Abstract Details

Title Matching-adjusted Indirect Comparisons of Intermittent Oral Rimegepant Versus Placebo and Injectable anti-CGRP-targeted Monoclonal Antibodies Examining Monthly Migraine Days in the Treatment of Migraine

Topic Headache

Presentation(s) P1 - Poster Session 1 (12:00 PM-1:00 PM)

Poster/Presentation
Number 7-010

Objective The objective of this study was to compare monthly migraine days (MMD) for oral rimegepant to those obtained in placebo-controlled trials for injectable anti-CGRP monoclonal antibodies (mAb) galcanezumab and erenumab.

Background Rimegepant is an orally administered small molecule CGRP receptor antagonist, with demonstrated efficacy in the acute treatment of migraine. Recent estimates from a single arm study (BHV3000-201) have also shown evidence of long-term preventive effects in MMD.

Design/Methods Matching-adjusted indirect comparisons (MAIC) were conducted using rimegepant patient-level data and published aggregate-level results from mAb trials. Rimegepant baseline characteristics were matched to the pooled patient characteristics from EVOLVE-1/2 (galcanezumab vs. placebo; N=1,773) and STRIVE (ereumab vs. placebo; N=955) by reweighting the rimegepant patients to more closely match the distributions observed in these studies. To align with inclusion criteria of the mAb trials, only the subset of rimegepant patients with a history of 4-14 MMD were included (n=257). Weighted mean differences were used to calculate adjusted change in MMD from baseline to week 12.

Results When matching to the EVOLVE studies, rimegepant was superior to placebo with a mean difference in MMD change-from-baseline [95% confidence intervals] of -1.16 [-1.80,-0.52], and comparable to galcanezumab 0.59 [-0.13,1.32]. When matching to the STRIVE study, rimegepant was superior to placebo -1.59 [-2.15,-1.03] and comparable to erenumab -0.06 [-0.61,0.50].

Conclusions Oral rimegepant was found to be superior to placebo and comparable to injectable galcanezumab and erenumab in reducing MMD. While a controlled trial would be the optimal methodology for assessing relative difference, the available data suggest that rimegepant may be effective in the prevention of migraine.

Authors/Disclosures
Evan Popoff PRESENTER	No disclosure on file
Karissa Johnston	Karissa Johnston has nothing to disclose.
Robert Croop, MD	Dr. Croop has received personal compensation for serving as an employee of Biohaven Pharmaceuticals, Inc. Dr. Croop has received personal compensation for serving as an employee of Pfizer Inc.. Dr. Croop has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Collima LLC. Dr. Croop has stock in Biohaven Pharmaceutical Holding Co Ltd. Dr. Croop has stock in Biohaven Ltd.. Dr. Croop has stock in Actio Biosciences, Inc. . Dr. Croop has received research support from Pfizer Inc. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care.
	No disclosure on file
	No disclosure on file
	No disclosure on file
Gilbert J. L'Italien	Gilbert J. L'Italien has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Gilbert J. L'Italien has stock in biohaven pharmaceuticals.