Objective. To evaluate the efficacy, including radiographic changes, and safety of etanercept and methotrexate (MTX), used in combination and alone, in patients with rheumatoid arthritis (RA) in whom previous treatment with a disease-modifying antirheumatic drug other than MTX had failed.Methods. Patients with RA were treated with etanercept (25 mg subcutaneously twice weekly), oral MTX (up to 20 mg weekly), or combination therapy with etanercept plus MTX through a second year, in a double-blinded manner. Clinical response was assessed using American College of Rheumatology (ACR) criteria and the Disease Activity Score (DAS), in a modified intent-to-treat analysis with the last observation carried forward (LOCF) and in a population of completers. Radiographs of the hands, wrists, and forefeet were scored for erosions and joint space narrowing at annual intervals.Results. A total of 503 of 686 patients continued into year 2 of the study. During the 2 years, significantly fewer patients receiving combination therapy withdrew from the study (29% of the combination therapy group, 39% of the etanercept group, and 48% of the MTX group). Both the LOCF and the completer analyses yielded similar results. The ACR 20% improvement (ACR20), ACR50, and ACR70 responses and the remission rates (based on a DAS of <1.6) were significantly higher with combination therapy than with either monotherapy (P < 0.01). Similarly, improvement in disability (based on the Health Assessment Questionnaire) was greater with combination therapy (P < 0.01). The combination therapy group showed significantly less radiographic progression than did either group receiving monotherapy (P < 0.05); moreover, radiographic progression was significantly lower in the etanercept group compared with the MTX group (P < 0.05). For

Objective: To assess methods to calculate achieving and sustaining remission in a double blind randomised trial in patients with RA who received etanercept, methotrexate, or an etanercept/ methotrexate combination. Methods: Remission was defined as DAS ,1.6, DAS28 ,2.6, and ACR70 response. Sustaining remission was analysed in three ways: (a) analysis of sustained DAS remission, DAS28 remission, or ACR70 response continuously for 6 months; (b) analysis of sustained remission appraised through a continuity rewarded scoring system, which is the weighted sum of all intervals in the study in which patients are in DAS or DAS28 remission; or (c) longitudinal modelling of remission odds using generalised estimating equations. Results: Significantly more patients treated with the etanercept/methotrexate combination reached DAS remission (37%) than those treated with either methotrexate (14%) or etanercept (18%) alone (p,0.01). Results for DAS28 and for the ACR70 response were similar. Agreement between DAS remission and DAS28 remission was good, but agreement between either of these and the ACR70 response was less. Patients in DAS or DAS28 remission had a lower level of disease activity (fewer active joints, lower ESR) than those achieving ACR70 response; the converse was seen using pain VAS. The three methods were comparable for sustainability of remission and showed significant advantage for combination therapy, which increased the number and durability of remission periods. Conclusions: DAS and DAS28 remission results were similar for assessing achieving and sustaining remission in RA, frequently differing from patients classified as ACR70 responders. The three methods of examining duration of remission produced comparable results. R heumatoid arthritis (RA) is associated with significant morbidity, mortality, and healthcare expenditure.

The purpose of this study is to evaluate bone mineral density (BMD) and bone turnover markers in men with ankylosing spondylitis (AS) and to determine their relationship with clinical features and disease activity. Serum carboxi terminal cross-linked telopeptide of type I collagen (CTX), osteocalcin (OC) levels, and BMD of lumbar spine and proximal femur were evaluated in 44 males with AS, 18-60 years of age, and compared with those of 39 age-matched healthy men. Men with AS had a significantly lower BMD at the femoral neck and total hip as compared to age-matched controls (all p < 0.01). Osteopaenia or osteoporosis was found in 59.5% AS patients at the lumbar spine and in 47.7% at the femoral neck. Mean serum levels of OC and CTX were similar in AS patients and controls. There were no significant differences in BMD and bone turnover markers when comparing subgroups stratified according to disease duration or presence of peripheral arthritis. No correlations were found between disease activity markers and BMD or OC and CTX. In a cohort of relatively young males with AS, we found a high incidence of osteopaenia and osteoporosis. Disease activity and duration did not show any significant influence on BMD or serum levels of OC and CTX.

Objective: The objectives of this study were: determination of serum hepcidin levels in patients with Rheumatoid arthritis (RA) with/without anemia and controls, and its correlation with disease activity and anemia parameters. Patients and Methods: 69 people were involved in our study: 54 patients and 15 healthy subjects (controls). Laboratory evaluation of anemia, iron parameters, serum hepcidin levels and disease activity was carried out. RA patients were divided in two groups: anemic group and non-anemic group (NA), according to hemoglobin levels (Hb). Soluble transferrin receptor-ferritin index (sTfR-F index) was used to classify anemia types: anemia of chronic disease (ACD) and anemia of chronic disease + iron deficiency anemia (ACD+IDA). Disease activity was evaluated using the following parameters: erythrocyte sedimentation rate (ESR), C-reactive protein (CPR), and disease activity score (DAS28). Results: ACD and ACD+IDA groups had significantly higher serum hepcidin concentrations than controls (p<0.001, p<0.001), and NA group (p=0.006, p=0.002). No difference in hepcidin levels was observed between ACD and ADC+IDA groups (p=0.85) and between NA and controls (p=0.66). ESR was significantly higher in ACD and ACD+IDA groups compared with NA group (p<0.001, p=0.002) and controls. (p<0.001, p<0.001).DAS 28 score was higher in anemic groups than NA group (ACD vs. NA, p=0.01), (ACD+IDA vs. NA, p=0.01) and no difference was observed between ACD and ACD+IDA In RA patients serum hepcidin concentration was significantly negatively correlated with hemoglobin (Hb) (r=-0.459, p<0.000) and serum iron(r=-0.357, p<0.01) and positively with disease activity variables: ESR (r=0.352, p<0.01) , CRP (r=0.369, p<0.01), DAS28 score (r=0.289, p<0.05). Conclusion: Hepcidin increases in RA patients with anemia and its levels correlate with Hb, serum iron, and disease activity variables.

AbstractQuantitative ultrasound (QUS) is of increasing interest for evaluation of osteoporosis because, compared with dual-energy X-ray absorptiometry (DXA), it is portable, less expensive, and radiation-free. The aim of our study was to determine the sensitivity, specificity, and cut-off values of quantitative ultrasound parameters in identifying patients with osteoporosis compared to the World Health Organization (WHO) standard definition. We performed a cross-sectional investigational study of 73 subjects, and determined total hip and lumbar spine T-scores by dual-energy X-ray absorptiometry (DXA) (Prodigy Advance Lunar-GE). The QUS parameters (broadband ultrasound attenuation [BUA], speed of sound, bone mineral density, the stiffness index, and QUS T-score) were determined with Sahara Hologic equipment. The AUC was 0.81 (95% CI 0.67–0.95, p<0.05) for speed of sound (SOS) and 0.76 (95% CI 0.62–0.90, p<0.05) for BUA for the patients with DXA T-scores ≥ −1 DS; the cut-off values were 1542.2 meters per second for SOS and 63.3 dB/MHz for BUA. In patients with DXA T-scores ≤ − 2.5 DS, AUC was 0.80 (95% CI 0.70–0.90, p<0.05) for SOS, and 0.76 (95% CI 0.65–0.87, p<0.05) for BUA. The cut-off values were 1504.95 meters per second for SOS and 49.5 dB/MHz for BUA. Pearson correlation coefficients were positive and statistically significant (> 50%) for all QUS parameters in both groups, (2-tailed, p<0.05). QUS parameters correctly identified normal patients (false negative 34.21% and false positive 2.53%) and those with osteoporosis (false negative 8.55% and false positive 7.82%). The patients with QUS parameters between the cut-off values corresponding to DXA T-scores of −1 SD and − 2.5 SD should be further evaluated by DXA.