The director at AbbVie discussed a subgroup analysis of the phase 3 ADVANCE study of atogepant in patients with migraine and its benefit on patient-reported outcome measures.
"We realize that for patients to understand our drugs and to understand its benefits, it’s important to include these patient-reported outcomes. We have whole groups within the company that are devoted to developing these outcomes.”
The phase 3 randomized, double-blind, parallel-group, placebo-controlled ADVANCE study (NCT02848326), which evaluated the efficacy and safety of atogepant, was the subject of a number of abstracts presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, April 17-22. Among them was a subanalysis that explored patient-reported outcome measures.
Compared with placebo, all groups treated with atogepant demonstrated improvement of function in patient-reported outcomes such as Performance of Daily Activities and Physical Impairment across the 12-week period. Atogepant, an orally administered anti-calcitonin gene-related peptide (CGRP) migraine treatment, could potentially become the next preventive migraine therapy on the market with a regulatory decision expected to come in the third quarter of 2021.
ADVANCE trial investigator Lawrence Severt, MD, PhD, director, AbbVie, told NeurologyLive that patient-reported outcomes are an important aspect to a drug’s efficacy profile. In an interview, he detailed the positive results observed with atogepant as well as the overall movement within the medical community to include these outcomes in clinical trials in an effort to elevate patient voices.
For more coverage of AAN 2021, click here.