Atogepant Reports Positive Data for Episodic Migraine in Phase 3 Trial

Patricia Pozo-Rosich, MD, PhD

AbbVie recently announced positive data from its phase 3 global, randomized, double-blind, placebo-controlled trial ELEVATE (NCT04740827), investigating atogepant (Qulipta) for preventive treatment of episodic migraine in adult patients who had previously failed 2 to 4 classes of oral preventive medications.¹

Among 309 participants enrolled, 56% had previously failed two classes of oral migraine preventive medications and 44% had previously failed three or more classes, discontinuing them because of concerns with efficacy or tolerability. Across the 12-week treatment period, findings showed that the atogepant 60 mg once daily (QD) arm experienced a decrease of 4.20 days in their mean monthly migraine days (MMDs), which was statistically significantly greater than the 1.85 day reduction observed in the placebo arm (P < .0001). 

The results were presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, April 22-27, in Boston, Massachusetts, during the Emerging Science session by Cristina Tassorelli, MD, PhD, a full professor and chair of neurology, director of the Nneurology residency program, and director of the department of Brain and Behavioral Sciences at the University of Pavia, in Italy.

"We understand that people living with migraine endure a chronic neurological disease and we are dedicated to providing them the best chance to live a life with less frequent migraines," Dawn Carlson, the vice president of neuroscience development at AbbVie, said in a statement.¹ "The data presented at AAN underscores the important role of atogepant, not only as a treatment option for people living with episodic migraine but also for those whose previous treatments failed to help reduce the impact of migraine on their lives."

In the trial, the primary end point was the change from baseline in mean monthly migraine days (MMDs) across the span of 12 weeks. The secondary end points, also assessed across 12 weeks, were the achievement of more than 50% reduction in MMDs, change from baseline in MMDs, and change from baseline in acute medication use days.

ELEVATE met all primary and secondary end points, revealing a statistically significant reduction in MMDs as well as showeing that atogepant 60 mg QD was well tolerated for patients with episodic migraine compared with placebo. Additionally, the safety results were consistent with the known safety profile of the treatment.

As for safety, treatment-emergent adverse events (AEs) among atogepant vs placebo, respectively, that were the most commonly reported—and occurred in at least 5% of each treatment arm—were constipation (10.3% vs 2.5%), COVID-19 (8.3% vs 9.6%), nausea (7.1% vs 3.2%), and nasopharyngitis (5.1% vs 7.6%).

"For those living with migraine, the path towards effective treatment can be a long and complex journey," Patricia Pozo-Rosich, MD, PhD, a professor of neurology and head of the Neurology Section at Vall d'Hebron Hospital and Institute of Research, in Spain, said in a statement.¹ "The ELEVATE trial demonstrates atogepant as a once-daily oral treatment that can significantly reduce monthly migraine days across a lifelong disorder, allowing people to experience relief in their daily lives, including those who have previously been failed by other preventive migraine treatments."

Migraine is estimated to affect 1 billion people worldwide and is among the highest causes of disability for people under 50 years of age.^2,3 Patients who experience migraine frequently have disabling attacks that prevent them from performing daily activities and affect their quality of life significantly.⁴ Thus, it is a highly prevalent, debilitating disease that imposes social and financial burdens not only for patients living with migraine, but also on health care systems.⁵

Atogepant is an oral calcitonin gene-related peptide receptor antagonist that was originally approved in September 2021,⁶ based on the results of its full clinical development program, including the ADVANCE study (NCT02848326). Then, in April 2023, the FDA expanded the indication for the treatment to include the prevention of chronic migraine in adults, adding to its existing indication for episodic migraine.⁷

Click here for more coverage of AAN 2023.

REFERENCES
1. AbbVie Announces Late-Breaking Results from Phase 3 Trial Evaluating Atogepant (QULIPTA®) for the Preventive Treatment of Episodic Migraine Among Patients with Prior Treatment Failure at the 2023 AAN Annual Meeting. News Release. AbbVie. Published April 21, 2023. Accessed April 23, 2023. https://news.abbvie.com/news/press-releases/abbvie-announces-late-breaking-results-from-phase-3-trial-evaluating-atogepant-qulipta-for-preventive-treatment-episodic-migraine-among-patients-with-prior-treatment-failure-at-2023-aan-annual-meeting.htm
2. The facts about migraine. Migraine Research Foundation. Accessed April 23, 2023. https://americanmigrainefoundation.org/resource-library/migraine-facts/.
3. Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z; Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020;21(1):137. Published 2020 Dec 2. doi:10.1186/s10194-020-01208-0
4. Lantéri-Minet M, Duru G, Mudge M, Cottrell S. Quality of life impairment, disability and economic burden associated with chronic daily headache, focusing on chronic migraine with or without medication overuse: a systematic review. Cephalalgia. 2011;31(7):837-850. doi:10.1177/0333102411398400
5. Messali A, Sanderson JC, Blumenfeld AM, et al. Direct and Indirect Costs of Chronic and Episodic Migraine in the United States: A Web-Based Survey. Headache. 2016;56(2):306-322. doi:10.1111/head.12755
6. FDA Approves QULIPTA™ (atogepant), the First and Only Oral CGRP Receptor Antagonist Specifically Developed for the Preventive Treatment of Migraine. News release. AbbVie. September 28, 2021. Accessed April 23, 2023. https://news.abbvie.com/news/press-releases/fda-approves-qulipta-atogepant-first-and-only-oral-cgrp-receptor-antagonist-specifically-developed-for-preventive-treatment-migraine.htm?view_id=1531
7. FDA Approves QULIPTA® (atogepant) for Adults With Chronic Migraine. News release. AbbVie. April 23, 2023. April 17, 2023.. https://news.abbvie.com/article_display.cfm?article_id=12576