Arthritis research & therapy
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Arthritis Res. Ther. · Jun 2016
Randomized Controlled Trial Multicenter StudySafety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study.
Systemic sclerosis (SSc) is a clinically heterogeneous, life-threatening disease characterized by fibrosis, microvasculopathy, and autoimmunity. Extensive nonclinical and clinical data implicate B cells in the pathogenesis of SSc. MEDI-551 is an investigational humanized monoclonal antibody that targets the B cell surface antigen CD19 and mediates antibody-dependent, cell-mediated cytotoxicity of B cells. This clinical study evaluated the safety and tolerability, pharmacokinetics, and pharmacodynamics of MEDI-551 in subjects with SSc. ⋯ A single escalating dose of MEDI-551 was tolerable and safe in this subject population. B cell depletion was achieved and was dose dependent. A signal of clinical effect was observed. Based on these results, further investigation of MEDI-551 as a disease-modifying treatment for SSc is warranted.
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Arthritis Res. Ther. · Jun 2016
Multicenter StudyThe prevalence and clinical characteristics of nonradiographic axial spondyloarthritis among patients with inflammatory back pain in rheumatology practices: a multinational, multicenter study.
Patients with ankylosing spondylitis (AS), who by definition have radiographic sacroiliitis, typically experience symptoms for a decade or more before being diagnosed. Yet, even patients without radiographic sacroiliitis (i.e., nonradiographic axial spondyloarthritis [nr-axSpA]) report a significant disease burden. The primary objective of this study was to estimate the prevalence and clinical characteristics of nr-axSpA among patients with inflammatory back pain (IBP) in rheumatology clinics in a number of countries across the world. A secondary objective was to estimate the prevalence of IBP among patients with chronic low back pain (CLBP). ⋯ These results suggest that, in the centers that participated in the study, 29 % of patients with IBP met the criteria for nr-axSpA and 39 % of patients with CLBP had IBP. The disease burden in nr-axSpA is substantial and similar to that of AS, with both groups of patients experiencing inadequate disease control. These findings suggest the need for early detection of nr-axSpA and initiation of available treatment options to slow disease progression and improve patient well-being.
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Arthritis Res. Ther. · Jan 2016
Randomized Controlled Trial Multicenter StudyTofacitinib, an oral Janus kinase inhibitor, as monotherapy or with background methotrexate, in Japanese patients with rheumatoid arthritis: an open-label, long-term extension study.
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. Here, tofacitinib safety and efficacy data from a long-term extension study in Japanese patients are presented. ⋯ Tofacitinib (with or without background methotrexate) demonstrated a stable safety profile and sustained efficacy in Japanese patients with active rheumatoid arthritis. The risk of herpes zoster appears to be higher in Japanese patients treated with tofacitinib than in the global population.
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Arthritis Res. Ther. · Nov 2015
Randomized Controlled Trial Multicenter StudyEffects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs.
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. ⋯ Tofacitinib monotherapy in DMARD-IR patients resulted in statistically significant and clinically meaningful improvements in multiple PROs versus placebo at month 3, with sustained improvements over 6 months.
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Arthritis Res. Ther. · Sep 2015
Multicenter StudySponyloarthritis features forecasting the presence of HLA-B27 or sacroiliitis on magnetic resonance imaging in patients with suspected axial spondyloarthritis: results from a cross-sectional study in the ESPeranza Cohort.
Chronic back pain (CBP) is frequently the presenting symptom in patients with suspected axial spondyloarthritis (axSpA). Presence of sacroiliitis on magnetic-resonance-imaging (MRI) or HLA-B27 adds to diagnostic certainty. However, these costly tests cannot be applied in all patients with CBP. This study aims to investigate which SpA features increase the likelihood of a positive HLA-B27 or positive MRI of the sacroiliac-joints (MRI-SI) in patients with suspected axSpA. ⋯ If patients with suspected axial SpA have either (1) IBP according to Calin/ASAS definition plus alternating buttock pain, or (2) IBP according to Calin definition plus awakening at night, or (3) dactylitis or 4) IBD, the probability of finding a positive MRI-SI increases significantly.