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学科主题: 临床医学
题名:
Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomized, double-blind, placebo-controlled multicenter trial
作者: 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
发表日期: 2012-06-05
DOI: 10.3760/cma.j.issn.0366-6999.2012.11.001
卷: 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
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/64961
Appears in Collections:北京大学第一临床医学院_皮肤性病科_期刊论文

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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

Recommended Citation:
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.
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