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《Chinese Journal of Rheumatology》 2006-09
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Infliximab versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate:a randomized,double blind,controlled trial

HUANG Feng DENG Xiao-hu ZHANG Jiang-lin LIANG Dong-feng GUO Jun-hua LI Sheng-guang ZHU Jian LI Xiao-feng.Department of Rheumatology,Chinese PLA General Hospital,Beijing 100853,China.  
Objective To evaluate the efficacy and safety of infliximab plus methotrexate (MTX) com- bination therapy in patients with rheumatoid arthritis (RA).Methods This was a randomized,double blind, controlled clinical trial,49 patients with active RA were randomised to placebo (n=25) or infliximab (n=24) at weeks 0,2,6 and 14 on a background of a stable dose of MTX.Patients were assessed at weeks 0,2,6,14 and 18.The primary endpoint was proportion of ACR20 responders.The secondary endpoints were the propor- tion of ACR50 and ACR70 responders.The change from baseline in duration of morning stiffness,tender joint count/index,swollen joint count/index,pain,fatigue,patient's global assessment,physician's global assessment, ESR and CRP were also evaluated.Results At week 2,the ACR20 was achieved in 62.5% of patients receiving infliximab plus MTX,compared with 8% of patients receiving placebo plus MTX (P=0.0002).The results for other secondary efficacy endpoints showed that infliximab could provide substantial benefits to pa- tients with RA by improving clinical signs and symptoms and quality of life.At week 18,the ACR20 improve- ment was achieved in 79.2% of patients receiving infliximab plus MTX,compared with 48% of patients receiv- ing placebo plus MTX (P=0.024).There was no significant difference between the two groups in adverse effects. Conclusion A regimen of infliximab plus MTX has demonstrated consistent evidence of more effective than MTX alone and is well tolerated in the treatment of active RA.
【Fund】: 国家自然科学基金(30571726)
【CateGory Index】: R593.22
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