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Abstract Details

Safety and Tolerability of Eptinezumab in Patients With Migraine: A Pooled Analysis of 5 Clinical Trials
Headache
Headache Posters (7:00 AM-5:00 PM)
124
Eptinezumab is an anti-CGRP monoclonal antibody indicated for the preventive treatment of migraine in adults. Its safety in this population has been evaluated in 5 large-scale clinical trials.
To comprehensively evaluate the safety and tolerability of eptinezumab in patients with migraine.
Safety data were pooled from 4 randomized, double-blind, placebo-controlled studies (2 single-dose and 2 multi-dose) and the first year of 1 open-label multi-dose study (administration once every 12 weeks; only included 300mg, no placebo).
The pooled population comprised 2867 adults; 2076 received eptinezumab (4797 infusions) and 791 received placebo (1675 infusions). A total of 1137/2076 (54.8%) patients who received eptinezumab experienced ≥1 treatment-emergent adverse event (TEAE), with rates being similar across eptinezumab 10- to 1000-mg dose groups. In the placebo-controlled trials, 414/791 (52.3%) patients who received placebo experienced ≥1 TEAE. In most patients, TEAEs were mild or moderate in severity and considered unrelated to study drug. Nasopharyngitis occurred in ≥2% of patients in the eptinezumab 300-mg group (from 5 trials) and with an incidence ≥2 percentage points greater than in the placebo group (from 4 trials); however, in most patients (eptinezumab, 139/140; placebo, 40/41) its occurrence was considered unrelated to study treatment. There were 30 infusion site-related AEs in 27/2076 (1.3%) patients who received eptinezumab and 7 in 7/791 (0.9%) patients who received placebo, which led to infusion interruption in 19/2076 (0.9%) and 5/791 (0.6%) patients in the eptinezumab and placebo groups, respectively. Adverse events coded to hypersensitivity occurred in 23/2076 (1.1%) patients treated with eptinezumab and no patients in the placebo group. Most hypersensitivity reactions were not serious and resolved with standard medical treatment or observation without treatment, usually within 1 day.

In adults with migraine, eptinezumab administered intravenously once every 12 weeks displayed a favorable safety and tolerability profile.

Authors/Disclosures
Timothy *USE ID 123628 Smith (StudyMetrix Research)
PRESENTER
The institution of Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vorso. The institution of Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel Neuropharma. The institution of Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Nocira. Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Impel Neuropharma. The institution of Timothy R. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie/Allergan. The institution of Timothy R. Smith has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurolief. Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amgen. Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Allergan (Abbvie). Timothy R. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biohaven. Timothy R. Smith has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. The institution of Timothy R. Smith has received research support from Allergan. The institution of Timothy R. Smith has received research support from Amgen. The institution of Timothy R. Smith has received research support from Biohaven. The institution of Timothy R. Smith has received research support from Charleston Laboratories. The institution of Timothy R. Smith has received research support from Electrocore. The institution of Timothy R. Smith has received research support from Impel Neuropharma. The institution of Timothy R. Smith has received research support from Lilly. The institution of Timothy R. Smith has received research support from Lundbeck (Alder). The institution of Timothy R. Smith has received research support from Satsuma. The institution of Timothy R. Smith has received research support from Theranica. The institution of Timothy R. Smith has received research support from Vorso. The institution of Timothy R. Smith has received research support from Boehringer Ingelheim. The institution of Timothy R. Smith has received research support from Novartis. The institution of Timothy R. Smith has received research support from Novo Nordisk. The institution of Timothy R. Smith has received research support from Teva. The institution of Timothy R. Smith has received research support from Nocira. The institution of Timothy R. Smith has received research support from Aeon Pharmaceuticals. The institution of Timothy R. Smith has received research support from Eliem Pharmaceuticals. Timothy R. Smith has a non-compensated relationship as a Member, Board of Directors with National Headache Foundation that is relevant to AAN interests or activities.
Egilius L H Spierings, MD,PhD (MEDVADIS RESEARCH) Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Manistee. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Dr. Spierings has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie.
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.
Joe Hirman, PhD Joe Hirman, PhD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck . Joe Hirman, PhD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Impel NeuroPharma.
Barbara Schaeffler No disclosure on file
Vivienne Shen Vivienne Shen has received personal compensation for serving as an employee of Lundbeck.
Bjoern Sperling (H Lundbeck A/S) Bjoern Sperling has received personal compensation for serving as an employee of Lundbeck . Bjoern Sperling has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Rehaler . Bjoern Sperling has stock in Lundbeck .
Thomas Brevig Thomas Brevig has received personal compensation for serving as an employee of H. Lundbeck A/S. Thomas Brevig has received personal compensation for serving as an employee of Gedeon Richter Plc.. Thomas Brevig has stock in H. Lundbeck A/S.
Mette Josiassen Mette Josiassen has received personal compensation for serving as an employee of Lundbeck. Mette Josiassen has received personal compensation in the range of $0-$499 for serving as a Lecturer with University of Copenhagen.
Elizabeth Brunner Elizabeth Brunner has received personal compensation for serving as an employee of Lundbeck. Elizabeth Brunner has received stock or an ownership interest from Lundbeck.
Lahar R. Mehta, MD Dr. Mehta has received personal compensation for serving as an employee of Amylyx Pharmaceuticals.