Qulipta Maintains Long-Term Safety Profile in 3-Year Migraine Prevention Extension Study
KEY TAKEAWAYS
- Qulipta (atogepant) was generally safe and well tolerated through 156 weeks in people with chronic or episodic migraine.
- No new safety signals were identified during the 3-year extension study.
- Exploratory efficacy outcomes, including reductions in monthly migraine days and acute medication use, were maintained throughout follow-up.
Long-term treatment with Qulipta (atogepant; AbbVie, Chicago, IL) was generally safe and well tolerated through 156 weeks in people with chronic migraine (CM) or episodic migraine (EM), according to final results from a phase 3 open-label extension study presented at the 68th Annual Scientific Meeting of the American Headache Society. Investigators reported no new safety signals and continued improvements in migraine-related outcomes over the 3-year treatment period.
The extension study enrolled participants who completed the phase 3 PROGRESS and ELEVATE trials. Participants received Qulipta 60 mg once daily for up to 156 weeks. The safety population included 595 participants (PROGRESS, n=325; ELEVATE, n=270), and 63.2% completed the full study period. The primary end point was long-term safety, with exploratory outcomes assessing monthly migraine days (MMDs), monthly acute medication use days (MAMDs), and ≥50% responder rates.
Results at a Glance
- Treatment-emergent adverse events (TEAEs) occurred in 83.2% of participants.
- The most common TEAEs were COVID-19 (33.6%) and nasopharyngitis (15.5%).
- Serious TEAEs occurred in 8.7% of participants.
- TEAEs led to treatment discontinuation in 6.7% of participants.
- ALT or AST elevations ≥3 times the upper limit of normal occurred in 3 participants; none met Hy’s Laww criteria.
- Mean change from baseline in MMDs was −8.2 days at weeks 13 to 16 (95% CI, −8.7 to −7.7) and −9.2 days at weeks 153–156 (95% CI, −9.8 to −8.7).
- Improvements in MAMDs and ≥50% responder rates were maintained throughout follow-up.
Investigators concluded that Qulipta was safe and well tolerated over 156 weeks. Improvements in exploratory efficacy outcomes were consistent through the 3-year open-label extension period.
Source
Ashina M, Ashina S, Tassorelli C, et al. Long-term safety, tolerability, and efficacy of atogepant for the preventive treatment of migraine: final results from a phase 3, open-label, 156-week, long-term safety extension study. Presented at: American Headache Society Annual Scientific Meeting; June 4–7, 2026; Orlando, FL. Abstract T2.