treatment groups and the placebo group for HR (measured in beats per minute: quarterly fremanezumab, 0.4 [0.32]; monthly fremanezumab, 0.4 [0.33]; placebo, 0.0 [0.32]), SBP (measured in mmHg; quarterly fremanezumab, −0.7 [0.39]; monthly fremanezumab, −0.8 [0.39]; placebo, −0.5 [0.38]), and DBP (measured in mmHg; quarterly fremanezumab, −0.3 [0.28]; monthly fremanezumab, −0.5 [0.29]; placebo, −0.8 [0.30]).

This pooled analysis showed that, at the end of 12 weeks of double-blind treatment, fremanezumab treatment resulted in minimal increases in HR and decreases in SBP and DBP from baseline that were not clinically significant and were comparable to those observed in the placebo group among individuals with migraine.