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Additional file 2. Informed Consent Form.

Additional file 1. SPIRIT 2013 Checklist.

Additional file 1: Table S1. Measurement values in depth of bone erosion at 6 months by HR-pQCT (full analysis set). Table S2. Change from baseline in bone erosion score and JSN score evaluated by X-ray (full analysis set). Table S3. Change from baseline in bone micro-architecture parameters evaluated by HR-pQCT, MRI, musculoskeletal ultrasound, and X-ray (full analysis set). Table S4. Actual measured values and percent changes from baseline in bone and cartilage biomarkers (full analysis set).

Background: This exploratory study compared the inhibition of bone erosion progression in rheumatoid arthritis (RA) patients treated with a conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) plus denosumab versus csDMARD therapy alone and investigated the effects of denosumab on bone micro-architecture and other bone-related parameters using high-resolution peripheral quantitative computed tomography (HR-pQCT). Methods: In this open-label, randomized, parallel-group study, patients with RA undergoing treatment with a csDMARD were randomly assigned (1:1) to continue csDMARD therapy alone or to continue csDMARDs with denosumab (60-mg subcutaneous injection once every 6 months) for 12 months. The primary endpoint was the change from baseline in the depth of bone erosion, measured by HR-pQCT, in the second and third metacarpal heads at 6 months after starting treatment. Exploratory endpoints were also evaluated, and adverse events (AEs) were monitored for safety. Results: In total, 46 patients were enrolled, and 43 were included in the full analysis set (csDMARDs plus denosumab, N = 21; csDMARD therapy alone, N = 22). Most patients were female (88.4%), and the mean age was 65.3 years. The adjusted mean (95% confidence interval) change from baseline in the depth of bone erosion, measured by HR-pQCT, in the 2–3 metacarpal heads at 6 months was − 0.57 mm (− 1.52, 0.39 mm) in the csDMARDs plus denosumab group vs − 0.22 mm (− 0.97, 0.53 mm) in the csDMARD therapy alone group (between-group difference: − 0.35 mm [− 1.00, 0.31]; P = 0.2716). Similar results were shown for the adjusted mean between-group difference in the width and volume of bone erosion of the 2–3 metacarpal heads. Significant improvements in bone micro-architecture parameters were shown. The incidence of AEs and serious AEs was similar between the csDMARDs plus denosumab and the csDMARD therapy alone groups (AEs: 52.2% vs 56.5%; serious AEs: 4.3% vs 8.7%). Conclusions: Although the addition of denosumab to csDMARDs did not find statistically significant improvements in bone erosion after 6 months of treatment, numerical improvements in these parameters suggest that the addition of denosumab to csDMARDs may be effective in inhibiting the progression of bone erosion and improving bone micro-architecture., Arthritis Research and Therapy, 24(1), art. no. 264; 2022

Reactivation of Epstein-Barr virus (EBV) is associated with the etiopathogenesis of a broad spectrum of diseases. This study aimed to investigate the association between psychological distress and EBV serological reactivation among community-dwelling older people and assess the role of sex differences in this association. This population-based cross-sectional survey was conducted among individuals who underwent annual health checkups (N = 2,821; median age 72.4 years). EBV serological reactivation was defined as elevation of EBV early antigen immunoglobulin G titers, and psychological distress was defined as Kessler 6 scores ≥5. Multivariable logistic regression analysis was performed to calculate odds ratios (OR) and 95% confidence intervals (CI) for EBV serological reactivation and psychological distress. EBV serological reactivation and psychological distress were detected in 16.4% and 8.7% of participants, respectively. Women accounted for 71% (328/463) of those with EBV serological reactivation. Multivariable logistic regression analysis showed psychological distress was not significantly associated with EBV serological reactivation among all participants (OR 1.31, 95% CI: 0.95, 1.82; P = 0.102). A sex-stratified multivariable analysis showed a positive association among women (OR 1.45, 95% CI: 1.01, 2.08; P = 0.043), but no association among men. EBV serological reactivation was independently associated with psychological distress in community-dwelling older women. The sex difference in our results warrants further investigation to clarify the physiological mechanisms underlying the association., Aging, 14(20), pp.8258-8269; 2022

Additional file 2: Supplemental Table 2. Characteristics of study population by status of reduced handgrip strength.

Additional file 1: Fig. S1. Changes in the serum levels of OPG over the 6-month abatacept treatment period. Serum OPG was significantly elevated at 6 months after the introduction of abatacept (Wilcoxon signed ranks test). Horizontal bar, median; boxes, 25th and 75th percentiles; bars, 5th and 95th percentiles. OPG: osteoprotegerin. Fig. S2. Comparison of the changes in the SDAI and total PD score between the patients with a low Dkk-1 (n = 30) and those with a high Dkk-1 (n = 29). Wilcoxon signed ranks test. Horizontal bar, median; boxes, 25th and 75th percentiles; bars, 5th and 95th percentiles. PD: power Doppler, SDAI: Simple Disease Activity Index. Fig. S3. Comparison of the changes in the SDAI and total PD score between the patients with a low SOST (n = 30) and those with a high SOST (n = 29). Wilcoxon signed ranks test. Horizontal bar, median; boxes, 25th and 75th percentiles; bars, 5th and 95th percentiles.

Additional file 1: Supplemental Table 1. Characteristics of study population by status of atherosclerosis.

Additional file 1: Supplementary Table S1. Comparison of baseline characteristics in patients with different backgrounds.

Additional file 1: Supplementary Table S1 Age adjusted ROC curve in each subset determined by multivariable logistic regression analysis

Additional file 1: Suppl. Fig. S1. Distribution of K6.