Comparative Efficacy, Safety, and Tolerability of Atogepant and Erenumab: Indirect Treatment Comparison of the TEMPLE and HER-MES Head-to-head Trials
Stewart Tepper1, Pranav Gandhi2, Ifeanyi Ubamadu2, Brett Dabruzzo2, Karen Carr2, Krisztian Nagy2, Astrid Gendolla3, Jan Versijpt4, Jessica Ailani5
1The New England Institute for Neurology and Headache, 2AbbVie, 3Praxis Gendolla, 4Universitair Ziekenhuis Brussel, 5Medstar Georgetown Neurology
Objective:
Indirect treatment comparison was conducted to compare the efficacy, safety, and tolerability of atogepant and erenumab for adult participants with migraine.
Background:
Atogepant and erenumab are calcitonin gene-related peptide receptor antagonists approved for preventive treatment of migraine. TEMPLE (phase 3b) and HER-MES (phase 4) were head-to-head trials comparing atogepant 60mg once daily or erenumab 70mg or 140mg once monthly to topiramate, respectively. The primary outcome of both trials was the proportion of subjects who discontinued treatment due to adverse events (AEs).
Design/Methods:
Tolerability and safety were assessed across 24 weeks, which included AEs, AEs leading to treatment discontinuation, and serious AEs. Efficacy was compared at Month 1 and Months 4–6 in the overall population and in participants were stratified into subgroups based on baseline monthly migraine days (MMDs)(4-7,8-14,≥15 MMDs). Atogepant and erenumab were compared using odds ratio or mean difference with corresponding 95% credible intervals. Efficacy endpoints included odds of achieving a ≥50% reduction in mean MMDs and difference in change from baseline (CFB) in mean MMDs.
Results:
Across 24 weeks, the tolerability and safety of atogepant and erenumab were comparable. In the overall population at Month 1, atogepant had significantly higher odds of achieving a ≥50% reduction in MMDs [1.73(1.07,2.82);P=0.03] and showed a similar CFB in MMDs [-0.69(-1.69,0.31);P=0.18] compared with erenumab. In participants with 8–14 baseline MMDs, atogepant showed a significantly greater CFB in MMDs at Month 1 compared with erenumab [-1.50(-2.69,-0.31);P=0.013]. Efficacy results were comparable at each timepoint across all other baseline MMD subgroups.
Conclusions:
Tolerability and safety were comparable between groups. Atogepant demonstrated significantly higher odds of achieving a ≥50% reduction in MMDs in the overall population at Month 1 and greater MMD reduction in the 8-14 baseline MMD subgroup at Month 1, indicating early onset of atogepant versus erenumab. Efficacy results were comparable at all other time points.
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