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Abstract Details

Efficacy and Safety of Eptinezumab Initiated During a Migraine Attack: Results from the RELIEF Study
Headache
Headache Posters (7:00 AM-5:00 PM)
033
To evaluate the efficacy and safety of the preventive migraine treatment, eptinezumab, initiated during a migraine attack.
Eptinezumab is a humanized anti?calcitonin gene-related peptide monoclonal antibody with rapid onset of preventive benefit, FDA-approved for the preventive treatment of migraine in adults.
RELIEF (NCT04152083) was a parallel-group, double-blind, placebo-controlled study. Patients aged 18–75 years, with migraine on 4–15 days/month in 3 months prior to screening, were randomized to eptinezumab 100mg or placebo, administered IV within 1-6h of a moderate to severe migraine attack onset. Co-primary efficacy endpoints were time to headache pain freedom and time to absence of most bothersome symptom (MBS; nausea, photophobia, or phonophobia). Key secondary efficacy endpoints were headache pain freedom and absence of MBS at 2h; other secondary included headache pain freedom and absence of MBS at 4h and use of rescue medication within 24h. Safety and tolerability of eptinezumab administered during a migraine attack were also assessed.
Eptinezumab-treated patients (n=238) compared with placebo-treated patients (n=242) achieved significantly faster headache pain freedom (median 4h vs 9h, respectively; hazard ratio=1.54, P=0.0006) and absence of MBS (median 2h vs 3h, respectively; hazard ratio=1.75, P<0.0001). At 2h, in the respective eptinezumab and placebo groups, headache pain freedom was reported by 23.5% and 12.0% (P=0.0009), and absence of MBS by 55.5% and 35.5% (P<0.0001); results remained significant at 4h. Significantly fewer eptinezumab-treated patients used rescue medication within 24h vs placebo patients (31.5% vs 59.9%, respectively; P<0.0001). Treatment-emergent adverse events occurred in 10.9% eptinezumab-treated and 10.3% placebo patients; no serious adverse events occurred.
Initiating preventive therapy with eptinezumab during a migraine attack resulted in rapid and sustained freedom from headache pain and MBS compared with placebo, starting 2h post-infusion, and decreased need for acute medication within 24h post-infusion. No notable safety findings were identified.
Authors/Disclosures
Paul Winner, DO, FÂ鶹´«Ã½Ó³»­ (Palm Beach Headache Ctr)
PRESENTER 		Dr. Winner has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Dr. Winner has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan. Dr. Winner has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck . Dr. Winner has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Winner has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan. Dr. Winner has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Lundbeck. Dr. Winner has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Winner has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for lilly. The institution of Dr. Winner has received research support from Amgen. The institution of Dr. Winner has received research support from Allergan. The institution of Dr. Winner has received research support from Lundbeck . The institution of Dr. Winner has received research support from Novartis. The institution of Dr. Winner has received research support from Lilly. The institution of Dr. Winner has received research support from Teva. The institution of Dr. Winner has received research support from Supernus. The institution of Dr. Winner has received research support from Biogen. The institution of Dr. Winner has received research support from Avinar. The institution of Dr. Winner has received research support from SAMUS.
Peter J. McAllister, MD, FÂ鶹´«Ã½Ó³»­ (New England Inst for Neurology and Headache) Dr. McAllister has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for pfizer. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for lilly. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for abbvie. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for lundbeck.
George Chakhava, MD, PhD (Multiprofile Clinic Consilium Medulla) Prof. Chakhava has nothing to disclose.
Jessica Ailani, MD, FÂ鶹´«Ã½Ó³»­ (Medstar Georgetown Neurology) Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aspya. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kallyope. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Self Magazine. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. The institution of Dr. Ailani has received research support from Lundbeck. The institution of Dr. Ailani has received research support from Merz. The institution of Dr. Ailani has received research support from Pfizer. Dr. Ailani has received research support from Mi-Helper. The institution of Dr. Ailani has received research support from ShiraTronic. Dr. Ailani has a non-compensated relationship as a Executive Board Member with American Headache Society that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
Lahar R. Mehta, MD Dr. Mehta has received personal compensation for serving as an employee of Amylyx Pharmaceuticals.
Anders Ettrup (H. Lundbeck A/S) Anders Ettrup has received personal compensation for serving as an employee of H. Lundbeck A/S.
No disclosure on file
No disclosure on file
Roger Cady, MD (RK Consulting, LLC) Dr. Cady has received personal compensation for serving as an employee of Lundbeck. Dr. Cady has stock in Alder Biopharmaceutical.