Galcanezumab demonstrated superior prevention against episodic migraine than placebo in a phase 3 placebo-controlled study presented at the 2022 American Headache Society (AHS) Annual Scientific Meeting, held from June 9-12, in Denver, Colorado, and virtually.
Galcanezumab, a monoclonal antibody, specifically binds to calcitonin gene-related peptides (CGRPs). CGRPs contribute to inflammation causing painful migraine attacks when released in the brain.
To determine the efficacy of galcanezumab in preventing episodic migraine, the researchers conducted PERSIST, a phase 3, double-blind, open-label, randomized, placebo-controlled trial in China, India, and Russia. The trial lasted 3 months with a 4-month follow-up.
The researchers randomly divided patients diagnosed with episodic migraine — 4 to 14 migraine headache days per month with or without aura — whose ages ranged from 18 to 65 years into the treatment group (n=261) and the placebo group (n=259). The treatment group received subcutaneous injections containing 120 mg of galcanezumab per month with an initial 240 mg loading dose.
Change in number of days in which patients experienced migraine headaches per month from baseline indicated galcanezumab’s efficacy compared with the placebo. Secondary outcomes included improvements in patient quality of life comparing average changes on the Role-Function Restrictive portion of the Migraine-Specific Quality of Life Questionnaire to baseline.
Additionally, they analyzed the percentage of patients whose migraine decreased by more than 50%, 75%, and those who had complete reduction of monthly headaches, as well as the number of times patients required medications each month compared with baseline.
At baseline, patients experienced a mean of 8.2 migraine days per month with no significant difference between the treatment and placebo groups.
Patients taking galcanezumab experienced significantly less migraine headache days per month over 3 months compared with the placebo group (least square [LS] mean: -3.81 vs -1.99; P <.0001). The researchers observed significant incremental improvements in migraine reductions each month. Compared with placebo, galcanezumab reduced migraine headache days by 50%, 75%, and 100% at significantly higher rates (P <.0001).
Quality of life improved in the patients receiving galcanezumab compared with those in the placebo group based on mean changes in the questionnaire scores (P <.0001). Patients in the treatment group also required significantly less acute medical treatment for migraine compared with placebo (P <.0001).
Patients in both groups commonly reported injection site adverse events that were mostly mild in severity (98.4%), including pain (galcanezumab, 7.3% vs placebo, 6.2%), pruritis (5.0% vs 0%), reactions (3.8% vs 0.4%), and discomfort (2.3% vs 0%). None of the 6 serious adverse events reported related to the treatment. More serious adverse events occurred in the placebo group (n=4) compared with the treatment group (n=2).
“The primary and all key secondary endpoints of the PERSIST study demonstrated the superiority of [galcanezumab] over placebo for the prevention of episodic migraine at a dose of 120 mg/month,” the researchers concluded.
Yu S, Hu B, Li G, et al. A phase 3 placebo-controlled study of galcanezumab in patients with episodic migraine: Results from the 3-month double- blind treatment phase of the PERSIST study. Presented at: AHS 2022 Annual Scientific Meeting; June 9-12, 2022; Denver, Colorado. Poster 149.