Eli Lilly and Company, Indianapolis, IN, USA.
Health Center on Broad Street, Glens Falls, NY, USA.
Adv Ther. 2021 Mar;38(3):1614-1626. doi: 10.1007/s12325-021-01632-x. Epub 2021 Feb 5.
Galcanezumab, a humanized monoclonal antibody that binds to calcitonin gene-related peptide, is approved for the preventive treatment of migraine in adults. It is self-administered once monthly as a subcutaneous injection. This paper describes the time course of effect of galcanezumab in patients with episodic and chronic migraine.
Data were based on three double-blind, placebo-controlled, phase 3 studies. Patients (1773 episodic and 1113 chronic) were randomized (2:1:1) to monthly doses of placebo, galcanezumab 120 mg with a 240 mg loading dose, or galcanezumab 240 mg (January 2016-March 2017). Onset of effect was determined using a sequential analysis approach based on earliest time point at which galcanezumab achieved and subsequently maintained statistical superiority to placebo. Maintenance of effect was a comparison of the percentages of galcanezumab- and placebo-treated patients with maintenance of at least 50% response at the individual patient level. Cessation of effect was determined during a 4-month post-treatment period on the basis of change from baseline in monthly migraine headache days.
Galcanezumab led to a lower percentage of patients who had a migraine headache on the first day after injection, provided maintenance of effect throughout the duration of the double-blind treatment period, and gradually lost effect without signs of rebound headache throughout the post-treatment period in most patients with episodic and chronic migraine.
Galcanezumab is a novel preventive therapeutic option for adult patients with migraine that has early onset of action, maintenance of effect, and gradual reduction of effect upon treatment cessation.
ClinicalTrials.gov: NCT02614183 (EVOLVE-1); NCT02614196 (EVOLVE-2); NCT02614261 (REGAIN).
加巴喷丁是一种与人源化单克隆抗体，可与降钙素基因相关肽结合，用于成人偏头痛的预防性治疗。它是一种每月一次的皮下注射。本文描述了加巴喷丁治疗发作性和慢性偏头痛患者的疗效时间过程。
数据基于三项双盲、安慰剂对照、3 期研究。患者（1773 例发作性和 1113 例慢性）按 2:1:1 的比例随机分为每月剂量的安慰剂、120mg 加巴喷丁加 240mg 负荷剂量或 240mg 加巴喷丁（2016 年 1 月至 2017 年 3 月）。根据加巴喷丁首次达到并随后持续优于安慰剂的统计学优势的最早时间点，采用序贯分析方法确定疗效的起始时间。维持疗效是比较加巴喷丁和安慰剂治疗患者中至少 50%个体患者水平维持反应的百分比。根据每月偏头痛头痛天数从基线的变化，在治疗后 4 个月的期间内确定疗效的终止。
加巴喷丁使更多的患者在注射后第一天出现偏头痛的比例降低，在双盲治疗期间保持疗效，在大多数发作性和慢性偏头痛患者中，在治疗后期间逐渐失去疗效，而没有反弹性头痛的迹象。
加巴喷丁是一种新型的偏头痛预防性治疗选择，对偏头痛患者具有起效迅速、疗效持久、治疗停止后逐渐降低疗效的特点。
ClinicalTrials.gov：NCT02614183（EVOLVE-1）；NCT02614196（EVOLVE-2）；NCT02614261（REGAIN）。
