The majority of patients with episodic migraine who achieved an initial treatment response with atogepant sustained their response through 52 weeks, according to study findings presented at the 2022 American Headache Society (AHS) Annual Scientific Meeting, held from July 9-12, in Denver, Colorado, and virtually.
The pivotal phase 3 trial ADVANCE demonstrated that with atogepant, an oral calcitonin gene-related peptide receptor antagonist, up to 61.1% of patients achieved a 50% or greater reduction in mean monthly migraine days (MMD) in the 1st month.
For this post hoc analysis, data from ADVANCE and the separate open-label trial (ClinicalTrials.gov Identifier: NCT03700320) which evaluated long-term safety and tolerability of atogepant. Participants who received 10, 30, or 60 mg atogepant and achieved an initial response of 50% or greater reduction in MMD were evaluated for sustained response through month 3 or week 52 subdivided into 4 quarters (Q1-Q4).
In ADVANCE, patients who achieved 50% or greater reduction in MMD sustained their response in months 2 and 3 on 10 mg (71.3% of n=94), 30 mg (70.8% of n=96), and 60 mg (81.1% of 127) atogepant. Patients achieving a 75% or greater reduction in MMD sustained their response on 10 mg (60.8% of n=51), 30 mg (47.3% of n=55), and 60 mg (61.9% of n=84) atogepant. A response of 100% reduction in MMD was maintained on 10 mg (41.7% of n=24), 30 mg (34.8% of n=23), and 60 mg (37.5% of n=40) atogepant.
In the separate long-term trial, all patients received 60 mg atogepant. Patients who achieved a 50% or greater reduction in MMD sustained their response in Q2 (92.4% of n=291), Q2-Q3 (88.2% of n=280), and Q2-Q4 (84.7% of n=262); those who achieved a 75% or greater MMD reduction maintained response in Q2 (82.2% of n=180), Q2-Q3 (75.7% of n=177), and Q2-Q4 (72.6% of n=164); and a 100% reduction in MMD was maintained in Q2 (54.0% of n=50), Q2-Q3 (48.9% of n=47), and Q2-Q4 (42.2% of n=45).
The long-term safety trial may have been limited by its open-label design.
The researchers concluded that “both ADVANCE and long-term safety trial demonstrate that the majority of participants who achieved an initial atogepant treatment response sustained response with continued treatment over a 52-week period.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Lipton RB, Nahas SJ, Pozo-Rosich P, et al. Sustained response to atogepant in individuals with episodic migraine: Post hoc analyzes of 12-and 52-week phase 3 trials. Presented at: AHS 2022 Annual Scientific Meeting; July 9-12, 2022; Denver, Colo. poster 202