Galcanezumab, a calcitonin gene-related peptide (CGRP) monoclonal antibody, is associated with a reduction in the frequency of migraine headache days and a reduction in potentially disabling nonpain symptoms associated with episodic migraine (EM) and chronic migraine (CM), a study in The Journal of Headache Pain suggests.

This study was an analysis of 3 randomized, placebo-controlled phase 3 trials that recruited patients with EM or CH. The 2 EM trials, which lasted 6 months, included a pooled total of 1773 patients with 4 to 14 monthly migraine headache days. A total of 1113 patients with CM with or without aura and 15 or more headache days per month were included in the single 3-month CM trial.

In the EM trials, patients were randomly assigned to either placebo (n=894) or 120 mg per month (n=444) of galcanezumab with a 240-mg loading dose or 240 mg of galcanezumab per month (n=435).

In the CH trial, patients were also randomized to either placebo (n=558) or 120 mg (n=278) of galcanezumab per month with a 240-mg loading dose or 240 mg (n=277) of galcanezumab per month.


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For each headache, patients recorded its characteristics, duration, and severity, and the presence of associated symptoms.

The study investigators analyzed changes from baseline in the number of monthly migraine headache days with nausea and/or vomiting, among several other outcomes. Other outcomes for the trials were the number of moderate to severe monthly migraine headache days, number of severe migraine headache days, and the average severity of remaining migraine headache days.

In the EM trials, treatment with galcanezumab was associated with significantly greater mean reductions in the number of monthly migraine headache days with nausea or vomiting across all 6 months (120 mg: mean difference, -0.95 days; 95% CI, -1.19 to -0.70; P <.001; 240 mg: mean difference, -0.88 days; 95% CI, -1.13 to -0.63; P <.001).

The study investigators saw similar significant improvements over placebo in the CM study (120 mg: mean difference, -1.21 days; 95% CI, 1.82 to -0.59; P <.001; 240 mg: mean difference, -1.28 days; 95% CI, -1.90 to -0.66; P <.001).

Treatment with galcanezumab in the EM and CM studies was also associated with greater reductions in the frequency of migraine headache days with symptoms associated with migraine such as nausea and/or vomiting, photophobia and phonophobia, and prodromal symptoms.

In the EM studies, galcanezumab reduced the frequency of migraine headache days with aura compared with placebo (120 mg: mean difference, -0.46 days; 95% CI, -0.67 to -0.24; P <.001; 240 mg: mean difference, -0.45 days; 95% CI, -0.67 to -0.24; P <.001).

Limitations of this analysis included its post hoc nature as well as the inclusion of studies that relied on self-reports for the presence of an aura.

The study authors concluded, “Overall, this study demonstrates that, while treatment with galcanezumab decreases the frequency of migraine days compared with placebo, there is also a decrease in potentially disabling [nonpain] symptoms even on days when migraine is present.”

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.

Reference

Ament M, Day K, Stauffer VL, et al. Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine. J Headache Pain. 2021;22(1):6. doi:10.1186/s10194-021-01215-9