Early improvements in function with atogepant as assessed by the Activity Impairment in Migraine-Diary: Post hoc analyses of three randomized, phase 3 clinical trials of atogepant for the preventive treatment of migraine
Abstract
Objective: Evaluate early functional improvements with the preventive migraine treatment atogepant using Activity Impairment in Migraine-Diary (AIM-D) individual and activity limitation items, and complete improvement in AIM-D Performance of Daily Activities (PDA) and Physical Impairment (PI) domain scores assessed weekly during the first 4 weeks of three phase 3 trials.
Background: Patient-reported functional outcomes are critical for assessing response to preventive migraine treatments, yet analyses of treatment effects on function at early timepoints are limited.
Methods: Post hoc analyses assessed AIM-D data in three multicenter, placebo-controlled, double-blind, parallel-group, 12-week, randomized clinical trials in participants who received once-daily atogepant 60 mg or placebo: ADVANCE (episodic migraine [EM], 4-14 monthly migraine days [MMDs]; United States trial, December 14, 2018-June 19, 2020), ELEVATE (EM with prior failure to two to four classes of oral preventive migraine treatments; international trial, March 5, 2021-August 4, 2022), and PROGRESS (chronic migraine [CM]; ≥15 monthly headache days, including ≥8 MMDs; international trial, March 11, 2019-January 20, 2022). A separate activity limitation item was included in the daily eDiary to assess limitation of activity over the past 24 h. The percent change from baseline in each AIM-D item score and the activity limitation item score, and the proportions of participants achieving complete improvement (i.e.,…
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Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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