Rimegepant confers long-term improvements in MMDs

Rimegepant is a small-molecule calcitonin gene-related peptide (CGRP)-receptor antagonist, approved for both the acute and preventive treatment of migraine [1]. Acute treatment with this drug conferred long-term improvements in median time to 30% and 50% reduction in monthly migraine days (MMDs). This was found in a post hoc analysis of an open-label safety study [2].

The proportion of patients achieving a 30% or 50% reduction in MMDs relative to baseline is considered clinically meaningful and is therefore recommended as a primary or key secondary trial endpoint per the most recent guidelines [3,4].

BHV3000-201 (NCT03266588) was a 52-week, open-label, phase 2/3, multicentre, long-term safety study investigating rimegepant for the acute treatment of migraine [2]. Among >1,000 participants with ≥6 MMDs at baseline who were included in the current post hoc analysis, mean age was 43.2 years and 91.1% were women. The mean disease duration was 22.5 years, 40.6% of patients had a history of migraine with aura, and mean MMDs at baseline was 10.9 days.

Treatment with 75 mg rimegepant resulted in a median time to ≥30% reduction in MMDs of 12 weeks and a median time to ≥50% reduction of 32 weeks (see Figure). MMD reduction was observed over time regardless of baseline migraine frequency, including low-frequency (baseline MMDs 8.7 days), moderate-frequency (baseline MMDs 11.5 days), and high-frequency (baseline MMDs 14.8 days) cluster groups. Higher baseline MMDs were associated with a longer time to achieve ≥30% or ≥50% MMD reduction.

Figure: Kaplan-Meier plots of time to 30% or 50% reduction in MMDs from baseline in the 6–14 MMD group treated with rimegepant [2]



In addition, the mean number of tablets per migraine type and the mean number of tablets over time were assessed. “After an initial period of 4–8 weeks, we observed a stabilisation of the utilisation across the 3 MMD clusters,” said Mr Evan Popoff (Broadstreet Health Economics & Outcomes Research, Canada). All ratios were consistently <1, implying that patients did not treat every migraine attack with rimegepant. These ratios became 0.7–0.9 during follow up across clusters. Furthermore, the absolute tablet count remained relatively constant given the corresponding trend towards fewer MMDs.

In conclusion, long-term acute treatment of migraine with rimegepant on an as-needed basis was associated with clinically relevant reductions in MMDs without evidence of medication-related increases in headache frequency. These findings are consistent with the preventive benefits of rimegepant demonstrated in a recent placebo-controlled study [1].

1. Croop R, et al. Lancet. 2021;397(10268):51–60.
2. Popoff E, et al. Acute treatment with rimegepant 75 mg confers long term improvements in median time to 30% and 50% reductions in monthly migraine days – post hoc results from an open label safety study (BHV3000-201). AL074, IHC 2021, 8–12 September.
3. Tassorelli C, et al. Cephalalgia. 2018;38(5):815–32.
4. Ailani J, et al. Headache. 2021;61(7):1021–39.

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Posted on 8 November 20211 February 2024