Twelve-months prospective real-world assessment of effectiveness and safety of eptinezumab in migraine patients difficult-to-treat and naïve to CGRP monoclonal antibodies: results of the French FHU INOVPAIN Registry
Abstract
Abstract Background . Randomized clinical trials have demonstrated the efficacy and safety of eptinezumab. The aim of this study was to evaluate the effectiveness and safety of eptinezumab in a real-world setting among patients with difficult-to-treat migraine in France. Methods . This is a one year-prospective real-word study including all consecutive adult patients from the FHU InovPain registry who received intravenous eptinezumab 100 mg. Results . Three hundred and two patients (83.8% female / mean age of 48.0 ± 13.9 years) were included. Patients had at least 8 monthly migraine days, had failed at least 3 previous prophylactic treatments across amitryptiline, betablockers, botulinum toxin, candesartan, and topiramate and were CGRP monoclonal antibodies naïve. Among them, 184 patients (60.9%) had chronic migraine and 118 (39.1%) had episodic migraine, whereas 229 patients (75.8%) presented a medication overuse. Regarding the primary endpoint, 50% responder rate at M3, M6, and M12 was 35.4% (107/302), 39.0% (96/246), and 45.7% (63/138), respectively. ≥30% responder rate at M3, M6, and M12 was 48.7% (147/302), 56.1% (138/246), and 63.0% (87/138), respectively. ≥75% responder rates at M3, M6, and M12 was 10.9% (33/302), 15.4% (38/246), and 23.2% (32/138), respectively. The effectiveness of eptinezumab was confirmed by significant changes in the values of all PRO measures at all assessment time points compared with baseline, demonstrating improvement in functional impact…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 229 participants or records.
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