To evaluate adverse events (AEs) in a subgroup of migraine patients with baseline cardiovas- cular (CV) medication use in this pooled analysis of three phase 3 trials of fremanezumab.Methods
This analysis included data from the HALO EM, HALO CM, and FOCUS studies, in which patients were randomized 1:1:1 to subcutaneous quarterly or monthly fremanezumab or matched placebo over 12 weeks. AEs were evaluated for patients with baseline CV medication use.Results
Overall, 280 of 2,842 patients (9–11% across treatment groups) in this pooled population were receiving CV medications at baseline, most commonly agents acting on the renin-angiotensin system (3–4%) and beta-blockers (3–4%). In the placebo, quarterly fremanezumab, and monthly fremanezumab groups, respectively, 53%, 66%, and 64% of patients reported at least 1 AE, and the most common AEs were injection-site-related (pain [19%, 29%, and 20%], erythema [10%, 20%, and 13%], and induration [8%, 18%, and 24%]). Cardiovascular AEs (CVAEs) were infrequent; no individual CVAE was reported for >1 patient in any treatment group. No safety signals were identified.Conclusion
In this pooled analysis, fremanezumab treatment was well tolerated over 12 weeks, with low incidences of CVAEs, comparable to placebo, in patients with migraine using CV medications at baseline.