Subsequent Response to Atogepant in Individuals with Episodic Migraine after an Initial Inadequate Response: Post Hoc Analysis of a 12-week Phase 3 Trial

Abstract text (incl. figure legends and references)

Objective: Post hoc analysis of ADVANCE (NCT03777059) to determine the proportion of participants who did not achieve initial response of ≥25% or ≥50% reduction in mean monthly migraine days (MMDs) that subsequently responded with continued atogepant treatment.

Methods: ADVANCE was a 12-week, phase 3 trial, evaluating the safety and efficacy of atogepant for preventive treatment of migraine. This analysis calculated the proportion of atogepant-treated participants who achieved <25% or <50% reduction from baseline in mean MMDs in month 1 that subsequently achieved at least that response in month 2 and in either month 2 or month 3, and the proportion of atogepant-treated participants who achieved <25% or <50% reduction in MMDs in month 1 and month 2 that achieved at least that response in month 3.

Results: Few atogepant-treated participants (6.1- 8.4%) achieved <25% reduction in MMDs monthly (atogepant 10mg 17/203; 30mg 17/220; 60mg 13/212). Of those with <25% response in month 1 (Table1), 36.2 – 48.3% achieved ≥25% reduction in MMDs in month 2 and 66.7 – 71.7% in month 2 or 3 Of participants with <50% reduction from baseline MMD in month 1 (Table1), 33.8 – 41.3% achieved ≥50% reduction from baseline MMDs in month 2 and 52.8 – 61.4% in month 2 or 3. Some participants who did not achieve ≥25% or ≥50% reductions in MMDs in months 1 or 2 (Table2) were able to achieve at least these responses. 31.6 – 48.5% achieved ≥25% reduction in MMDs in month 3 and 16.7 – 37.2% achieved ≥50% reduction in MMDs in month 3.

Conclusion: While the majority of atogepant-treated participants in the ADVANCE trial responded to treatment within the first month, of those who did not, a substantial number achieved at least a 25% or 50% reduction in monthly migraine days in the second or third month.