Objectives To compare efficacy and safety of 4 treatment regimens in early (<2 years duration) RA including methotrexate (MTX), leflunomid (LEF) and combinations of MTX with glucocorticoids (GC).
Methods One hundred eighteen pts with early RA (100 women, mean age 55, mean disease duration 7 months, mean DAS28 5,83) were randomly assigned to receive one of the 4 treatment regimens for one year: MTX 10–20 mg/week (30 pts); MTX (10–20 mg/week) + GC (equivalent of 10 mg/day prednisolone, 31 pts); MTX (10–20 mg/week) + GC (equivalent of 10 mg/day prednisolone) + one single intravenous infusion of 1000 mg methylprednisolone (MP) at the first day of treatment (31 pts); LEF 20 mg/day (26 pts). According to clinical and demographic data all groups were comparable. Efficacy of therapy was assessed by EULAR criteria.
Results By now seventy one pts completed one-year course of treatment. Results of the therapy by that time are shown in the table (%).
In the MTX group 19% of the pts reached clinical remission (DAS28 <2,6); in the MTX+GC group, 46%; in the MTX+GC+MP group, 47%; in the LEF group, 28%.
Side effects of the treatment were as follows: MTX, skin depigmentation (1 pt) and hair loss (1); MTX+GC, increase of ALT and AST level (1) and hair loss (1); MTX+GC+MP, hair loss (1); LEF, urticaria (3), leucopenia (1) and increase of ALT and AST level (1).
Conclusion All 4 treatment regimens proved to be effective in early RA but the most promising results were obtained in groups with the combination of MTX and GC. The total amount of remissions in the whole group of early RA after one year of therapy was 34% which can be considered as satisfactory. Tolerability of all regimens was good.