Abstract Details

Title Rimegepant 75 mg Results in Reductions in Monthly Migraine Days: Secondary Analysis of a Multicenter, Open Label Long-term Safety Study of Rimegepant for the Acute Treatment of Migraine

Topic Headache

Presentation(s) P7 - Poster Session 7 (5:30 PM-6:30 PM)

Poster/Presentation
Number 7-011

Objective To evaluate longitudinal changes in monthly migraine days (MMD) from the observational period (OP) across 3 rimegepant treatment groups by conducting a post-hoc analysis of data from a long-term safety study.

Background Rimegepant is an orally administered small molecule CGRP receptor antagonist with demonstrated efficacy and safety in the acute treatment of migraine. Though acute treatment efficacy is established, data on rimegepant’s association with migraine day frequency are limited.

Design/Methods Data came from the BHV3000-201 safety study (NCT03266588). In total, 1,800 patients were assigned to 1 of 3 treatment groups: Group 1 had 2-8 MMD and received as needed dosing (PRN 2-8); Group 2 had 9-14 MMD and dosed PRN (PRN 9-14); Group 3 had 4-14 MMD and dosed every other day (QOD) plus PRN (QOD/PRN 4-14). For the PRN 2-8 and PRN 9-14 groups, treatment duration was up to 52 weeks and, for the QOD/PRN 4-14 group, treatment duration was up to 12 weeks.. Mixed effects models were used assess changes in MMD per 4 week interval.

Results There were 1,033 (57.4%) subjects in the PRN 2-8 group, 481 (26.7%) in the PRN 9-14 group, and 286 (15.9%) in the QOD/PRN 4-14 group. Longitudinal modeling with quadratic time trends demonstrated that, at baseline, PRN 9-14 subjects had greater MMD than QOD/PRN 4-14 subjects, which had greater MMD than PRN 2-8 subjects (p<.0001). The QOD/PRN 4-14 group showed more rapid early decreases in MMD (eg, rate-of-change [ROC] at baseline, -2.19 migraine days/month) compared to other groups (p<.0001).

Conclusions In people with migraine, treatment with rimegepant 75 mg was associated with notable reductions in MMD. Long-term benefits were most visible with QOD/PRN dosing, which suggests that increased rimegepant exposure may be linked to greater reductions in MMD.

Authors/Disclosures
James McGinley PRESENTER	James McGinley has received personal compensation for serving as an employee of Vector Psychometric Group, LLC. An immediate family member of James McGinley has received personal compensation for serving as an employee of UPMC Children's Community Pediatrics. James McGinley has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for McGinley Statistical Consulting, LLC. James McGinley has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for SAGE Cephalalgia (journal). James McGinley has stock in various companies. The institution of James McGinley has received research support from National Headache Foundation.
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.
	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.
Vladimir Coric	Vladimir Coric has received personal compensation for serving as an employee of Biohaven. Vladimir Coric has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Bioahven. Vladimir Coric has stock in Biohaven. Vladimir Coric has received intellectual property interests from a discovery or technology relating to health care.
Richard B. Lipton, MD, F�鶹��ýӳ�� (Albert Einstein College of Medicine)	Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has or had stock in Biohaven.Dr. Lipton has or had stock in Manistee.Dr. Lipton has or had stock in Axon.Dr. Lipton has or had stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.

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