Very low‐dose prednisolone in early rheumatoid arthritis retards radiographic progression over two years: A multicenter, double‐blind, placebo‐controlled trial

Abstract

Objective. To assess the effect of 5 mg/day prednisolone on disease progression in patients with early rheumatoid arthritis (RA) receiving standardized diseasemodifying antirheumatic drug (DMARD) therapy.Methods. Patients with active RA of <2 years' duration were randomly assigned in a double-blinded manner to receive prednisolone or placebo while starting concomitant DMARD therapy (gold sodium thiomalate or methotrexate). Hand and foot radiographs were taken at baseline and at 6, 12, and 24 months and were evaluated according to the Ratingen score and the total modified Sharp/van der Heijde score (SHS).Results. Of 192 included patients, 166 were available for the intent-to-treat analysis (ITT). Seventy-six patients completed the study per protocol (PP). Radiographic progression (increase in the Ratingen score) was significantly less with prednisolone than with placebo. The difference in the progression rate between the groups was greatest in the first 6 months. At 24 months in the ITT population, the least squares (LS) mean difference was 3.14 (95% confidence Conclusion. The very low daily dose of 5 mg prednisolone given over 2 years in combination with background DMARD therapy substantially decreased radiographic progression in early RA at low risk.interval

Prevalence and incidence of osteoporotic fractures in patients on long-term glucocorticoid treatment for rheumatic diseases: the Glucocorticoid Induced OsTeoporosis TOol (GIOTTO) study

“…The main objective of this multicenter study was to evaluate, with a transversal and longitudinal approach, in real life, the prevalence and incidence of osteoporotic fractures and to identify their major determinants in a sample of patients with ed that the treatment with disease-modifying anti-rheumatic drugs (DMARDs) in association with GCs may induce high and persistent remission rates (5). This disease-modifying effect of GCs is supported by different studies (5)(6)(7)(8)(9)(10)(11)(12). In addition, the results also showed that GCs have an action in retarding the progression of erosive joint damage in early RA (prior to any joint damage) and a control of disease activity (5)(6)(7)(8)(9)(10)(11)(12).…”

The Prediction and Monitoring of Toxicity Associated with Long-Term Systemic Glucocorticoid Therapy

“…A study of low-dose GC reported weight gain in fewer (4/93) patients [ 77 ]. Weight gain contributes to the risk of GC-induced DM [ 74 ]; EULAR and the BSR recommend monitoring weight during follow-up [ 15 , 80 , 81 ].…”

“…Regarding low-dose GC, the existing data appear reassuring [ 78 , 90 , 91 ] and it is important to bear in mind the benefits of effectively treating disease; depression may be ameliorated by low-dose GCs in RA [ 77 ]. In contrast, patients receiving high-dose GCs appear more likely to experience neuropsychiatric symptoms, although confounding by indication limits interpretation of existing data.…”

Is the Availability of Delayed‐Release Prednisone an Important Clinical Advance?

“…Clinical effectiveness and less joint damage were demonstrated. Subsequently a number of studies from Europe were published examining low-dose prednisone versus placebo in early RA showing similar results, including less joint damage (13)(14)(15)(16). These studies utilized low single-morning doses of 5 mg, 7.5 mg, and 10 mg per day, all with comparable results.…”