Danilo Antonio Montisano, Gloria Vaghi, Claudia Altamura, Alessandra Parisi, Roberto De Icco, Marilena Marcosano, Alessia Marcassoli, Erika Guastafierro, Michele Corrado, Domenico D'Amico, Grazia Sances, Fabrizio Vernieri, Cristina Tassorelli, Alberto Raggi, Licia Grazzi
A significant reduction in MMDs and MAMs and an improvement in both HWq scales in patients under mAbs treatment was found from the 3-month follow-up onwards. The positive impact on work-related disability should be taken into consideration in planning cost-effectiveness evaluations and drug policy strategy.
BACKGROUND: Migraine's economic burden is mostly due to reduced work productivity, which is underestimated by commonly used patient-reported outcome measures (PROMs). In this prospective, multicentric, real-world study, we used the HEADWORK questionnaire (HWq), a disease-specific work-related PROM, to assess the impact of anti-calcitonin gene receptor peptide (anti-CGRP) monoclonal antibodies (mAbs) on work-related limitations.
METHODS: Migraine patients eligible for treatment with anti-CGRP mAbs were enrolled from three headache centers: IRCCS C.Besta, Mondino Foundation and Policlinico Campus Bio-Medico. Migraine days per month (MMDs), monthly acute medications (MAMs), and HWq were collected every 3 months up to 12 months of follow-up. A GLM design was used to address change in HWq scales' score (primary endpoint), MAMs and MMDs; we also tested whether change in HWq differed across responders' group and defined minimum clinically important difference (MCID) for HWq.
RESULTS: Out of 175 patients (130 females, mean age 48.9 ± 8.8) 152 completed the study. Among them: 37 (24.3%) were non-responders, 69 (45.4%) were responders, and 46 (30.3%) were super-responders. A reduction in all endpoints was observed since the first 3 months of treatment and maintained up to 12-month follow-up. Time*group interaction showed a superior effect, both in HWq scales and MAMs, with super-responders achieving the best outcome.
CONCLUSIONS: A significant reduction in MMDs and MAMs and an improvement in both HWq scales in patients under mAbs treatment was found from the 3-month follow-up onwards. The positive impact on work-related disability should be taken into consideration in planning cost-effectiveness evaluations and drug policy strategy.