Impact of Atogepant on Activity Limitation in Participants With Episodic Migraine and Chronic Migraine: Post Hoc Analyses of ADVANCE, ELEVATE, and PROGRESS
Richard Lipton1, Pranav Gandhi2, Rashmi Halker Singh3, Hsiangkuo Yuan4, Andreas Gantenbein5, Brett Dabruzzo2, Kandavadivu Umashankar2, Molly Duan2, Jonathan Stokes2, Dawn Buse1
1Albert Einstein College of Medicine, 2AbbVie, 3Mayo Clinic, 4Thomas Jefferson University Headache Center, 5ZURZACH Care
Objective:
To evaluate the proportion of participants treated with atogepant (Ato) versus placebo (Pbo) reporting they had no activity limitations on a daily diary measure with scores calculated for Weeks 1, 2, 3, and 4 across three phase 3 Ato trials.
Background:
Ato is an oral calcitonin gene-related peptide receptor antagonist approved for preventive treatment of migraine in adults. ADVANCE, ELEVATE, and PROGRESS were phase 3, multicenter, randomized, double-blind, Pbo-controlled, 12-week trials that included adults with episodic migraine (EM), EM with prior inadequate responses to 2-4 classes of oral preventive treatments, and chronic migraine (CM), respectively.
Design/Methods:
This post-hoc analysis compared the proportion of participants who reported that they had no activity limitations when treated with Ato 60 mg once daily versus Pbo for Weeks 1, 2, 3, and 4 across three phase 3 clinical trials. Participants who reported at least some activity limitations at baseline answered a single question to evaluate activity limitation over the past 24 hours with a 5-level response scale ranging from “0─Not at all limited─I could do everything” to “4─Extremely limited”. Participants reporting no activity limitations reported “I could do everything” for all available days within each week.
Results:
Across all three phase 3 trials, a higher proportion of participants treated with Ato compared with Pbo reported they could do everything at Week 1 [(ADVANCE: Ato, 43.2%(79/183), Pbo, 24.1%(38/158); P<0.001) (ELEVATE: Ato, 29.6%(40/135), Pbo, 6.5%(9/138); P<0.001) (PROGRESS: Ato, 11.5%(28/244), Pbo, 3.8%(9/239); P<0.01)]. The results were consistent at Weeks 2, 3, 4 and across the three phase 3 trials.
Conclusions:
As early as week 1, after initiating Ato, a higher proportion of participants reported they could do everything compared with Pbo treated participants. The results were consistent at Weeks 2, 3, 4 across the three phase 3 trials and suggest the rapid onset of improved function in Ato treated participants.
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