Fremanezumab, a fully-humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is approved for preventive migraine treatment in adults and has demonstrated efficacy and tolerability for preventive treatment of chronic and episodic migraine in the HALO CM, HALO EM, and FOCUS studies. Injection-site AEs were the most common AEs reported in clinical trials of fremanezumab.

This pooled analysis included 2,842 patients. In the quarterly fremanezumab (n=943), monthly fremanezumab (n=954), and placebo (n=945) groups, respectively, injection-site AEs were reported for 37%, 37%, and 31% of patients, most commonly pain (22%, 20%, and 20%), induration (15%, 18%, and 13%), and erythema (16%, 15%, and 12%). Across the quarterly fremanezumab, monthly fremanezumab, and placebo groups, respectively, these AEs were most common within <1 month of initiating study treatment (injection-site pain, 18%, 17%, and 16%; injection-site induration, 13%, 12%, and 10%; injection-site erythema, 14%; 12%, and 10%) and decreased over time (>3 months: injection-site pain, <1%, 0%, and <1%; injection-site induration, <1%, <1%, and <1%; injection-site erythema, <1%, <1%, and <1%). Most injection site reactions were mild to moderate and resolved without treatment. Across all treatment groups, injection-site AEs were more common in the limb than in the abdomen.