Abstract Details

Title Effect of Galcanezumab on Severity of Headache and Associated Symptoms of Migraine in Phase 3 Trials in Patients with Episodic or Chronic Migraine

Topic Headache

Presentation(s) P4 - Poster Session 4 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-015

Objective Demonstrates that galcanezumab alleviates severity of headache and associated symptoms of migraine.

Background Galcanezumab, a humanized monoclonal antibody that binds calcitonin gene-related peptide (CGRP), has demonstrated in multiple studies a significant reduction in monthly migraine headache days (MHD) compared to placebo.

Design/Methods EVOLVE-1 (N=418) and EVOLVE-2 (N=446) were 6-month double-blind studies in patients with episodic migraine. REGAIN (N=547) was a study in patients with chronic migraine with a 3-month double-blind treatment phase. For the three studies, patients were randomized to subcutaneous monthly injections of placebo, or 120 or 240mg of galcanezumab. Patients randomized to the 120mg galcanezumab group received a loading dose of 240mg. Patients recorded headache characteristics (duration and severity), as well as presence of nausea, vomiting, photophobia, phonophobia, aura, and prodromal symptoms with each migraine attack in an electronic diary. The reported parameters were changes from baseline in moderate to severe monthly headache days, mean severity of remaining MHD, and monthly MHD with nausea and/or vomiting, photophobia and phonophobia, aura, and prodromal symptoms. Analyses were conducted on the intent-to-treat population.

Results Galcanezumab was superior to placebo in reducing the numbers of monthly moderate to severe headache days in patients with episodic and chronic migraine (p<0.001) and in reducing mean severity of remaining migraine headaches (p<0.05), except in EVOLVE-1. Galcanezumab was superior to placebo in reducing the frequency of MHDs with associated symptoms of migraine (p<0.01), with the exception of aura in chronic migraine patients.

Conclusions With the exception of mean severity of remaining MHDs in EVOLVE-1 and monthly MHDs with aura in REGAIN, both doses of galcanezumab were statistically significantly superior to placebo in reducing severity of headache and associated symptoms of migraine. Overall, along with the previously reported reductions in monthly MHDs, galcanezumab can alleviate potentially disabling symptoms in patients with migraine.

Authors/Disclosures
PRESENTER	No disclosure on file
Michael A. Ament, MD (Cherry Creek Neurology/Ament Headache Center)	No disclosure on file
	No disclosure on file
Vladimir Skljarevski	No disclosure on file
Mallikarjuna Rettiganti, PhD (Eli Lilly and Company)	Dr. Rettiganti has received personal compensation for serving as an employee of Eli Lilly and Company. Dr. Rettiganti has received stock or an ownership interest from Eli Lilly and Company.
Eric Pearlman, MD	Dr. Pearlman has received personal compensation for serving as an employee of Eli Lilly and Co. Dr. Pearlman has received stock or an ownership interest from Eli Lilly and Co.
Sheena K. Aurora, MD (Department of Neurology and Neurological Sciences)	Dr. Aurora has received personal compensation for serving as an employee of Alzheimer's Association.

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