This pooled analysis of fremanezumab clinical trial data evaluated efficacy outcomes in patients with episodic migraine (EM) by category of baseline migraine frequency.

Patients with higher-frequency EM (HFEM; 10-14 migraine days/month) may experience greater disease burden and different treatment response than those with lower-frequency EM. Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets the calcitonin gene-related peptide (CGRP), has proven efficacy for migraine preventive treatment. This pooled analysis evaluated the efficacy of fremanezumab in patients with HFEM and moderate-frequency EM (MFEM; 4-9 days/month).

This analysis included patients with EM from 2 double-blind phase 3 trials (HALO EM and FOCUS [patients with inadequate response to 2-4 prior preventive treatment classes]). Patients were randomized 1:1:1 to quarterly fremanezumab, monthly fremanezumab, or placebo for 12 weeks. Changes in monthly average migraine days (MMDs) and headache days of at least moderate severity (MHDs) and proportions of patients with ≥50% reduction in MMD were evaluated in patients with MFEM and HFEM at baseline.

Among 1,174 participants, 659 had MFEM and 515 had HFEM at baseline. Least-squares mean(SE) reductions from baseline in MMDs over 12 weeks were significantly greater with fremanezumab versus placebo in the MFEM group (quarterly, −3.5[0.22]; monthly, −3.4[0.22] vs placebo, −1.5[0.21]) and HFEM group (quarterly, −4.2[0.35]; monthly, −4.7[0.35] vs placebo, −2.8[0.35]; all P≤0.0009), as were reductions in MHDs (MFEM: quarterly, −3.0[0.19]; monthly, −2.8[0.19] vs placebo, −0.8[0.18]; HFEM: quarterly, −3.5[0.31]; monthly, −3.7[0.31] vs placebo, −1.8[0.30]; all P<0.0001). Proportions of patients with ≥50% reduction in MMDs were also significantly higher with fremanezumab versus placebo in both groups (MFEM: quarterly, 51%; monthly, 50% vs placebo, 25%; HFEM: quarterly, 38%; monthly, 42% vs placebo, 21%; all P≤0.0005).

Fremanezumab demonstrated efficacy, based on reductions in MMDs and MHDs versus placebo, with similar therapeutic gains in the MFEM and HFEM groups.