Abstract Details

Title Patient-reported Outcomes Through 12-weeks of Double-blind Rimegepant Treatment for the Prevention of Episodic Migraine in Adults with Prior Inadequate Response to Oral Preventatives

Topic Headache

Presentation(s) P1 - Poster Session 1 (8:00 AM-9:00 AM)

Poster/Presentation
Number 15-008

Objective Evaluate change in patient-reported outcomes (PROs) with rimegepant treatment for the prevention of episodic migraine (EM) in adults with inadequate response to prior non-migraine specific oral preventive medications (OPMs).

Background A recent multinational, randomized, placebo-controlled, double-blind trial evaluated the efficacy and tolerability of rimegepant 75 mg orally disintegrating tablet (ODT) taken once every other day (EOD) in participants with EM and a documented prior inadequate response to 2-4 categories of non-migraine specific OPM.

Design/Methods PROs were collected at baseline and through 12 weeks of double-blind treatment. Differences (rimegepant vs placebo) in least squares mean (LSM) change from baseline were calculated using linear mixed effects models with repeated measures.

Results 652 participants received double-blind study treatment (328 rimegepant and 324 placebo). Findings favored rimegepant at weeks 4, 8, and 12 for the Migraine-Specific Quality of life Questionnaire role function-restrictive (LSM change [95% CI] difference at week 12: 6.6 [3.60, 9.54]; p<0.0001), role function-preventive (5.3 [2.54, 8.07]; nominal p [np]=0.0002), and emotional function domains (6.2 [2.81, 9.51]; np=0.0003); Migraine Interictal Burden score (−0.9 [−1.36, −0.38]; p=0.0006); Work Productivity and Activity Impairment: Migraine questionnaire presenteeism (−7.9 [−12.94, −2.92]: np=0.002), work productivity loss (−7.6 [−12.91, −2.26]; np=0.005), and activity impairment domains (−7.7 [−11.83, −3.53]; np=0.0003), and Headache Impact Test–6 score (−1.9 [−3.00, −0.73]; np=0.001). Average change in Migraine Functional Impact Questionnaire subscale scores also favored rimegepant at months 1, 2, and 3 across all domains (np≤0.006).

Conclusions Rimegepant 75 mg ODT EOD is associated with reductions in disease burden when taken for the prevention of EM for 12 weeks in participants with documented prior inadequate response to 2-4 categories of non-migraine specific OPM. NCT05518123

Authors/Disclosures
Amaal J. Starling, MD, FAAN (Mayo Clinic) PRESENTER	Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome Therapeutics. Dr. Starling has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Starling has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Miller Medical. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Salvia. Dr. Starling has received personal compensation in the range of $0-$499 for serving as a Consultant for Abbvie. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Starling has received personal compensation in the range of $500-$4,999 for serving as a Consultant for eNeura. Dr. Starling has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Woodberry Associates .
Jan Versijpt	Jan Versijpt has nothing to disclose.
Marja-Liisa Sumelahti, MD (Terveystalo)	The institution of Dr. Sumelahti has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer. The institution of Dr. Sumelahti has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pfizer. The institution of Dr. Sumelahti has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Pfizer. Dr. Sumelahti has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for pfizer. Dr. Sumelahti has received publishing royalties from a publication relating to health care.
Ayse Neslihan Aslan, MD	Dr. Aslan has received personal compensation for serving as an employee of Pfizer. Dr. Aslan has stock in Pfizer Inc.
Harpreet Seehra, BSc(Hons), MSc	Ms. Seehra has stock in Pfizer.
Sara A. Ramaker, BA	Mrs. Ramaker has received personal compensation for serving as an employee of Pfizer. Mrs. Ramaker has stock in Pfizer.
Shannin McCollum, RN	Ms. McCollum has received personal compensation for serving as an employee of Pfizer.
Alexandra Thiry, PhD	Dr. Thiry has received personal compensation for serving as an employee of Pfizer. Dr. Thiry has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Dr. Thiry has stock in Pfizer. Dr. Thiry has stock in Biohaven Pharmaceuticals.
Lucy Abraham (Pfizer R&D UK Ltd)	Lucy Abraham has received personal compensation for serving as an employee of Pfizer R&D UK Ltd. Lucy Abraham has stock in Pfizer R&D UK Ltd.
Robert Fountaine	Robert Fountaine has received personal compensation for serving as an employee of Pfizer, Inc.. Robert Fountaine has or had stock in Pfizer, Inc.Robert Fountaine has or had stock in Viatris, Inc.
Luz M. Ramirez, MD	Dr. Ramirez has received personal compensation for serving as an employee of Pfizer.

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