Atogepant for the preventive treatment of chronic migraine

In the placebo-controlled, phase 3 PROGRESS trial, atogepant demonstrated statistically significant reductions in mean monthly migraine days (MMDs) in patients with chronic migraine across a treatment period of 12 weeks. Treatment with this oral calcitonin gene-related peptide (CGRP) receptor antagonist was safe and generally well tolerated.

PROGRESS (NCT03855137) was a global 12-week, double-blind, parallel-group, phase 3 trial [1]. It was set up to evaluate the efficacy, safety, and tolerability of atogepant in adults with chronic migraine. The participants were randomised 1:1:1 to atogepant 30 mg twice daily, 60 mg once daily, or placebo. The primary efficacy endpoint was change from baseline in MMDs after 12 weeks.

Of 778 participants, 773 were included in the safety population and 755 in the modified intention-to-treat (mITT) population. The average age was 42 years; 88% were women; 59% were White and 36% Asian. The double-blind treatment period was completed by  89.2% of randomised participants. At baseline, the mean MMDs were 18.6–19.2 across groups. The mean change after 12 weeks was -5.1 days for placebo, -7.5 days for atogepant 30 mg twice daily (difference vs placebo -2.4 days; P<0.001), and -6.9 for atogepant 60 mg once daily (difference vs placebo -1.8 days; P=0.0009).

For all secondary outcomes, significant improvements were noted in both active treatment arms. A key secondary endpoint was the proportion of patients with a ≥50% reduction in 3-month average of MMDs. This endpoint was achieved by 26.0% in the placebo group, 42.7% in the atogepant 30 mg twice-daily group (P=0.0003 vs placebo), and 41.0% in the atogepant 60 mg once-daily group (P=0.0009 vs placebo).

Atogepant was generally safe and well-tolerated, with no new safety signals. Treatment-emergent adverse events (TEAEs) were reported by 49% in the placebo group, 56% in the atogepant 30 mg twice-daily group, and 63% in the atogepant 60 mg once-daily group. The most frequent TEAEs in these 3 respective groups were constipation (3%, 11%, and 10%, respectively) and nausea (4%, 8%, and 10%). Serious TEAEs were reported by 1%, 2%, and 3%; none were deemed treatment-related.

 

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   1. Pozo-Rosich P, et al. Atogepant for the preventive treatment of chronic migraine: results from the PROGRESS phase 3 trial. P103, EHC 2022, 07–10 December, Vienna, Austria.

 

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Posted on 5 January 20238 February 2024