Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies

BMC Neurology

David Kudrow¹  Laura Yunes-Medina²  Tina M. Oakes²  Virginia L. Stauffer²  Shufang Wang²  Mark E. Bangs²  Gisela M. Terwindt³  Delphine Magis⁴ 

[1] California Medical Clinic for Headache;Eli Lilly and Company, Lilly Corporate Center;Leiden University Medical Center;Neurology Dept and Pain Clinic (CMTD), CHR East Belgium;

关键词: CGRP;    Galcanezumab;    Migraine;    Safety;    Tolerability;   

DOI  :  10.1186/s12883-020-1609-7

来源: DOAJ

【 摘 要 】

Abstract Background Galcanezumab, a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide, has demonstrated a significant reduction in monthly migraine headache days in phase 2 and 3 trials. In these analyses, we aimed to evaluate the safety and tolerability of galcanezumab compared with placebo for prevention of episodic or chronic migraine. Methods Data were integrated from three double-blind clinical studies for the up to 6-month galcanezumab exposure group (N = 1435), and from five clinical studies for the up to 1-year all-galcanezumab exposure group (N = 2276). Patients received a monthly 120 mg subcutaneous injection of galcanezumab (with a 240 mg loading dose in month 1), 240 mg galcanezumab, or placebo. Outcomes measured were treatment-emergent adverse events (TEAEs), serious AEs (SAEs), and discontinuation due to AEs (DCAEs). Laboratory results, vital signs, electrocardiogram (ECG), suicidal ideation and behavior results were evaluated. Results TEAEs that occurred more frequently in galcanezumab-treated patients included injection site pain, injection site reactions excluding pain, constipation, vertigo, and pruritus. The proportion of DCAEs among galcanezumab-treated patients ranged between 1.8 and 3.0%, and differed from placebo group for galcanezumab 240 mg (P < 0.05). Fewer than 2.0% of patients in either galcanezumab dose-group compared with 1.0% of placebo-treated patients reported a SAE. There were no clinically meaningful differences between galcanezumab and placebo in laboratory measures, vital signs including blood pressure, ECGs, cardiovascular-related AEs, or suicidal ideation and behavior. Conclusions Galcanezumab demonstrated a favorable safety and tolerability profile for up to 1 year of treatment for the prevention of migraine. Trial registration Clinical Trials CGAB =  NCT02163993 , EVOLVE-1 =  NCT02614183 , EVOLVE-2 =  NCT02614196 , REGAIN =  NCT02614261 , and CGAJ =  NCT02614287 . All were first posted on 25 November 2015, except CGAB posted on 16 June 2014, and before enrolling the first patient.

【 授权许可】

Unknown