EAN 2026 | CONFIDENCE: real-world consistency of response to rimegepant for the acute treatment of migraine

So I’m happy to tell you about the CONFIDENCE study, which was an observational real-world study that evaluated rimegepant as an acute treatment of migraine. One unique thing about the CONFIDENCE study is that it was conducted using an app called Migraine Buddy, which is the most widely used migraine app in the world. And we delivered customized questions at baseline and then delivered diaries through the app for a one-month period to gather information on how people who had been prescribed rimegepant responded to the treatment. And using apps in this way is a relatively new way of gathering real-world evidence on treatments and one aspect of what made me excited to work on this study. The second aspect has to do with the importance of consistency itself. So in typical clinical trials of migraine, we study the benefit of an active treatment versus placebo, and usually each person contributes only one attack to the study. But in the real world, because migraine is a recurrent event, many people treat multiple attacks over time with a medication that was effective. So the objective of this analysis was to assess the consistency of response to rimegepant across multiple attacks in a real-world setting. So the study had a 28-day observation period, and on average, people treated about seven attacks with rimegepant over the study period. We enrolled people who had three to 14 headache days in the last 30, who had a rimegepant prescription, and who planned on using rimegepant to treat their headaches over the study period. The primary outcome of the CONFIDENCE study was the consistency of rimegepant response across multiple attacks. And the endpoints that we studied were the proportion of people who achieved meaningful pain relief within two hours or within four hours, and the proportion of people who had meaningful improvement in function within two hours or four hours. And we also looked at a measure of satisfaction. The study enrolled 416 participants and recorded data on 2,169 rimegepant-treated attacks. It was a relatively typical population in that it was predominantly a female population that was midlife. It was a slightly unusual population in that 40% of people had severe disability or very severe disability as measured on the MIDAS questionnaire. Among all rimegepant-treated attacks, 61% achieved meaningful pain relief and 58% achieved meaningful improvement in function within two hours, and 68 percent achieved treatment satisfaction. So in this real-world context, rimegepant showed high levels of efficacy at two hours. When we look at consistency, we define this as the proportion of people who treated at least three attacks, who had a good outcome in at least two of their first three recorded attacks. And there, 65% had consistent two-hour relief, and 60% had consistent, meaningful improvement of function over the attacks. So based on this information, we conclude that in a real-world setting, rimegepant delivers consistent, meaningful pain relief and consistent, meaningful improvement in function across multiple attacks in a large real-world study.

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