Low dose prednisolone therapy (LDPT) retards radiographically detectable destruction in early rheumatoid arthritis--preliminary results of a multicenter, randomized, parallel, double blind study

Objective:To test if continuous LDPT decreases radiographically detectable joint destruction in early RA. Methods: Patients with active RA (< 2 years from symptom onset) were treated with prednisolone 5 mg daily or placebo for 2 years in a double blind, randomized, multi-center study. At the same time in all patients DMARD treatment with either gold sodium thiomalate (GSTM) or methotrexate (MTX) was started; in the case of side effects or inefficacy the medication could be switched to the other DMARD. Radiographs of hands and forefeet were taken at baseline and after 6, 12 and 24 months. All radiographs were evaluated by one observer (S. W.) knowing the time sequence of the film but unaware of the patient identity or treatment using the Ratingen score and van der Heijde's modification of Sharp's method. Results: 196 patients were included; 76 patients completed the study per protocol. Of these patients 34 were treated with prednisolone, 42 with placebo, 48 initially with GSTM, 28 with MTX. 17 patients switched from GSTM to MTX, 1 from MTX to GSTM. The mean values of the radiographic scores of both groups are given in the table. During the first year, especially during the first 6 months, the radiographic progression within the prednisolone group was significantly lower than in the placebo group: the Sharp erosion score increased by 0.4% of the maximum possible score during the first and the second 6 months in the prednisolone group, while in the placebo group there was an increase of 1.8% during the first 6 month and 0.8% during the second 6 months. During the second year the progression was significantly lower (−0.1% in the prednisolone group, 0.2% in the placebo group). After 24 months the total score had increased by 2.6% of the maximum score in the placebo group and by 1.1% in the prednisolone group. The results of the completers were confirmed by the intention-to-treat analysis (80 patients in the prednisolone group, 86 patients in the placebo group). Conclusion: Continuous low dose prednisolone treatment with 5 mg daily over 2 years administered in addition to conventional DMARD treat with MTX of GSTM decreases radiographic progression in early RA. The results of the study also show that in the placebo group there is a sharp decrease of the progression after 6–12 months as a result of the DMARD treatment. During the second year there is nearly no progression in this group. The data of the “completers” are confirmed by the analysis of the “intention to treat” population.