Objective: A pooled analysis evaluated reductions in migraine and headache days among chronic migraine (CM) patients with comorbid depression (scores ≥10 on the 9-item Patient Health Questionnaire [PHQ-9]) in two placebo-controlled phase 3 trials of fremanezumab, a fully humanized monoclonal antibody (IgG2_a) that selectively targets calcitonin gene-related peptide (CGRP) and is approved for the preventive treatment of migraine in adults.
Methods: In the two 12-week, double-blind trials, patients with CM were randomized to receive subcutaneous injections of fremanezumab quarterly (Months 1/2/3, 675 mg/placebo/placebo) or monthly (Months 1/2/3, 675/225/225 mg) or placebo.
Results: This pooled analysis included 368 patients (fremanezumab quarterly, n=131; fremanezumab monthly, n=130; placebo, n=107). Over 12 weeks, patients treated with fremanezumab quarterly and monthly had mean reductions in monthly migraine days of 4.6 (standard error, 0.56) and 4.9 (0.59), respectively, versus 1.9 (0.63) with placebo (both P < 0.001 vs placebo). Over 12 weeks, patients treated with fremanezumab quarterly and monthly had mean reductions in monthly headache days of at least moderate severity of 4.6 (0.53) and 5.2 (0.56), respectively, versus 1.7 (0.59) with placebo (both P < 0.02 vs placebo). Reductions from baseline in monthly migraine days and headache days of at least moderate severity to months 1, 2, and 3 were also significantly greater among patients treated with fremanezumab versus placebo (P < 0.02).
Conclusions: Patients with chronic migraine and comorbid depression treated with fremanezumab had statistically significant reductions in the number of migraine days and headache days of at least moderate severity versus placebo at all time points of follow-up.