LAS VEGAS — Monthly injections of 120 mg or 240 mg galcanezumab offer clinical benefit in reducing migraine pain compared with placebo, according to findings from the EVOLVE-1 and EVOLVE-2 phase 3 randomized studies presented at PAINWeek 2017, held September 5-6.1
Migraine headache affects approximately 39 million people in the United States alone;2 generally, more females than males due to hormonal factors.3 Galcanezumab is a humanized monoclonal antibody designed to prevent migraine headache by binding to calcitonin gene-related peptide.3 Current research is focused on determining its clinical efficacy and tolerability in chronic migraine headache.
A research team led by Vladimir Skljarevski, MD, medical fellow at Eli Lilly & Company, Indianapolis, Indiana, sought to investigate the superiority of galcanezumab injections vs placebo in patients with migraine in the double-blind EVOLVE-1 (ClinicalTrials.gov identifier: NCT02614183) and EVOLVE-2 (ClinicalTrials.gov Identifier: NCT02614196) studies.
The average number of migraine headache days at baseline was 9.1 for both EVOLVE-1 and EVOLVE-2. Compared with placebo, the galcanezumab doses were associated with a significant improvement in overall mean change in monthly migraine headache days (P <.001).
In addition, ≥50%, ≥75%, or 100% reductions in migraine headache days were higher with galcanezumab than placebo (P <.001 for all). In both studies, the average change in Patient Global Impression-Severity of Illness and Migraine-Specific Quality of Life Questionnaire scores was also significant for galcanezumab treatment relative vs placebo (P <.05 and P <.001, respectively ).
No significant differences in adverse events were observed between the groups; however, a higher rate of injection-site erythema was observed in EVOLVE-2 with 240 mg galcanezumab (P <.05).
The investigators concluded that based on the EVOLVE-1 and EVOLVE-2 studies, monthly injections of 120 mg or 240 mg galcanezumab showed superiority over placebo for improving function and providing clinical benefit in patients with chronic migraine.
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- Skljarevski V, Stauffer VL, Zhang Q, et al. Phase 3 studies (EVOLVE-1 & EVOLVE-2) of galcanezumab in episodic migraine: results of 6-month treatment phase. Poster 64. Presented at: PainWeek 2017. Las Vegas, Nevada; September 5-9, 2017.
- Migraine Facts. Migraine Research Foundation website. http://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed August 28, 2017.
- Headache disorders. World Health Organization (WHO) website. www.who.int/mediacentre/factsheets/fs277/en/. Updated April 2016. Accessed August 28, 2017.
- Mitsikostas DD, Reuter U. Calcitonin gene-related peptide monoclonal antibodies for migraine prevention: comparisons across randomized controlled studies. Curr Opin Neurol. 2017;30(3):272-280.
This article originally appeared on Clinical Pain Advisor