Atogepant 60 mg once daily group had significantly larger reductions in mean monthly migraine days across weeks 1-12 and weeks 9-12, with no statistical difference in treatment-emergent adverse events or all-cause discontinuation.
New data from a matching-adjusted indirect comparison analysis showed that patients treated with atogepant (Qulipta; AbbVie) 60 mg once daily (QD) demonstrated significant improvements in both efficacy and quality of life end points compared with those treated with rimegepant (Nurtec ODT; Biohaven Pharmaceuticals) 75 mg every other day (QOD).
Presented at the 2023 American Headache Society (AHS) Annual Meeting, held June 15-18, in Austin, Texas, the analysis included data from 2 phase 3 atogepant trials (PROGRESS: NCT03855137; and ADVANCE: NCT024848326) and 1 phase 2/3 rimegepant trial (BHV3000-305: NCT). Of note, the analysis only included patients who met the BHV3000-305 inclusion/exclusion criteria for these factors: at least 6 monthly migraine days (MMDs) at baseline and less than 18 monthly headache days (MHDs) at baseline.
Led by Cristina Tassorelli, MD, PhD, professor and chair of neurology at the University of Pavia, a Bucher comparison was performed utilizing the aggregated data for the reweighted atogepant trial sample vs the observed effects in BHV3000-305 using placebo as an anchor between the studies. In addition to change in MMDs, investigators observed between-group differences in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Role Function-Restrictive (RFR) domain scores after 12 weeks of treatment.
In total, the analysis included 252 patients in the pooled atoegpent 60 mg QD group and 348 patients in the rimegepant 75 mg QOD group, with baseline characteristics that were balanced after weighting. Across weeks 1-12, atogepant-treated patients demonstrated a statistically significant greater reduction in mean MMDs vs rimegepant (mean difference, –1.65; 95% CI, –2.49 to –0.81; P <.001).
Despite the fact that the atogepant 60 mg QD group had similar odds of experiencing a treatment-emergent adverse event (OR, 0.91; 95% CI, 0.56-1.45; P = .7366) and numerically higher odds of discontinuation because of any reason (OR, 1.43; 95% CI, 0.69-3.06) vs rimegepant, neither difference was statistically significant. In addition to showing greater impact on MMDs, the atogepant group outperformed rimegepant in a scenario analysis across weeks 9-12, with statistically significant greater reduction in MMDs observed (mean difference, –1.5; 95% CI, –2.55 to –0.43; P <.01). Furthermore, atogepant 60 mg QD demonstrated a significantly higher MSQ v2.1 RFR domain score (mean difference, 7.36; 95% CI, 1.88-12.82; P <.01) vs rimegepant 75 mg QOD.
Atogepant was originally FDA-approved in September 2021 for the treatment of episodic migraine in adults, with data from ADVANCE supporting the agency’s decision. Earlier this year, the FDA expanded the indication for the CGRP-targeting agent to include the prevention of chronic migraine.2 The approval was granted based on data from PROGRESS, which showed that 60-mg atogepant resulted in a significant reduction in MMDs compared with placebo over a 12-week period.
Rimegepant has been around for slightly longer, originally receiving FDA approval as an acute treatment for migraine in October 2020. Less than a year later, the agency expanded its indication, allowing for the preventive treatment of migraine, thus making rimegepant the first CGRP antagonist to be approved for both acute and preventive therapy.3
1. Tassorelli C, Onishchenko K, Duan M, et al. Comparative efficacy, quality of life, and safety/tolerability of atogepant and rimegepant in migraine prevention: a matching-adjusted indirect comparison. Presented at: 2023 AHS Annual Meeting; June 15-18; Austin, TX. P-42.
2. U.S. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine. News release. AbbVie. April 17, 2023. Accessed June 16, 2023. https://news.abbvie.com/article_display.cfm?article_id=12576
3. FDA Approves Biohaven's NURTEC® ODT (rimegepant) for Prevention: Now the First and Only Migraine Medication for both Acute and Preventive Treatment. News release. May 27, 2021. Accessed June 16, 2023. https://www.prnewswire.com/news-releases/fda-approves-biohavens-nurtec-odt-rimegepant-for-prevention-now-the-first-and-only-migraine-medication-for-both-acute-and-preventive-treatment-301301304.html