Nat Med:Eruxifermin治疗非酒精性脂肪性肝炎的疗效如何?

2021-07-31 MedSci原创 MedSci原创

efruxifermin治疗显著降低了F1-F3期NASH患者的HFF,且其安全性可接受。

临床前和临床数据表明,成纤维细胞生长因子21 (FGF21)具有抗纤维化、改善代谢状态和治疗非酒精性脂肪性肝炎(NASH)的潜力。

近日,顶级医学期刊Nature Medicine上发表了一篇研究文章,研究人员旨在评估长效Fc-FGF21融合蛋白efruxifermin在NASH治疗中的安全性和有效性。

该研究是在美国27个中心完成的针对NASH患者的随机、安慰剂对照研究 (ClinicalTrials.gov NCT03976401)。八十名患者,根据肝脏脂肪分数(HFF)和纤维化程度进行分层,并应用集中管理最小化算法进行随机分组,并按1:1:1:1每周接受安慰剂(n=21)、efruxifermin 28mg (n=19)、efruxifermin 50mg (n=20)或efruxifermin 70mg(n=20)皮下注射,共计治疗16周。该研究的主要终点为经磁共振成像检查测量的HFF-质子密度脂肪分数从基线到第12周时的绝对变化。

肝脏损伤的标志

对于整个分析集,在28mg、50mg和70mg的efruxifermin治疗组中,从基线开始HFF的最小二乘平均绝对变化(单边97.5%置信区间)分别为-12.3%(-无限(-inf)为-10.3)、-13.4% (-inf为-11.4)和-14.1%(-inf为-12.1),而安慰剂组为0.3%(-inf为-1.6),并且efruxifermin治疗组与安慰剂组之间的差异具有统计学意义(P<0.0001)。总的来说,79例接受治疗的患者中有70例(89%)至少经历了一次需要治疗的紧急不良事件(TEAE),其中大多数为1-2级(64例(81%)),5例(6%)为3级,1例为4级。最常报道的药物相关TEAE为1-2级胃肠道(36例(46%))。

由此可见,efruxifermin治疗显著降低了F1-F3期NASH患者的HFF,且其安全性可接受

原始出处:

Stephen A. Harrison, et al.Efruxifermin in non-alcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a trial.Nature Medicine.2021.https://www.nature.com/articles/s41591-021-01425-3

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    2021-09-07 liye789132251
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    2021-10-30 qjddjq
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    2021-07-31 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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