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
Amaal Starling1, Jan Versijpt2, Marja-Liisa Sumelahti3, Ayse Neslihan Aslan4, Harpreet Seehra5, Sara Anne Ramaker4, Shannin McCollum4, Alexandra Thiry4, Lucy Abraham5, Robert Fountaine4, Luz Ramirez4
1Mayo Clinic, 2Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel, 3University of Tampere, 4Pfizer Inc., 5Pfizer R&D UK Ltd.
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
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