Impact of Atogepant on the Improvement in the Severity of Overall Migraine Symptoms Using PGI-S: Post hoc Analyses from ADVANCE, ELEVATE, and PROGRESS
Belinda Savage-Edwards1, Pranav Gandhi2, Umer Najib3, Hsiangkuo Yuan4, Kandavadivu Umashankar2, Molly Duan2, Jonathan Stokes2, Teshamae Monteith5, Jessica Ailani6
1Rehabilitation & Neurological Services, 2AbbVie, 3West Virginia University Hospital, 4Thomas Jefferson University Headache Center, 5University of Miami, 6Medstar Georgetown University Hospital
Objective:
To evaluate the proportion of participants treated with atogepant (Ato) versus placebo (Pbo) who had at least moderate symptoms at baseline and had an improvement in severity of overall migraine symptoms at Weeks 4, 8, and 12 in 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 used the patient global impression–severity (PGI-S) scale to assess the improvement in severity of overall migraine symptoms between Ato 60 mg daily and Pbo groups. All participants experienced at least moderate symptoms at baseline and improvement was quantified by a single item questionnaire with 5-point rating scale ranging from “0─none” to “4─very severe,” with higher scores indicating greater severity.
Results:
Across three Ato trials, a higher proportion of participants treated with Ato achieved no/mild migraine symptoms at Week 4 compared with Pbo [(ADVANCE: Ato, 70.3%(121/172), Pbo, 46.5%(72/155), P<0.001) (ELEVATE: Ato, 62.0%(80/129), Pbo, 38.3%(51/133), P<0.001) (PROGRESS: Ato, 49.3%(108/219), Pbo, 35.5%(76/214), P=0.004)]. Results were consistent at Week 8 for all trials and Week 12 for ADVANCE and ELEVATE. A higher proportion of participants treated with Ato had no/mild overall migraine symptoms across all three timepoints in each trial compared to Pbo [(ADVANCE: Ato, 53.5%(92/172), Pbo, 25.2%(39/155), P<0.001) (ELEVATE: Ato, 38.0%(49/129), Pbo, 17.3%(23/133), P<0.001) (PROGRESS: Ato 32.9%(72/219), Pbo 17.8%(38/214), P<0.001)].
Conclusions:
A higher proportion of participants achieved no/mild migraine symptoms, as assessed by PGI-S, with Ato treatment compared with Pbo starting at Week 4. A higher proportion of Ato-treatment participants had no/mild migraine symptoms across three timepoints in the three phase 3 trials.
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