The Journal of the American Medical Association Publishes Data on Efficacy and Safety of Preventive Migraine Treatment VYEPTI? (eptinezumab-jjmr) When Administered During an Active Migraine A
DEERFIELD, Ill.--(BUSINESS WIRE)--The full results from the RELIEF study were published today in?The Journal of the American Medical Association?(JAMA). VYEPTI? (eptinezumab-jjmr) met both co-primary endpoints, showing early benefit for time to headache pain freedom, and time to the absence of most bothersome symptoms (MBS), compared to placebo. Patients treated with VYEPTI experienced headache pain freedom and absence of their MBS at 2 hours post-infusion, achieving the key secondary endpoints. The RELIEF study evaluated how preventive migraine candidates may benefit from a VYEPTI infusion during an active migraine attack when administered within 1 to 6 hours of a moderate to severe migraine attack. VYEPTI is the first and only intravenous (IV) infusion approved for the preventive treatment of migraine in adults.
?Historically, patients with migraine have had to wait several weeks for the effect of their preventive medications to manifest,? says Paul Winner, D.O., Director of the Palm Beach Headache Center, and one of the lead authors of the study. ?The RELIEF data in?JAMA?validates that treatment with VYEPTI in the midst of a migraine attack may mitigate the duration and most bothersome symptoms associated with the current attack, while still providing the therapeutic benefit of preventing future attacks. Furthermore, an active migraine would not be an obstacle for initiating preventive treatment with VYEPTI.?
Patients receiving a 100 mg VYEPTI infusion during a migraine attack achieved co-primary endpoints of the time to freedom from headache pain (hazard ratio [HR]=1.54, p<0.001) and time to absence of their MBS (HR=1.75, p<0.001) earlier than placebo. Patients receiving VYEPTI reported a median time to headache pain freedom of 4 hours vs. 9 hours among those who received placebo, and a median time of 2 hours to the absence of their MBS vs. 3 hours with placebo.
The key secondary endpoints met statistical significance, demonstrating that at 2 hours after the start of the infusion, headache pain freedom was reported by 23.5% patients receiving VYEPTI and 12.0% receiving placebo (p<0.001), while absence of MBS was reported by 55.5% patients receiving VYEPTI and 35.8% receiving placebo (p<0.001). The exploratory endpoint of time to next migraine was met (10 days with VYEPTI vs. 5 days with placebo).
Consistent with previous pivotal trials, VYEPTI was well-tolerated in the RELIEF study with similar rates of treatment-emergent adverse events (TEAE) seen vs. placebo. In the RELIEF study, TEAE occurred in 10.9% of VYEPTI group and 10.3% of the placebo group. The most frequently reported TEAE in the VYEPTI group was hypersensitivity, 2.1% vs. none in the placebo group.
?We purposefully designed the RELIEF study with the knowledge that patients experiencing high-frequency of migraine attacks could have an active migraine when administered preventive treatment with VYEPTI,? said Roger Cady, M.D., Vice President of Neurology at Lundbeck. ?In the RELIEF study, administering VYEPTI during an active migraine resolved headache and migraine-associated symptoms, and extended the time to the next migraine attack vs. placebo. These data provide important insights into the spectrum of therapeutic needs of patients experiencing frequent migraine episodes.?
About the RELIEF Study Publication in?JAMA
The RELIEF study (NCT04152083) is a parallel group, double-blind, randomized, placebo-controlled study that evaluated the efficacy and safety of VYEPTI, initiated within 1-6 hours of the onset of a migraine attack in adult patients who are candidates for preventive therapy, experiencing 4 to 15 migraine days per month. Subjects were randomized to receive a single 100 mg dose of VYEPTI or placebo in a 1:1 ratio (n=480) administered via a 30-minute IV infusion.
The RELIEF study met co-primary endpoints of time to headache pain freedom (HR 1.54, p<0.001) and time to absence of MBS (HR 1.75, p<0.001) for VYEPTI-treated patients, compared with placebo. Most Bothersome Symptoms (MBS) include nausea, photophobia, and phonophobia. Patients receiving VYEPTI reported a median time to freedom from headache pain of 4 hours vs. 9 hours among those who received placebo and a median time of 2 hours to the absence of their MBS vs. 3 hours with placebo.
Participants treated with VYEPTI vs. placebo met statistical significance on all secondary endpoints, including:
- Headache pain freedom:?23.5% vs. 12%, respectively, achieved headache pain freedom (p<0.001) at 2 hours post-treatment. This benefit was maintained 4 hours post-treatment (46.6% vs. 26.4%, respectively)
- Absence of MBS:?55.5% vs. 35.8%, respectively, experienced an absence of MBS (p<0.001) at 2 hours post-treatment. This benefit was maintained at 4 hours post-treatment (65.1% vs. 37.5%, respectively)
- Use of rescue medication:?Fewer VYEPTI-treated patients (31.5%) vs. placebo (59.9%) required rescue medications within 24 hours of treatment
- VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included angioedema.
- Hypersensitivity reactions:?Hypersensitivity reactions, including angioedema, urticaria, facial flushing, and rash, have occurred with VYEPTI in clinical trials. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI, and institute appropriate therapy.
- The most common adverse reactions (=2 percent and at least 2 percent or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.