Abstract:
OBJECTIVES:The aim of this report is to demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence as well as similar efficacy, safety and immunogenicity between GP2013, a biosimilar rituximab, and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate response or intolerance to tumour necrosis factor inhibitor (TNFi) treatment. METHODS:In this multinational, randomised, double-blind, parallel-group study, 312 patients with active disease despite prior TNFi therapy were randomised to receive GP2013 or either the EU (RTX-EU) or the US (RTX-US) reference product, along with methotrexate (MTX) and folic acid. The primary endpoint was the area under the serum concentration-time curve from study drug infusion to infinity (AUC0-inf). Additional PK and PD parameters, along with efficacy, immunogenicity and safety outcomes were also assessed up to week 24. RESULTS:The 90% CI of the geometric mean ratio of the AUCs were within the bioequivalence limits of 80% to 125% for all three comparisons; GP2013 versus RTX-EU: 1.106 (90% CI 1.010 to 1.210); GP2013 versus RTX-US: 1.012 (90% CI 0.925 to 1.108); and RTX-EU versus RTX-US: 1.093 (90% CI 0.989 to 1.208). Three-way PD equivalence of B cell depletion was also demonstrated. Efficacy, safety and immunogenicity profiles were similar between GP2013 and RTX. CONCLUSIONS:Three-way PK/PD equivalence of GP2013, RTX-EU and RTX-US was demonstrated. Efficacy, safety and immunogenicity profiles were similar between GP2013 and RTX. TRIAL REGISTRATION NUMBER:NCT01274182; Results.
journal_name
Ann Rheum Disjournal_title
Annals of the rheumatic diseasesauthors
Smolen JS,Cohen SB,Tony HP,Scheinberg M,Kivitz A,Balanescu A,Gomez-Reino J,Cen L,Zhu P,Shisha Tdoi
10.1136/annrheumdis-2017-211281subject
Has Abstractpub_date
2017-09-01 00:00:00pages
1598-1602issue
9eissn
0003-4967issn
1468-2060pii
annrheumdis-2017-211281journal_volume
76pub_type
杂志文章,多中心研究,随机对照试验abstract::Chemotactic migration of leucocytes largely depends on adhesive interaction with the substratum and recognition of a chemoattractant gradient. Both aspects, cell adhesion and chemotaxis, are regulated by members of the family of chemotactic cytokines (chemokines) comprising structurally related and secreted proteins o...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,评审
doi:10.1136/ard.2004.028316
更新日期:2004-11-01 00:00:00
abstract:OBJECTIVES:To characterise and quantify the CD4+ CD25+ T cell population in patients with systemic lupus erythematosus (SLE) and to detect the possible influence of treatments and clinical manifestations. METHODS:Characterisation of CD25(low) and CD25(high) CD4+ T cells from healthy controls and from patients with SLE...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2005.049924
更新日期:2006-11-01 00:00:00
abstract::Naproxen at 10 mg per kg body weight was compared with aspirin at 80 mg per kg body weight in children suffering from juvenile chronic polyarthritis. It was found to be as effective as aspirin, with certainly no more and possibly fewer gastrointestinal side effects. A long-term tolerance study up to 12 months confirme...
journal_title:Annals of the rheumatic diseases
pub_type: 临床试验,杂志文章
doi:10.1136/ard.38.2.152
更新日期:1979-04-01 00:00:00
abstract::An 85 year old man with a longstanding history of non-tophaceous gout developed a single large tophus, unassociated with inflammation, on his paretic leg over a six week period following an acute hemiplegia. The rapidity of tophus formation, its localisation to the paretic limb, and the apparent blunting of the acute ...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.52.4.308
更新日期:1993-04-01 00:00:00
abstract::There is no agreement as to which variable best mirrors disease activity in rheumatoid arthritis (RA) and no studies have been performed on the validity of disease activity variables. In this study the validity of 10 commonly used single variables and three composite indices was tested. All patients participated in a ...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.51.2.177
更新日期:1992-02-01 00:00:00
abstract:AIM:To assess the prevalence and the nature of autonomic neuropathy (AN) in 17 patients with inactive or mild active systemic lupus erythematosus (SLE). METHODS:Patients were tested using questionnaires related to possible AN symptoms, and four non invasive cardiovascular autonomic function tests at rest, during lying...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.53.10.671
更新日期:1994-10-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to assess the value of power Doppler ultrasound (PDUS) in combination with routine management in a cohort of patients with very early inflammatory arthritis (IA). METHODS:50 patients with < or =12 weeks of inflammatory symptoms with or without signs had clinical, laboratory and ima...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2008.106658
更新日期:2010-02-01 00:00:00
abstract:BACKGROUND:Anti-tumour necrosis factor (TNF) therapy may be associated with opportunistic infections (OIs). OBJECTIVE:To describe the spectrum of non-tuberculosis OIs associated with anti-TNF therapy and identify their risk factors. METHODS:A 3-year national French registry (RATIO) collected all cases of OI in patien...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,多中心研究
doi:10.1136/ard.2010.137422
更新日期:2011-04-01 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
abstract::Antibody production in response to the primary immunogen bacteriophage phi X174 was investigated in 14 patients with previous yersinia arthritis (YA) and in 15 controls. HLA-B27 occurred in 10 patients with YA and in three controls. After primary and secondary immunisation the antibody responses were essentially simil...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.46.12.883
更新日期:1987-12-01 00:00:00
abstract:BACKGROUND:Antibodies directed to proteins containing the non-standard amino acid citrulline, are extremely specific for rheumatoid arthritis (RA). Peptidylcitrulline can be generated by post-translational conversion of arginine residues. This process, citrullination, is catalysed by a group of calcium dependent peptid...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2003.012211
更新日期:2004-04-01 00:00:00
abstract:BACKGROUND:Comprehensive multisystem clinical assessment using the Birmingham Vasculitis Activity score (BVAS) is widely used in therapeutic studies of systemic vasculitis. Extensive use suggested a need to revise the instrument. The previous version of BVAS has been revised, according to usage and reviewed by an exper...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2008.101279
更新日期:2009-12-01 00:00:00
abstract:OBJECTIVE:To investigate if the increased concentrations of stromelysin (MMP-3) found in the synovial fluid (SF) of patients with various arthritides reflect the concentrations in the circulation. METHODS:Using a double antibody ELISA, we have measured proMMP-3 concentrations in sera from these patient groups and in o...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.53.11.768
更新日期:1994-11-01 00:00:00
abstract::The radiological development from normal bone of geodes and subsequent fractures in phalanges of two adjacent fingers is described in a patient with classical rheumatoid arthritis. Presentation was as a septic, discharging focus, but infection was excluded; the pathology is described. ...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.44.2.130
更新日期:1985-02-01 00:00:00
abstract:OBJECTIVE:To formulate EULAR recommendations for the management of early arthritis. METHODS:In accordance with EULAR's "standardised operating procedures", the task force pursued an evidence based approach and an approach based on expert opinion. A steering group comprised of 14 rheumatologists representing 10 Europea...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,实务指引
doi:10.1136/ard.2005.044354
更新日期:2007-01-01 00:00:00
abstract::Polyclonal anticardiolipin antibodies purified from pooled serum samples of patients with systemic lupus erythematosus were shown to have inhibitory effects on cultured normal rat brain astrocytes (RBA-1 cells). Anticardiolipin antibodies at concentrations from 50 to 200 micrograms/ml inhibited the [3H]thymidine incor...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.51.6.707
更新日期:1992-06-01 00:00:00
abstract:OBJECTIVES:To evaluate changes in bone mineral density (BMD) in the hands, hip and spine after 1 and 2 years of follow-up, in relation to antirheumatic and antiresorptive therapies and disease and demographic variables in patients with recent-onset rheumatoid arthritis (RA). METHODS:Changes in BMD measured in metacarp...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,多中心研究
doi:10.1136/ard.2007.086348
更新日期:2009-03-01 00:00:00
abstract:OBJECTIVES:Leri's pleonosteosis (LP) is an autosomal dominant rheumatic condition characterised by flexion contractures of the interphalangeal joints, limited motion of multiple joints, and short broad metacarpals, metatarsals and phalanges. Scleroderma-like skin thickening can be seen in some individuals with LP. We u...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/annrheumdis-2013-204309
更新日期:2015-06-01 00:00:00
abstract:BACKGROUND:There is emerging evidence that the development and progression of osteoarthritis (OA) is associated with inflammation. C reactive protein (CRP), a systemic marker for inflammation, may be elevated in OA patients but the evidence is conflicting. OBJECTIVE:To systematically review the literature for the rela...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,meta分析,评审
doi:10.1136/annrheumdis-2013-204494
更新日期:2015-04-01 00:00:00
abstract:BACKGROUND:Diagnosis of active pulmonary and paranasal involvement in patients with Wegener's granulomatosis (WG) can be difficult. The diagnostic value of gallium-67 scintigraphy in WG is unclear. OBJECTIVE:To evaluate the added diagnostic value of gallium-67 scintigraphy in patients with WG with suspected granulomat...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.62.7.659
更新日期:2003-07-01 00:00:00
abstract:OBJECTIVE:To evaluate the potential utility of a dual energy CT (DECT) scan in assessing urate deposits among patients with tophaceous gout, and obtain computerised quantification of tophus volume in peripheral joints. METHODS:20 consecutive patients with tophaceous gout and 10 control patients with other arthritic co...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2008.099713
更新日期:2009-10-01 00:00:00
abstract::The case presented is of a patient with migratory polyarthritis and serological evidence of a recent streptococcal infection, consistent with the diagnosis of acute rheumatic fever, who in addition had multisystem disease manifestations. This case supports the concept that the sequelae of streptococcal infection can e...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.50.5.328
更新日期:1991-05-01 00:00:00
abstract::The relation between the basal and stimulated gastric acid secretion, plasma gastrin, and the gastric microflora was examined in 45 patients with rheumatoid arthritis. Sixteen patients (36%) had basal achlorhydria, and of these, 10 (22%) had achlorhydria or hypochlorhydria after stimulation with pentagastrin. The peak...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.45.6.475
更新日期:1986-06-01 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::A 33-year-old male with definite Behçet's disease had rheumatoid-like nodules at his elbows. This finding, we believe, represents another manifestation of vasculitis in Behçet's disease. ...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.40.2.182
更新日期:1981-04-01 00:00:00
abstract::Three patients presented with septal fasciitis and panniculitis, associated with clinical and laboratory features which precluded straight-forward classification into eosinophilic fasciitis, localised scleroderma, or lupus erythematosus profundus. Treatment with cimetidine caused the remission of cutaneous manifestati...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.49.10.788
更新日期:1990-10-01 00:00:00
abstract:OBJECTIVE:To determine the influence of TAP1 and TAP2 alleles in northwestern Colombian patients with systemic lupus erythematosus (SLE). METHODS:Unselected patients with SLE (n=140) and controls (n=120) matched for sex, age, and ethnicity were analysed. Clinical manifestations, clinical activity, and severity of dise...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,多中心研究
doi:10.1136/ard.62.4.363
更新日期:2003-04-01 00:00:00
abstract:OBJECTIVES:Prior studies have suggested a potential link between nasal microbes and granulomatosis with polyangiitis (GPA; Wegener's), but these studies relied on culture-dependent methods. This study comprehensively examined the entire community of nasal microbiota (bacteria and fungi) in participants with GPA compare...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/annrheumdis-2018-213645
更新日期:2018-10-01 00:00:00
abstract::Sepsis is a severe complication of abdominal infections such as peritonitis and is associated with high mortality. Unfortunately, the molecular mechanisms controlling the development of sepsis are still incompletely understood. Interestingly, the interleukin (IL) 12 family member IL27 seems to play a key role in sepsi...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章,评审
doi:10.1136/ard.2007.078337
更新日期:2007-11-01 00:00:00
abstract:BACKGROUND:Qualitative differences in synovitis between the cartilage-pannus junction (CPJ) region and the adjoining suprapatellar pouch (SPP) have been reported in rheumatoid arthritis and the spondyloarthropathies. OBJECTIVE:To determine if the distribution of synovitis is the same in osteoarthritis (OA) using sensi...
journal_title:Annals of the rheumatic diseases
pub_type: 杂志文章
doi:10.1136/ard.2004.033688
更新日期:2005-09-01 00:00:00