A phase 3 randomized, double-blind, multicenter comparative study evaluating the effect of etanercept versus methotrexate on radiographic outcomes, disease activity, and safety in Japanese subjects with active rheumatoid arthritis

Takeuchi, Tsutomu; Miyasaka, Nobuyuki; Zang, Chuanbo; Alvarez, Daniel; Fletcher, Tracey; Wajdula, Joseph; Yuasa, Hirotoshi; Vlahos, Bonnie

doi:10.3109/s10165-012-0742-6

Cited by 30 publications

(3 citation statements)

References 22 publications

(24 reference statements)

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“…From this pool of 151 articles we identified 36 RCTs (Figure 1), 31 TNFi RCTs and 5 RCTs, which could link an otherwise untreated placebo group to the network, 1 study of MTX vs. placebo, 3 studies of sulfasalazine vs. placebo, and 1 study of MTX vs. sulfasalazine. These 36 RCTs were published in 35 articles [14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48].…”

Section: Resultsmentioning

confidence: 99%

Different Original and Biosimilar TNF Inhibitors Similarly Reduce Joint Destruction in Rheumatoid Arthritis—A Network Meta-Analysis of 36 Randomized Controlled Trials

Graudal

Kaas‐Hansen

Guski

et al. 2019

IJMS

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The effect of five approved tumour necrosis factor inhibitors (TNFi: infliximab, etanercept, adalimumab, certolizumab, and golimumab) on joint destruction in rheumatoid arthritis (RA) have been compared versus methotrexate (MTX) in randomized controlled trials (RCTs) but have not been compared directly to each other or to an otherwise untreated placebo control. The present analysis compares effects of standard doses, high doses, and low doses of TNFis on radiographic joint destruction in RA and relate these effects to MTX and placebo by means of a Bayesian network meta-analysis. We identified 31 RCTs of the effect of TNFis on joint destruction and 5 RCTs with controls, which indirectly could link otherwise untreated placebo controls to the TNFi treatments in the network. The previously untested comparison with placebo was performed to estimate not only the effect relative to another drug, but also the absolute attainable effect. Compared to placebo there was a highly significant inhibitory effect on joint destruction of infliximab, etanercept, adalimumab, certolizumab, and golimumab, which was about 0.9% per year as monotherapy and about 1.2% per year when combined with MTX. Although significantly better than MTX and placebo, golimumab seemed inferior to the remaining TNFis. There was no difference between original reference drugs (Remicade, Enbrel) and the almost identical copy drugs (biosimilars).

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Section: Resultsmentioning

confidence: 99%

Different Original and Biosimilar TNF Inhibitors Similarly Reduce Joint Destruction in Rheumatoid Arthritis—A Network Meta-Analysis of 36 Randomized Controlled Trials

Graudal

Kaas‐Hansen

Guski

et al. 2019

IJMS

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“…The use of bDMARDs in this article is defined as the continuous use of bDMARDs over the last 6 months before knee radiography was performed. This cutoff value of 6 months was adopted because some previous studies have reported an effect of bDMARDs on the radiographic progression of structural joint damage 6 months after administration 18 , 19 .…”

Section: Methodsmentioning

confidence: 99%

Increasing trend of radiographic features of knee osteoarthritis in rheumatoid arthritis patients before total knee arthroplasty

Takeda

Matsumoto

Maenohara

et al. 2022

Sci Rep

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To investigate the trend and factors related to the occurrence of osteoarthritis (OA)-like features on knee radiographs of rheumatoid arthritis (RA) patients undergoing total knee arthroplasty (TKA) in the recent decades. To classify antero-posterior knee radiographs into ‘RA’ and ‘OA-like RA’ groups, a deep learning model was developed by training the network using knee radiographs of end-stage arthropathy in RA patients obtained during 2002–2005 and in primary OA patients obtained during 2007–2009. We used this model to categorize 796 knee radiographs, which were recorded in RA patients before TKA during 2006–2020, into ‘OA-like RA’ and ‘RA’ groups. The annual ratio of ‘OA-like RA’ was investigated. Moreover, univariate and multivariate analyses were performed to identify the factors associated with the classification as OA-like RA using clinical data from 240 patients. The percentage of ‘OA-like RA’ had significant increasing trend from 20.9% in 2006 to 67.7% in 2020. Higher body mass index, use of biologics, and lower level of C-reactive protein were identified as independent factors for ‘OA-like RA’. An increasing trend of knee radiographs with OA-like features was observed in RA patients in the recent decades, which might be attributed to recent advances in pharmacotherapy.

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“…Moreover, in a Japanese trial of tocilizumab (61), increases in the total Sharp score (TSS) and its components and the erosion and joint narrowing scores were significantly lower with tocilizumab monotherapy than in DMARD therapy, providing the first evidence that biologics are superior to DMARDs for inhibiting structural damage. Subsequent clinical trials and studies of other biologic agents with methotrexate revealed a striking inhibition of structural damage, indicating that joint damage in RA can be attenuated (61)(62)(63)(64)(65)(66)(67) (Fig. 3).…”

Section: Biological Agents Targeting Cytokinesmentioning

confidence: 97%

A Paradigm Shift in Rheumatoid Arthritis over the Past Decade

Kaneko

Takeuchi

2014

Intern. Med.

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Recent advances have improved our understanding of the pathogenesis of rheumatoid arthritis (RA), and the development of new therapeutics, including biological agents, have thus made it possible to strive for remission as a primary goal. Biological agents targeting a specific molecule have powerful functional capabilities, and the introduction of biological therapies has brought about revolutionary progress in RA management, culminating in a paradigm shift. There is clear evidence that a delay in treatment initiation and poor control of disease activity are associated with joint damage progression, so treatment should be started immediately after the diagnosis of RA and adapted according to disease activity as assessed by validated composite measures. In this review, we will summarize the changes in the classification and remission criteria and describe the clinical efficacies of biological agents in RA. We also discuss new promising therapies and propose future perspectives in the rheumatology field.

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A phase 3 randomized, double-blind, multicenter comparative study evaluating the effect of etanercept versus methotrexate on radiographic outcomes, disease activity, and safety in Japanese subjects with active rheumatoid arthritis

Abstract: ETN 25 mg BIW and ETN 10 mg BIW slowed radiographic progression and improved clinical outcomes more effectively than MTX in this Japanese population.

Cited by 30 publications

References 22 publications

Different Original and Biosimilar TNF Inhibitors Similarly Reduce Joint Destruction in Rheumatoid Arthritis—A Network Meta-Analysis of 36 Randomized Controlled Trials

Different Original and Biosimilar TNF Inhibitors Similarly Reduce Joint Destruction in Rheumatoid Arthritis—A Network Meta-Analysis of 36 Randomized Controlled Trials

Increasing trend of radiographic features of knee osteoarthritis in rheumatoid arthritis patients before total knee arthroplasty

A Paradigm Shift in Rheumatoid Arthritis over the Past Decade

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