Rapid complete responses with atogepant

According to data from multiple clinical trials, atogepant leads to higher proportions of patients with early and complete migraine response among participants with episodic migraine (including hard-to-treat episodic migraine) and chronic migraine than placebo.

ADVANCE (NCT03777059, episodic migraine), ELEVATE (NCT04740827, episodic migraine with insufficient response to 2–4 therapies), and PROGRESS (NCT03855137, chronic migraine) were multicentre, randomised, double-blind, placebo-controlled phase 3 trials assessing the treatment effect of atogepant for 12 weeks. Dr Andreas Gantenbein (Zurzach Care, Switzerland) and colleagues reported a post-hoc analysis assessing participants with early complete responses in these 3 trials [1]. Responses were measured using the Performance of Daily Activities (PDA) or Physical Impairment (PI) domains of the Activity Impairment in Migraine-Diary (AIM-D), with scores of 0 corresponding to a complete response.

The analysis included all participants from the 3 trials with available data for the AIM-D tool and non-zero baseline values. The mean age in the cohorts was 40–43 years and 86–89% of participants were women. In the ADVANCE trial, among patients who had episodic migraine, 33.3% and 39.2% of the atogepant-treated patients compared with 23.4% and 27.8% of the placebo-treated patients achieved a score of 0 on the PDA and PI domains of the AIM-D tool at week 1 (P<0.05), respectively. Furthermore, compared with placebo, atogepant also led to higher proportions of patients with episodic migraine and inadequate response achieving a score of 0 at week 1 in ELEVATE (atogepant-treated: 24.1% for PDA and 25.4% for PI domain vs placebo-treated: 7.6% for PDA and 8.5% for PI domain; P<0.05). Finally, among patients in PROGRESS with chronic migraine, atogepant versus placebo also led to higher proportions of patients with a score of 0 on the 2 domains of AIM-D at week 1 (atogepant-treated: 8.0% for PDA and 10.2% for PI domain vs placebo-treated: 1.2% for PDA and 3.8% for PI domain; P<0.05). Overall, the improvement in patients with a score of 0 in either domain were also seen at weeks 2, 3, and 4 of the respective trials.

The authors concluded that “as early as week 1, a greater proportion of atogepant-treated participants achieved complete improvement in the PDA and PI AIM-D domains, compared with placebo.” Furthermore, these results were sustained at weeks 2, 3, and 4 of the respective trials.

1. Gantenbein AR, et al. Impact of atogepant on achieving complete improvement as early as week 1 based on the Activity impairment in Migraine-Diary (AIM-D) domains: post hoc analysis from the ADVANCE, ELEVATE, and PROGRESS trials. 18^th European Headache Congress, 4–7 December 2024, Rotterdam, the Netherlands.

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Posted on 6 January 20256 January 2025