Rimegepant for long-term acute Tx of migraine cuts monthly attack days, shows no MOH signal
24 Sep 2024
In patients with ≥1 year’s history of migraine and ≥6 monthly migraine days (MMDs), acute treatment of migraine with rimegepant 75 mg up to once daily as needed for up to 52 weeks is associated with reduced MMDs, with no increase in monthly tablet utilization and no evidence of medication overuse headache (MOH), a post hoc analysis of an open-label safety study has shown.
Triptans, commonly used in acute treatment of migraine, have not been associated with a reduction in MMDs when used over the long term. [Headache 2013;53:1548-1563] Frequent use of triptans may contribute to MOH, a secondary headache disorder that develops as a consequence of regular overuse of acute or symptomatic headache medication. [J Headache Pain 2018;19:38; J Neurol 2023;270:5692-5710]
The present post hoc analysis included 1,044 patients (mean age, 43.2 years; female, 91.1 percent) with ≥1 year’s history of migraine and ≥6 MMDs at baseline who used rimegepant 75 mg up to once daily pro re nata (PRN) for up to 52 weeks in a multicentre open-label safety study. [J Headache Pain 2022;23:10]
Among these patients, the mean number of MMDs decreased from 10.9 at baseline to 8.9 by week 52. In addition to the 2-day reduction in MMDs, long-term acute treatment of migraine with rimegepant was also associated with an estimated benefit of 0.08 quality-adjusted life-years (equivalent to 29.2 migraine-free days) over the 52-week study period.
“Mean monthly tablet use remained stable with a trend towards a decrease over the study period, from 7.9 tablets in weeks 4–8 to 7.3 tablets in weeks 48–52,” the investigators reported. “There was no evidence of medication-related increases in migraine frequency.”
“Based on this trajectory and estimated pain hours per migraine event, rimegepant was estimated to be associated with 16.9 percent more pain-free hours, 24.4 percent fewer mild pain hours, 44.9 percent fewer moderate pain hours, and 44.7 percent fewer severe pain hours compared with continuing the usual care trajectory from baseline to week 52,” they noted.
Health-related quality of life, measured by Migraine-specific Quality-of-life Questionnaire version 2.1 (MSQv2), improved across all domains (ie, emotional function, role function–preventive, role function–restrictive). “There was a consistent trend of rapid increase in the first 12 weeks, which was sustained and exhibited further improvements between weeks 12 and 52,” the investigators pointed out.
Rimegepant was also shown to be well tolerated when used for up to 52 weeks in acute treatment of migraine. In the multicentre open-label safety study, most on-treatment adverse events were mild or moderate, and no signal of hepatotoxicity, potential drug abuse or MOH was found. The study included 1,800 adult patients with ≥1 year’s history of migraine (mean age, 43.1 years; female, 89.4 percent; mean number of moderate-to-severe migraine attacks, 6.7 per month), who were enrolled into three groups. The first two groups were patients with 2–8 or 9–14 moderate-to-severe migraine attacks per month who took rimegepant 75 mg up to once daily PRN for 52 weeks (PRN 2–8 group, n=1,033; PRN 9–14 group, n=481), while the third group comprised patients with 4–14 moderate-to-severe migraine attacks per month who took rimegepant 75 mg every other day (QOD) as scheduled plus a PRN dose for migraine attacks of any severity on nonscheduled dosing days for 12 weeks (QOD + PRN group, n=286). [Cephalalgia 2024;44:1-11]
Triptans, commonly used in acute treatment of migraine, have not been associated with a reduction in MMDs when used over the long term. [Headache 2013;53:1548-1563] Frequent use of triptans may contribute to MOH, a secondary headache disorder that develops as a consequence of regular overuse of acute or symptomatic headache medication. [J Headache Pain 2018;19:38; J Neurol 2023;270:5692-5710]
The present post hoc analysis included 1,044 patients (mean age, 43.2 years; female, 91.1 percent) with ≥1 year’s history of migraine and ≥6 MMDs at baseline who used rimegepant 75 mg up to once daily pro re nata (PRN) for up to 52 weeks in a multicentre open-label safety study. [J Headache Pain 2022;23:10]
Among these patients, the mean number of MMDs decreased from 10.9 at baseline to 8.9 by week 52. In addition to the 2-day reduction in MMDs, long-term acute treatment of migraine with rimegepant was also associated with an estimated benefit of 0.08 quality-adjusted life-years (equivalent to 29.2 migraine-free days) over the 52-week study period.
“Mean monthly tablet use remained stable with a trend towards a decrease over the study period, from 7.9 tablets in weeks 4–8 to 7.3 tablets in weeks 48–52,” the investigators reported. “There was no evidence of medication-related increases in migraine frequency.”
“Based on this trajectory and estimated pain hours per migraine event, rimegepant was estimated to be associated with 16.9 percent more pain-free hours, 24.4 percent fewer mild pain hours, 44.9 percent fewer moderate pain hours, and 44.7 percent fewer severe pain hours compared with continuing the usual care trajectory from baseline to week 52,” they noted.
Health-related quality of life, measured by Migraine-specific Quality-of-life Questionnaire version 2.1 (MSQv2), improved across all domains (ie, emotional function, role function–preventive, role function–restrictive). “There was a consistent trend of rapid increase in the first 12 weeks, which was sustained and exhibited further improvements between weeks 12 and 52,” the investigators pointed out.
Rimegepant was also shown to be well tolerated when used for up to 52 weeks in acute treatment of migraine. In the multicentre open-label safety study, most on-treatment adverse events were mild or moderate, and no signal of hepatotoxicity, potential drug abuse or MOH was found. The study included 1,800 adult patients with ≥1 year’s history of migraine (mean age, 43.1 years; female, 89.4 percent; mean number of moderate-to-severe migraine attacks, 6.7 per month), who were enrolled into three groups. The first two groups were patients with 2–8 or 9–14 moderate-to-severe migraine attacks per month who took rimegepant 75 mg up to once daily PRN for 52 weeks (PRN 2–8 group, n=1,033; PRN 9–14 group, n=481), while the third group comprised patients with 4–14 moderate-to-severe migraine attacks per month who took rimegepant 75 mg every other day (QOD) as scheduled plus a PRN dose for migraine attacks of any severity on nonscheduled dosing days for 12 weeks (QOD + PRN group, n=286). [Cephalalgia 2024;44:1-11]