Time to First and Sustained Improvement in Weekly Migraine Days Among Patients Receiving Preventive Treatment With Rimegepant 75 mg
Stewart Tepper1, Lucy Abraham2, Andrew Bushmakin3, Joseph Cappelleri3, Terence Fullerton3, Jiyue Yang3, Richard Lipton4
1New England Institute for Neurology and Headache, 2Pfizer R&D UK Ltd, 3Pfizer Inc, 4Montefiore Headache Center and the Albert Einstein College of Medicine
Objective:
To assess onset of preventive benefit for rimegepant 75 mg in treatment of migraine.
Background:
Rimegepant is an oral CGRP-receptor antagonist approved for acute and preventive migraine treatment.
Design/Methods:
In this phase 2/3 trial (NCT03732638) adults with 4–18 moderate-to-severe migraine attacks/month completed a 28-day observational run-in period (baseline), followed by double-blinded treatment with rimegepant or placebo every-other-day (EOD) for 12-weeks. Next, was an open-label rimegepant EOD and pro re nata (PRN) period with treatment up to once-daily for 52 weeks. Migraine attacks were recorded using electronic diaries. Median (25th, 75th percentiles) time-to-first and -sustained reductions in weekly migraine days (WMDs) were estimated. Improvements from baseline were evaluated in 10% increments. Time-to-first improvement was based on the first week an improvement of a particular magnitude was achieved, and time-to-stable improvement were defined as the week improvement was achieved and sustained on average until study end.
Results:
Among 370 participants, the median (25th, 75th percentiles) time-to-first reduction in WMDs of 50% was 2 weeks (1, 4). Thus, half of patients are expected to experience at least one week with at least a 50% improvement in WMDs within the first 2 weeks. The corresponding values for 30% and 70% reductions were 1 (1, 2) and 3 (1, 8) weeks, respectively. The median time to a stable reduction in WMDs of 50% was 3 weeks (1, 14). Accordingly, half of patients are expected to experience a 50% reduction in WMDs by week 3 and maintain on average this improvement up to the week 64. The corresponding values for time to stable reduction in WMDs of 30% and 70% were 1 (1, 3) and 11 (2, 55) weeks, respectively.
Conclusions:
Following rimegepant 75 mg treatment initiation, it is expected that half of patients will experience first and sustained 50% reductions in WMDs by week 2 and 3, respectively.
Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff.