Consistency of response to rimegepant for the acute treatment of migraine among real-world users – findings from the prospective observational CONFIDENCE study

BACKGROUND: Real-world data on the effectiveness of rimegepant for the acute treatment of migraine is limited, particularly regarding consistency of response over multiple attacks. METHODS: CONFIDENCE was a prospective observational survey study with screening and baseline questionnaires; a 28-day observational period where participants completed daily assessments on migraine occurrence, treatment, and outcomes; and an end of study questionnaire. Adults in the United States with 3-14 headache days in the last 30 days, a rimegepant prescription for the acute treatment of migraine, and plans to use rimegepant in the next 30 days were recruited in phases via the Migraine Buddy® app; firstly, those with/without preventive therapies, and then, those taking specific preventive therapies. A primary outcome of CONFIDENCE was consistency of rimegepant response across multiple attacks at the population and participant levels regardless of preventive migraine therapy. Positive treatment outcomes were defined as (1) meaningful pain relief (MPR) within 2 hours, (2) meaningful improvement in function (MIF) within 2 hours, and (3) attacks where participants reported being 'satisfied' or 'extremely satisfied' with rimegepant (treatment satisfaction). RESULTS: 416 participants recorded data for 2169 rimegepant-treated migraine attacks (median: 7/participant). Participants' mean age was 40 years, 91% were female, 90% were White, and 84% took ≥ 1 preventive therapy. At baseline, participants reported a median (IQR) of 8 (5, 10) headache days/month and 40% had very severe migraine-related disability as measured by the Migraine Disability Assessment score ≥ 41. Among all rimegepant-treated migraine attacks recorded in the study, 61% achieved MPR and 58% achieved MIF within 2 hours, while 68% achieved treatment satisfaction. Of the 349 participants who treated ≥ 3 attacks, favorable outcomes were achieved in ≥ 2 of their first 3 recorded attacks for MPR within 2 hours in 65%, MIF within 2 hours in 60%, and treatment satisfaction in 74%. 55%, 48%, and 66% of participants achieved these outcomes in ≥ 3 of their first 4 attacks (n = 289 participants with ≥4 attacks). CONCLUSIONS: Consistently positive treatment outcomes were observed at the population (all attacks) and participant levels in this real-world observational study of > 400 participants and >2000 migraine attacks treated with rimegepant. TRIAL REGISTRATION: NCT06467370.