Tolerability, Safety, and Efficacy of Atogepant Versus Topiramate in Participants Requiring Preventive Treatment for Migraine: Results from the Head-to-head TEMPLE Trial
Uwe Reuter1, Annelies Van Dycke2, Stewart Tepper3, Mark Kristof Farkas4, Giovanna Forero5, Lei Luo5, Hua Guo5, eric cohen5, Krisztian Nagy5
1University Hospital Greifswald & Charité Universitätsmedizin Berlin, 2General Hospital Sint-Jan Bruges, 3The New England Institute for Neurology and Headache, 4Semmelweis University, 5AbbVie, Inc.
Objective:
Compare the tolerability, safety, and efficacy between atogepant, an oral calcitonin gene-related peptide receptor antagonist, and topiramate in participants requiring preventive migraine treatment.
Background:

Atogepant and topiramate are approved for the preventive treatment of migraine. For comparative treatment analyses, head-to-head trials are considered the gold standard.  TEMPLE was a head-to-head trial comparing the tolerability, safety, and efficacy of atogepant with the highest tolerated dose of topiramate in migraine

Design/Methods:

TEMPLE was a 24-week, randomized, double-blind (DB), double-dummy, active controlled trial with a 52-week open-label safety extension to evaluate tolerability, safety, and efficacy of atogepant 60mg once daily (QD) compared to the highest tolerated dose of topiramate (50, 75, or 100 mg/day) for preventive treatment of migraine in participants with episodic or chronic migraine. The primary endpoint was treatment discontinuation due to treatment-emergent adverse events (TEAEs) in the safety population (atogepant n=273; topiramate n=267) during the 24-week DB period. Secondary clinical efficacy endpoints included the proportion of participants with ≥50% reduction in mean monthly migraine days (MMDs) and change from baseline (CFB) in mean MMDs across Months 4-6 of the DB period in the modified intent-to-treat population (atogepant n=270; topiramate n=257).

Results:

Atogepant demonstrated superior tolerability versus topiramate with significantly lower treatment discontinuations due to TEAEs (atogepant=12.1%; topiramate=29.6%; RR:0.41[0.28,0.59],P<.0001) across 24 weeks. A higher proportion of participants experienced TEAEs with topiramate compared to atogepant (88.8% vs 76.9%). A higher proportion experienced TEAEs related to study treatment with topiramate compared to atogepant (77.9% vs 56.0%).

Atogepant demonstrated superior efficacy versus topiramate with a significantly greater proportion of participants achieving a ≥50% response (atogepant=64.1%; topiramate=39.3%; RR:1.63 [1.37,1.95], P<.0001) and a significant mean MMD reduction (atogepant=-6.27; topiramate=-4.49; ∆:-1.78[-2.52,-1.04], P<.0001) across Months 4-6.

Conclusions:

Atogepant 60mg QD demonstrated superior tolerability and efficacy compared with topiramate. Atogepant was generally safe and well tolerated and no new safety signals were identified.

10.1212/WNL.0000000000215537
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