Galcanezumab in chronic migraine The randomized, double-blind, placebo-controlled REGAIN study
Galcanezumab in chronic migraine The randomized, double-blind, placebo-controlled REGAIN study
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DOI：
10.1212/wnl.0000000000006640
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发表时间：
2018-12-11
期刊：
影响因子：
9.9
通讯作者：
Aurora, Sheena K.
中科院分区：
文献类型：
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作者：
Detke, Holland C.;Goadsby, Peter J.;Aurora, Sheena K.
目的评价选择性结合降钙素基因相关肽的人源化单抗Galcanezumab预防慢性偏头痛的有效性和安全性。方法LY2951742在慢性偏头痛患者中的3期随机、双盲、安慰剂对照研究(Galcanezumab在预防慢性偏头痛中的评价)为3期研究，包括3个月的双盲、安慰剂对照治疗阶段和9个月的开放标签延期。符合条件的18-65岁慢性偏头痛患者被随机分为每月皮下注射安慰剂(n=558)、Galcanezumab 120 mg(负荷量240 mg，n=278)或Galcanezumab 240 mg(n=277)。主要终点是在3个月的双盲治疗阶段中，偏头痛月天数与基线相比的总体平均变化。与安慰剂(安慰剂-2.7g，Galcanezumab120 mg-4.8Galcanezumab240 mg-4.6p<；每剂与安慰剂相比，P<；0.001)相比，两个Galcanezumab剂量组每月MHD的总体平均减少更多。在任何安全性或耐受性结果上，Galcanezumab剂量与安慰剂之间都没有临床意义上的差异，除了Galcanezumab240-mg组治疗急诊注射部位反应(p<；0.001)、注射部位红斑(p<；0.001)、注射部位瘙痒(p<；0.01)和鼻窦炎(p<；0.05)的发生率高于安慰剂。Galcanezumab对于慢性偏头痛的预防治疗显示出有效、安全和良好的耐受性。临床试验。政府识别器NCT02614261。证据分类这项干预性研究提供了I类证据，表明Galcanezumab在减少每月MHD数量方面优于安慰剂。
ObjectiveTo evaluate the efficacy and safety of galcanezumab, a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide, in the preventive treatment of chronic migraine.MethodsA phase 3, randomized, double-blind, placebo-controlled study of LY2951742 in patients with chronic migraine (Evaluation of Galcanezumab in the Prevention of Chronic Migraine [REGAIN]) was a phase 3 study with a 3-month double-blind, placebo-controlled treatment phase and a 9-month open-label extension. Eligible patients 18 to 65 years of age with chronic migraine were randomized 2: 1: 1 to monthly subcutaneous injections of placebo (n = 558), galcanezumab 120 mg (with a 240-mg loading dose, n = 278), or galcanezumab 240 mg (n = 277). The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days (MHDs) during the 3-month double-blind treatment phase.ResultsMean number of monthly MHDs at baseline was 19.4 for the total sample. Both galcanezumab dose groups demonstrated greater overall mean reduction in the number of monthly MHDs compared to placebo (placebo -2.7, galcanezumab 120 mg -4.8, galcanezumab 240 mg -4.6) (p < 0.001 for each dose compared to placebo). There were no clinically meaningful differences between galcanezumab doses and placebo on any safety or tolerability outcome except for a higher incidence of treatment-emergent injection-site reaction (p < 0.01), injection-site erythema (p < 0.001), injection-site pruritus (p < 0.01), and sinusitis (p < 0.05) in the galcanezumab 240-mg group relative to placebo.ConclusionsBoth doses of galcanezumab were superior to placebo in reducing the number of monthly MHDs. Galcanezumab appears efficacious, safe, and well tolerated for the preventive treatment of chronic migraine.ClinicalTrials.gov identifierNCT02614261.Classification of evidenceThis interventional study provides Class I evidence that galcanezumab is superior to placebo in the reduction of the number of monthly MHDs.