Abstract Details

Title Safety from Phase 3 Clinical Studies Comparing Galcanezumab and Placebo in Patients with Episodic and Chronic Migraine

Topic Headache

Presentation(s) P2 - Poster Session 2 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-014

Objective To evaluate the safety and tolerability of galcanezumab compared with placebo each given monthly (subcutaneous injection) for up to six months for prevention of migraine.

Background

Migraine is one of the most prevalent neurological diseases worldwide and preventive treatments with favorable safety and tolerability profiles are needed. Galcanezumab has demonstrated efficacy in the reduction of monthly migraine headache days.

Design/Methods Data were integrated from three double-blind clinical studies (EVOLVE-1=NCT02614183; EVOLVE-2=NCT02614196; REGAIN=NCT02614261); two galcanezumab dose-groups (120- and 240-mg) were pooled. Adverse events (AEs) that were treatment-emergent (TEAEs), discontinuation due to AEs (DCAEs), and serious AEs (SAEs) were analyzed. Laboratory results, vital signs, and ECG results were also assessed.

Results A total of 1,435 patients were treated with galcanezumab and 1,451 with placebo. At baseline, 18.5% of placebo- and 17.2% of galcanezumab-treated patients reported CV risk factors. TEAEs occurring in 1.5% or more of galcanezumab-treated patients, more frequently than among placebo-treated patients, and significantly different between galcanezumab and placebo included nasopharyngitis, injection site reaction, injection site erythema, injection site pruritus, and constipation. The proportion of DCAEs among galcanezumab-treated patients was low (≤3%), and the proportion of patients who discontinued due to an injection-site related AE was less than 0.5%. None of the TEAEs related to injection site were reported as an SAE, and the majority of patients reported the events as mild or moderate in severity. Fewer than 2.0% of galcanezumab-treated patients reported an SAE. There were no significant differences between galcanezumab- and placebo-treated patients in the frequency of serious CV TEAEs, or discontinuations due to CV TEAEs. There were no clinically meaningful differences between galcanezumab- and placebo-treated patients in laboratory analytes, vital signs, ECGs, or cardiovascular-related TEAEs.

Conclusions

Galcanezumab (120- and 240-mg monthly) demonstrated a favorable benefit/risk profile for the prevention of episodic and chronic migraine.

Authors/Disclosures
PRESENTER	No disclosure on file
David B. Kudrow, MD (David Kudrow MD)	Dr. Kudrow has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Dr. Kudrow has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie.
Shufang Wang	No disclosure on file
Tina Oakes	Tina Oakes has received personal compensation for serving as an employee of Eli Lilly. Tina Oakes has received stock or an ownership interest from Eli Lilly.
	No disclosure on file
G.M. Terwindt (MSD BV B03)	G.M. Terwindt has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis, Teva, Allergan, Lilly, Lundbeck. The institution of G.M. Terwindt has received research support from Dutch Research Council, Dutch Brain Council, IRRF, Dioraphte.
	No disclosure on file
	No disclosure on file

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