The Efficacy of Short-Term Bridging Strategies With High- and Low-Dose Prednisolone on Radiographic and Clinical Outcomes in Active Early Rheumatoid Arthritis: A Double-Blind, Randomized, Placebo-Controlled Trial.

OBJECTIVE: In active early rheumatoid arthritis (RA), glucocorticoids are often used for bridging, due to the delayed action of methotrexate. This study was undertaken to compare the effect of 3 bridging strategies, including high-dose and low-dose prednisolone, on radiographic and clinical outcomes. METHODS: Adult RA patients from 1 rheumatology hospital and 23 rheumatology practices who presented with moderate/high disease activity were randomized (1:1:1) to receive 60 mg prednisolone (high-dose prednisolone [HDP]) or 10 mg prednisolone (low-dose prednisolone [LDP]) daily (tapered to 0 mg within 12 weeks) or placebo. The 12-week intervention period was followed by 40 weeks of therapy at the physicians' discretion. The primary outcome measure was radiographic change at 1 year measured using the total modified Sharp/van der Heijde score (SHS). Disease activity was assessed with the Disease Activity Score in 28 joints using the erythrocyte sedimentation rate (DAS28-ESR). RESULTS: Of 395 randomized patients (HDP, n = 132; LDP, n = 131; placebo, n = 132), 375 (95%) remained in the modified intention-to-treat analysis. Mean ± SD changes in SHS scores in the 3 groups after 1 year were comparable: mean ± SD 1.0 ± 2.0 units in the HDP group, 1.1 ± 2.2 units in the LDP group, and 1.1 ± 1.5 units in the placebo group. The primary analysis showed no superiority of HDP compared to placebo (estimated difference of the mean change -0.04 [95% confidence interval (95% CI) -0.5, 0.4]). At week 12, the mean DAS28-ESR differed: -0.6 (95% CI -1.0, -0.2) for HDP versus placebo; -0.8 (95% CI -1.2, -0.5) for LDP versus placebo. At week 52, there was no significant difference in DAS28-ESR between the 3 groups (range 2.6-2.8). Serious adverse events occurred similarly often. CONCLUSION: Short-term glucocorticoid bridging therapy at a high dose showed no benefit with regard to progression of radiographic damage at 1 year.

The Structured Delegation of Medical Care Services for Patients With Inflammatory Rheumatic Diseases.

BACKGROUND: In some areas of Germany, there is a shortage of specialist physicians for patients with inflammatory rheumatic diseases. Delegating certain medical care services to qualified, specialized rheumatological assistants (SRAs) might be an effective way to supplement the available capacity for specialized medical care. METHODS: Patients under stable treatment for rheumatoid arthritis (RA) or psoriatic arthritis (PsA) were included in this trial, which was designed to demonstrate, in a first step, the non-inferiority of a form of care involving delegation of physicians' tasks to SRAs (team-based care), in comparison to standard care, with respect to changes in disease activity at one year. "Non-inferiority," in this context, means either superiority or else an irrelevant extent of inferiority. In a second step, in case non-inferiority could be shown, the superiority of team-based care with respect to changes in patients' health-related quality of life would be tested as well. Disease activity was measured with the Disease Activity Score 28, and health-related quality of life with the EQ-5D-5L. This was a randomized, multicenter, rater-blinded trial with two treatment arms (team-based care and standard care). The statistical analysis was performed with mixed linear models (DRKS00015526). RESULTS: From September 2018 to June 2019, 601 patients from 14 rheumatological practices and 3 outpatient rheumatological clinics in the German states of North Rhine-Westphalia and Lower Saxony were randomized to either team-based or standard care. Team-based care was found to be non-inferior to standard care with respect to changes in disease activity (adjusted difference = -0.19; 95% confidence interval [-0.36; -0.02]; p <0.001 for non-inferiority). Superiority with respect to health-related quality of life was not demonstrated (adjusted difference = 0.02 [-0.02; 0.05], p = 0.285). CONCLUSION: Team-based care, with greater integration of SRAs, is just as good as standard care in important respects. Trained SRAs can effectively support rheumatologists in the care of stable patients with RA or PsA.

Dose tapering of biologic agents in patients with rheumatoid arthritis-results from a cohort study in Germany.

OBJECTIVE: To assess the association of demographic and clinical factors with the clinical decision of tapering biologic disease modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA) in daily practice. METHODS: All RA patients receiving bDMARDs were documented by 14 rheumatologists when presenting in 9 specialized private practices. Statistical analyses employed multivariable logistic models for dose reduction with the covariates age, gender, disease duration until bDMARD start, smoking status, disease activity, comorbidity, functional capacity, radiographic damage, concomitant methotrexate (MTX) treatment, rheumatoid factor positivity, and glucocorticoid use. In the multivariable model (MVM), missing values were imputed. RESULTS: Data of 586 RA patients on bDMARD treatment were available, 171 of which (29%) received a reduced dose. The highest rates of patients with dose reduction were seen for rituximab (67%) and infliximab (50%). The degree of dose reduction was most prominent for rituximab (57%). In the MVM, 6/11 covariates were significantly associated with dose reduction: age (odds ratio (OR) 1.03, 95% confidence interval (CI) 1.01-1.05; P = 0.002), time between disease onset and bDMARD start (OR 1.03, 95% CI 1.01-1.06; P = 0.015), DAS 28 < 2.6 (OR 1.55, 95% CI 1.01-2.37; P = 0.045), MTX therapy (OR 1.52, 95% CI 1.03-2.25; P = 0.036), comorbidity (OR 1.20, 95% CI 1.01-1.42; P = 0.036), and glucocorticoid dose (OR 0.82, 95% CI 0.76-0.89; P < 0.001). CONCLUSION: DAS 28 remission, concomitant MTX, and lower glucocorticoid doses were positively associated with dose tapering of bDMARDs in RA patients. While this could be expected, the reason for the association with age, comorbidity, and the time between disease onset and bDMARD start is less clear. Key points • In rheumatology practice, tapering of biologic disease modifying antirheumatic drugs is feasible in nearly 30% of patients with rheumatoid arthritis. • The degree of dose reduction may exceed 50% of the recommended dose. • In a multivariable model, concomitant methotrexate is positively associated with dose tapering of biologic disease modifying antirheumatic drugs.