Background Early RA contains the “the window of opportunities” for achieving the best results of therapy including remissions. It is very important to determine the influence of different treatment regimens on the remission rate in patients (pts) with early RA.

Objectives To compare development of remissions in pts with early (<2 years duration) RA who were randomly assigned to receive four different strategies of DMARDs treatment.

Methods One hundred forty-one pts with RA of less than 2 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 (P) 10 mg daily (MTX-P, 34 pts); MTX-P plus methylprednisolone (MP) 1000 mg 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. Efficacy of therapy was assessed by EULAR criteria. Control points were 3, 6 and 12 months from the beginning of therapy. The primary endpoint was the development of remission.

Results At baseline all groups were comparable in their demographic, clinical and radiographic characteristics. One hundred twenty-seven pts completed the study. By the 3d month in the MTX group only 3.1% of the patients reached clinical remission, while in the combination groups of MTX with GC (including MP intravenously) 21.3% and 28.6%, respectively. By the 6th month the same tendency continued: combination of MTX with GC showed the greatest frequency of remissions – 33.3% and 23.5%, respectively. In the MTX and LEF monotherapy groups the corresponding figures were 15.2% and 20.6%, respectively. By the 12th month the frequency of remissions was significantly higher in pts treated with the combination of MTX and GC, including high doses of MP (37.5% and 29.4%, respectively) than in the MTX and LEF monotherapy groups (11.4% and 16.2%, respectively).

Conclusions In pts with early RA combined treatment with MTX and GC led to the significantly higher remission rate as compared with MTX and LEF monotherapy.