Objectives To compare safety data in patients (pts) with early (<2 years duration) RA who were randomly assigned to receive 4 different regimens 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 DAS 28 5,9; 64% RF-positive,59% ACCP-positive) were randomly allocated 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. Control points were 3, 6 and 12 months from the initiation of therapy. Safety data was assessed at the main control points.

Results At baseline all groups were comparable in their demographic, clinical and radiographic characteristics. Onehundred twenty-seven pts completed the study. Side effects were registered in the same number of patients in eachgroup (9 patients; 24.3%-26%). Therapy had to bestopped in six patients due to side effects: MTX − 1 (depigmentation of the skin), MTX-P − none, MTX-P-MP − 1 (stomatitis) and LEF − 4 (dermatitis-2; pancytopenia with platelet count 43 ×10⁹/L, erythrocyte 2.9×10¹² /L, WBC 2×10⁹ /L-1; angioedema, periorbital oedema and dermatitis with itching-1). Other side effects were mild: MTX − 8 pts (dyspepsia-1,elevation of transaminases-6, hair loss-1), MTX-P − 9 pts (Cushing^,s syndrome-1, hair loss-1,anaemia-1, elevation of transaminases-4, arterial hypertension-2), MTX-P-MP − 8 pts (hair loss-1, dermatitis-1, elevation of transaminases-5, Cushing's syndrome-1) and LEF − 5 pts (elevation of transaminases-5).

Conclusion Safety profile was the same in all groups. In most cases side effects were moderate or minimal. The most serious side effects, leading to the discontinuation of the therapy, were registered in LEF group. There was no withdrawal of treatment in MTX-P group.