Abstract Details

Title Long-Term Safety of Fremanezumab: Results of a 1-Year Study

Topic Headache

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-015

Objective

To assess the long-term safety and tolerability of fremanezumab in adults with migraine.

Background These is a need for preventive migraine therapies that are safe and well-tolerated over long-term treatment. Fremanezumab, a fully-humanized monoclonal antibody (IgG2?a) that selectively targets calcitonin gene-related peptide (CGRP), is approved in the US for the preventive treatment of migraine.

Design/Methods This 52-week, multicenter, randomized, double-blind, parallel-group study evaluated two subcutaneous dose regimens of fremanezumab in adults with chronic migraine (CM) and episodic migraine (EM). The study included patients rolled over from two placebo-controlled studies, as well as 312 new patients. Patients were assigned to either monthly dosing (225 mg monthly; CM: starting dose of 675 mg), or quarterly dosing (675 mg every 3 months). Safety and tolerability were assessed by adverse event (AE) reporting, vital sign measurements, clinical lab tests, systematic local injection-site assessments (immediately and at 1 hour post-injection), and testing for immunogenicity.

Results A total of 1890 patients were enrolled; 1494 (79%) completed 12 months of treatment as of the cutoff date (5/30/2018). The most-common reasons for study discontinuation were withdrawal by patient (8%), lack of efficacy (4%), AE (4%), and lost to follow-up (3%). The most common AEs were injection-site reactions (induration, pain, and erythema), which occurred in 26–33% of all patients; most AEs were mild to moderate in severity. The number of patients with ≥1 AE leading to discontinuation was low (4%). There was a low incidence of cardiovascular and cerebrovascular AEs; no specific pattern was observed. No signals of liver toxicity, anaphylaxis, or severe hypersensitivity were detected. Anti-drug antibody rates were low (3%) and there were no AEs potentially related to the immune complex.

Conclusions

Safety and tolerability of fremanezumab was maintained over 12 months of treatment, with no new safety signals.

Authors/Disclosures
Xiaoping Ning (Teva pharmaceuticals) PRESENTER	Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical . Ms. Ning has received personal compensation for serving as an employee of Teva Pharmaceutical.
	No disclosure on file
Nathan L. Bennett, MD (Preferred Headache Center)	Dr. Bennett has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan / AbbVie. Dr. Bennett has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Bennett 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. Bennett has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Allergan / Abbvie. Dr. Bennett has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amgen. Dr. Bennett has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biohaven.
Paul P. Yeung, MD, PhD	No disclosure on file
	No disclosure on file

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