Atogepant reduced mean monthly migraine days by more than 2 days compared to placebo in the ELEVATE trial.
Atogepant (Qulipta; AbbVie) lowered mean monthly migraine days (MMDs) by 4.20 days across 12 weeks, according to results from the phase 3 ELEVATE trial. The results showed that atogepant is an effective preventive treatment of episodic migraine in people who had previously failed 2 to 4 classes of oral preventive medications. Investigators presented the positive data at the 2023 American Academy of Neurology (AAN) Annual Meeting in Boston, Massachusetts.
“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," said Dawn Carlson, vice president, neuroscience development, AbbVie, in the press release.
More than 1 billion people experience migraine worldwide. Migraine is among the leading causes of disability in those aged 50 years and younger. The disabling attacks can prevent people from performing daily activities, reduce quality of life (QoL), and can pose a significant social and financial burden for patients and health systems.
Investigators enrolled a cohort of 309 patients into the phase 3, global, randomized, double-blind, and placebo controlled ELEVATE study. The trial evaluated the efficacy, safety, and tolerability of daily atogepant (60 mg) against placebo in preventing episodic migraine in adult participants who previously failed 2 to 4 classes of oral prophylactic treatments.
The primary endpoint was a change from baseline in MMDs across 12 weeks. Key secondary endpoints were reduction in MMDs (more than 50%), change from baseline to MMDs, and change in days using acute medication from baseline in 12 weeks.
Daily atogepant 60 mg reduced MMDs by 4.20 days across the 12-week study period, meeting the primary endpoint. The medication produced a significantly greater reduction in MMDs than the 1.85-day reduction experienced by the placebo arm. Atogepant also met all key secondary endpoints.
Additionally, it was well tolerated and has a consistent safety profile with previous studies. The most common adverse events (AEs) were constipation, COVID-19, nausea, and nasopharyngitis.
Atogepant is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist. Recent clinical trials have found that CGPR levels are elevated during a migraine attack. Although selective CGRP receptor antagonists have been shown to improve migraine, CGRP antagonist atogepant is only US FDA approved, as the UK awaits approval until the safety and efficacy are evaluated.
“For those living with migraine, the path towards effective treatment can be a long and complex journey," said Patricia Pozo-Rosich, MD, PhD, Head of Neurology Section, Vall d'Hebron Hospital and Institute of Research, Spain, in a recent press release. Individuals with episodic migraine can expect to “experience relief in their daily lives, including those who have previously been failed by other preventive migraine treatments."
AbbVie. 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. April 21, 2023. Accessed on April 21, 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