Subgroup findings boost ubrogepant benefit for migraine
Ubrogepant sustains its favourable effect for migraine regardless of demographic and clinical features, and concomitant medication use, according to pooled results of the ACHIEVE I and II studies presented at AHS 2020.
In both phase III trials, participants (mean age 41 years, 90 percent female) were randomized 1:1:1 to receive ubrogepant (50 or 100 mg [ACHIEVE I]/25 or 50 mg [ACHIEVE II]) or placebo. Data on ubrogepant 50 mg and placebo were pooled and analysed. Following completion of the double-blind phase, participants may enter an open-label, 52-week extension phase wherein they were randomized 1:1:1 to receive ubrogepant 50 or 100 mg, or usual care.
Demographic, clinical features
In the cohort evaluating demographic and clinical parameters (n=1,938), the incidences of treatment-related TEAEs* 2 days post-dose in the ubrogepant arm were similar regardless of age (8 percent vs 4 percent [<50 vs ≥50 years]), sex (5 percent vs 7 percent [male vs female]), race (8 percent vs 4 percent [whites vs non-whites]), BMI (7 percent vs 8 percent [<30 vs ≥30 kg/m2]), and anxiety/depression medication use (6 percent vs 8 percent [use vs nonuse]). [AHS 2020, poster session]
The 1-month post-dose evaluation saw similar treatment-related TEAE rates, suggesting that demographic and clinical parameters do not influence the safety and tolerability of ubrogepant. The most commonly reported TEAE at both timepoints was nausea (2 percent).
“There is a need to understand the impact of [demographic and clinical characteristics] on the safety and tolerability of ubrogepant,” said the researchers, owing to the variability of such parameters among patients with migraine.
Although more than half of ubrogepant recipients only took the initial dose, the findings nonetheless reflect the study drug’s consistent safety and tolerability within the evaluated subgroups, with no new safety signals reported, they added.
In the cohort evaluating concomitant use of preventive treatment (n=2,247), 19 percent self-reported preventive medication use. A similar percentage (18 percent) of preventive medication use was reported in the extension phase cohort (n=813). [AHS 2020, poster session]
Among ubrogepant recipients, no significant differences were seen between adults with and without concomitant medication use in terms of pain freedom (22 percent vs 20 percent), MBS** freedom (42 percent vs 38 percent), or pain relief at 2 hours (58 percent vs 62 percent).
Efficacy-wise, the rates of pain freedom were significantly better with ubrogepant vs placebo regardless whether preventive medication was concomitantly used (22 percent vs 8 percent) or not (20 percent vs 14 percent; p<0.001 for both). The effect was similar in terms of MBS freedom (42 percent vs 19 percent [with use] and 38 percent vs 30 percent [without]) and pain relief at 2 hours (58 percent vs 41 percent and 62 percent vs 51 percent, respectively; p<0.001 for all).
In the long-term extension phase, adults with vs without concomitant medication use had similar TEAE (73 percent vs 68 percent) and treatment-related TEAE rates (8 percent vs 11 percent). The most common TEAEs were URTI, nasopharyngitis, and sinusitis.
“[The findings suggest that] concomitant preventive medication use did not impact the efficacy of ubrogepant for the acute treatment of migraine and was not associated with additional safety concerns,” said the researchers. “[These imply that] ubrogepant is safe and efficacious in people with migraine who are using concomitant preventive medications.”