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Concomitant preventive medication has no impact on efficacy of ubrogepant

Presented By
Dr Andrew M. Blumenfeld, Headache Center of Southern California, USA
Conference
MTIS 2020
Trial
Phase 3, ACHIEVE I and II

Ubrogepant is an oral, small-molecule calcitonin gene-related peptide receptor (CGPR) antagonist, which is FDA-approved for the acute treatment of adult migraine patients with or without aura. Concomitant preventive medication use did not impact the efficacy of ubrogepant and was not associated with additional safety concerns.    

Patients with migraine frequently need to take both acute and preventive medications. As ubrogepant is a novel acute treatment, the potential impact of concomitant preventive medication use on the safety and efficacy of ubrogepant is of clinical interest and was investigated in the current study [1].

ACHIEVE trials

In the phase 3 ACHIEVE I and ACHIEVE II trials, adults with a history of migraine with or without aura were included. Participants randomly received placebo or ubrogepant 25, 50, or 100 mg. Co-primary endpoints were (i) the percentage of patients with pain freedom at 2 hours after the initial dose; and (ii) the percentage of patients with freedom from most bothersome symptoms at 2 hours after the initial dose. These endpoints were evaluated in the subgroups with and without self-reported use of concomitant preventive medication.

After completion of the ACHIEVE trials, participants could enrol in a randomised, open-label, 52-week extension trial, in which they received either ubrogepant or placebo. A total of 2,247 participants from ACHIEVE I and II were enrolled in the extension, of whom 417 (18.6%) reported use of concomitant preventive treatments. Data from the 50 mg ubrogepant and placebo groups were pooled in the current analysis.

Safe and efficacious

In the long-term extension trial, no significant differences were observed for pain freedom, freedom from the most bothersome symptom, or pain relief at 2 hours between those who did and did not report use of concomitant preventive medication. However, numerically, a greater therapeutic gain was suggested to trend toward significance for those who reported concomitant preventive medication use compared with those who did not use preventive medication at the same time as ubrogepant use. Percentages of placebo responders for all outcome measures were greater among those not reporting use of preventive medication.

In the long-term extension study, treatment-emergent adverse events (AEs) in any dose group were reported by 74% and 68% of participants who did and did not report concomitant preventive medication use, respectively. Treatment-related AEs were reported in 8% and 11% between those who reported preventive medication use and those who did not, respectively.

A significant, acute treatment effect of ubrogepant was observed in both subgroups. No additional safety concerns were noted with the use of concomitant preventive medications with ubrogepant. Taken together, the results indicate that ubrogepant is safe and efficacious in patients with migraine who are using concomitant preventive medications.

 

  1. Blumenfeld AM. Efficacy and safety of ubrogepant in participants taking concomitant preventive medication. MTIS 2020 Virtual Symposium, abstract MTV20-DP-037.


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