This pooled analysis evaluated efficacy of fremanezumab in patients with chronic migraine (CM) by category of baseline migraine frequency.

Increasing frequency of migraine attacks is associated with greater burden and more difficult-to-treat disease. Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets the calcitonin gene-related peptide (CGRP), has been approved for the preventive treatment of migraine in adults. This pooled analysis evaluated the efficacy of fremanezumab in patients with higher-frequency CM (HFCM; ≥19 migraine days/month) and lower-frequency CM (LFCM; 15-18 days/month).

This analysis included patients with CM from 2 double-blind phase 3 trials (HALO CM and FOCUS [included patients with inadequate response to 2-4 prior preventive treatment classes]). Patients were randomized 1:1:1 to quarterly fremanezumab (Months 1/2/3: 675mg/placebo/placebo), monthly fremanezumab (675mg/225mg/225mg), 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 LFCM and HFCM at baseline.

A total of 511 patients had LFCM and 500 had HFCM at baseline. With fremanezumab versus placebo, significantly greater least-squares mean(SE) reductions from baseline over 12 weeks were observed in patients with both HFCM and LFCM in MMDs (LFCM: quarterly, −5.9[0.50]; monthly, −5.9[0.48] vs placebo, −3.2[0.51]; HFCM: quarterly, −4.6[0.52]; monthly, −5.5[0.52] vs placebo, −2.9[0.52]; all P≤0.0078) and MHDs (LFCM: quarterly, −4.9[0.44]; monthly, −5.3[0.43] vs placebo, −2.2[0.46]; HFCM: quarterly, −4.6[0.50]; monthly, −5.4[0.49] vs placebo, −2.5[0.50]; all P≤0.0007). Proportions of patients with ≥50% reduction in MMDs were also significantly higher with fremanezumab versus placebo in patients with LFCM (quarterly, 34%; monthly, 31% vs placebo, 16%) and HFCM (quarterly, 18%; monthly, 23% vs placebo, 10%; all P≤0.0464).

Fremanezumab demonstrated efficacy for CM, based on reductions in MMDs and MHDs versus placebo, regardless of baseline migraine frequency.