Favorable Outcomes Reported from OLE Study of Qulipta Treatment for Migraine Prevention

Analysis of interim results from an open-label extension (OLE) study (NCT04686136) evaluating the long-term safety, tolerability, and efficacy of oral Qulipta (atogepant; AbbVie, Chicago, IL) for the preventive treatment of chronic and episodic migraine showed reductions in monthly migraine days, monthly headache days, and monthly acute medications day. Additionally, the overall long-term safety profile was consistent with the known safety profile of Qulipta, and no new safety signals were identified. These results were presented at the American Academy of Neurology (AAN) 2024 Annual Meeting.

The ongoing phase 3, multicenter, open-label 156-week extension study included participants who had previously enrolled in the phase 3 PROGRESS (NCT03855137) and ELEVATE (NCT04740827) trials, with a baseline monthly migraine day burden of 14.5 days. The primary objective of the extension study was to evaluate the long-term safety, tolerability, and efficacy of Qulipta in participants who received ≥1 dose of study intervention in the extension study (N=595). Efficacy endpoints included changes from baseline in monthly migraine days, monthly headache days, and monthly acute medication use days.

Interim results were analyzed using eDiary at weeks 13-16, 29-32, and 45-48, and showed the following:

• Monthly migraine days improved by an average of 8.5 days at weeks 13-16, and this improvement was sustained over 48 weeks.
• 70% of participants achieved a ≥50% reduction in monthly migraine days at weeks 13-16, and this was consistent throughout the 48-week study period.
• The most common treatment-emergent adverse events were COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation (8.2%).