Long-Term Atogepant for Migraine Prevention Is a Safe, Effective Treatment

Atogepant (Qulipta; AbbVie) demonstrates long-term safety, tolerability, and efficacy consistent with its known safety profile for migraine prevention, according to study results presented by AbbVie at the 2024 American Academy of Neurology (AAN) annual meeting, held from April 13 to 18, 2024, in Denver, Colorado.

Researchers conducted an interim analysis of an ongoing phase 3, open-label 156-week extension study to assess the long-term safety, tolerability, and efficacy of oral atogepant as a preventive medication for migraine among adult patients with chronic or episodic migraine. The present study (Study 3101-312-002; ClinicalTrials.gov Identifier: NCT04686136) included patients who were enrolled in the phase 3 ELEVATE (ClinicalTrials.gov Identifier: NCT04740827) and PROGRESS (ClinicalTrials.gov Identifier: NCT03855137) trials (N=595) who had a baseline monthly migraine day burden of 14.5 days.

The researchers evaluated efficacy via electronic diary at weeks 13 to 16, 29 to 32, and 45 to 48. The modified intention to treat population comprised patients who received at least 1 dose of atogepant and had at least 1 evaluable post-baseline 4-week period of diary data (n=524). Efficacy endpoints included the change from baseline in monthly migraine days, monthly headache days, and monthly acute medication use days, as well as the percentage of participants with at least a 50% improvement in monthly migraine days. The interim analysis was conducted following the completion of the efficacy data period at week 52 or early termination.

At weeks 13 to 16, monthly migraine days improved on average by 8.5 day, which was consistent over 48 weeks. Patients reported similar improvements in monthly headache days and monthly acute medication use days. 

At weeks 13 to 16, 70% of patients experienced at least 50% reduction in monthly migraine days, which remained consistent over the 48 weeks of open-label treatment.

Atogepant maintained its known safety profile at a dose of 60 mg and no new safety signals were observed. COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation (8.2%) were the most common treatment-emergent adverse events (≥5%).

“As the first report of one-year atogepant data in patients with chronic migraine, this builds on the long-term observed safety and efficacy in the episodic migraine population and demonstrates atogepant’s ability to reduce migraine days and acute medication use across the spectrum of the disease,” said lead author Sait Ashina, MD, assistant professor of neurology and anesthesia at Harvard Medical School, director of the Comprehensive Headache Center at Beth Israel Deaconess Medical Center in Boston, in a AbbVie news release.