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OBJECTIVE: Etanercept, a fully human tumor necrosis factor soluble receptor, is effective in treatment of ankylosing spondylitis (AS). Current guidelines suggest sulfasalazine (SSZ) treatment as initial therapy for the management of patients with AS with peripheral arthritis versus therapy with biologics. We compared the efficacy of etanercept with SSZ in patients with AS with peripheral joint involvement. METHODS: The efficacy of etanercept 50 mg once weekly was compared with that of SSZ up to 3 g daily in subjects with ≥ 1 swollen peripheral joint at baseline, using data from a 16-week randomized double-blind study in subjects with AS. Efficacy was assessed by the Assessment in AS criteria and the Bath AS Disease Activity, Functional, and Metrology indices. The last observation carried forward method was used for imputation of missing values. RESULTS: Of 566 subjects included in original study, 181 (etanercept 121; SSZ 60) had ≥ 1 swollen peripheral joint and 364 (etanercept 250; SSZ 124) had none at baseline. AS patients treated with etanercept showed significantly greater improvement than those treated with SSZ in all joint assessments regardless of swollen joint involvement. CONCLUSION: In this analysis, etanercept was significantly more effective than SSZ for management of patients with AS and peripheral joint involvement.

OBJECTIVE: To determine the reliability and feasibility of a new magnetic resonance imaging (MRI) score to quantify bone marrow edema (BME), synovitis, and erosions in the cervical spine of patients with rheumatoid arthritis (RA); and to investigate the correlations among neck pain, clinical markers of RA disease activity, and MRI features of disease activity in the cervical spine. METHODS: Thirty patients with RA (50% with neck pain) and a Disease Activity Score 28-joint count > 3.2 had an MRI scan of their cervical spine. STIR, VIBE, and T1-weighted postcontrast sequences were used to quantify BME. MRI scans were scored for total BME, synovitis, and erosions using a new scoring method developed by the authors and assessed for reliability and feasibility. Associations between neck pain and clinical markers of disease activity were investigated. RESULTS: BME was present in 14/30 patients; 9/14 (64%) had atlantoaxial BME, 10/14 (71%) had subaxial BME, and 5/14 (36%) had both. Interobserver reliability for total cervical BME score was moderate [intraclass correlation coefficient (ICC) = 0.51]. ICC improved to 0.67 if only the vertebral bodies and dens were considered. There was no correlation between neck pain or clinical measures of RA disease activity and the presence of any MRI features including BME, synovitis, or erosions. CONCLUSION: Current RA disease activity scores do not identify activity in the cervical spine. An MRI score that quantifies BME, synovitis, and erosions in the cervical spine may provide useful information regarding inflammation and damage. This could alert clinicians to the presence of significant pathology and influence management.

OBJECTIVE: To create a core set of measurement concepts for use in the creation and maintenance of anti-tumor necrosis factor-α patient registries in ankylosing spondylitis (AS). METHODS: A Delphi-based approach was used to identify elements that best identify a patient's clinical state, disease progression, and potential drug-related toxicities. Decision-making was based on systematic literature reviews and clinical experience and expertise. RESULTS: A core set of measurement domains was defined including disease activity and physical function outcomes. Comparison with domains used in existing AS registries showed excellent agreement with current practice. CONCLUSION: This core set is a basis for data collection across AS populations.

OBJECTIVE: To assess the performance of the Barthel Index (BI) in patients with rheumatoid arthritis (RA) in the acute care hospital, as compared to the Stanford Health Assessment Questionnaire (HAQ) and the Hannover Functional Questionnaire (Funktionsfragebogen Hannover, FFbH). METHODS: A prospective study of 97 patients with RA admitted to an acute rheumatology hospital with new onset or acute flare of RA. Patients were required to self-complete the BI, the HAQ, and the FFbH. Disease activity was measured using the Disease Activity Score (DAS28). RESULTS: Seventy-eight percent of patients were female, average age was 61.5 (SD 12.5) years, and 72.2% were rheumatoid factor-positive. The median HAQ was 1.29 (range 0-3), median FFbH was 50% (6-100%), and median BI was 95 (0-100), and distribution was highly skewed. All measures of physical functioning were significantly correlated with each other and with the DAS28; however, the BI discriminated poorly between low and high disease activity. CONCLUSION: The BI is not a useful instrument to assess physical functioning in patients with acute symptoms of RA, but may have a role in assessing patients with comorbidities and in assessing nursing care needs in the acute care hospital.

OBJECTIVE: To evaluate the short-term effects of bosentan on myocardial perfusion and function assessed by cardiac magnetic resonance imaging (MRI) and Tissue-Doppler echography (TDE) respectively in patients with systemic sclerosis (SSc). METHODS: We prospectively evaluated 18 SSc patients without clinical heart failure and with normal pulmonary arterial pressure. MRI perfusion index and systolic and diastolic strain rates (SR) determined by TDE were assessed at baseline for comparison with healthy controls (after a 72-hour vasodilator washout period), and repeated after 4 weeks of bosentan treatment (62.5 mg bid for 2 weeks titrated to 125 mg bid for 2 weeks). RESULTS: Patients with SSc had decreased MRI perfusion index and TDE SR in comparison with healthy controls. Bosentan treatment led to a significant increase in median (range) global MRI perfusion index [from 0.17 (0.09-0.23) at Day 0 to 0.22 (0.13-0.30) after bosentan treatment; p = 0.0004], systolic SR [from 2.1 (1.3-3.1) s-1 to 2.8 (2.1-4.8) s-1; p = 0.0002), and diastolic SR [from 2.6 (1.4-6.7) to 3.6 (2.0-7.6) s-1; p = 0.0003]. CONCLUSION: Short-term treatment with bosentan simultaneously improves myocardial perfusion and function, as evaluated by highly sensitive and quantitative methods, in patients with SSc. Whether additional remodeling effect may be observed after longterm treatment with bosentan remains to be determined.

Magnetic resonance imaging (MRI) of the sacroiliac (SI) joints and the spine is increasingly important in the assessment of inflammatory activity and structural damage in clinical trials with patients with ankylosing spondylitis (AS). We investigated inter-reader reliability and sensitivity to change of several scoring systems to assess disease activity and change in disease activity in patients with AS. Twenty sets of consecutive MRI, derived from a randomized clinical trial comparing an active drug with placebo and selected on the basis of the presence of activity at baseline, were presented electronically to 7 experienced readers from different countries (Europe, Canada). Readers scored the MRI by 3 different methods including: a global score (grading activity per SI joint); a more comprehensive global score (grading activity per SI joint per quadrant); and a detailed scoring system [Spondyloarthritis Research Consortium of Canada (SPARCC) scoring system], which scores 6 images, divided into quadrants, with additional scores for "depth" and "intensity." A fourth and a fifth scoring system were constructed afterwards. The fourth method included the SPARCC score minus the additional scores for "depth" and "intensity," and the fifth method included the SPARCC slice with the maximum score. Inter-reader reliability was investigated by calculating intraclass correlation coefficients (ICC) for all readers together and for all possible reader pairs. Sensitivity to change was investigated by calculating standardized response means (SRM) on change scores that were made positive. Overall inter-reader ICC per method were between 0.47 and 0.58 for scoring status, and between 0.40 and 0.53 for scoring change. ICC per possible reader pairs showed much more fluctuation per method, with lowest observed values close to zero (no agreement) and highest observed values over 0.80 (excellent agreement). In general, agreement of status scores was somewhat better than agreement of change scores, and agreement of the comprehensive SPARCC scoring system was somewhat better than agreement of the more condensed systems. Sensitivity to change differed per reader, but in general was somewhat better for the comprehensive SPARCC system. This experiment under "real life," far from optimal conditions demonstrates the feasibility of scoring exercises for method comparison, provides evidence for the reliability and sensitivity to change of scoring systems to be used in assessing activity of SI joints in clinical trials, and sets the conditions for further validation research in this field.

Magnetic resolution imaging (MRI) is a promising tool in the assessment of inflammation and structural damage in clinical trials in ankylosing spondylitis (AS). The ASAS/OMERACT MRI in AS working group, a collaborative initiative of rheumatologists and musculoskeletal radiologists with a special interest in this field, collected data on all available scoring methods for both sacroiliac (SI) joints and spine, and tested them with respect to the OMERACT filter. These data were presented together with the technical specifications of all methods at the OMERACT 7 conference. In addition, the results of 2 separate experiments on the inter-reader reliability of scoring methods to assess activity in SI joints, and on the comparison of STIR sequence versus T1 post-gadolinium (Gd) sequence for the spine, were presented. Thereafter, 8 groups discussed these data and proposed a research agenda, each on a different topic. This information was reported back to all participants and a prioritized research agenda was compiled by voting. Research on scoring methods for assessing disease activity, in both the spine and SI joints, was considered most important. Research on assessing structural damage was considered less important. The specific process and results of this initiative are discussed.

OBJECTIVE: Tumor necrosis factor-alpha (TNF-alpha) has been detected in sacroiliac joints of patients with spondyloarthropathies (SpA). Anti-TNF-a therapy has been efficacious in patients with active ankylosing spondylitis (AS) and psoriatic arthritis. Similar to these SpA subtypes, therapeutic options in undifferentiated SpA (uSpA) are also limited. We tested the efficacy of the monoclonal anti-TNF-alpha antibody infliximab in patients with active and severe uSpA in an open observation trial. METHODS: Six patients with uSpA were treated with 3 infusions of infliximab in a dosage of 3 (n = 3) or 5 mg/kg (n = 3) at Weeks 0, 2, and 6. The total observational period was 12 weeks. The Bath AS Disease Activity Index (BASDAI), the Functional Index (BASFI), pain on a visual analog scale, the Bath AS Metrology Index (BASMI), and quality of life (SF-36) were assessed before, during, and after therapy. RESULTS: Significant improvement at Day 1 after the first infusion lasting until Week 12 was reported by 5/6 patients. Improvement of > or = 50% in all activity, function, pain, and swollen joint scores was observed in the patients taking 5 mg/kg. The 3 mg/kg dose was less effective, resulting in > or = 15% improvement in outcome variables. Peripheral arthritis, enthesitis, and spinal symptoms improved equally. C-reactive protein dropped in 4 patients. Health related quality of life increased. No serious side effects or infections occurred. CONCLUSION: These observations suggest that anti-TNF-alpha therapy has significant short term efficacy in patients with severe uSpA.