Efficacy of Rimegepant Similar Among Black and African American Adults

Larry Charleston IV, MD, MSc, FAHS

In a post-hoc subgroup analysis of 3 double-blind, randomized, placebo-controlled studies of rimegepant (Nurtec ODT; Pfizer), findings showed that the benefits observed from the therapy were similar among Black and African American adults compared with the overall trial population.¹

These data were presented at the 2023 American Headache Society (AHS) Annual Meeting, June 15-18, in Austin, Texas, by Larry Charleston IV, MD, MSc, FAHS, director of Headache and Facial Pain at Michigan State University Clinical Center. In comparison to those on placebo, treatment with 75 mg of rimegepant resulted in higher response rates for 2-hour pain freedom (24.4% vs 18.2%; P = .0473) and freedom from most bothersome symptom (MBS; 43.1% vs 35.5%; P = .0413).

With its approved expanded indication in 2021, rimegepant became the first calcitonin gene-related peptide (CGRP) antagonist to be approved for prevention of migraine, and the first to be approved for both acute and preventative therapy. The orally disintegrating anti-CGRP tablet was originally approved in a 75-mg dose for the acute treatment of migraine in February 2020—the first approval of the therapy for Biohaven.

In total, 696 Black or African American participants were included in the subgroup analysis, with demographics that were comparable to those seen in the overall study population. Of note, there were fewer women (79% vs 83%) and less use of preventive medications (14% vs 22%) in the data. Patients were at least 18 years old, had a minimum of 1 year history of migraine, and were assessed on changes of pain freedom and MBS at 2 hours postdose. Treatment groups were compared using nominal P values.

READ MORE: Migraine Related Stigma and its Impact on Patients in Healthcare

Compared with the overall population, outcomes for the coprimary end points of pain freedom at 2 hours postdose (20.1% vs 12.2%; P <.0001) and freedom from the MBS at 2 hours postdose (36.4% vs 26.6%; P <.0001) were both superior for rimegepant over placebo. In addition, no serious adverse events were recorded in the subgroup analysis.

Since it was approved, there have been several studies to further understand the efficacy of rimegepant in different populations of patients. In April 2022, a phase 1 study showed that the therapy is safe in lactating women, as excretion of rimegepant into human milk was very low. Of note, no clinically meaningful abnormalities were observed in maternal vital signs, laboratory values, hematology results, chemistry results, or urinalysis parameters. Considering that more than 30 million women in America are impacted by migraine, those findings proved to be significant.²

Rimegepant is currently being assessed in the phase 4 CHALLENGE-MIG trial (NCT05127486), the first head-to-head clinical trial comparing 2 medications targeting targeting CGRP. Announced in July 2021, the randomized, double-blind, double-dummy, parallel-group trial compares galcanezumab (Emgality; Eli Lilly), an FDA-approved preventive treatment for migraine, with rimegepant, for a 6-month period. Galcanezumab, a monoclonal antibody, binds to the CGRP protein, preventing it from attaching to the CGRP receptors, whereas rimegepant blocks the receptor for this protein.³

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REFERENCES
1. Charleston L, Armand C, Helveston W, et al. 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. Presented at: 2023 AHS Annual Meeting; June 15-18; Austin, TX. P-69.
2. Baker TE, Croop R, Kamen L, et al. Human milk and plasma pharmacokinetics of single-dose Rimegepant 75 mg in health lactating women. Published online March 16, 2022. doi:10.1089/bfm.2021.0250
3. Emgality versus Nurtec ODT head-to-head migraine preventive treatment study now enrolling patients. News release. Lilly. November 18, 2021. Accessed June 16, 2023. https://www.prnewswire.com/news-releases/emgality-versus-nurtec-odt-head-to-head-migraine-preventive-treatment-study-now-enrolling-patients-301427983.html