Early Nonradiographic Axial Spondyloarthritis Research Articles

Brief Report: Clinical Course Over Two Years in Patients With Early Nonradiographic Axial Spondyloarthritis and Patients With Ankylosing Spondylitis Not Treated With Tumor Necrosis Factor Blockers: Results From the German Spondyloarthritis Inception Cohort.

To investigate the clinical course of disease over 2 years in patients with nonradiographic axial spondylarthritis (SpA) and patients with ankylosing spondylitis (AS). The study group comprised 303 patients with axial SpA (158 patients with AS and a symptom duration of ≤10 years and 145 patients with nonradiographic axial SpA and a symptom duration of ≤5 years) who did not receive tumor necrosis factor (TNF) blockers during 2 years of followup. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) did not differ between patients with nonradiographic axial SpA and those with AS at any time point during followup. The Bath Ankylosing Spondylitis Functional Index was significantly higher in patients with AS at baseline only, but spinal mobility was generally better in patients with nonradiographic SpA compared with those with AS. At all time points, C-reactive protein (CRP) levels were significantly higher in patients with AS compared with patients with nonradiographic axial SpA. Accordingly, the Ankylosing Spondylitis Disease Activity Score (ASDAS) was significantly higher in the patients with AS at 2 of 4 time points. When patients with a BASDAI score of ≥4 plus an elevated CRP level at baseline were analyzed over time, there were no significant differences in the proportions of patients with nonradiographic axial SpA and those with AS who reached low disease activity status at ≥2 time points during 2 years of followup when a clinical definition of low disease activity was used (38% and 35%, respectively, achieved a BASDAI score of <4, and 13% and 15%, respectively, achieved a score of ≤2). When definitions that included the CRP level were used, however, a greater percentage of patients with nonradiographic axial SpA achieved low disease activity (25% of patients with nonradiographic axial SpA and 10% of patients with AS achieved a BASDAI score of <4 and a normal CRP level, and 13% of patients with nonradiographic axial SpA and 3% of those with AS achieved ASDAS-defined low disease activity). Patients with nonradiographic axial SpA and those with AS who were not treated with TNF blockers demonstrated a similar clinical disease course over 2 years. Patients with nonradiographic axial SpA achieved a status of low disease activity more frequently than those with AS if outcome parameters that included the CRP level were used.

Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study

ObjectiveTo evaluate the efficacy and safety of etanercept (ETN) after 48 weeks in patients with early active non-radiographic axial spondyloarthritis (nr-axSpA).MethodsPatients meeting Assessment of SpondyloArthritis international Society (ASAS) classification criteria...

Symptomatic efficacy of etanercept and its effects on objective signs of inflammation in early nonradiographic axial spondyloarthritis: a multicenter, randomized, double-blind, placebo-controlled trial.

To assess the efficacy of etanercept in the treatment of early active nonsteroidal antiinflammatory drug (NSAID)-refractory nonradiographic axial spondyloarthritis (SpA). The study population consisted of patients who met the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA but not the modified New York radiographic criteria for ankylosing spondylitis (as assessed by a radiologist at the central trial site), had a symptom duration of >3 months but <5 years, had a score of ≥4 on the Bath Ankylosing Spondylitis Disease Activity Index, and had been treated unsuccessfully with ≥2 NSAIDs. Patients were randomized to receive etanercept 50 mg/week or placebo and continued background NSAID treatment for 12 weeks (double-blind study); during the subsequent open-label period, all patients received etanercept 50 mg/week. The primary study end point was meeting the ASAS criteria for 40% improvement (ASAS40) at week 12. Magnetic resonance imaging (MRI) of the sacroiliac joints and spine was performed at baseline and week 12. One hundred six patients were randomized to the etanercept group and 109 to the placebo group. Of the 215 patients, the mean ± SD age at baseline was 32.0 ± 7.8 years, 154 (72%) were HLA-B27 positive, and 174 (81%) had MRI-confirmed sacroiliitis. At 12 weeks, the proportion of patients with improvement according to the ASAS40 was significantly higher in the etanercept group than in the placebo group (34 of 105 [32%] versus 17 of 108 [16%]; P = 0.006). Patients who received etanercept exhibited a greater reduction in MRI-based scores for sacroiliac joint inflammation (-46.9% versus -10.9%; P < 0.001) and spinal inflammation (-45.4% versus -33.4%; P = 0.04) compared with placebo-treated patients at week 12. Post hoc analyses suggested a possible association between higher baseline C-reactive protein levels or MRI sacroiliac joint inflammation scores and higher rates of ASAS40 response to etanercept. At week 24, patients in the placebo group who had switched to etanercept at 12 weeks exhibited improvement similar to that observed in patients who had received etanercept for 24 weeks. In patients with nonradiographic axial SpA, etanercept treatment was associated with rapid, significant improvement in symptomatic disease activity, function, and systemic and skeletal inflammation over 12 weeks; clinical/functional improvement was sustained over 24 weeks.

SAT0350 Quality of Life with Etanercept in Early Non-Radiographic Axial Spondyloarthritis: 24 and 48-Week Data from A Randomized, Double-Blind, Placebo-Controlled Trial

BackgroundAnti-TNF agents are recommended treatment for NSAID-resistant radiographic ankylosing spondylitis (AS). Long-term quality of life (QoL) data available in axial spondyloarthritis (axSpA), prior to radiographic detection of change (i.e., non-radiographic...

SAT0372 Clinical and Imaging Efficacy of Etanercept in Early Non-Radiographic Axial Spondyloarthritis: 48-Week Treatment Data

BackgroundOur previous data show that Etanercept (ETN) has superior clinical and anti-inflammatory efficacy to placebo (PBO) in patients with non-radiographic axial spondyloarthritis (nr-axSpA) and inadequate response to NSAIDs in a...

OP0108 Clinical and Imaging Efficacy of Etanercept in Early Non-Radiographic Axial Spondyloarthritis: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial

BackgroundAnti-TNF agents are currently recommended for the treatment of NSAID-resistant ankylosing spondylitis, but limited data are available on their efficacy in axial spondyloarthritis (axSpA), particularly non-radiographic axSpA (nr-axSpA).ObjectivesTo compare the...

Decreased Th17 and Th1 cells in the peripheral blood of patients with early non-radiographic axial spondyloarthritis: a marker of disease activity in HLA-B27+ patients

To examine the frequency and phenotype of Th17 cells in the peripheral blood of patients with early non-radiographic axial SpA (early nrSpA). CD4(+) T cells were isolated from the peripheral blood of 30 early nrSpA patients, 11 AS patients and 41 age- and sex-matched healthy controls by Ficoll-Hypaque gradient and magnetic negative selection. After polyclonal stimulation, the frequency of Th17 and Th1 cells and of cells producing TNF-α or IL-10 was determined by cytometry and concentrations of IL-17, IL-22, IFN-γ, TNF-α, IL-10 and IL-4 were measured by ELISA. Early nrSpA but not AS patients demonstrated a significantly lower percentage of circulating Th17, Th1 and Th17/Th1 cells, together with lower CD4-derived IL-17 and IFN-γ secretion, as compared with controls. In contrast, the percentage of circulating cells producing IL-10 or TNF-α, and the secretion of CD4-derived IL-10, TNF-α, IL-22 and IL-4 in early nrSpA were not different from controls. All Th17 cells were CD45RO(+)CD45RA(-) and CCR6(+). The frequency of circulating Th17, Th1 and Th17/Th1 was negatively correlated with BASDAI, BASFI, ASDAS-CRP, ASDAS-ESR, AS quality of life (ASQOL) and patient's global assessment in HLA-B27(+) but not in HLA-B27(-) early nrSpA patients. A positive correlation between circulating Th17 cells and BASDAI was observed in AS. A decreased percentage of Th17, Th1 and Th17/Th1 cells is apparent in peripheral blood CD4(+) T cells from early nrSpA. Th17, Th1 and Th17/Th1 cell numbers are related to disease activity indices in HLA-B27(+), but not in HLA-B27(-), early nrSpA patients.