Galcanezumab Deemed Safe, Effective for Migraine

Galcanezumab is a safe and effective treatment option for episodic migraine, according to new research.

This finding emerged from a study of 1671 patients aged 18 to 65 years with at least a 1-year history of migraine who were enrolled in the EVOLVE-1 trial.
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Each patient had 4 to 14 headache days per month and an average of at least 2 migraine attacks per month in the previous 3 months, and were diagnosed before age 50 years.

Patients were randomly assigned to once-monthly treatments with 120 mg or 240 mg galcazenumab or placebo. Follow-up lasted 5 months.

The primary outcome was defined as the overall mean change from baseline in the number of migraine headache days per month.

Secondary outcomes included at least 50%, at least 75%, and 100% decreases in migraine headache days per month, migraine headache days with acute medication use, Migraine-Specific Quality of Life questionnaire score, Patient Global Impression of Severity score, and Migraine Disability Assessment score.

Ultimately, 858 patients were included in the present analysis. Results indicated that both doses of galcanezumab achieved the primary outcome, reducing monthly migraine headache days by 4.7 days (120 mg) and 4.6 days (240 mg) compared with placebo (2.8 days).

Following multiplicity adjustment, galcanezumab was found to achieve all key secondary outcomes as well.

The researchers noted that there were no significant differences in efficacy between the 120-mg and 240-mg doses.

“Galcanezumab 120-mg and 240-mg monthly injections provided clinical benefits and improved functioning,” the researchers concluded. “The incidence rate of adverse events was low, demonstrating the favorable tolerability profile of galcanezumab.”

—Christina Vogt

Reference:

Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial [Published online May 29, 2018]. JAMA Neurol. doi:10.1001/jamaneurol.2018.1212