Real-world efficacy and tolerability of fremanezumab in adults with chronic migraine: a 3-month, single-center, prospective, observational study

Abstract

BackgroundFollowing the promising pre-marketing placebo-controlled randomized clinical trials of fremanezumab, post-marketing studies are necessary to verify efficacy and tolerability in various real-world settings. The present study assessed real-world efficacy and safety of fremanezumab.MethodsA 3-month, single-center, prospective, observation study of adults with chronic migraine who were treated with monthly subcutaneous injections of 225 mg fremanezumab in Denmark. The primary outcome was defined as proportion of patients who achieved ≥30% reduction in monthly migraine days (MMDs) from baseline to weeks 9–12. Among secondary outcomes were ≥50 and ≥75% responder rates and the proportion of patients reporting adverse events.ResultsA total of 91 patients with chronic migraine were enrolled and received at least one dose of fremanezumab of whom 89 patients (98%) completed the 3-months treatment period. At baseline, the mean (SD) number of monthly headache days was 24.3 ± 5.8 and mean number of MMDs was 18.5 ± 7.4. The number of patients who achieved ≥30% reduction in MMDs from baseline to weeks 9–12 was 58 (65%), while 45 (51%) and 21 (24%) had ≥50 and 75% reduction in MMD, respectively. Twenty-one patients (23%) reported adverse event, in which the most common were constipation (4.4%), fatigue (4.4%) and dizziness (3.3%). No serious adverse events were reported.ConclusionIn adult chronic migraine patients with previous failure of conventional oral migraine preventives, fremanezumab was found to be effective and well-tolerated.

Twelve-month efficacy of CGRP monoclonal antibodies and predictive value of short-term response: results of an Australian multicentre study

“…This study compares favourably with similar studies in other academic centres. Argyriou et al, who also reported a cohort of patients with at least three preventative treatment failures, reported a ≥50% reducation in MHD at 3 months of 62.6%, with similar reports by Cullum et al 17 18 Iannone et al reported lower rates of treatment continuation at 12 months compared with our cohort. 19 The reported adverse event rate varies in the literature between 19.5% and 73.3%, 2 13 20 with similar reported events.…”