OBJECTIVETo evaluate the efficacy and safety of the combined therapy with leflunomide and methotrexate in the patients with juvenile rheumatoid arthritis (JRA).

METHODSForty patients with active polyarthritis JRA were divided into 2 groups. Group 1 (n = 21) received leflunomide tablet (1 mg/(kg x day) on days 1 - 3; then [(0.2 - 0.4) mg/kg per day] plus methotrexate (0.3 mg/kg i.v. every two weeks till clinical remission, then oral tablet 0.2 mg/kg weekly). Group 2 received the same doses of methotrexate in the same way. Permitted concomitant drugs included stable doses of NSAIDs and a low dose of prednisone during the course of treatments. The clinical assessments included the number of tender and swollen joints, tender articular index, swollen articular index, general articular function score, parents and physician's evaluation score, erythrocyte sedimentation rate, serum C-reactive protein and rheumatoid factor. Drug safety was assessed by observing the reaction of mucous membrane, skin, gastrointestinal tract, nervous system, hematologic changes, liver and renal function. Statistical comparison between two groups was performed by using analysis of variance, t test and chi(2) test.

RESULTSEfficacy and safety was assessed at 12th and 26th week. Average improvement rate of leflunomide plus methotrexate group at 12th week and 26th week was respectively 39.6% and 71.9%; while that of control group was 27.5% and 49.5%, i.e., there was significant difference between the two groups (P < 0.01). Average remission rate of leflunomide plus methotrexate group at 12th week and 26th week was respectively 4.76% and 38.10%; while that of control group (methotrexate only) was respectively 0, 0. The clinical improvement in the group treated with leflunomide plus methotrexate was significantly greater than control group (P < 0.01). There was no significant difference (9.5% v 5.3%) in occurrence rate of side effects between the two groups. Side effects included leucocytopenia and raised aminotransferase. They were mostly mild and tolerable.

CONCLUSIONThe effect of the leflunomide and methotrexate therapy in patients with active JRA was better than methotrexate alone. The combination therapy with leflunomide and methotrexate was safe and well tolerated.