Efficacy of ubrogepant based on prior exposure and response to triptans: A post hoc analysis.

Abstract

OBJECTIVE:

To determine the potential efficacy of ubrogepant for acute treatment of migraine based on historical experience with triptans.

BACKGROUND:

Although triptans have improved migraine treatment, their efficacy and tolerability may limit their utility in some individuals. Ubrogepant is a small-molecule, oral calcitonin gene-related peptide receptor antagonist approved by the Food and Drug Administration for acute treatment of migraine in adults.

METHODS:

This post hoc analysis of pooled data from the pivotal trials ACHIEVE I and II, identically designed, randomized, double-blind, phase 3, single-attack trials of ubrogepant in adults with a history of migraine with/without aura, examined the efficacy and tolerability of ubrogepant 50 mg versus placebo based on participants' historical experience with triptans: triptan responder, triptan-insufficient responder, and triptan naïve. Co-primary efficacy endpoints were pain freedom and absence of most bothersome migraine-associated symptom (MBS) 2 h post initial dose. Adverse events (AEs) within historical triptan experience subgroups were evaluated.

RESULTS:

In the pooled analysis population (n = 1799), 682 (placebo, n = 350; ubrogepant 50 mg, n = 332), 451 (placebo, n = 223; ubrogepant, n = 228), and 666 (placebo, n = 339; ubrogepant, n = 327) participants were triptan responders, triptan-insufficient responders, and triptan-naïve, respectively. Response rates on co-primary efficacy endpoints were higher for ubrogepant versus placebo across all groups. Treatment-by-subgroup interaction p values based on odds ratios for pain freedom (p = 0.290) and absence of MBS (p = 0.705) indicated no significant impact of historical triptan experience on ubrogepant efficacy. AE incidence for ubrogepant did not differ appreciably across historical triptan experience subgroups.

CONCLUSIONS:

Ubrogepant efficacy and tolerability did not differ for the acute treatment of migraine in participants classified as triptan responders, triptan-insufficient responders, and triptan-naïve based on their historical experience with triptans.

• Authors: Andrew M Blumenfeld, Peter J Goadsby, David W Dodick, Susan Hutchinson, Chengcheng Liu, Michelle Finnegan, Joel M Trugman, Armin Szegedi
• Journal: Headache (Headache) Vol. 61 Issue 3 Pg. 422-429 (Mar 2021) ISSN: 1526-4610 [Electronic] United States
• PMID: 33749826 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2021 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.

Chemical References

• Calcitonin Gene-Related Peptide Receptor Antagonists
• Pyridines
• Pyrroles
• Serotonin 5-HT1 Receptor Agonists
• ubrogepant

Topics

• Adult
• Calcitonin Gene-Related Peptide Receptor Antagonists (adverse effects, pharmacology)
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Outcome Assessment, Health Care
• Pyridines (adverse effects, pharmacology)
• Pyrroles (adverse effects, pharmacology)
• Serotonin 5-HT1 Receptor Agonists (adverse effects, pharmacology)