Abstract Details

Title Matching-adjusted Indirect Comparisons of Intermittent Oral Rimegepant Versus Placebo and Injectable anti-CGRP Monoclonal Antibodies (mAb) Examining Health-related Quality of Life (HRQoL).

Topic Headache

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

Poster/Presentation
Number 7-011

Objective Compare HRQoL of oral rimegepant to injectable anti-CGRP mAbs galcanezumab and erenumab.

Background Migraine is a debilitating neurological condition, affecting 15% of Americans. Many people suffering from severe migraine attacks are unable to perform daily activities and can be confined to bed. Recent estimates from BHV3000-201 (N=1800) showed evidence of long-term improvement in HRQoL associated with rimegepant treatment, an oral small molecule CGRP antagonist with demonstrated efficacy in the acute treatment of migraine.

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 pooled patient characteristics from EVOLVE-1/2 (galcanezumab vs placebo;N=1,773) and STRIVE (erenumab vs placebo;N=955) by re-weighting rimegepant patients to distributions observed in these studies. To align with mAb trials, only the subset of rimegepant patients with a history of 4-14 monthly migraine days (MMD) at baseline were included (n=257). Weighted mean differences were used to calculate adjusted change in total MIDAS score and MSQOL (baseline to 12 weeks).

Results Rimegepant showed superior MIDAS results when compared to placebo in both EVOLVE studies (-7.37 [-12.91, -1.83]) and in the STRIVE study (-5.67 [-10.65, -0.69]). Rimegepant was comparable to both galcanezumab (-0.09 [-6.01, 5.83]) and erenumab (1.75 [-3.24, 6.73]). For MSQOL, rimegepant showed superior results to placebo and erenumab across all domains, while being comparable to galcanezumab in preventative role and emotional domains and inferior in the restrictive role domain.

Conclusions Intermittent oral rimegepant was found to be superior to placebo and comparable to injectable galcanezumab and erenumab in reducing MIDAS, superior to placebo and erenumab in improving MSQOL, and generally comparable to galcanezumab in improving MSQOL. When adjustments were made to reflect baseline characteristics in published literature, current data suggest that rimegepant is an effective therapy in reducing disability and enhancing migraine specific HRQoL.

Authors/Disclosures
Evan Popoff PRESENTER	No disclosure on file
Karissa Johnston	Karissa Johnston has nothing to disclose.
	No disclosure on file
	No disclosure on file
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
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.