Ubrogepant Was Safe and Well Tolerated in the Acute Treatment of Perimenstrual Migraine
Jelena M. Pavlovic1,2, Jessica Ailani3, Susan Hutchinson4, Hongxin Lai5, Brett Dabruzzo5, Sung Yun Yu5, Joel M. Trugman5, E. Anne MacGregor6,7
1Albert Einstein College of Medicine, 2Montefiore Headache Center, 3Medstar Georgetown University Hospital, 4Orange County Migraine and Headache Center, 5AbbVie, 6Barts and the London School of Medicine and Dentistry, Centre for Neuroscience, Surgery and Trauma, Blizard Institute of Cell and Molecular Science, 7St. Bartholomew’s Hospital, Centre for Reproductive Medicine
Objective:
To determine the efficacy and safety of ubrogepant in the acute treatment of perimenstrual migraine (pmM) attacks.
Background:
Ubrogepant is an oral calcitonin gene–related peptide receptor antagonist approved for the acute treatment of migraine in adults. More than 50% of women report an association between migraine attacks and monthly menstruation.
Design/Methods:
Phase 3, multicenter, randomized, open-label, 52-week extension trial of adults with migraine randomized 1:1:1 to usual care, ubrogepant 50mg, or ubrogepant 100mg. Participants treated ≤8 migraine attacks every 4 weeks for 1 year. A migraine headache attack was considered perimenstrual (pmM) if it started on or between 2 days before and 3 days after the start of menstrual bleeding. Menstruation included withdrawal bleeding from exogenous hormones. Ubrogepant efficacy was assessed via pain freedom and pain relief at 2 hours. Safety and tolerability were also assessed.
Results:
The trial included 808 ubrogepant participants in the modified intent-to-treat population who treated 21,419 migraine attacks with ubrogepant. 354 (43.8%) were menstruating women of whom 278 (78.5%) treated at least 1 pmM. 8,620 (40.2%) pmMs were treated in total. In the 50mg dose group, pain freedom at 2 hours was achieved in a significantly greater percentage of ubrogepant-treated pmMs (28.7%) compared with non-pmMs (22.3%, P=0.046). In the 100mg dose group, pain freedom at 2 hours was achieved in 29.7% of ubrogepant-treated pmMs compared with 24.8% of non-pmMs (P=0.406). Pain relief at 2 hours was achieved in 64.8% of pmMs vs 64.9% of non-pmMs in the 50mg dose group (P=0.396) and 67.1% vs 67.8% in the 100mg dose group (P=0.253). Treatment-related adverse events were reported by 18/137 (12.8%) and 12/141 (8.8%) in the ubrogepant 50mg and 100mg subgroups of participants who experienced a pmM, respectively.
Conclusions:
In this randomized 52-week extension trial, efficacy of ubrogepant for the treatment of pmMs was comparable to that observed for non-pmMs.