Abstract:
:The first biological therapeutics in rheumatology are approaching patent expiration, encouraging development of 'follow-on' versions, known as 'biosimilars'. Biological agents range from simple replacement hormones to complex monoclonal antibodies and soluble receptors: large, intricate proteins with unique tertiary and quaternary structures that are inherently difficult to replicate. Post-translational modifications, such as glycosylation, may occur from changes in cell lines and/or manufacturing processes, resulting in products that are highly similar, but not identical, to approved 'reference' agents, hence, the term 'biosimilar', rather than 'bioidentical'. Even minor modifications in manufacturing processes, which iteratively occur with reference products due to improvements in efficiency, scale up to meet commercial demands or changes in manufacturing sites, may alter biological function and/or immunogenicity, potentially changing their safety and efficacy profile. As biosimilars are now in randomised controlled trials for treatment of rheumatic diseases, rheumatologists face decisions regarding equipoise and will need to consider their clinical use versus reference products. A clear understanding of the inherent differences between reference antibodies and biosimilars, their clinical implications and the processes governing regulation, approval and clinical use of biosimilars, is paramount. A panel of international experts in the field of rheumatology recently convened to evaluate and discuss these issues.
journal_name
Ann Rheum Disjournal_title
Annals of the rheumatic diseasesauthors
Dörner T,Strand V,Castañeda-Hernández G,Ferraccioli G,Isaacs JD,Kvien TK,Martin-Mola E,Mittendorf T,Smolen JS,Burmester GRdoi
10.1136/annrheumdis-2012-202715subject
Has Abstractpub_date
2013-03-01 00:00:00pages
322-8issue
3eissn
0003-4967issn
1468-2060pii
annrheumdis-2012-202715journal_volume
72pub_type
杂志文章,评审abstract:OBJECTIVE:To describe the associations between overweight measures in childhood and knee pain, stiffness and dysfunction among adults 25 years later. METHODS:Subjects broadly representative of the Australian population (n=449, aged 31-41 years, female 48%) were selected from the Australian Schools Health and Fitness S...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/annrheumdis-2013-204161
更新日期:2015-04-01 00:00:00
abstract::We report two patients with systemic lupus erythematosus who subsequently developed thrombotic thrombocytopenic purpura. In each case the coexistence of these two conditions was confirmed by pathological findings. Both patients responded to treatment, but one eventually died. A review of the literature suggests a poss...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.45.4.319
更新日期:1986-04-01 00:00:00
abstract:OBJECTIVE:To examine the effect of infliximab plus methotrexate (MTX) compared with placebo plus MTX on bone loss in patients with early rheumatoid arthritis (RA) in a double-blind randomised study design. Further, to explore the associations between bone loss and markers of RA disease. METHODS:All 20 patients with RA...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,随机对照试验
doi:10.1136/ard.2008.106484
更新日期:2009-12-01 00:00:00
abstract:OBJECTIVE:To identify predictors of radiographic progression in a 2-year randomised, double-blind, clinical study (CIMESTRA) of patients with early rheumatoid arthritis (RA). METHODS:Patients with early RA (n = 130) were treated with methotrexate, intra-articular betamethasone and ciclosporin/placebo-ciclosporin. Base...
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.2008.088245
更新日期:2009-03-01 00:00:00
abstract:OBJECTIVES:To study the reliability and construct validity of ultrasound in interphalangeal finger joints affected by erosive osteoarthritis (EOA) and non-EOA with MRI as the reference method. METHODS:252 joints were examined by ultrasound, conventional radiography and clinical examination. Ultrasound was performed us...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2010.134932
更新日期:2011-02-01 00:00:00
abstract:OBJECTIVE:To conduct a cross-sectional review of non-selected consecutive outpatients with rheumatoid arthritis (RA) as part of standard clinical care in 15 countries for an overview of the characteristics of patients with RA. METHODS:The review included current disease activity using data from clinical assessment and...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,多中心研究
doi:10.1136/ard.2006.069252
更新日期:2007-11-01 00:00:00
abstract::Biological therapies directed at proinflammatory cytokines have irrevocably changed the landscape of treatment of rheumatoid arthritis (RA) and other autoimmune diseases. With the advances in our knowledge in cytokine signalling, the question emerges whether targeting intracellular signalling might also be a safe and ...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,评审
doi:10.1136/annrheumdis-2012-202576
更新日期:2013-04-01 00:00:00
abstract::The biochemical evidence against incorporation of the purine analogues, allopurinol and oxipurinol, into nucleic acids is reviewed. Cytological experiments have been carried out to investigate the possibility that chromosomal damage might result from exposure of human lymphocytes to these drugs. Lymphocytes from 19 pa...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.35.2.143
更新日期:1976-04-01 00:00:00
abstract:OBJECTIVES:To evaluate the risk of incident myocardial infarction (MI), stroke and peripheral vascular disease (PVD) in individuals with systemic sclerosis (SSc) in a general population context. METHODS:We conducted a cohort study using a UK primary care database containing records from 1986 to 2011. SSc diagnoses, ou...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/annrheumdis-2012-202007
更新日期:2013-07-01 00:00:00
abstract:OBJECTIVES:Reduced caveolin-1 levels in lung fibroblasts from patients with scleroderma and the lungs of bleomycin-treated mice promote collagen overexpression and lung fibrosis. This study was undertaken to determine whether caveolin-1 is deficient in leucocytes from bleomycin-treated mice and patients with scleroderm...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2009.117580
更新日期:2010-06-01 00:00:00
abstract:OBJECTIVE:To determine the circulating serum concentrations of nerve growth factor (NGF) and compare them with indices of disease activity in juvenile chronic arthritis. METHODS:NGF concentrations were evaluated with a two site immunoenzymatic assay (ELISA), in 17 children with systemic, 39 with polyarticular, and 24 ...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.55.10.745
更新日期:1996-10-01 00:00:00
abstract::The modulation of interleukin 1 (IL-1) effects on proteoglycan metabolism in intact murine patellar cartilage by transforming growth factor beta (TGF-beta) was investigated in vitro and in vivo. In vitro TGF-beta (400 pmol/l) had no effect on basal proteoglycan degradation. Proteoglycan degradation induced by IL-1, ho...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.52.3.185
更新日期:1993-03-01 00:00:00
abstract:BACKGROUND:Since approval of tocilizumab (TCZ) for treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA), interleukin 6 (IL-6) pathway inhibition was evaluated in trials of TCZ and other agents targeting the IL-6 receptor and ligand in various RA populations and other inflammatory diseases. Thi...
journal_title:Annals of the rheumatic diseases
pub_type: 共识发展会议,杂志文章
doi:10.1136/annrheumdis-2012-202469
更新日期:2013-04-01 00:00:00
abstract:OBJECTIVE:To assess the effects of tumour necrosis factor (TNF) antagonist therapy on B lymphocyte stimulator (BLyS) expression in patients with rheumatoid arthritis (RA). METHODS:Blood from 38 patients with RA from a single centre was collected prior to and following initiation of TNF antagonist therapy. Plasma BLyS ...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2007.079954
更新日期:2008-08-01 00:00:00
abstract:OBJECTIVE:To evaluate the safety, efficacy and therapeutic mechanism of BI 655064, an antagonistic anti-CD40 monoclonal antibody, in patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX-IR). METHODS:In total, 67 patients were randomised to receive weekly subcutaneous doses of 120 mg ...
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/annrheumdis-2018-214729
更新日期:2019-06-01 00:00:00
abstract:OBJECTIVES:The severity of joint destruction is highly variable between rheumatoid arthritis (RA) patients. The majority of its heritability is still unexplained. Several autoimmune diseases share genetic risk variants that may also influence disease progression. We aimed to identify genetic risk factors for the severi...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/annrheumdis-2013-203375
更新日期:2014-06-01 00:00:00
abstract:OBJECTIVES:The recombinant zoster vaccine (RZV) containing a strong non-aluminium adjuvant is associated with increased risk of gout flares, presumably via NLRP3 inflammasome activation. We tested the possibility that other vaccines may also be associated with gout flares. METHODS:We conducted an online case-crossover...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/annrheumdis-2019-215724
更新日期:2019-11-01 00:00:00
abstract:OBJECTIVES:To determine whether hormonal dysfunction involving the hypothalamic-pituitary-adrenal (HPA) axis, prolactin (PRL) secretion, and sex hormone status contribute to development of systemic lupus erythematosus (SLE). METHODS:11 patients with SLE and 9 healthy controls were tested for their total anterior pitui...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2003.018325
更新日期:2004-12-01 00:00:00
abstract:OBJECTIVES:Vascular endothelial growth factor (VEGF) is thought to play an important role in systemic sclerosis (SSc) pathogenesis. It was found to be upregulated in the serum and in the affected skin of scleroderma patients. However, its involvement in scleroderma lung disease is not clear. This study aimed to evaluat...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/annrheumdis-2011-200657
更新日期:2012-09-01 00:00:00
abstract:OBJECTIVE:Knee osteoarthritis commonly requires joint replacement, substantially reduces quality of life and increases healthcare utilisation and costs. This study aimed to identify whether quantitative measures of articular cartilage structure predict knee replacement, and to establish their utility as outcomes in cli...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,多中心研究
doi:10.1136/annrheumdis-2011-201164
更新日期:2013-05-01 00:00:00
abstract::The effect of intranasal salmon calcitonin on pain, erosion progression, and bone loss in 40 women with rheumatoid arthritis was investigated. The study design was double blind, placebo controlled for the first four months and open for the next 36 months, allowing for cross over to active drug treatment or to the cont...
journal_title:Annals of the rheumatic diseases
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1136/ard.51.6.761
更新日期:1992-06-01 00:00:00
abstract:OBJECTIVES:The exact regulation of the synthesis of cartilage specific molecules, such as collagen type II and aggrecan, by articular chondrocytes is unknown, but growth factors and hormones probably play an important part. The effects of glucocorticosteroids (prednisolone and triamcinolone), in combination with insuli...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.52.10.734
更新日期:1993-10-01 00:00:00
abstract::Six measurements of joint mobility were made in a group of 446 normal adolescents. A method of measuring hip and knee rotation is presented. All these data are normally distributed, and would suggest that joint hypermobility lies at the end of the normal spectrum. There was a weak but significant correlation between e...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.43.2.288
更新日期:1984-04-01 00:00:00
abstract:OBJECTIVE:To better understand the characteristics of synoviocytes located in the rheumatoid arthritis (RA) pannus. METHODS:One cell line, termed PSC, was cloned from RA pannus lesions. Phenotypic analysis was done by contrast microscopy, indirect immunostaining, and safranin O staining. Transcription of several proto...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.56.4.262
更新日期:1997-04-01 00:00:00
abstract:BACKGROUND:Although natural regulatory T cells (nTregs) can suppress osteoclastogenesis, the role of TGF-β-induced CD4+Foxp3+ Tregs (iTregs) in osteoclastogenesis remains unknown. OBJECTIVE:To determine the effects of iTregs on osteoclastogenesis in vitro and on bone erosion in vivo in collagen-induced arthritis (CIA)...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/annrheumdis-2011-201052
更新日期:2012-09-01 00:00:00
abstract::After in vitro incubation with 3H-thymidine, the proliferation of synovial lining cells and fibroblasts was investigated in surgically-removed articular tissue. Under normal conditions, in nonrheumatoid arthritis and in osteoarthrosis, low proliferation rates for both cell types were observed. In rheumatoid arthritis,...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.34.3.219
更新日期:1975-06-01 00:00:00
abstract:BACKGROUND:Increased apoptosis may induce autoimmune conditions. Apoptosis is induced by binding of death receptor ligands, members of the tumour necrosis factor (TNF) superfamily, to their cognate receptors. The Fas-Fas ligand pathway has been studied extensively in relation to systemic lupus erythematosus (SLE). Howe...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2004.029058
更新日期:2005-06-01 00:00:00
abstract::The 13 questions to which 173 rheumatic outpatients most frequently wished to know the answer were made the basis of a structured interview. Two lengths of interview were conducted in a controlled trial (short being of 2 minutes' duration, long ranging from 4 to 11 minutes). Sixty patients referred directly from their...
journal_title:Annals of the rheumatic diseases
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1136/ard.41.3.250
更新日期:1982-06-01 00:00:00
abstract:OBJECTIVE:To investigate the prevalence and clinical significance of carotid artery intima-media thickness (IMT) in patients with primary antiphospholipid syndrome (APS). METHODS:28 patients with primary APS with at least a five year follow up, and 28 healthy subjects, matched by age and sex, were included in the stud...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.62.7.607
更新日期:2003-07-01 00:00:00
abstract:OBJECTIVE:To determine the serum levels of nucleosome in patients with systemic sclerosis (SSc) and relate the results to the clinical features of SSc. METHODS:Serum nucleosome levels in 91 patients with SSc were examined by ELISA. The expression of Toll-like receptor (TLR) 9 in T and B cells was quantified by flow cy...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/annrheumdis-2015-207405
更新日期:2016-10-01 00:00:00