Monoclonal Antibody Reduces Monthly Migraine Headache Days

In results from 3 studies, galcanezumab (GMB) demonstrated a significant reduction in monthly migraine days for participants who failed and those who did not fail ≥2 previous preventative treatments. An analysis of the sub-group who failed ≥2 prior preventatives suggested better results compared to placebo for this group due to a much lower placebo effect.

“In this subgroup analysis, where there’s been a previous belief that these patients may be more treatment-resistant to therapy, we actually showed better effect size,” said Sheena Aurora, MD, medical fellow and migraine launch leader for Eli Lilly and Company, who presented the results.

"At the highest level, any healthcare provider will want to know that galcanezumab has a positive efficacy profile for people living with a difficult-to-treat condition," added Aurora. "This post-hoc subgroup analysis reaffirms galcanezumab’s potential as preventive option for people living with migraine, regardless of past preventive therapy use."

Galcanezumab is a humanized monoclonal antibody that binds selectively to calcitonin gene-related peptide. Doses of 120mg or 240mg/month were tested in 3 double-blind, randomized, phase 3 studies. EVOLVE-1 and EVOLVE-2 (n=1773) included patients with episodic migraine and lasted 6 months, while REGAIN (n=1113) studied patients with chronic migraine over 3 months. Patients who had previously failed ≥2 preventative treatments accounted for 9.8% of EVOLVE participants (n=172) and 29.5% of REGAIN (n=323) participants.

"Like other recurrent and chronic pain conditions, migraine has a significant impact on a person's physical, social and economic well-being, yet there remains both a stigma and an unmet need for treatment options for this debilitating disease," said Robert Conley, MD, Distinguished Lilly Scholar and Lilly global development leader for migraine therapeutics.

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