Qulipta Effective as Preventive Option for Those With Episodic Migraine Who Failed Other Treatments

Qulipta (atogepant; AbbVie, Chicago, IL), an oral calcitonin gene-related peptide receptor antagonist, was shown to be well tolerated at 60 mg once daily and was effective in providing relief for people with episodic migraine who experienced prior failure of 2 to 4 conventional oral preventative treatments. As compared to placebo, Qulipta was associated with significant and clinically relevant reductions in monthly migraine days over a period of 12 weeks. These results of the phase 3b ELEVATE clinical trial (NCT04740927) were published online in The Lancet Neurology.

ELEVATE was a randomized, double-blind, placebo-controlled, parallel group study that included 309 participants in the off-treatment hypothetical estimand (OTHE) population recruited from 73 sites in Canada, Czechia, Denmark, France, Germany, Hungary, Italy, the Netherlands, Poland, Russia, Spain, the United Kingdom, and the United States. Participants were eligible if they were aged 18 to 80 years and had episodic migraine that was unsuccessfully treated by 2 to 4 previously attempted oral prophylactic medications. Participants were randomized 1:1 to receive either Qulipta at 60 mg or placebo once daily. The primary endpoint of this study was the change from baseline in monthly migraine days over 12 weeks.

Key results include the following:

• At 12 weeks, Qulipta exhibited statistically superior efficacy relative to placebo, decreasing monthly migraine days by -4.2, compared to a change of -1.9 days for placebo (least squares mean difference, -2.4; 95% CI, -3.2 to -1.5; adjusted P<.0001).
• The most common treatment-emergent adverse event was constipation in 10% of participants treated with Qulipta and 3% of participants treated with placebo.