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

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 

SUBMITTER: Bangs ME 

PROVIDER: S-EPMC6966798 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature