|The following article is part of conference coverage from the 2018 American Headache Society Annual Scientific Meeting in San Francisco, California. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AHS 2018.|
SAN FRANCISCO — The onset of effect of galcanezumab, a humanized monoclonal antibody that binds to calcitonin gene-related peptide, occurs approximately 1 week after treatment and is associated with a significant reduction in migraine headache days (MHDs), according to a study presentedat the 60th Annual Scientific Meeting of the American Headache Society, June 28-July 1, 2018 in San Francisco, California.
“For patients with migraine, the impact of this disease cannot be underestimated. We are hopeful that these findings reinforce the need for new preventive treatment options for patients with migraine, many of whom have spent years living with this disease,” study co-author Sheena Aurora, MD, of Stanford Health Care , told Neurology Advisor. “Overall, the research demonstrates the potential for galcanezumab-gnlm to help people experience more migraine-free days, as early as the first week of treatment.”
The EVOLVE-1 (ClinicalTrials.gov Identifier: NCT02614183) and EVOLVE-2 (ClinicalTrials.gov Identifier: NCT02614196) phase 3, double-blind, placebo-controlled trials obtained data from patients with episodic migraine (n=1773). In both studies, all patients were randomly assigned to receive subcutaneous galcanezumab 120 mg or 240 mg (n=879) or placebo (n=894).
Treatment occurred once per month for a total of 6 months. The average migraine diagnosis across both studies occurred 20 years prior to study enrollment. In the post-hoc analysis, researchers evaluated the time to onset of effect of galcanezumab as well as whether treatment with the study drug was associated with a reduction in MHDs. The time to onset of effect was defined by the earliest week where significant differences were observed between the treatment and placebo groups and were maintained for 1 month.
The onset of effect occurred at week 1, demonstrating that galcanezumab had a rapid onset of effect. Patients treated with galcanezumab also had significantly greater odds of experiencing fewer weekly MHDs by week 1 compared with patients in the placebo group. These effects were sustained for weeks 2 through 4.
“Despite available preventive options on the market, research has shown nearly half of patients prescribed preventive therapy have discontinued these treatments due to side effects or lack of efficacy. Further, many therapies that are currently available require patients to start at a low dose and be titrated over time to a full therapeutic dose, a process that can take several months to achieve,” Dr Aurora added. “If approved, galcanezumab-gnlm offers the potential to provide patients more migraine-free days for patients in need.”
Disclosure: This study was sponsored by Eli Lilly and Company.
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Aurora S, Detke HC, Millen BA, et al. Rapid onset of effect of galcanezumab for the prevention of episodic migraine: post-hoc analyses of two phase 3 studies. Presented at: 2018 American Headache Society Annual Scientific Meeting. June 28-July 1, 2018; San Francisco, CA. Abstract 442404.