Long-Term Safety, Tolerability, and Efficacy of Atogepant for the Preventive Treatment of Migraine: Final Results from a Phase 3, Open-Label, 156-Week, Long-Term Safety Extension Study
Messoud Ashina1, Sait Ashina2, Cristina Tassorelli3, Peter Goadsby4, Soo-Jin Cho5, Rebeka Man6, Hua Guo6, Eric Cohen6, Krisztian Nagy6, Jonathan Smith6
1Danish Headache Center, Department of Neurology, Copenhagen University Hospital – Rigshospitalet, 2Beth Israel Deaconess Medical Center, Harvard Medical School, 3University of Pavia, 4King Abdullah Univeristy of Science and Technology, 5Hallym University College of Medicine, 6AbbVie
Objective:
To evaluate the long-term safety, tolerability, and efficacy of atogepant for the preventive treatment of migraine.
Background:
Atogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the preventive treatment of migraine. PROGRESS and ELEVATE were phase 3, randomized, double-blind, placebo-controlled trials evaluating atogepant for the preventive treatment in participants with chronic migraine (CM) or episodic migraine (EM) who previously had an inadequate response to 2–4 classes of conventional oral preventive treatment, respectively.
Design/Methods:
An open-label, 156-week, long-term safety extension study evaluated the safety, tolerability, and efficacy of atogepant 60 mg once daily for the preventive treatment of CM or EM in participants who completed the PROGRESS or ELEVATE trials. The primary outcome was safety. Exploratory endpoints were prespecified and included change from baseline (CFB) in mean monthly migraine days (MMDs), monthly acute medication use days (MAMDs), and ≥50% responder rate (RR).
Results:
The safety population included 595 participants (PROGRESS, n=325; ELEVATE, n=270). Overall, 63.2% of participants completed the 3-year open-label treatment period. Treatment-emergent adverse events (TEAEs) occurred in 83.2% of participants. Common TEAEs (≥10%) were COVID-19 (33.6%) and nasopharyngitis (15.5%). Serious TEAEs occurred in 8.7% of participants, including one death attributed to asphyxia by housefire, and none were related to atogepant. TEAEs leading to discontinuation occurred in 6.7% of participants. ALT/AST ≥3 x ULN occurred in 3 participants; none met Hy’s Law. Least square (LS) mean CFB in MMDs at Weeks 13-16 was −8.2 (95% CI: −8.7 to −7.7) and consistent over 156 weeks [LS mean CFB at Weeks 153-156 was −9.2 (95% CI: −9.8 to −8.7)]. Consistent improvements were also observed for CFB in MAMDs and ≥50% RR.
Conclusions:
Atogepant was safe and well-tolerated over 156 weeks for the preventive treatment of migraine. No new safety signals were identified. Improvements in efficacy outcomes were consistent over 156-weeks.
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