Ubrogepant ACHIEVES primary endpoint regardless of prior triptan treatment for migraine
The novel small-molecule CGRP* receptor inhibitor ubrogepant was effective in relieving migraine pain and resolving the most bothersome migraine-associated symptom (MBS) regardless of prior triptan treatment, including in patients in whom triptans were ineffective, according to a pooled analysis of ACHIEVE I and II studies presented at AHS 2019.
“Use of triptans for the acute treatment of migraine is often limited by suboptimal efficacy, side effects, or contraindications,” the researcher pointed out. “It is therefore clinically relevant to determine if ubrogepant … is effective in patients for whom triptans are ineffective.”
Both the multicentre, double-blind, phase III studies each randomized more than 1,600 adults with a history of migraine to receive ubrogepant (50 or 100 mg in ACHIEVE-I; 25 or 50 mg in ACHIEVE II) or placebo for the treatment of a single migraine attack of moderate or severe pain intensity.
In the current analysis, participants were further stratified into three groups based on their experience with triptans: triptan-effective, triptan-ineffective, or triptan-naïve. Only the data from ubrogepant 50 mg (n=887) and placebo (n=912) were pooled for the current analysis. [AHS 2019, abstract IOR02]
Among triptan-ineffective patients, ubrogepant-treated patients were more than twice as likely to achieve the primary endpoint of freedom from pain 2 hours after dosing compared with the placebo group (16 percent vs 8 percent, odds ratio [OR], 2.16, 95 percent confidence interval [CI], 1.19–3.95).
The ubrogepant group was also more likely to be free from MBS 2 hours post-dosing than the placebo group (36 percent vs 23 percent, OR, 1.76, 95 percent CI, 1.16–2.68).
Similar benefits were seen with ubrogepant 50 mg vs placebo in the triptan-effective and triptan-naïve subgroups. In the triptan-effective group, more patients receiving ubrogepant achieved the coprimary endpoints of freedom from pain (20 percent vs 11 percent, OR, 2.03, 95 percent CI, 1.32–3.11) and MBS (39 percent vs 27 percent, 95 percent CI, 1.31–2.52). Similarly, freedom from pain (24 percent vs 18 percent, OR, 1.37, 95 percent CI, 0.94–2.01) and MBS (41 percent vs 39 percent, OR, 1.50, 95 percent CI, 1.09–2.08) were also seen in more patients receiving ubrogepant vs placebo.
There were no significant differences in the magnitude of benefit among the three subgroups for freedom of pain (p=0.2898) and MBS (p=0.7045), which according to the researchers, indicates “comparable treatment effect regardless of triptan experience.”
Among the three subgroups, the response rate to placebo was lowest in the triptan-ineffective subgroup and highest in the triptan-naïve subgroup.
Incidence of adverse events were comparable across subgroups, with no safety concerns reported.
“Ubrogepant was effective for the acute treatment of migraine, [even] in patients categorized as triptan-ineffective,” the researchers concluded.