Eptinezumab to prevent difficult-to-treat migraine: prospective, six-month, real-world multicenter evidence from the GRASP study group.

OBJECTIVE: The objective of this multicenter, real-world study, designed by the Greek Research Alliance for the Study of headache and Pain (GRASP), was to prospectively evaluate the 6-month effectiveness and safety of eptinezumab 100 mg for migraine prophylaxis in difficult-to-treat patients. METHODS: A total of 142 participants (81% female; aged 46.1 ± 12.2 years) with either high-frequency episodic migraine (HFEM) or chronic migraine (CM) were consecutively recruited and received eptinezumab 100 mg quarterly for 6 months (2 cycles). The primary outcome was the proportion of patients who achieved > 50% response at month 3 (T1) and 6 (T2), post-treatment. Secondary outcomes included the changes in monthly migraine/headache days (MMDs/MHDs); monthly days with moderate/severe peak headache intensity; monthly acute medication intake; MIDAS HIT-6 and EQ-5D VAS scores at T2, compared with baseline. Safety was also assessed. RESULTS: The percentage of patients obtaining > 50% reduction in MMDs was 67.4% at T1 (first course) and 73.5% at T2 (second course) for HFEM. For CM the corresponding percentages were 55.9% at T1 and 57.6% at T2. At T2, MMDs were reduced with a significant effect by a median of 9 days from baseline in HFEM, whereas MHDs dropped by a median of 16.5 days in CM patients. A clinically-meaningful improvement in all other effectiveness and disability outcomes was observed at T2, compared to baseline. Quality of life improved by + 87.5% in HFEM and by + 133.3% in CM patients. Response rates favored CGRP-naïve patients in HFEM but not in CM, where outcomes were similar between naïve individuals and prior non-responders. Eptinezumab was generally safe and well-tolerated. CONCLUSIONS: Eptinezumab 100 mg demonstrated a favorable benefit/risk profile during the 6-month observation period.