Abstract:
OBJECTIVES:To compare the efficacy and safety of innovator infliximab (INX) and CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment. METHODS:Phase III randomised, double-blind, multicentre, multinational, parallel-group study. Patients with active disease despite MTX (12.5-25 mg/week) were randomised to receive 3 mg/kg of CT-P13 (n=302) or INX (n=304) with MTX and folic acid. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 30. Therapeutic equivalence of clinical response according to ACR20 criteria was concluded if the 95% CI for the treatment difference was within ±15%. Secondary endpoints included ACR response criteria, European League Against Rheumatism (EULAR) response criteria, change in Disease Activity Score 28 (DAS28), Medical Outcomes Study Short-Form Health Survey (SF-36), Simplified Disease Activity Index, Clinical Disease Activity Index, as well as pharmacokinetic (PK) and pharmacodynamic (PD) parameters, safety and immunogenicity. RESULTS:At week 30, ACR20 responses were 60.9% for CT-P13 and 58.6% for INX (95% CI -6% to 10%) in the intention-to-treat population. The proportions in CT-P13 and INX groups achieving good or moderate EULAR responses (C reactive protein (CRP)) at week 30 were 85.8% and 87.1%, respectively. Low disease activity or remission according to DAS28-CRP, ACR-EULAR remission rates, ACR50/ACR70 responses and all other PK and PD endpoints were highly similar at week 30. Incidence of drug-related adverse events (35.2% vs 35.9%) and detection of antidrug antibodies (48.4% vs 48.2%) were highly similar for CT-P13 and INX, respectively. CONCLUSIONS:CT-P13 demonstrated equivalent efficacy to INX at week 30, with a comparable PK profile and immunogenicity. CT-P13 was well tolerated, with a safety profile comparable with that of INX. CLINICALTRIALS.GOV IDENTIFIER: NCT01217086.
journal_name
Ann Rheum Disjournal_title
Annals of the rheumatic diseasesauthors
Yoo DH,Hrycaj P,Miranda P,Ramiterre E,Piotrowski M,Shevchuk S,Kovalenko V,Prodanovic N,Abello-Banfi M,Gutierrez-Ureña S,Morales-Olazabal L,Tee M,Jimenez R,Zamani O,Lee SJ,Kim H,Park W,Müller-Ladner Udoi
10.1136/annrheumdis-2012-203090subject
Has Abstractpub_date
2013-10-01 00:00:00pages
1613-20issue
10eissn
0003-4967issn
1468-2060pii
annrheumdis-2012-203090journal_volume
72pub_type
杂志文章,多中心研究,随机对照试验abstract::Using clinical, radiological, and morbid anatomical data about patients with arthritis of the hip and their femoral heads resected during total hip replacement, an attempt has been made first, to classify patients and femoral heads by a cluster analysis technique, and secondly and more realistically, to use existing c...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.34.4.298
更新日期:1975-08-01 00:00:00
abstract:OBJECTIVES:Antiphospholipid antibodies (aPLA) have been shown to enhance thrombus formation by increasing the expression of adhesive receptors such as P-selectin on endothelial cells. The P-selectin counter-receptor on leucocytes is P-selectin glycoprotein ligand-1 (PSGL-1). We have previously described a variable numb...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2007.075945
更新日期:2007-10-01 00:00:00
abstract::Short term immobilisation (seven days) of an antigen induced arthritic knee joint of the mouse led to attachment of polymorphonuclear leucocytes to the cartilage surface and severe cartilage damage. The events at the patellar cartilage surface were studied by scanning electron microscopy and compared with the changes ...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.48.10.832
更新日期:1989-10-01 00:00:00
abstract:OBJECTIVE:To investigate the inflammatory response in giant cell arteritis (GCA) by characterising the DNA methylation pattern within the temporal artery microenvironment. METHODS:Twelve patients with non-equivocal histological evidence for GCA and 12 age-matched, sex-matched and ethnicity-matched controls with normal...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/annrheumdis-2014-207116
更新日期:2016-06-01 00:00:00
abstract:OBJECTIVES:To evaluate the effect of infliximab on health related quality of life (HRQoL) and physical function in patients with active psoriatic arthritis (PsA) in the IMPACT 2 trial. METHODS:200 patients with PsA unresponsive to conventional treatment were randomised to intravenous infusions of infliximab 5 mg/kg or...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1136/ard.2005.040196
更新日期:2006-04-01 00:00:00
abstract:OBJECTIVES:To determine clinical and ultrasonographic predictors of joint replacement surgery across Europe in primary osteoarthritis (OA) of the knee. METHODS:This was a 3-year prospective study of a painful OA knee cohort (from a EULAR-sponsored, multicentre study). All subjects had clinical evaluation, radiographs ...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,多中心研究
doi:10.1136/ard.2008.099564
更新日期:2010-04-01 00:00:00
abstract::Today, patients' functioning is a central issue in medicine. Concepts, classifications, and measurements of functioning and health, such as the International Classification of Functioning, Disability and Health (ICF) are of prime importance in clinical practice, teaching, and research. This report compares the content...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,评审
doi:10.1136/ard.2004.028233
更新日期:2004-11-01 00:00:00
abstract:OBJECTIVES:To develop recommendations for monitoring patients with systemic lupus erythematosus (SLE) in clinical practice and observational studies and to develop a standardised core set of variables to monitor SLE. METHODS:We followed the European League Against Rheumatism (EULAR) standardised procedures for guideli...
journal_title:Annals of the rheumatic diseases
pub_type: 共识发展会议,杂志文章,实务指引
doi:10.1136/ard.2009.117200
更新日期:2010-07-01 00:00:00
abstract:OBJECTIVE:To compare arterial haemodynamics in adults with long-term juvenile idiopathic arthritis (JIA) to that of healthy controls, and explore the influence of traditional cardiovascular risk factors and disease characteristics on arterial haemodynamics plus coronary artery calcification. METHODS:87 JIA patients (m...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/annrheumdis-2013-204804
更新日期:2015-08-01 00:00:00
abstract:BACKGROUND:The 2010 ACR/EULAR classification criteria for rheumatoid arthritis (RA) were developed to improve the identification of individuals for studies of RA. We aimed to summarise the performance of the criteria based on the published literature. METHODS:We performed a systematic literature search to identify all...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,meta分析,评审
doi:10.1136/annrheumdis-2013-203284
更新日期:2014-01-01 00:00:00
abstract::Mild iron deficiency induced by treatment with the iron chelator desferrioxamine reduced the incidence and severity of joint inflammation associated with adjuvant disease in rats but did not alter the local primary inflammatory response or the systemic sequelae. Both rats treated with desferrioxamine and control rats ...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.46.4.327
更新日期:1987-04-01 00:00:00
abstract::Four hundred and forty unrelated British Caucasoid patients with rheumatoid arthritis (RA) have been HLA typed for class I and class II antigens. Analyses of HLA antigen associations were performed on the overall group and in patient subsets selected according to particular disease parameters or sex, or both. The resu...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.45.8.627
更新日期:1986-08-01 00:00:00
abstract::Psoriatic arthritis (PsA) is characterised by several unique clinical features that differentiate it from rheumatoid arthritis (RA). Attempts to identify immunopathological mechanisms, some shared with psoriasis, that underlie these differences from RA have been most challenging. Recent research studies, however, high...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,评审
doi:10.1136/ard.2004.031740
更新日期:2005-03-01 00:00:00
abstract:OBJECTIVES:To compare levels of disability of people with and without hip and knee arthroplasty in a random national sample. METHODS:In 1999 a screening questionnaire to classify people into groups of increasing probabilities of disability was sent to 417 500 people; response rate 86%. The study population was obtaine...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.62.8.748
更新日期:2003-08-01 00:00:00
abstract:OBJECTIVES:To evaluate coronary atherosclerosis in patients with psoriatic arthritis (PsA) and control subjects using coronary CT angiography (CCTA). METHODS:Ninety consecutive patients with PsA (male: 56(62.2%); 50.3±11.1 years) were recruited. 240 controls (male: 137(57.1%); 49.6±10.7 years) without known cardiovasc...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/annrheumdis-2016-210390
更新日期:2017-07-01 00:00:00
abstract:OBJECTIVES:Interferon regulatory factor 5 (IRF5) is a member of the IRF family of transcription factors, which regulate the production of proinflammatory cytokines. Polymorphisms in the IRF5 gene have been associated with susceptibility to systemic lupus erythaematosus (SLE) in Caucasian and Asian populations, but thei...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,多中心研究
doi:10.1136/ard.2007.085704
更新日期:2009-03-01 00:00:00
abstract::In a search for aspects of behaviour related to oral contraceptive use which might explain the favourable effect of oral contraception on the onset of rheumatoid arthritis (RA), cigarette smoking and alcohol consumption were studied as possible risk factors. Information on cigarette smoking and alcohol consumption was...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.49.12.980
更新日期:1990-12-01 00:00:00
abstract::Cultures of synovial cells obtained at surgery from patients with rheumatoid arthritis produced a protein which inhibits the mitosis of normal rabbit and human synovial cells, and of human lung fibroblasts. This mitotic inhibitory effect can be transferred to rabbit synovial cells by intra-articular injection of the a...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.37.2.187
更新日期:1978-04-01 00:00:00
abstract::A series of observations have led to the hypothesis that normal intestinal microbiota in patients with rheumatoid arthritis may harbour, for genetic reasons, bacteria with cell walls capable of inducing arthritis. Differences occur between bacterial species, and even between strains of a single species, because some c...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,评审
doi:10.1136/ard.62.9.807
更新日期:2003-09-01 00:00:00
abstract:BACKGROUND:Systemic lupus erythematosus (SLE) is characterised by the presence of antibodies to double stranded DNA (dsDNA), which are involved in the pathogenesis of SLE. Previous studies showed that at least two thirds of patients develop a clinical relapse within six months after a significant rise in the anti-dsDNA...
journal_title:Annals of the rheumatic diseases
pub_type: 临床试验,杂志文章
doi:10.1136/ard.62.6.534
更新日期:2003-06-01 00:00:00
abstract:OBJECTIVE:To assess the effects of acute stress on inflammatory, haemostatic, rheological, and haemodynamic activity in patients with rheumatoid arthritis (RA) in comparison with patients with osteoarthritis (OA). METHODS:21 patients with RA and 10 with OA underwent a brief mental stress task while standing. Inflammat...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,多中心研究
doi:10.1136/ard.2004.032151
更新日期:2005-09-01 00:00:00
abstract:OBJECTIVES:Evidence suggests that doxycycline might have disease-modifying properties in osteoarthritis. However, the clinically relevant question as to whether doxycycline also modifies symptoms in knee osteoarthritis is unanswered. The objective of this study was to investigate the effectiveness of doxycycline on pai...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,随机对照试验
doi:10.1136/ard.2010.147967
更新日期:2011-07-01 00:00:00
abstract::Current drug development programs produce high quality data on the efficacy of new drugs, substantial data on safety, but little data on actual applicability of the new product compared to standard of care. After successful registration and launch, such data require years to accumulate and often remain incomplete. Thi...
journal_title:Annals of the rheumatic diseases
pub_type: 评论,杂志文章
doi:10.1136/ard.2009.110007
更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:In 2001, the European League Against Rheumatism developed and disseminated the first guidelines for musculoskeletal (MS) ultrasound (US) in rheumatology. Fifteen years later, the dramatic expansion of new data on MSUS in the literature coupled with technological developments in US imaging has necessitated an...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,实务指引
doi:10.1136/annrheumdis-2017-211585
更新日期:2017-12-01 00:00:00
abstract:OBJECTIVE:FoxO3a is a transcriptional factor implicated in cell cycle regulation and apoptosis. Since rheumatoid arthritis (RA) is associated with apoptosis defects, the expression level, regulation and phosphorylation status of FoxO3a was investigated in blood and synovium from patients with RA. METHODS:In microarray...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2009.109991
更新日期:2010-04-01 00:00:00
abstract:OBJECTIVES:MRI scoring systems for hand osteoarthritis (HOA) are currently not available. The present work proposes the Oslo HOA MRI (OHOA-MRI) score and examines the intrareader and inter-reader reliability. METHODS:Relevant HOA features were included in the initial version of the OHOA-MRI score after literature revi...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2010.144527
更新日期:2011-06-01 00:00:00
abstract:OBJECTIVES:To assess the safety of intra-articular (IA) autologous tolerogenic dendritic cells (tolDC) in patients with inflammatory arthritis and an inflamed knee; to assess the feasibility and acceptability of the approach and to assess potential effects on local and systemic disease activities. METHODS:An unblinded...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,随机对照试验
doi:10.1136/annrheumdis-2015-208456
更新日期:2017-01-01 00:00:00
abstract:OBJECTIVE:The British Society for Rheumatology Biologics Register (BSRBR) has collected data on adverse events including pregnancies in patients with rheumatoid arthritis treated with anti-tumour necrosis factor (anti-TNF) therapy. The purpose of this report is to summarise the pregnancy outcomes in women treated with ...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2010.140822
更新日期:2011-05-01 00:00:00
abstract:OBJECTIVES:To further evaluate the role of bacterial antigens in triggering inflammation in the joint in patients with reactive arthritis by studying local antibody synthesis in the joint. METHODS:Yersinia-specific antibodies in paired serum and synovial fluid samples from 29 patients with yersinia triggered reactive ...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.53.8.535
更新日期:1994-08-01 00:00:00
abstract:OBJECTIVE:To assess and characterise the risk of bladder cancer, and its relation to cyclophosphamide, in patients with Wegener's granulomatosis. METHODS:In the population based, nationwide Swedish Inpatient Register a cohort of 1065 patients with Wegener's granulomatosis, 1969-95, was identified. Through linkage with...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,评审
doi:10.1136/ard.2003.019125
更新日期:2004-10-01 00:00:00