Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Adults of Hispanic or Latino Ethnicity: Post Hoc Analysis of Three Randomized, Placebo-Controlled Trials

This post hoc exploratory analysis evaluated the efficacy and safety of rimegepant 75 mg for the acute treatment of migraine in patients that are Hispanic or Latino (HL), non-HL White (nHLW), and non-HL Black/African American (nHLB/AA). Data were pooled from three multicenter, double-blind, randomized, placebo-controlled, phase 3 trials of rimegepant. Each study comprised a 28-day screening period, treatment phase (up to 45 days), and end of treatment visit within 7 days. Patients treated a single migraine attack of moderate to severe pain intensity during the treatment phase. Co-primary endpoints in the phase 3 trials were pain freedom and freedom from most bothersome symptom (MBS) both at 2 h post dose. A total of 546 patients that are HL and 2872 patients that are non-HL (nHLW, n = 2215; nHLB/AA, n = 657) were enrolled. Patients that are HL exhibited a trend, but did not achieve statistical significance, with nominal p < 0.05 for pain freedom (PF) (19.9% rimegepant vs. 13.6% placebo, p = 0.051) or freedom from MBS (31.8% rimegepant vs. 31.8% placebo, p = 0.999), both at 2 h post dose. Exploratory analyses showed that patients that are nHLW and patients that are nHLB/AA achieved responses at 0.75–1.5 h and 1–2 h post dose, respectively, for pain relief, PF, and freedom from MBS, and these were maintained through 48 h. Responses for each were delayed in patients that are HL, starting at 3–4 h post dose and maintained through 48 h. Safety outcomes were similar across subgroups. Rimegepant was effective and safe for the acute treatment of migraine. Co-primary endpoints at 2 h post dose were not met in patients that are HL; exploratory analyses suggest that patients that are HL may experience a 1–2 h delayed response to rimegepant, with a greater proportion of patients that are HL having responded at 24–48 h post treatment. ClinicalTrials.gov identifiers: NCT03235479; NCT03237845; NCT03461757. Migraine is a long-term disorder that causes recurrent headaches called migraine attacks. Acute migraine treatments are taken to treat migraine attacks that have already begun. In clinical studies, the number of individuals of ethnic and racial groups other than White is often low. This makes it difficult to understand if the results of clinical trials are applicable to everyone. This study aimed to test whether rimegepant is effective and safe for the acute treatment of migraine within different ethnicities. Researchers used data from three completed clinical studies in which individuals treated a single migraine attack with rimegepant or a placebo. A total of 546 individuals that are Hispanic/Latino, 2215 individuals that are White, and 657 individuals that are Black/African American individuals were included in this study. Individuals that are White had pain relief, pain freedom, and freedom from their most bothersome symptom between 45 min to 1.5 h after taking rimegepant. The same benefits were seen in individuals that are Black/African American 1–2 h after taking rimegepant, and 3–4 h after taking rimegepant in individuals that are Hispanic/Latino. In each group, the benefits of rimegepant treatment continued for 48 h. The number of side effects was similar among each group of individuals. Researchers concluded that rimegepant was an effective and safe acute migraine treatment in all three groups. Individuals that are Hispanic/Latino may see a short delay in how long it takes to benefit from rimegepant treatment. However, at 24–48 h, greater proportions of individuals that are Hispanic/Latino had pain freedom, pain relief, and freedom from most bothersome symptoms relative to individuals that are White or individuals that are Black/African American.