Abstract
Rheumatoid arthritis is a chronic inflammatory disease which could lead to severe joint damage and disability. This study was performed to determine the efficacy and safety of methotrexate (MTX) therapy combined with maintenance or discontinuation of etanercept biosimilar rhTNFR:Fc in active rheumatoid arthritis patients in Chinese patients. In this controlled, randomized and open-label study, 89 patients with active rheumatoid arthritis were enrolled at 7 institutions in China between September 2010 and May 2011. In a period of 52 weeks, patients were randomly assigned to one of three treatment groups: MTX plus rhTNFR:Fc for 52 weeks, MTX plus rhTNFR:Fc for 24 weeks, or MTX monotherapy. The primary endpoint was the joint damage evaluated by change from baseline (CFB) of van de Heijde modified Total Sharp Score (mTSS). Intention-to-treat population were used for analysis. A total of 89 enrolled patients were eligible for this study, of whom 32 were assigned to MTX plus rhTNFR:Fc52 group, 31 to MTX plus rhTNFR:Fc24, and 26 to MTX monotherapy. Only one patient was lost to follow up in the MTX plus rhTNFR:Fc24 group. The mTSS CFB was lower in the rhTNFR:Fc pooled group (combination of data in the MTX plus rhTNFR:Fc52 group and MTX plus rhTNFR:Fc24 group) comparing with MTX monotherapy at week 24 and 52 (P = 0.03 and P < 0.01). Additionally, ACR50 and ACR70 response rates were both higher in the rhTNFR:Fc pooled group than MTX monotherapy (P < 0.05). Combination of MTX and rhTNFR:Fc in patients with active rheumatoid arthritis could effectively inhibit joint structure damage.
Highlights
Rheumatoid arthritis is a chronic inflammatory disease which could lead to severe joint damage and disability
A total of four adverse events were reported in MTX group, of which there was one with palpitation, two with abnormal liver function and one with anemia. In this controlled, randomized and open-label study, we observed that combination of MTX and rhTNFR:Fc significantly inhibited joint damage comparing with MTX monotherapy in Chinese patients with active rheumatoid arthritis
This finding was similar with previous studies[8,12], www.nature.com/scientificreports indicating that combination of etanercept and MTX therapy was superior to MTX monotherapy with radiographic non-progression for patients with early severe active rheumatoid arthritis
Summary
Rheumatoid arthritis is a chronic inflammatory disease which could lead to severe joint damage and disability. This study was performed to determine the efficacy and safety of methotrexate (MTX) therapy combined with maintenance or discontinuation of etanercept biosimilar rhTNFR:Fc in active rheumatoid arthritis patients in Chinese patients. In this controlled, randomized and open-label study, 89 patients with active rheumatoid arthritis were enrolled at 7 institutions in China between September 2010 and May 2011. The potential mechanisms of action of methotrexate for rheumatoid arthritis include antagonism of folate-dependent processes, generation of reactive oxygen species, stimulation of adenosine signaling, inhibition of methyl-donor production, downregulation of adhesion-molecule expression, eicosanoids and matrix metalloproteinases and modification of cytokine profiles[4] Targeted therapies such as tumor necrosis factor inhibitor (TNFi) and Janus kinase inhibitors were recommended when first-line therapy such as MTX fails[1,5,6].
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