Treatment with humanized monoclonal antibody galcanezumab for up to 1 year was safe and tolerable for episodic and chronic migraine prophylaxis, a study in the BMC Neurology suggests.
Investigators aimed to report integrated safety data compared with placebo for up to 6 months in a large cohort of patients with migraine. Moreover, they sought to confirm the safety and tolerability profile in patients receiving galcanezumab up to 1 year.
As such, the researchers integrated data from 3 double-blind, phase 3 studies (EVOLVE-1, EVOLVE-2, and REGAIN), which included patients with migraine randomized to once-monthly, subcutaneous doses of galcanezumab (120 mg [with an initial loading dose of
240 mg] and 240 mg) compared with placebo. Data were analyzed to inform the researchers on the 6-month safety and tolerability profile of the drug. Across the 3 trials, a total of 1435 patients were exposed to galcanezumab (536.3 patient-years of exposure).
Data from 5 clinical studies were also included for the up to 1-year all-galcanezumab exposure group. In these 5 trials, 2276 patients were exposed to either galcanezumab 120 mg or galcanezumab 240 mg (1416.5 patient-years of exposure). Outcomes of the overall analysis included treatment-emergent adverse events (TEAEs), serious AEs (SAEs), and discontinuation due to AEs (DCAEs).
In patients treated with galcanezumab, the most frequent TEAEs were injection site pain, injection site reactions excluding pain, constipation, vertigo, and pruritus. Between 1.8% and 3.0% of patients treated with galcanezumab discontinued treatment due to AEs. A significantly greater proportion of patients treated with 240 mg galcanezumab had DCAE compared to patients treated with placebo (P <.05). The rates of reported SAEs were <2.0% in patients treated with both galcanezumab doses and 1.0% in patients treated with placebo.
A limitation of the study was the exclusion of patients with acute or serious cardiovascular risk as well as the exclusion of women who were pregnant.
The researchers wrote that the “tolerability or unsatisfactory efficacy of current migraine preventive treatments often results in non-compliance and treatment failure,” making the once-monthly dosing of galcanezumab a potentially more attractive option.
Disclosure: This clinical trial was supported by Eli Lilly. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Bangs ME, Kudrow D, Wang S, et al. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020;20(1):25