|The following article features coverage from PAINWeek 2017 in Las Vegas, Nevada. Click here to read more of Clinical Pain Advisor‘s conference coverage.|
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.
Researchers randomly assigned patients 2:1:1 to monthly subcutaneous injections of placebo, 120 mg galcanezumab, or 240 mg galcanezumab.
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.
Read more of Clinical Pain Advisor‘s coverage of PAINWeek 2017 by visiting the conference page.
- 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.