Stauffer VL, et al. - In the prevention of an episodic migraine with or without aura, researchers ascertained if galcanezumab is superior to placebo. They observed that galcanezumab 120-mg and 240-mg monthly injections provided clinically and statistically significant benefits across several migraine-relevant outcomes, with a favorable tolerability profile. Findings suggested an association of galcanezumab with low discontinuation rates owing to adverse events, and adverse events were transient and predominantly mild or moderate in severity.

Methods

• The EVOLVE-1 (Evaluation of LY2951742 in the Prevention of Episodic Migraine 1) trial was a double-blind, randomized, placebo-controlled (January 11, 2016, to March 22, 2017) trial.
• Galcanezumab (120 mg and 240 mg) vs placebo were compared in this multicenter, clinic-based study, including 90 sites in North America.
• For this investigation, patients received treatments once monthly for 6 months (subcutaneous injection via prefilled syringe) and were followed up for 5 months after their last injection.
• Study participants were adults (aged 18 to 65 years) with at least a 1-year history of migraine, 4 to 14 migraine headache days per month and a mean of at least 2 migraine attacks per month within the past 3 months, and were diagnosed prior to age 50 years.
• No other preventive medications were allowed during the study.
• An aggregate of of 1671 patients were analyzed; 809 did not meet study entry or baseline criteria, and 858 were included in the intent-to-treat population.
• After that, patients were randomized (2:1:1) to monthly placebo, galcanezumab, 120 mg, and galcanezumab, 240 mg.
• Overall mean change from baseline in the number of monthly migraine headache days during the treatment period was the primary outcome.
• At least 50%, at least 75%, and 100% reduction in monthly migraine headache days, migraine headache days with acute medication use, and scores from the Migraine-Specific Quality of Life questionnaire, Patient Global Impression of Severity, and Migraine Disability Assessment were the included secondary measures.
• Finally, treatment-emergent adverse events and serious adverse events were reported.

Results

• As per data, of the 1671 patients assessed, 858 (mean age, 40.7 years; 718 women [83.7%]) met study entry criteria and received at least 1 dose of investigational product.
• It was noted that the primary objective was met for both galcanezumab doses; treatment with galcanezumab significantly reduced monthly migraine headache days (both P < .001) by 4.7 days (120 mg) and 4.6 days (240 mg) compared with placebo (2.8 days).
• After multiplicity adjustment, all key secondary objectives were also significant.
• No meaningful differences were noted between 120-mg and 240-mg doses of galcanezumab on measures of efficacy.
• The findings demonstrated that completion rate during treatment was high (81.9%; n = 718), and the incidence of discontinuation owing to adverse events was less than 5% across all treatment groups.