IR@PKUHSC  > 北京大学第一临床医学院  > 皮肤性病科
学科主题临床医学
Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled multicenter trial
Yang Hai-zhen1; Wang Ke1; Jin Hong-zhong2,3; Gao Tian-wen4; Xiao Sheng-xiang5; Xu Jin-hua6; Wang Bao-xi7,8; Zhang Fu-ren9; Li Chun-yang10; Liu Xiao-ming11; Tu Cai-xia12; Ji Su-zhen1; Shen Yang13; Zhu Xue-jun1
关键词infliximab psoriasis biologics
刊名CHINESE MEDICAL JOURNAL
2012-06-05
DOI10.3760/cma.j.issn.0366-6999.2012.11.001
125期:11页:1845-1851
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Medicine, General & Internal
研究领域[WOS]General & Internal Medicine
关键词[WOS]QUALITY-OF-LIFE ; NECROSIS-FACTOR-ALPHA ; TO-SEVERE PSORIASIS ; MAINTENANCE THERAPY ; TNF-ALPHA ; INDUCTION ; IMPROVEMENT
英文摘要

Background Tumor necrosis factor-a is a key mediator in the pathogenesis of psoriasis. Infliximab is a monoclonal antibody that specifically binds to tumor necrosis factor-a. The purpose of this study was to validate the efficacy and safety of 5 mg/kg infliximab therapy in Chinese patients with moderate to severe plaque psoriasis.

Methods In this multicenter, double-blind, placebo-controlled trial, 129 patients with moderate-to-severe psoriasis were randomized to the induction therapy (weeks 0, 2 and 6) with infliximab 5 mg/kg (n=84) or placebo (n=45), followed with infliximab 5 mg/kg scheduled at week 14 and week 22 in the infliximab group, and infliximab 5 mg/kg scheduled at weeks 10, 12 and 16 in the placebo group. The primary end point was the proportion of patients who achieved at least 75% improvement in Psoriasis Area and Severity Index (PASI 75 response rate) from baseline at week 10.

Results At week 10, 81.0% of patients treated with infliximab (5 mg/kg) achieved a 75% or greater improvement compared with 2.2% of patients treated with placebo (P <0.001). A significant improvement in PASI, Physician′s Global Assessment (PGA) and Dermatology Life Quality Index (DLQI), was seen from week 6 through week 14 in the infliximab group compared with the placebo group. Through week 22, PASI, PGA, DLQI were well maintained. The incidence of adverse events for the infliximab treatment group was slightly higher in comparison to the placebo treatment group during the first 10 weeks without statistical significance. However, there were 3 cases of tuberculosis that developed during the 26 weeks treatment with infliximal.

Conclusions Infliximab treatment was effective as induction and maintenance treatments for Chinese patients with moderate to severe plaque psoriasis. Most drug-induced adverse events were mild to moderate, and well tolerated. Screening for tuberculosis is essential and prophylactic treatment should be given if necessary. Chin Med J 2012;125(11):1845-1851

语种英语
WOS记录号WOS:000305259700001
引用统计
被引频次:20[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/64961
专题北京大学第一临床医学院_皮肤性病科
作者单位1.Peking Univ, Hosp 1, Dept Dermatol, Beijing 100034, Peoples R China
2.Chinese Acad Med Sci, Peking Union Med Coll Hosp, Dept Dermatol, Beijing 100730, Peoples R China
3.Peking Union Med Coll, Beijing 100730, Peoples R China
4.Fourth Mil Med Univ, Xijing Hosp, Dept Dermatol, Xian 710032, Shaanxi, Peoples R China
5.Xi An Jiao Tong Univ, Northwest Hosp, Dept Dermatol, Xian 710004, Shaanxi, Peoples R China
6.Fudan Univ, Huashan Hosp, Dept Dermatol, Shanghai 200040, Peoples R China
7.Peking Union Med Coll, Nanjing 210042, Jiangsu, Peoples R China
8.Chinese Acad Med Sci, Inst Dermatol, Nanjing 210042, Jiangsu, Peoples R China
9.Shandong Prov Inst Dermatol & Venereol, Shandong Prov Hosp Dermatol, Jinan 250022, Shandong, Peoples R China
10.Shandong Univ, Qilu Hosp, Dept Dermatol, Jinan 250012, Shandong, Peoples R China
11.Dalian Med Univ, Affiliated Hosp 1, Dept Dermatol, Dalian 116011, Liaoning, Peoples R China
12.Dalian Med Univ, Affiliated Hosp 2, Dept Dermatol, Dalian 116027, Liaoning, Peoples R China
13.Xian Janssen Pharmaceut Ltd, China Res & Dev, Beijing 100025, Peoples R China
推荐引用方式
GB/T 7714
Yang Hai-zhen,Wang Ke,Jin Hong-zhong,et al. Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled multicenter trial[J]. CHINESE MEDICAL JOURNAL,2012,125(11):1845-1851.
APA Yang Hai-zhen.,Wang Ke.,Jin Hong-zhong.,Gao Tian-wen.,Xiao Sheng-xiang.,...&Zhu Xue-jun.(2012).Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled multicenter trial.CHINESE MEDICAL JOURNAL,125(11),1845-1851.
MLA Yang Hai-zhen,et al."Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled multicenter trial".CHINESE MEDICAL JOURNAL 125.11(2012):1845-1851.
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