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Subcutaneous injection of galcanezumab 120 mg or 240 mg once per month is associated with a rapid onset of effect and results in greater response than placebo in patients with episodic migraine, study results published in Headache suggest.
Patients with episodic migraine from the double-blind phase 3 EVOLVE-1 (n=858) and EVOLVE-2 (n=915) trials were pooled in this analysis. In both studies, patients were randomly assigned to receive either monthly subcutaneous injections of galcanezumab 120 mg (plus a 240-mg loading dose) or 240 mg (n=879) or placebo (n= 894) for up to 6 months.
In this analysis, researchers aimed to assess the monthly onset of treatment effect, which was defined by the earliest month in which galcanezumab established and maintained statistical superiority to placebo in the change of the mean number of monthly migraine headache days (MHDs). In addition, the researchers assessed the day of onset of effect, as well as monthly and weekly onset and the occurrence of a ≥50% reduction in the number of MHDs from baseline.
At month 1 and each subsequent month, there was a statistically significant separation of galcanezumab from placebo in terms of the change in monthly MHDs from baseline (each month P <.001). Patients treated with galcanezumab had higher odds of experiencing fewer MHDs in the first week of treatment in the EVOLVE-1 trial (odds ratio [OR], 2.71; 95% CI, 2.00-3.66; P <.001) and EVOLVE-2 trial (OR, 2.88; 95% CI, 2.16-3.86; P <.001). Significant treatment effects were observed for each subsequent week during the first month (P ≤.004).
There was onset of effect on day 1, which was the first day after the day of injection. Treatment with galcanezumab was superior to placebo for achieving a ≥50 reduction in MHDs beginning in week 1. The percentage of patients with a 50% response to treatment was higher in the galcanezumab vs the placebo group in the EVOLVE-1 (54.3% vs 32.4%, respectively; P <.001) and EVOLVE-2 (59.4% vs 38.0%, respectively; P <.001) trials.
Limitations of the trials included in this analysis were the inclusion of only patients with episodic migraine and the predominantly white, middle-aged, and female patient population.
“This rapid onset of effect of galcanezumab makes it a promising treatment for prevention of migraine in patients with episodic migraine,” the researchers wrote.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. This clinical trial was supported by Eli Lilly and Company. Please see the original reference for a full list of authors’ disclosures.
Reference
Detke HC, Millen BA, Zhang Q, et al. Rapid onset of effect of galcanezumab for the prevention of episodic migraine: analysis of the EVOLVE studies [published online November 11, 2019]. Headache. doi:10.1111/head.13691
