Efficacy and safety of rimegepant for the acute treatment of migraine in Black or African American adults: A post hoc pooled subgroup analysis from three randomized, placebo-controlled clinical trials.

objectiveThis post hoc subgroup analysis was conducted using pooled data from three US-based clinical trials to compare efficacy and safety of rimegepant 75 mg versus placebo in acute migraine in adults who are Black or African American.

backgroundMigraine, characterized by recurring moderate-to-severe unilateral head pain, affects approximately 13% of the population and in the United States affects Black or African American and White populations at similar rates. Despite this, there is stark underrepresentation of Black or African American patients in clinical trials. Rimegepant, an oral small molecule calcitonin gene-related peptide receptor blocker or antagonist, is approved for acute migraine treatment in the United States; however, treatment has not previously been analyzed in Black or African American adults.

methodsUsing pooled data from three US-based, double-blind, randomized, placebo-controlled, multicenter clinical trials (ClinicalTrials.gov, NCT03235479; NCT03237845; NCT03461757), efficacy analyses were conducted on a modified intent-to-treat population including all participants who received study medication, had a migraine attack of moderate or severe pain intensity at the time of dosing, and provided ≥1 efficacy datapoint after receiving study treatment. Trials were conducted July 2017 to January 2018 (NCT03235479, NCT03237845) or February 2018 to October 2018 (NCT03461757). The coprimary efficacy endpoints of each trial were freedom from pain (score 0 = none on a 4-point pain scale) and freedom from most bothersome symptom (MBS) at 2 h post dose. Safety was assessed through reported on-treatment adverse events, defined as events occurring on or after treatment was received. Analyses were performed in the Black or African American population, in the White population, and in the overall pooled study population (including Black or African American, White, Asian, American Indian or Alaskan Native, Native Hawaiian or other Pacific Islander, and multiple races).

resultsOverall, 3551 treated participants were in the pooled population; 696 (19.6%) were Black or African American; 2700 (76.0%) were White. In the Black or African American population, rimegepant showed improvements versus placebo in the two coprimary endpoints. For pain freedom 2 h post dose, the stratified risk was 24.4% (88/359) for rimegepant and 18.2% (59/323) for placebo in Black or African American participants; risk difference was 6.2% (95% confidence interval [CI]: 0.1, 12.3; p = 0.047). For MBS freedom 2 h post dose, the stratified risk was 43.1% (155/359) for rimegepant and 35.5% (115/323) for placebo in Black or African American participants; risk difference was 7.6% (95% CI: 0.3, 14.9; p = 0.041). The risk difference was similar in White participants: 7.9% (95% CI: 5.2, 10.6; p < 0.001) for pain freedom 2 h post dose and 9.9% (95% CI: 6.5, 13.4; p < 0.001) for MBS freedom 2 h post dose. Adverse event rates among Black or African American participants treated with rimegepant were 10.7% (39/365) and 7.9% (26/331) in participants receiving placebo.

conclusionThis pooled analysis showed rimegepant 75 mg was effective and well tolerated for migraine treatment in Black or African American adult participants.