Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Black and African American Adults: Results From 3 Randomized, Placebo-Controlled Clinical Trials
Larry Charleston1, Cynthia Armand2, Wendell Helveston3, Teshamae Monteith4, Hope O'Brien5, Robert Croop6, Alexandra Thiry6, Beth Morris6, Micaela Forshaw6, Chandra Abbott6
1Michigan State University College of Human Medicine, 2Montefiore Medical Headache Center, 3Hattiesburg Clinic, 4University of Miami, 5Headache Center of Hope, 6Biohaven Pharmaceuticals
Objective:

Compare the efficacy of rimegepant 75 mg with placebo in the acute treatment of migraine in Black and African American adults.

Background:

Rimegepant is an orally administered small molecule calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the acute and preventive treatment of migraine. Studies showing the effects of medications for the acute treatment of migraine in Black and African American individuals are limited. It is unclear whether the acute treatment effects of rimegepant in under-represented populations are similar to those in the overall migraine population.

Design/Methods:

Post hoc subgroup analyses were conducted using pooled data from 3 double-blind, randomized, placebo-controlled studies of rimegepant 75 mg for acute treatment in Black and African American adults aged ≥18 years with a ≥1-year history of migraine. The co-primary efficacy endpoints were pain freedom and most bothersome symptom (MBS) freedom at 2 hours postdose. Treatment groups were compared using nominal p-values.

Results:

Of the 3551 efficacy-evaluable participants, 19.6% were Black or African American (N=696, rimegepant n=365, placebo n=331). The demographics of Black and African American participants were comparable to those seen in the overall study population, but there were fewer women (79% vs 83%) and the use of preventive medication was lower (14% vs 22%). Response rates were higher on rimegepant than placebo for 2-hour pain freedom (24.4% vs 18.2%, p=0.0473) and MBS freedom (43.1% vs 35.5%, p=0.0413). Outcomes on the coprimary endpoints in the overall population were similar for pain freedom at 2 hours postdose (20.1% vs 12.2%, p<0.0001) and freedom from the MBS at 2 hours postdose (36.4% vs 26.6%, p<0.0001). Treated participants reported no serious adverse events.

Conclusions:

Rimegepant 75 mg showed benefits for the acute treatment of migraine in Black and African American adults that were similar to those observed in the overall trial population.

10.1212/WNL.0000000000203999