RELIEF study: Vyepti improves migraine pain, provides symptom relief faster than placebo

Treatment with Vyepti during a migraine provided earlier freedom from headache pain and most bothersome migraine symptoms — either photophobia, phonophobia or nausea — compared with placebo, according to results from the RELIEF study.

Researchers presented the study results during the American Academy of Neurology annual meeting, which was held virtually, according to a press release.

“Even though migraine disease remains one of the most common and debilitating neurological disorders globally, many patients do not receive preventive treatment that may reduce the frequency of attacks,” Peter McAllister, MD, cofounder and chief medical officer of the New England Institute for Neurology and Headache and lead study author, said in the release.

McAllister and colleagues presented data from two abstracts based on results from the RELIEF study, a parallel-group, double blind, randomized, placebo-controlled trial that examined the efficacy and safety of Vyepti (eptinezumab-jjmr, Lundbeck), the first IV preventive treatment for migraine, when administered within 1 to 6 hours of a moderate to severe migraine. Time to freedom from pain and to absence of the most bothersome symptom served as the coprimary endpoints. The study allowed patients to select the most bothersome symptom of either photophobia, phonophobia or nausea.

The first abstract on Vyepti infusion (100 mg) administered during a migraine attack met its coprimary endpoints of time to freedom from headache pain (HR = 1.54; P = .0006) and to absence of the most bothersome symptom (HR = 1.75; P < .0001) sooner than placebo. Specifically, patients taking Vyepti reported a median time of freedom from headache pain of 4 hours, compared with 9 hours for patients taking placebo, and a median time of 2 hours to the absence of their most bothersome symptom, compared with 3 hours for patients taking placebo.

The second abstract, which looked at exploratory endpoints, reported that Vyepti, when started during a migraine, delayed the time to the next migraine by a median of 10 days, compared with 5 days with placebo. It also provided a “clinically meaningful improvement” in the six-item Headache Impact Test total score compared with placebo at four weeks after the infusion (mean change, –8.7 vs. –4.5), according to the press release.

“The RELIEF data show that preventive migraine candidates could benefit from treatment even in the midst of a migraine attack,” McAllister said. “The medication has the potential to still provide a therapeutic benefit in preventing future attacks.”

Reference:

Lundbeck. New data presented at 2021 American Academy of Neurology (AAN) annual meeting shows VYEPTI® (eptinezumab-jjmr) demonstrated earlier time to freedom from headache pain and absence of most bothersome symptoms compared to placebo when initiated during migraine attack in patients who were candidates for preventive therap. Available at: https://www.newsroom.lundbeckus.com/news-release/2021/new-data-presented-at-2021-american-academy-of-neurology-aan-annual-meeting. Accessed April 26, 2021.