David Dodick (Scottsdale, AZ/ US), Richard B. Lipton (Bronx, NY/ US), Stephanie Nahas (Philadelphia, PA/ US), Patricia Pozo-Rosich (Barcelona/ ES), Peter McAllister (Stamford, CT/ US), Laszlo Mechtler (Buffalo, NY/ US), Julia Ma (Madison, NJ/ US), Brett Dabruzzo (Madison, NJ/ US), Matthew Dufek (Madison, NJ/ US), Lawrence Severt (Madison, NJ/ US), Michelle Finnegan (Madison, NJ/ US), Joel Trugman (Madison, NJ/ US), Karen Carr (Chicago, IL/ US)
Abstract text (incl. figure legends and references)
Objective: To characterize the magnitude of treatment effect in atogepant responders and nonresponders. In the phase 3 ADVANCE trial, treatment with atogepant 60mg reduced mean monthly migraine days (MMDs) from 7.8 days at baseline to 3.0 at weeks 9-12 (∆=-4.7) in the overall episodic migraine population, which included treatment responders and nonresponders (ie, participants with marked benefit and those with minimal benefit). This approach obscures clinically relevant information regarding the magnitude of treatment effect in these two populations.
Design/Methods: This post hoc analysis used data from participants who completed the 12-week ADVANCE trial. Mean MMDs, acute medication use days, and Migraine-Specific Quality of Life-Role Function-Restrictive (MSQ-RFR) scores were calculated in treatment responders (based on a percentage reduction in MMDs) and nonresponders.
Results: During weeks 9-12, a ≥50% improvement (ie, a 50%-100% reduction in MMDs from baseline) was achieved by 71% (139/195) of participants. In these responders, MMDs were reduced from 7.6 at baseline to 1.3 at weeks 9-12 (∆=-6.3). A ≥75% response was achieved in 50% (97/195) of participants. In this group, MMDs were reduced from 7.7 at baseline to 0.6 at weeks 9-12 (∆=-7.1). Atogepant 60mg nonresponders (<25% reduction in MMDs) comprised 15% (30/195) of participants and showed an MMD change from 7.7 at baseline to 9.1 at weeks 9-12 (∆=+1.4). Acute medication use days in ≥50% MMD responders decreased from 7.1 at baseline to 1.6 at weeks 9-12 (∆=-5.5). In treatment nonresponders (<25% reduction in MMDs), acute medication use days were 7.3 at baseline and 7.2 at weeks 9-12 (∆=-0.1). Similar results were observed for mean MSQ-RFR score changes in responders and nonresponders.
Conclusions: For the 71% of participants who experienced a ≥50% reduction in MMDs, a substantial treatment effect (∆MMD =-6.3) was observed, which represents an 83% reduction in MMDs.