Evaluation of Cardiovascular Risks in Patients Treated With Longer-term Exposure to Galcanezumab (2344)

Objective: To evaluate cardiovascular (CV) outcomes in patients with longer-term exposure to galcanezumab in clinical studies of migraine and cluster headache.

Background: Galcanezumab, a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), has been approved for the prevention of migraine and treatment of cluster headache.

Design/Methods: Data were integrated across the migraine and cluster headache clinical studies (pooling doses) as follows: i) five Phase 3 placebo-controlled studies with up to 6 months of galcanezumab exposure (573.41 patient-years of exposure), and ii) data from nine controlled and not-controlled Phase 2 and Phase 3 galcanezumab studies (all-galcanezumab group) representing 1799.4 patient-years of exposure. CV treatment-emergent adverse events (CV-TEAE), increases or new start in CV-related concomitant medications and changes in blood pressure (BP), pulse, and electrocardiogram (ECG) were evaluated.

Results: In the placebo-controlled studies, a similar percentage of patients in the placebo and galcanezumab groups reported ≥1 CV TEAE (3.3% and 3.1%, respectively) and <1% of placebo- and galcanezumab-treated patients reported a CV SAE. In the all-galcanezumab patients’ group, 5.3% of patients reported ≥1 CV TEAE and the frequency of CV SAE remained <1%. Increased use of CV-related concomitant medications was similar for galcanezumab and placebo patients in the placebo-controlled studies and did not increase with longer exposure in the all-galcanezumab group. Changes in BP, pulse, and QTcF were similar in the placebo and galcanezumab groups and did not increase with longer exposure in the all-galcanezumab group.

Conclusions: The incidence of CV TEAEs, SAEs, use of CV-related concomitant medications, or hemodynamic changes did not increase with longer treatment duration, nor were there clinically meaningful differences observed between patients treated with galcanezumab or placebo.

Disclosure: Tina Oakes has received personal compensation for serving as an employee of Eli Lilly. Tina Oakes has received stock or an ownership interest from Eli Lilly. Richard Kovacs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Richard Kovacs has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Cook Research Inc. Richard Kovacs has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Prilenia. Richard Kovacs has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for University Southern California. Richard Kovacs has received personal compensation in the range of $100,000-$499,999 for serving as an officer or member of the Board of Directors for American College of Cardiology. The institution of Richard Kovacs has received research support from NHLBI. Dr. Rosen has received personal compensation for serving as an employee of Northwell Health. An immediate family member of Dr. Rosen has received personal compensation for serving as an employee of New York University. Dr. Rosen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/ Abbvie. Dr. Rosen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen/ Novartis. Dr. Rosen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Rosen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Rosen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel. Dr. Rosen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Rosen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. Dr. Rosen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Rosen has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/ Abbvie. Dr. Rosen has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer. Dr. Rosen has received personal compensation in the range of $0-$499 for serving as a Speaker with AAN. Dr. Rosen has received personal compensation in the range of $500-$4,999 for serving as a Speaker with American Headache Society. Dr. Kemmer has received personal compensation for serving as an employee of Eli Lilly and Company. Dr. Kemmer has received stock or an ownership interest from Eli Lilly and Company. Jason Hinzman has received personal compensation for serving as an employee of Eli Lilly. Jason Hinzman has received stock or an ownership interest from Eli Lilly. Laura Yunes-Medina has received personal compensation for serving as an employee of Eli Lilly and Company. Angelo Camporeale has received personal compensation for serving as an employee of Eli Lilly Italy. Angelo Camporeale has received stock or an ownership interest from Eli Lilly & Co.