title: A randomized, controlled trial of efficacy and safety of Anbainuo, a bio-similar etanercept, for moderate to severe rheumatoid arthritis inadequately responding to methotrexate.
abstract: 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.
authors.affiliation: Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China.
authors.forename: Xiao-Xiang
authors.initials: XX
authors.lastname: Chen
authors.affiliation: Peking University People's Hospital, Beijing, China.
authors.forename: Zhan-Guo
authors.initials: ZG
authors.lastname: Li
authors.affiliation: The Second Hospital, Affiliated to Zhejiang University, Hangzhou, China.
authors.forename: Hua-Xiang
authors.initials: HX
authors.lastname: Wu
authors.affiliation: Changhai Hospital, Affiliated to the Second Military Medical University, Shanghai, China.
authors.forename: Dong-Bao
authors.initials: DB
authors.lastname: Zhao
authors.affiliation: Qilu Hospital, Affiliated to Shandong University, Jinan, China.
authors.forename: Xing-Fu
authors.initials: XF
authors.lastname: Li
authors.affiliation: The First Hospital, Affiliated to Anhui medical University, Hefei, China.
authors.forename: Jian-Hua
authors.initials: JH
authors.lastname: Xu
authors.affiliation: The Second Hospital, Affiliated to Guangzhou Medical School, Guangzhou, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Tao
authors.affiliation: West China Hospital of Sichuan University, Chengdu, China.
authors.forename: Nan-Ping
authors.initials: NP
authors.lastname: Yang
authors.affiliation: Tongji Hospital, Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Shao-Xian
authors.initials: SX
authors.lastname: Hu
authors.affiliation: The Union Hospital, Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: An-Bin
authors.initials: AB
authors.lastname: Huang
authors.affiliation: Zhongshan Hospital, Affiliated to Fudan University, Shanghai, China.
authors.forename: Lin-di
authors.initials: LD
authors.lastname: Jiang
authors.affiliation: China-Japan Friendship Hospital, Beijing, China.
authors.forename: Guo-Chun
authors.initials: GC
authors.lastname: Wang
authors.affiliation: People's Hospital of Guangdong Province, Guangzhou, China.
authors.forename: Xiao
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200001, China. baochunde_1678@126.com.
authors.forename: Chun-de
authors.initials: CD
authors.lastname: Bao
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007141:Immunoglobulin Fc Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D008875:Middle Aged; D047889:Receptors, Tumor Necrosis Factor, Type II / Q000009:adverse effects / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D019233:Retreatment; D012720:Severity of Illness Index; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: C582199:Anbainuo protein, human; D018501:Antirheumatic Agents; D007141:Immunoglobulin Fc Fragments; D047889:Receptors, Tumor Necrosis Factor, Type II; D011993:Recombinant Fusion Proteins; D008727:Methotrexate
keywords: Etanercept; Rheumatoid arthritis; Tumor necrosis factor