Paul Rizzoli (Boston, MA/ US), Michael Marmura (Philadelphia, PA/ US), Jennifer Robblee (Phoenix, AZ/ US), Jennifer McVige (Amherst, NY/ US), Sara Sacco (Matthews, NC/ US), Rosa De Abreu Ferreira (Chicago, IL/ US), Ludmyla Rekeda (Madison, NJ/ US), Julia Ma (Madison, NJ/ US), Brett Dabruzzo (Madison, NJ/ US), Messoud Ashina (Copenhagen/ DK), Krisztian Nagy (Budapest/ HU)
Abstract text (incl. figure legends and references)
Objective: To characterize the safety and tolerability profile of atogepant for the preventive treatment of migraine, using pooled data across 4 clinical trials.
Methods: Data were pooled from 2 randomized double-blind, placebo-controlled (RPC) trials (a phase 2b/3 trial, and a phase 3 trial [ADVANCE]), and 2 open-label, long-term safety (LTS) trials of atogepant in participants with episodic migraine (EM). The phase 2b/3 trial evaluated atogepant 10, 30, and 60 mg once daily and 30 and 60 mg twice daily vs placebo. The ADVANCE trial evaluated the efficacy and safety of atogepant 10, 30, and 60 mg once daily vs placebo. Participants who completed the phase 2b/3 trial and the ADVANCE trial were eligible to participate in the 52-week and 40-week LTS trials, respectively. Both LTS trials assessed the safety and tolerability of atogepant 60 mg once daily. Here, we focus on the US-approved atogepant dosing of 10, 30, and 60 mg once daily.
Results: A total of 1550 participants from RPC trials and 1424 participants from LTS trials were pooled for this analysis. Of the 1142 participants who received atogepant once daily in the RPC trials, 643 (56.3%) experienced ≥1 treatment-emergent adverse event (TEAE) vs 218 (53.4%) in the pooled placebo group, and serious TEAEs were reported in 7 (0.6%) participants who received atogepant vs 4 (1.0%) in the pooled placebo group (Table). The most commonly reported TEAEs (>5% in either arm) in the RPC trials (atogepant vs placebo) were nausea (6.6% vs 3.2%), constipation (6.1% vs 1.2%), and upper respiratory tract infection (5.3% vs 6.1%). Of the 1228 participants who received atogepant in the LTS trials, 792 (64.5%) experienced ≥1 TEAE, and 47 (3.8%) reported serious TEAEs. The most commonly reported TEAEs (>5%) among those who received atogepant in the LTS trials were similar to those reported in the RPC trials.
Conclusions: The daily administration of atogepant in adults with EM up to 52 weeks was safe and generally well tolerated.