Details

Autor(en) / Beteiligte

• Yang, Hai-Zhen
• Wang, Ke
• Jin, Hong-Zhong
• Gao, Tian-Wen
• Xiao, Sheng-Xiang
• Xu, Jin-Hua
• Wang, Bao-Xi
• Zhang, Fu-Ren
• Li, Chun-Yang
• Liu, Xiao-Ming
• Tu, Cai-Xia
• Ji, Su-Zhen
• Shen, Yang
• Zhu, Xue-Jun

Titel

Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis： a randomized, double-blind, placebo-controlled multicenter trial

Ist Teil von

• Chinese medical journal, 2012-06, Vol.125 (11), p.1845-1851

Ort / Verlag

China: Department of Dermatology, Peking University First Hospital,Beijing 100034, China%Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China%Department of Dermatology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi 710032,China%Department of Dermatology, Northwest Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi 710004, China%Department of Dermatology, Huashan Hospital, Fudan University,Shanghai 200040, China%Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Mcdical College, Nanjing,Jiangsu 210042, China%Shandong Provincial Hospital of Dermatology, Shandong Provincial Institute of Dermatology and Venereology, Jinan,Shandong 250022, China%Department of Dermatology, Qilu Hospital of Shandong University, Jinan, Shandong 250012, China%Department of Dermatology, First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China%Department of Dermatology, Second Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116027, China%China Rescarch and Development, Xian Janssen Pharmaceutical Ltd, Beiiing 100025, China

Erscheinungsjahr

2012

Quelle

MEDLINE

Beschreibungen/Notizen

• Background Tumor necrosis factor-α is a key mediator in the pathogenesis of psoriasis. Infliximab is a monoclonal antibody that specifically binds to tumor necrosis factor-α. 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.