A randomized, controlled trial of efficacy and safety of Anbainuo, a bio-similar etanercept, for moderate to severe rheumatoid arthritis inadequately responding to methotrexate
单位：[1]Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200001, China[2]Peking University People’s Hospital, Beijing, China[3]The Second Hospital, Affiliated to Zhejiang University, Hangzhou, China[4]Changhai Hospital, Affiliated to the Second Military Medical University, Shanghai, China[5]Qilu Hospital, Affiliated to Shandong University, Jinan, China[6]The First Hospital, Affiliated to Anhui medical University, Hefei, China[7]The Second Hospital, Affiliated to Guangzhou Medical School, Guangzhou, China[8]West China Hospital of Sichuan University, Chengdu, China四川大学华西医院[9]Tongji Hospital, Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属同济医院[10]The Union Hospital, Affiliated to TongjiMedical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属协和医院[11]Zhongshan Hospital, Affiliated to Fudan University, Shanghai, China[12]China-Japan Friendship Hospital, Beijing, China[13]People’s Hospital of Guangdong Province, Guangzhou, China
The objective of the study was to evaluate the efficacy and safety of etanercept (Anbainuo) treatment in Chinese moderate to severe rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX-IR); 600 patients (360 in phase III-1 and 240 in phase III-2) poorly responding to MTX were enrolled in the study and randomized at a ratio of 2:1 into an Anbainuo treatment or control group. The study was designed as a 12-week double-blind, placebo-controlled period followed by a 12-week open-label study. The primary endpoint was the ACR20 response rate at week 12. Secondary endpoints included the ACR50, ACR70, ACR-N, and safety. At week 12, ACR20 response was observed in 60.9 % of the Anbainuo group-significantly higher than that of the control group (20.6 %). At week 24, the ACR20 response in the Anbainuo group increased to 70.2 %; there was no significant difference compared with that of the control group (61.8 %, P > 0.05). At week 12, the ACR50 and ACR70 responses of the Anbainuo group increased to 25.6 and 6.8 %, compared to 4 and 1 % in the control group (P < 0.001, P = 0.002). The ACR-N was 2.85 +/- 6.73 vs. -3.24 +/- 8.78 % in the control group (P < 0.001). During the first 12 weeks of treatment, 66 adverse events (AE) were reported in the Anbainuo group (15.6 %) and 21 AEs (10.5 %) occurred in the control group, whereby the rate of the Anbainuo group was slightly higher than the control group (P = 0.042). Severe adverse events (SAEs) occurred in the Anbainuo group (1.3 %) and one (SAE) occurred in the control group (0.5 %) (P = 0.19). Anbainuo displays a rapid onset of efficacy as well as good tolerance and safety in MTX-IR patients having moderate to severe RA.
第一作者单位：[1]Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 200001, China
通讯作者：
推荐引用方式(GB/T 7714)：
Chen Xiao-Xiang,Li Zhan-guo,Wu Hua-xiang,et al.A randomized, controlled trial of efficacy and safety of Anbainuo, a bio-similar etanercept, for moderate to severe rheumatoid arthritis inadequately responding to methotrexate[J].CLINICAL RHEUMATOLOGY.2016,35(9):2175-2183.doi:10.1007/s10067-016-3302-1.
APA：
Chen, Xiao-Xiang,Li, Zhan-guo,Wu, Hua-xiang,Zhao, Dong-bao,Li, Xing-fu...&Bao, Chun-de.(2016).A randomized, controlled trial of efficacy and safety of Anbainuo, a bio-similar etanercept, for moderate to severe rheumatoid arthritis inadequately responding to methotrexate.CLINICAL RHEUMATOLOGY,35,(9)
MLA：
Chen, Xiao-Xiang,et al."A randomized, controlled trial of efficacy and safety of Anbainuo, a bio-similar etanercept, for moderate to severe rheumatoid arthritis inadequately responding to methotrexate".CLINICAL RHEUMATOLOGY 35..9(2016):2175-2183
