TY - JOUR
T1 - Efficacy of ubrogepant based on prior exposure and response to triptans
T2 - A post hoc analysis
AU - Blumenfeld, Andrew M.
AU - Goadsby, Peter J.
AU - Dodick, David W.
AU - Hutchinson, Susan
AU - Liu, Chengcheng
AU - Finnegan, Michelle
AU - Trugman, Joel M.
AU - Szegedi, Armin
N1 - Funding Information:
This study was sponsored by Allergan (prior to its acquisition by AbbVie) Writing and editorial assistance was provided to the authors by Cory R. Hussar, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, and was funded by AbbVie. Armin Szegedi was an employee of AbbVie at the time of the study.
Publisher Copyright:
© 2021 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.
PY - 2021/3
Y1 - 2021/3
N2 - 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.
AB - 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.
KW - ACHIEVE
KW - calcitonin gene–related peptide receptor antagonist
KW - migraine
KW - pain freedom
KW - pain relief
KW - triptan
UR - http://www.scopus.com/inward/record.url?scp=85102801715&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85102801715&partnerID=8YFLogxK
U2 - 10.1111/head.14089
DO - 10.1111/head.14089
M3 - Article
C2 - 33749826
AN - SCOPUS:85102801715
SN - 0017-8748
VL - 61
SP - 422
EP - 429
JO - Headache
JF - Headache
IS - 3
ER -