Investigation of treatment continuity, usefulness, and nocebo effect in switching from the original etanercept to its biosimilar in patients with rheumatoid arthritis: A JET observational study in Japanese clinical practice.

OBJECTIVES: To assess the usefulness and onset of nocebo effects after switching from the original etanercept (ETN) to a biosimilar (BS) in routine clinical practice at rheumatology clinics in Japan (13 sites). METHODS: A total of 165 patients (87.0% women, age = 57.88 ± 15.07 years, and disease duration = 10.32 ± 7.71 years), whose low disease activity was maintained with the original ETN for ≥12 weeks, and who agreed to switch treatment to its BS, were included. The end-points were disease activity score 28 (DAS28)-C-reactive protein and DAS28-erythrocyte sedimentation rate. RESULTS: No significant difference was observed between the changes in DAS28-C-reactive protein and DAS28-erythrocyte sedimentation rate >12 weeks before switching and >12 weeks after switching (P = 0.132 and 0.334, respectively). The treatment continuation rate during the 52 weeks after switching to BS was 97.3%. During this period, BS was discontinued in only four patients, and no nocebo effects were suspected in these four patients. CONCLUSION: Switching from ETN to BS was effective even in routine clinical practice at rheumatology clinics in Japan, and no nocebo effects were observed. Sufficient explanations to patients by rheumatologists and the additional payment for drug costs between patients at hospital visits effectively improved the continuation rate without any nocebo effect.

[Optimal Conditions for 3D Non-contrast T1-weighted Magnetic Resonance Imaging Segmented Turbo Fast Low-angle Shot for Tissue Characterization of Coronary Plaques].

In three-dimensional (3D) T1-weighted magnetic resonance imaging used for tissue characterization of coronary plaques, the contrast for electrocardiographic synchronization may vary according to the R-R interval (RR). The coronary artery plaque image shows suppression of the fluid compartment signal for the coronary artery luminal blood as well as the fat signal in the region of interest; in addition, it is necessary to ensure that the value of the plaque-to-muscle signal intensity ratio (PMR) does not change according to the difference in RR. In the current study, the phantom review and clinical data suggested that the PMR changes that occur due to the differences in RR can be minimized by adjusting the inversion time (TI) in the range of the required black blood effect. Moreover, the signal-to-noise ratio (SNR), which varies according to the difference between the RR and the TI, was determined to identify the maximum value flip angle (FA) value that would lead to improvement in the SNR. Thus, signal suppression of the PMR, SNR, and the fluid compartment of the coronary artery luminal blood can be controlled using different RRs with the relational expressions for calculating optimal TI and FA.

Hemagglutination of preoperative blood donation in patients with rheumatoid arthritis.

We gave preoperative blood transfusions to 37 patients with rheumatoid arthritis (RA) and 35 patients with osteoarthritis (OA), including some whose baseline hemoglobin level was less than 10 g/dl. Transfusion packs can preserve whole blood containing citrate phosphate dextrose (CPD) for 3 weeks. The baseline hemoglobin level of RA cases was 10.4 g/dl (range 8.4-13.1 g/dl), and that of OA cases was 11.9 g/dl (range 10.4-15.0 g/dl). By collecting 200-400 g every week before the operation, the total was 800-1200 g. Erythropoietin was given to patients intramuscularly when their hemoglobin was less than 13 g/dl after blood had been collected. Hemagglutination, with diameters of more than 1 cm, made filter occlusions in 11 RA cases (30%) and one OA case (3%) (P << 0.0031) after retransfusion. There were no differences between hemagglutination patients (agglutination group) and nonhemagglutination patients (nonagglutination group) regarding baseline C-reactive protein (CRP), white blood cells, platelets, or fibrinogen. We could not predict the formation of macrohemagglutination in the packs collected during the clinical course. In RA cases, allogenic transfusions were performed for four cases (36%) in the agglutination group and for one case (12%) in the nonagglutination group. Preoperative transfusion for the RA patients showed hemagglutination in some cases, and highlighted the need for modifications to reduce these hemagglutinations.