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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
To comprehensively evaluate the safety and tolerability of eptinezumab in patients with migraine.
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.
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

PRESENTER 		No disclosure on file
Egilius L. 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.
No disclosure on file
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 or had stock in Lundbeck .
No disclosure on file
No disclosure on file
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.