Ubrogepant continues to show benefit for migraine, subgroup analyses show

Subgroup analyses of the ACHIEVE I and II studies presented at AAN 2021 continued to demonstrate favourable outcomes associated with the 50-mg dose of the FDA-approved oral CGRP* receptor antagonist ubrogepant for acute treatment of migraine in adults, particularly among those who were classified as “triptan-insufficient responders”**. Its safety and tolerability were also consistent across various demographic and clinical characteristic subgroups.

Both phase III trials randomized adults with a history of migraine with or without aura in a 1:1:1 ratio to receive ubrogepant 50 or 100 mg (ACHIEVE I) or 25 or 50 mg (ACHIEVE II), or placebo. The analyses were based on pooled participants who were receiving ubrogepant 50 mg and placebo.

Function, satisfaction, impression

This analysis comprised 1,799 participants (n=887 and 912 for ubrogepant and placebo, respectively). At baseline, 25 percent (n=451) were categorized as triptan-insufficient responders. [AAN 2021, abstract P10.110]

At 2 hours post-dose, compared with placebo, a significantly greater fraction of participants on ubrogepant were able to function normally based on the functional disability scale (FDS; 38.2 percent vs 28.7 percent; odds ratio [OR], 1.57, 95 percent confidence interval [CI], 1.01–2.45; p=0.046).

The favourable 2-hour outcomes on functionality were amplified by other parameters. There were more ubrogepant vs placebo recipients who noted satisfaction/extreme satisfaction with the trial drug (33.0 percent vs 20.9 percent; OR, 1.84, 95 percent CI, 1.19–2.83; p=0.006). There were also more ubrogepant vs placebo recipients who indicated that their migraine was much better/very much better based on the Patient Global Impression of Change (PGIC; 30.5 percent vs 18.2 percent; OR, 2.00, 95 percent CI, 1.22–3.29; p=0.006).

Similar safety, tolerability across subgroups

The pooled safety cohort (n=954 [ubrogepant] and 984 [placebo]) evaluated the rates of treatment-emergent AEs (TEAEs) within 48 hours post-dose in the ubrogepant arm. [AAN 2021, abstract P10.040]

The TEAE rates were similar across subgroups, including age (12.2 percent vs 8.4 percent [<50 vs ≥50 years]), gender (14.1 percent vs 10.9 percent [male vs female]), race (12.0 percent vs 7.5 percent [Whites vs non-Whites]), BMI (10.8 percent vs 11.7 percent [<30 vs ≥30]), and use of anxiety/depression medication (9.5 percent vs 11.7 percent (with vs without]).

Nausea was the most commonly reported TEAE, both within 48 hours and 30 days post-dose.

There were no notable differences observed in terms of treatment-related AE, serious AE, or AE rates within 30 days post-dose within the evaluated subgroups.

“Demographic and clinical characteristics vary among people with migraine,” the researchers explained. “[As such,] there is a need to understand the impact of these parameters on the safety and tolerability of ubrogepant.”

“[Our findings showed that the] safety and tolerability of ubrogepant were consistent within the various demographic and clinical characteristic subgroups, with no new safety signals identified,” they said.