Galcanezumab in episodic migraine: the phase 3, randomized, double-blind, placebo-controlled PERSIST study

作者：Bo Hu, Gang Li, Xiaohong Li, Shan Wu, Tingmin Yu, Xiang Li, Hongru Zhao, Zhihua Jia, Junpeng Zhuang, Shengyuan Yu · 发表于：The Journal of Headache and Pain · 年份：2022 · DOI：10.1186/s10194-022-01458-0 · 被引用次数：37 · 研究领域：Migraine and Headache Studies、Vagus Nerve Stimulation Research、Neurological Complications and Syndromes

BACKGROUND: Galcanezumab, a humanized monoclonal antibody that binds calcitonin gene-related peptide, has demonstrated efficacy and good tolerability in patients with episodic migraine in previous phase 3 trials. We report results from the PERSIST study, which was designed to assess the efficacy and safety of galcanezumab in patients with episodic migraine from China, India, and Russia. METHODS: This phase 3 study was conducted at 40 centers in China (n = 26), India (n = 10), and Russia (n = 4). Eligible adult patients with episodic migraine were randomized in a 1:1 ratio to receive monthly galcanezumab 120 mg (with 240 mg loading dose) or placebo during a double-blind, 3-month treatment period. The primary endpoint was the overall mean change from baseline in monthly migraine headache days (MHDs). Key secondary endpoints were the mean proportion of patients with ≥ 50%, ≥ 75%, and 100% reductions from baseline in MHDs and mean change in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role Function-Restrictive domain score. RESULTS: In total, 520 patients were randomized and received at least one dose of galcanezumab (N = 261) or placebo (N = 259). The least squares (LS) mean reduction from baseline in monthly MHDs over 3 months was significantly greater with galcanezumab compared with placebo (-3.81 days vs. -1.99 days; p < 0.0001). Significantly greater mean proportions of patients with galcanezumab versus placebo had ≥ 50%, ≥ 75%, and 100% reductions from baseline...