Abstract | OBJECTIVE: METHODS: Matching-adjusted indirect comparisons (MAICs) were conducted using rimegepant subject-level data and published aggregate-level results from mAb trials. Rimegepant baseline characteristics were matched to the pooled subject characteristics from EVOLVE-I/II ( galcanezumab vs. placebo; n = 1773) and STRIVE (ereumab vs. placebo; n = 955) by reweighting the rimegepant subjects to more closely match the distributions observed in these trials. To align with inclusion criteria of the mAb trials, only the subset of rimegepant subjects with a history of 4-14 MMDs were included (n = 257). Weighted mean differences were used to calculate adjusted change in MMDs, Migraine Disability Assessment Test (MIDAS) score, and Migraine-Specific Quality of Life Questionnaire version 2 (MSQv2) scores from baseline to week 12. RESULTS: When matched to the EVOLVE trials, rimegepant was superior to placebo with a mean difference in MMD change from baseline [95% confidence interval] of -1.16 [-1.80, -0.52] and was not statistically significantly different from galcanezumab 0.59 [-0.13, 1.32]. When matched to the STRIVE trial, rimegepant was superior to placebo -1.59 [-2.15, -1.03] and was not statistically significantly different from erenumab -0.06 [-0.61, 0.50]. Rimegepant showed superior MIDAS and MSQv2 results compared with placebo in both EVOLVE trials and in the STRIVE trial, no statistically significant differences from galcanezumab and erenumab regarding MIDAS, and favorable results compared with erenumab across all MSQv2 domains, while being generally similar to galcanezumab across all MSQv2 domains. CONCLUSIONS: When adjustments were made to reflect baseline characteristics in published literature, supporting data from BHV3000-201 suggest that rimegepant every other day is an effective therapy in reducing disability and MMDs and enhancing migraine-specific HRQoL. These data support the preventive benefit observed in randomized trials of rimegepant and further validate its efficacy for both acute and preventive treatment of migraine.
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Authors | Evan Popoff, Karissa Johnston, Robert Croop, Alexandra Thiry, Linda Harris, Lauren Powell, Vladimir Coric, Gilbert L'Italien, James Moren |
Journal | Headache
(Headache)
Vol. 61
Issue 6
Pg. 906-915
(06 2021)
ISSN: 1526-4610 [Electronic] United States |
PMID | 34021585
(Publication Type: Comparative Study, Journal Article)
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Copyright | © 2021 American Headache Society. |
Chemical References |
- Antibodies, Monoclonal, Humanized
- Piperidines
- Placebos
- Pyridines
- rimegepant sulfate
- galcanezumab
- erenumab
- Calcitonin Gene-Related Peptide
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Topics |
- Administration, Oral
- Adult
- Antibodies, Monoclonal, Humanized
(therapeutic use)
- Calcitonin Gene-Related Peptide
- Female
- Humans
- Male
- Middle Aged
- Migraine Disorders
(drug therapy, epidemiology)
- Piperidines
(administration & dosage)
- Placebos
- Pyridines
(administration & dosage)
- Quality of Life
- Surveys and Questionnaires
- Treatment Outcome
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