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Objectives To compare safety data in patients (pts) with early ( 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 One hundred twenty-seven pts completed the study. Side effects were registered in the same number of patients in each group (9 patients; 24,3%>26%). Therapy had to be stopped 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 edema 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 (Cushing9s syndrome - 1, hair loss - 1, anemia - 1, elevation of transaminases - 4, arterial hypertension - 2), MTX-P-MP - 8 pts (hair loss-1,dermatitis-1, elevation of transaminases-5, Cushing9s syndrome - 1) and LEF - 5 pts (elevation of transaminases-5). At baseline all groups were comparable in their demographic, clinical and radiographic characteristics. Conclusions 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. Safety profile was the same in all groups. Disclosure of Interest None declared |
