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 treate d with prednisolone 5 mg daily or placebo for 2 years in a double blind, ra ndomized, multi-center study. At the same time in all patients DMARD treatm ent with either gold sodium thiomalate (GSTM) or methotrexate (MTX) was sta rted; in the case of side effects or inefficacy the medication could be swi tched to the other DMARD. Radiographs of hands and forefeet were taken at b aseline and after 6, 12 and 24 months. All radiographs were evaluated by on e 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 pr otocol. Of these patients 34 were treated with prednisolone, 42 with placeb o, 48 initially with GSTM, 28 with MTX. 17 patients switched from GSTM to M TX, 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 radiograph ic progression within the prednisolone group was significantly lower than i n the placebo group: the Sharp erosion score increased by 0.4 % of the maxi mum possible score during the first and the second 6 months in the predniso lone group, while in the placebo group there was an increase of 1.8 % durin g the first 6 months and 0.8 % during the second 6 months. During the secon d year the progression was significantly lower(-0.1 % in the prednisolone g roup, 0.2 % in the placebo group). After 24 months the total score had incr eased by 2.6 % of the maximum score in the placebo group and by 1.1 % in th e prednisolone group. The results of the completers were confirmed by the intention-to-treat anal ysis (80 patients in the prednisolone group, 86 patients in the placebo gro up). Conclusion: Continuous low dose prednisolone treatment with 5 mg daily over 2 years administered in addition to conventional DMARD treatment with MTX or GSTM decreases radiographic progression in early RA. The results of the study also show that in the placebo group there is a sha rp decrease of the progression after 6-12 months as a result of the DMARD t reatment. During the second year there is nearly no progression in this gro up. The data of the "completers" are confirmed by the analysis of the "intentio n to treat" population.