Effect of atogepant on the Activity Impairment in Migraine–Diary and Work Productivity and Activity Impairment Questionnaire in a 12-week, double-blind, randomized, phase 3 (PROGRESS) trial for preventive treatment of chronic migraine (CM)

Abstract text (incl. figure legends and references)

Objective:To evaluate impact of atogepant (ATO) on key secondary and exploratory patient-reported outcomes (PROs) for measures of daily functioning and work productivity among individuals with CM.

Methods:A phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled, parallel-group trial. Participants (≥1-year history of CM, ≥15 headache d/mo in the past 3 months, and ≥15 headache days [≥8 migraine days] during the 28-day screening period) were randomized to receive ATO 30mg twice daily (BID), ATO 60mg once daily (QD), or PBO for 12 weeks. PROs included the Activity Impairment in Migraine–Diary (AIM-D) and Work Productivity and Activity Impairment Questionnaire (WPAI): Migraine. Improvements across the 12-week period in AIM-D Performance of Daily Activities (PDA) and Physical Impairment (PI) domains were key secondary endpoints in all regions except Europe and Canada. A graphical approach with weighted Bonferroni test procedure was used to control the overall type I error rate at the 2-sided α=.05 level for key secondary endpoints. For exploratory endpoints, nominal P values were provided without adjusting for multiplicity.

Results:Of 773 participants (mean age: 42.1y; 87.6% female) from the safety population, 755 were included in the modified intent-to-treat population (ATO 30mg BID, n=253; ATO 60mg QD, n=256; PBO, n=246). Both ATO groups had statistically significant improvements from baseline across the 12-week treatment period in AIM-D PDA (Figure) and PI domain scores (P<.01), and nominally significant improvements at weeks 1-4, weeks 5-8, and weeks 9-12 (only for 30mg BID) for both AIM-D domains vs placebo. Nominally significant improvements were seen in presenteeism, overall work productivity loss (Figure), and activity impairment at all time points, and in absenteeism at weeks 4 and 12, for both doses vs PBO (P<.05).

Conclusions:ATO demonstrated statistically significant improvements in PRO measures of daily functioning and work productivity.