LEFLUNOMIDE TREATMENT IN PATIENTS WITH EARLY AND REFRACTORY RHEUMATOID ARTHRITIS

The present work aimed to evaluate the therapeutic efficacy and safety profile of leflunomide (LEF) in patients with early and refractory rheumatoid arthritis (RA), compared with methotrexate (MTX). In 24-month clinical trial, 233 patients with active rheumatoid arthritis (RA) were randomised to receive either LEF or MTX treatment. The patients were divided in 2 groups with early RA and refractory RA. For evaluation of therapeutic efficacy of LEF and MTX, the following criteria were used: American College of Rheumatology 20, 50, 70 (ACR20, 50 and 70) responder rates, Disease Activity Score 28-joint (DAS 28) for assessment of disease activity, Health Assessment Questionnaire (HAQ-score) for physical function, and Sharp/van der Heijde scoring method for evaluation of radiographic disease progression. The safety profile was evaluated by means of anamnesis, physical examination, as well as laboratory control. Treatment with LEF led to rapid therapeutic response at the end of the 1st month of therapy initiation, followed by an increase in the effect until the end of the 12th month and sustained efficacy until the end of the 24th month, with no significant difference compared to MTX. The therapeutic effect of LEF over physical function was superior compared to MTX in early, as well as in refractory RA. LEF slowed down the radiographic progression in both groups. LEF showed very good therapeutic efficacy in patients with early and refractory RA and exhibited a satisfactory safety profile in a study with a relatively long duration of 2 years.