The following is a summary of “Sustained response to atogepant in episodic migraine: post hoc analyses of a 12-week randomized trial and a 52-week long-term safety trial,” published in the May 2024 issue of Pain by Lipton et al.
Researchers conducted a retrospective study to analyze the data from clinical trials to determine the proportion of participants who maintained positive responses to atogepant for migraine prevention over 12 or 52 weeks.
They conducted post hoc analyses of ADVANCE, a 12-week, double-blind, randomized trial testing atogepant 10, 30, and 60 mg once daily versus placebo for preventing episodic migraine. Additionally, a separate open-label long-term safety (LTS) trial administered atogepant 60 mg once daily over 52 weeks. The 60 mg dose aimed to identify safety concerns. Initial response criteria included ≥50%, ≥75%, or 100% reduction from baseline in monthly migraine days (MMDs) for ADVANCE or quarterly for the LTS trial. Proportions of participants were calculated, maintaining a response above each defined threshold monthly for ADVANCE and quarterly for LTS.
The results showed that in ADVANCE, sustained response rates during months 2 and 3 varied with dose: 70.8–81.1% for an initial ≥50% response, 47.3–61.9% for an initial ≥75% response, and 34.8–41.7% for an initial 100% response. Of those with an initial ≥75% or 100% response in month 1, over 79% maintained at least a 50% response in months 2 and 3. In the LTS trial, sustained response rates through quarters 2, 3, and 4 were 84.7% for an initial ≥50% response, 72.6% for an initial ≥75% response, and 37.8% for an initial 100% response. Of those with an initial ≥75% or 100% response in quarter 1, over 90% sustained at least a 50% response through quarters 2, 3, and 4.
Investigators concluded that atogepant treatment led to sustained positive responses in over 70% of initial responders, suggesting its long-term effectiveness for migraine prevention.
Source: thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-024-01783-6
