Galcanezumab demonstrated clinically and statistically significant benefits across several migraine-relevant outcomes when compared to placebo.
While migraine is a neurological disease characterized by phases of severe headaches, many of the treatment options that reduce migraine-associated headaches have adverse effects (AEs) that lead to treatment discontinuation. Monthly injections of the monoclonal antibody, galcanezumab, may be effective in reducing these migraine episodes.
A recent study aimed to demonstrate that galcanezumab is superior to placebo in the prevention of episodic migraine, with or without aura—which denote recurrent attacks of neurologic symptoms. In the EVOLVE-1 (Evaluation of LY2951742 in the Prevention of Episodic Migraine 1) trial, patients received monthly treatments for 6 months and were monitored for 5 months after the last treatment.
“Galcanezumab is a humanized monoclonal antibody that binds CGRP and prevents its biological activity without blocking the CGRP receptor; it is being developed for the preventive treatment of migraine,” explained the authors.
The participants were adults with at least a 1-year history of migraine, 4 to 14 migraine headache days per month, had an average of at least 2 migraine attacks per month within the past 3 months, and were diagnosed before the age of 50. The patients were randomized to receive either the monthly placebo, 120 mg galcanezumab, or 240 mg galcanezumab.
The primary outcome was an overall average change from baseline in the number of monthly migraine headache days during the treatment period.
A total of 1671 patients were evaluated, and 858 met the necessary criteria and received at least 1 dose of the investigational treatment. The primary objective was reached for both galcanezumab doses because galcanezumab significantly reduced monthly migraine headache days by 4.7 days (120 mg) and 4.6 days (240 mg) compared to the placebo which only decreased migraine days by 2.8 days.
“These data provided consistent, clinically meaningful evidence that treatment with galcanezumab reduced migraine frequency and migraine-related disability and improved patient functioning,” the study stated.
Additionally, the study established that there was no significant difference between the 120 mg and 240 mg doses of galcanezumab. The incidence of discontinuation due to adverse events was less than 5% for all treatment groups, according to the authors.
“Data from this study demonstrated the favorable safety profile of galcanezumab in people with migraine; discontinuations owing to AEs were low, providing further support for the tolerability of galcanezumab,” they concluded.
The researchers noted that a limitation of the study was that patients were not tested to determine whether galcanezumab could be effective as an adjunctive treatment. Additionally, the study was conducted in North America, which regionally limits the generalizability of the results.
Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. 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.