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Background and Objectives: The 52-week, randomized, double-blind, noninferiority, government-funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) versus patients switched to CT-P13 at week 52 (switch group). The primary outcome was disease worsening during follow-up based on disease-specific composite measures., Methods: Patients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis., Results: Baseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per-protocol set). Adjusted risk difference was 5.9% (95% CI -1.1 to 12.9). Frequency of adverse events, anti-drug antibodies, changes in generic disease variables and disease-specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases., Conclusion: The NOR-SWITCH extension showed no difference in safety and efficacy between patients who maintained CT-P13 and patients who switched from originator infliximab to CT-P13, supporting that switching from originator infliximab to CT-P13 is safe and efficacious., (© 2019 The Authors. Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine.)

To establish whether dual-energy CT (DECT) is a diagnostic tool, i.e., associated with initiation or discontinuation of a urate lowering drug (ULD). Secondly, to determine whether DECT results (gout deposition y/n) can be predicted by clinical and laboratory variables. Digital medical records of 147 consecutive patients with clinical suspicion of gout were analyzed retrospectively. Clinical data including medication before and after DECT, lab results, and results from diagnostic joint aspiration and DECT were collected. The relationship between DECT results and clinical and laboratory results was evaluated by univariate regression analyses; predictors showing a p < 0.10 were entered in a multivariate logistic regression model with the DECT result as outcome variable. A backward stepwise technique was applied. After the DECT, 104 of these patients had a clinical diagnosis of gout based on the clinical judgment of the rheumatologist, and in 84 of these patients, the diagnosis was confirmed by demonstration of monosodium urate (MSU) crystals in synovial fluid (SF) or by positive DECT. After DECT, the current ULD was modified in 33 (22.4%) of patients; in 29 of them, ULD was started and in 1 it was intensified. Following DECT, the current ULD was stopped in three patients. In the multivariable regression model, cardiovascular disease (OR 3.07, 95% CI 1.26-7.47), disease duration (OR 1.008, 95% CI 1.001-1.016), frequency of attack (OR 1.23, 95% CI 1.07-1.42), and creatinine clearance (OR 2.03, 95% CI 0.91-1.00) were independently associated with positive DECT results. We found that the DECT result increases the confidence of the prescribers in their decision to initiation or discontinuation of urate lowering therapy regimen in of mono- or oligoarthritis. It may be a useful imaging tool for patients who cannot undergo joint aspiration because of contraindications or with difficult to aspirate joints, or those who refuse joint aspiration. We also suggest the use of DECT in cases where a definitive diagnosis cannot be made from signs, symptoms, and MSU analysis alone. [ABSTRACT FROM AUTHOR]