Effects of erenumab on migraine aura frequency: a REFORM study

Anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies effectively prevent migraine headache, but their impact on aura is unclear. The aim of this study was to characterize longitudinal changes in migraine aura frequency during and after preventive treatment with erenumab in adults with frequent, prospectively confirmed migraine aura. This prospective, longitudinal, single-center investigation enrolled adults diagnosed with migraine with aura who reported ≥ 4 monthly migraine days and ≥ 2 monthly aura days during a 4-week baseline period. Erenumab was administered subcutaneously at a dose of 140 mg every 4 weeks for 24 weeks, followed by a 12-week post-treatment follow-up period. Headache and aura outcomes were recorded prospectively using standardized headache diaries completed throughout baseline, treatment, and follow-up. The primary outcome consisted of the mean absolute change in monthly aura days from baseline, evaluated at four-week intervals across the study period. Eighty participants with migraine with aura provided outcome data eligible for analysis. The mean (SD) age was 43.1 (11.9) years, and 74 participants (93%) were female. At baseline, participants reported a mean of 8.0 (SD, 5.1) monthly aura days. After 24 weeks of treatment, the mean change in monthly aura days was − 4.9 (95% CI, − 5.8 to − 4.0) compared to baseline (p < 0.001). This improvement was partially sustained during the subsequent 12-week post-treatment follow-up, with a mean change of − 3.2 days (95% CI, − 4.2 to − 2.2) relative to baseline (p < 0.001). Exploratory analyses identified that greater reductions in monthly aura days were independently associated with a higher baseline number of monthly aura days (β = −0.60; 95% CI, − 0.72 to − 0.47; p < 0.001) and a greater reduction in monthly migraine days (β = −0.36; 95% CI, − 0.49 to − 0.23; p < 0.001). Preventive treatment with erenumab was associated with substantial and sustained reductions in aura frequency in adults with frequent migraine aura. These findings underscore the relevance of incorporating aura-specific outcomes into future controlled trials evaluating preventive migraine treatments. The study was registered on ClinicalTrials.gov (NCT04603976).