A 3-year migraine management with anti-CGRP monoclonal antibodies: an intention-to-treat analysis of real-world evidence

Background: The present prospective, real-world study aims to assess anti-CGRP monoclonal antibodies (mAbs) effectiveness across a 3-year follow-up by means of a conservative intention to treat (ITT) analysis. Methods: We enrolled 179 subjects (75.4% females, 51.3 [49.2-53.4] years, 87.2% with chronic migraine and medication overuse) who started mAbs between 2018 and 2020. We recorded clinical data supported by a prospectively filled headache diary up to a 3-year follow-up. The ITT analysis was performed with a multivariate linear mixed model considering the entire population. Results: We described a reduction in monthly migraine days (MMDs) of -10.9 [-12.1 - -9.8] during the first year of treatment (C1), -10.9 [-12.1- -9.7] during the second year (C2) and -11.5 [-12.8 - -10.3] during the third year (C3) (p=0.193). Residual MMDs were: 23.4 [22.5-24.3] to 11.8 [10.4-13.1] during C1, 19.1 [17.5-20.6] to 11.6 [10.3-12.9] during C2, and 16.1 [14.7-17.6] to 10.6 [9.1-11.9] during C3 (p=0.001). Conclusion: In our cohort, mAbs induced a meaningful and sustained reduction in MMDs across a 3-year follow-up. The ITT analysis revealed a remaining high burden of disease. While confirming mAbs effectiveness in migraine prevention, these findings underscore the need for more treatment approaches and for exploring other non-CGRP dependent pathways.