SHR0302的临床疗效和安全性,一个高度选择性Janus激酶1抑制剂,在中度到重度特应性皮炎患者:二期随机临床试验。

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张赵Y, L,丁Y,道X,霁C,董X,陆J,吴L,王R, Q,吴作栋啊,刘R,张Z,张J

SHR0302的临床疗效和安全性,一个高度选择性Janus激酶1抑制剂,在中度到重度特应性皮炎患者:二期随机临床试验。

11月是中国新药杂志。2021;22 (6):877 - 889。doi: 10.1007 / s40257 - 021 - 00627 - 2。Epub 2021年8月9日。

PubMed ID
34374027 (在PubMed
]
文摘

背景:特应性皮炎是一种慢性炎症条件造成大量患者和照顾者的负担。SHR0302口服,高选择性,Janus激酶1抑制剂在调查中炎症性皮肤病。目的:本研究的目的是调查的有效性和安全性SHR0302中国患有中度到重度特应性皮炎。设计和设置:随机、双盲、安慰剂对照、多中心、二期试验是在中国进行的2019年10月至2020年8月。参与者:病人18 - 75岁(n = 105)中度到重度的皮炎和停止响应或不能容忍包括局部或传统的系统性治疗。干预措施:病人被随机分配的比例比接受SHR0302 4毫克每天一次,SHR0302 8毫克每天一次,12周或安慰剂。主要结果测量:主要疗效终点是患者的比例实现调查员的全球评估(IGA)响应(IGA(0)(清晰)或1(几乎清晰)与改善> / = 2年级)在第12周。次要疗效评估包括湿疹面积和严重程度指数(EASI)和瘙痒数值评定量表(NRS)分数。结果:在12周,IGA反应是实现在9个患者(25.7%;90%可信区间[CI] 13.6 - -37.9%; p = 0.022) in the SHR0302 4 mg group, 19 patients (54.3%; 90% CI 40.4-68.1%; p < 0.001) in the SHR0302 8 mg group, and two patients (5.7%; 90% CI 0.0-12.2%) in the placebo group. EASI75 was achieved in 51.4% (p = 0.013), 74.3% (p < 0.001), and 22.9% of patients in the SHR0302 4 mg, SHR0302 8 mg, and placebo groups, respectively, while an NRS >/=3-point improvement occurred in 65.7% (p < 0.001), 74.3% (p < 0.001), and 22.9% of patients, respectively. Treatment-emergent adverse events were reported in 60.0%, 68.6%, and 51.4% of patients in the SHR0302 4 mg, SHR0302 8 mg, and placebo groups, respectively. The adverse events were mild in most cases. Three serious adverse events were reported, all being worsening of atopic dermatitis. No serious infection was reported. CONCLUSIONS AND RELEVANCE: Oral SHR0302 was effective and well tolerated in Chinese adult patients with moderate to severe atopic dermatitis. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04162899; URL: https://clinicaltrials.gov/ . Date first registered: 14 November 2019.

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