PHILADELPHIA — Ubrogepant has demonstrated efficacy in treating acute migraine among individuals for whom triptan has not been effective. This research was recently presented at the American Headache Society 61st Annual Scientific Meeting, held July 11 to 14, 2019, in Philadelphia, Pennsylvania.
This study pooled data from from 2 double-blind (n=1799), multicenter, phase-III trials (ACHIEVE-I, trial identifier: NCT02828020; ACHIEVE-II, trial identifier: NCT02867709), 912 of whom were randomized to the placebo group and 887 of whom were randomized to the ubrogepant 50 mg group. The original trials classified participants as having a history of migraine with or without aura and randomized them 1:1:1 to placebo ubrogepant 50/100 mg (ACHIEVE-1), or 25/50 mg (ACHIEVE-II); this study’s investigators only pooled data from individuals receiving placebo and 50 mg ubrogepant.
Using medical history, participants were further categorized as triptan-naive (37% of 50 mg ubrogepant, 37% of placebo), triptan-effective (37% of 50 mg ubrogepant, 38% of placebo), or triptan-ineffective (26% of 50 mg ubrogepant, 24% of placebo) subgroups. Primary efficacy endpoints consisted of freedom from pain and lack of most bothersome migraine associated symptoms 2 hours after initial dose. Logistic regression was used to estimate treatment effect of ubrogepant vs placebo, which included subgroup interaction.
Among those who were triptan-ineffective, 50 mg ubrogepant was associated with greater 2-hour pain freedom rates compared with placebo (16% vs 8%, respectively; odds ratio [OR] 2.16 [95% CI, 1.19-3.95]), as well as lack of most bothersome migraine-related symptoms (36% vs 23%, respectively; OR 1.76 [95% CI, 1.16-2.68]). Similar trends were observed among the triptan-effective group. No significant difference in magnitude of effect was observed amongst 3 subgroups when comparing ubrogepant vs placebo in terms of pain freedom (P =.29) or lack of most bothersome symptoms (P =.70), suggesting triptan experience did not have a significant effect on treatment efficacy. The triptan-ineffective group had the lowest placebo response rate, while the triptan-naive group had the highest. Adverse events were similar across subgroups and no safety concerns were reported.
Study researchers concluded that “[u]brogepant was effective for the acute treatment of migraine in patients categorized as triptan-ineffective. No differences were observed in the magnitude of treatment effect between the defined triptan subgroups.”
Blumenfeld A, Goadsby P, Dodick D, et al. Ubrogepant is effective for the acute treatment of migraine in patients for whom triptans are ineffective. Poster presented at: American Headache Society 61st Annual Scientific Meeting; July 11-14, 2019; Philadelphia, PA. Submission 629077.