Background Joint damage is especially rapid during early phases of RA and a key outcome measure in this disease. Therefore it is very important to assess effect of different treatment regimens on radiographic progression in early RA.
Objectives To compare effect of 4 treatment regimens on the progression of joint destruction in patients (pts) with early RA.
Methods One hundred forty-one pts with RA of less than two years' duration (122 women, mean age 51 years, mean disease duration 24 weeks, mean DAS28 5,9; 64% RF-positive, 59% ACCP-positive) were randomised to receive one of the following treatment regimens: methotrexate (MTX, up to 20 mg/week, 35 pts); MTX plus prednisolone 10 mg daily (MTX-P, 34 pts); MTX-P plus methylprednisolone 1000mg intravenously on the first day of treatment (MTX-P-MP, 35 pts); leflunomide 20 mg daily (Lef, 37 pts). Duration of treatment was one year. Radiographs of hands and feet were scored using the Sharp–van der Heijde scoring method.
Results At baseline all groups were comparable in their demographic, clinical and radiographic characteristics. One hundred twenty-seven pts completed the study. At 12 months there was no radiographic progression in the majority of pts (>75% in each group). Increase of the number of erosions and joint space narrowings was maximal in MTX group (mean, 35 and 80 respectively), and minimal in MTX-P group (mean, 12 and 20 respectively), p = 0.066. Slowing of disease progression with Lef was similar to MTX. There were no significant differences in radiological score between groups MTX-P and MTX-P-MP at 12 months Relative slowing of disease progression was noted in groups MTX-P and MTX-P-MP in comparison with MTX group (p = 0.08) but not with Lef group (p>0,1). Of note, among 20 pts with evident radiographic joint progression 9 pts had good clinical response according to EULAR criteria. RF and ACCP had no predictive value for the radiologic progression.
Conclusion All 4 treatment regimens led to the slowing of joint destruction in the greater part of patients with early RA. In a portion of patients no correlation was found between clinical response and radiographic changes. Effects of MTX and Lef did not differ. High dose of Met at the start of treatment had no significant impact on the final results. Low dose of prednisolone given in addition to MTX substantially reduced radiologically detected progression of disease.