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Novel agent shows promise in migraine prevention
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Both 120 mg and 300 mg monthly subcutaneous injections of galcanezumab showed efficacy for the preventive treatment of migraine, according to phase 2b trial findings recently published in JAMA Neurology.
“Currently, there are five U.S. FDA–approved medications for migraine prevention, none of which was developed for migraine or with any mechanistic understanding of their action in migraine,” Vladimir Skljarevski, MD, Eli Lilly and Company, and colleagues wrote. “Treatment responses are variable; adherence over time is low, especially with oral preventive drugs; and all of the currently available drugs have well-established and troublesome adverse effects in some patients.”
“New treatment options with improved efficacy and tolerability are needed for patients with migraine; ideally, those options would be developed specifically for the disease and reflect a better understanding of its pathophysiology,” they added.
Researchers randomly assigned 410 participants (mean age, 40.2 years) who had their first migraine before they turned 50 years old and experienced 4 to 14 migraine headache days per month, to galcanezumabor a placebo. Participants received subcutaneous injection doses of 5, 50, 120, or 300 mg, or placebo each month during a 3-month treatment period.
Skljarevski and colleagues found that the 120-mg dose of galcanezumab met the study’s primary objective of significantly reduced migraine headache days compared with placebo (99.6% posterior probability 4.8 days; 90% Bayesian credible interval, 5.4 to 4.2 days vs. 95% superiority threshold 3.7 days; 90% Bayesian credible interval, 4.1 to 3.2 days).
According to researchers, adverse events reported by 5% or more of patients in at least one galcanezumab dose group and more often than placebo included nausea, dysmenorrhea, nasopharyngitis, upper respiratory tract infection and injection-site pain.
“These results provided sufficient efficacy, tolerability and safety data to justify further development of galcanezumab, 120 mg and 240 mg, in larger phase 3 clinical trials,” Sklijarevski and colleagues concluded. – by Janel Miller
Disclosures: Sklijarevski reports being a full-time employee and stockholder of Eli Lilly and Company and/or one of its subsidiaries. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Stephen Silberstein, MD
This study showed that monthly subcutaneous injections of galcanezumab, both 120 mg and 300 mg, demonstrated efficacy (repeated-measures analysis) for the preventive treatment of migraine and supported the need for larger phase 3 studies. All dosages were safe and well-tolerated for the preventive treatment of episodic migraine. Galcanezumab is one of four new monoclonal antibodies directed against calcitonin gene-related peptide or its receptor that have been shown to be safe, tolerable and effective in the treatment of migraine.
I’m not surprised by these results. Every single study done on monoclonal antibodies has been positive in preventing or treating migraines, and this latest study further supports this fact. For the first time in a long time, we have a treatment based on what causes migraines that has shown to be safe and effective and was very tolerable, with practically no side effects except for the needle injection. The other significance of galcanezumab and other monoclonal antibodies is that although most migraine medicines involve titration for 6 to 8 weeks to see if they work, patients will know within a week if galcanezumab is providing a benefit.
Based on these findings reported in JAMA Neurology and other findings, I’ve been telling my patients with migraines that they shouldn’t give up hope, but rather they should be hopeful that they will someday soon have this new and exciting treatment for their migraines. I would encourage other doctors to do the same.
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