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Abstract Details

Clinical Immunogenicity Evaluation of Eptinezumab, a Therapeutic Humanized Monoclonal Antibody for the Preventive Treatment of Migraine
Headache
Headache Posters (7:00 AM-5:00 PM)
097
Eptinezumab is a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide and is FDA-approved for the preventive treatment of migraine.
To characterize the immunogenic profile of eptinezumab using rigorously collected and analyzed data from clinical trials of eptinezumab for migraine prevention.
Immunogenicity data were from five studies, including 2076 patients with episodic or chronic migraine treated with eptinezumab (anti-drug antibody [ADA] results available from 2074) over dose levels from 10 to 1000mg administered intravenously for up to 4 doses at 12-week intervals. Four studies were randomized, double-blind, placebo-controlled (56-week ADA monitoring); the fifth was a 2-year, open-label, phase 3 safety study (104-week ADA monitoring; first year data available for current analysis). Patients confirmed ADA-positive at the end-of-study visit were monitored for up to 6 months. Development of ADAs and neutralizing antibodies (NAbs) were evaluated to explore three key areas of potential impact: pharmacokinetics (trough plasma concentrations); efficacy (change in monthly migraine days); and safety (treatment-emergent adverse events; adverse events of special interest).
The prevalence of pre-existing ADAs was 0.7%. Treatment-emergent ADAs and NAbs occurred in 15.9% and 6.2% of patients, respectively. Highly consistent profiles were observed across studies, with detectable ADA onset at 8 weeks and maximal ADA frequency and titer observed at week 24, regardless of eptinezumab dose level or number of infusions. After 24 weeks, ADA and NAb steadily declined to the end of study despite additional eptinezumab doses. Evaluations of pharmacokinetic exposure, efficacy, and safety indicated no meaningful impact of ADAs or NAbs on the eptinezumab clinical benefit-risk profile.
This large integrated analysis did not find clinically impactful immunogenicity with eptinezumab. The incidence and magnitude of ADAs and NAbs declined with long-term treatment and did not impact the efficacy and safety profiles of eptinezumab in patients with episodic or chronic migraine.
Authors/Disclosures
Susan M. Pederson (Lundbeck Seattle BioPharmaceuticals, Inc.)
PRESENTER
Susan M. Pederson has nothing to disclose.
David M. Biondi, DO, FAAN Dr. Biondi has received personal compensation for serving as an employee of Cohen Veterans Bioscience, Inc. Dr. Biondi has received personal compensation for serving as an employee of Alder Biopharmaceuticals, Inc. Dr. Biondi has received stock or an ownership interest from Johnson & Johnson . The institution of Dr. Biondi has received research support from US Department of Defense .
Brent Allan 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.
Barbara Schaeffler No disclosure on file
Brian Baker (Alder BioPharmaceuticals) Brian Baker has received personal compensation for serving as an employee of Lundbeck Seattle BioPharmaceuticals. Brian Baker has received stock or an ownership interest from Alder BioPharmaceuticals.
John Latham No disclosure on file