Change in Migraine Based on a Patient Global Impression of Change in Participants with Episodic Migraine and Chronic Migraine: Results from 5 Atogepant Clinical Trials
Peter Goadsby1, Pranav Gandhi2, Simona Sacco3, Christopher Rhyne4, Tanya Bilchik5, Karen Carr2, Natty Chalermpalanupap2, Jonathan Stokes2, Brett Dabruzzo2, Stewart Tepper6
1Kings College London; University of California, Los Angeles, 2AbbVie, 3University of L'Aquila, 4Diamond Headache Clinic, 5Yale University Department of Neurology, 6The New England Institute for Neurology and Headache
Objective:
To evaluate migraine outcome based on a Patient Global Impression of Change (PGIC) across 5 atogepant trials including participants with episodic migraine (EM) and chronic migraine (CM).
Background:
Atogepant is an oral calcitonin gene-related peptide receptor antagonist approved in the US and EU for preventive treatment of migraine.
Design/Methods:
CGP-MD-01 (EM) was a phase 2b/3, randomized, double-blind, placebo-controlled 12-week trial and 3101-302-002 (EM) was a randomized, open-label, 52-week long-term safety study. ADVANCE (EM), ELEVATE (EM with prior inadequate response to 2–4 oral preventive treatment classes), and PROGRESS (CM) were phase 3, randomized, double-blind, placebo-controlled, 12-week trials. PGIC is a single-item patient-reported questionnaire measuring participants’ impression of overall change in migraine since the first study medication dose. PGIC is an anchor item aiding the interpretation of scores from other patient-reported outcomes and is associated with improvements in efficacy outcomes and treatment continuation. PGIC uses a 7-point scale with responders defined as “much better” or “very much better” and was assessed via eTablet at Week 12, and up to Week 52 in 3101-302-002. Data for atogepant 60 mg once daily (QD) and placebo treatment are presented with nominal P values.
Results:
A higher proportion of atogepant-treated participants reported “much better” or “very much better” at Week 12 on PGIC compared with placebo in CGP-MD-01 (70.7% vs 52.0%, odds ratio [OR]: 2.23 [95% CI: 1.40, 3.55]; P=0.0008]), ADVANCE (76.1% vs 46.1%, OR: 3.83 [95% CI: 2.52, 5.84]; P<0.0001]), ELEVATE (70.9% vs 30.9%, OR: 5.48 [95% CI: 3.33, 9.00]; P<0.0001]), and PROGRESS (52.8% vs 35.3%, OR: 2.16 [95% CI: 1.48, 3.15]; P<0.0001]) trials. In 3101-302-002, >75% of atogepant-treated participants reported “much better” or “very much better” at all time points.
Conclusions:
Using PGIC, participants reporting improvement in migraine were substantially higher among EM and CM participants treated with atogepant 60 mg QD across 5 atogepant trials.