Clinical Analysis of Chinese Patients With Rheumatoid Arthritis Treated With Leflunomide and Methotrexate Combined With Different Dosages of Glucocorticoid

OBJECTIVE: To analyze the safety of combined leflunomide (LEE), methotrexate (MTX), and glucocorticoicl (GC) therapy, we investigated the adverse effects of such combination therapy in patients with early active rheumatoid arthritis (RA). METHODS: Two hundred sixty-six patients with RA who were receiving LEF and MTX therapy were randomly assigned to 3 groups, as follows: group 1 received no GC, group 2 received 7.5 mg prednisone, and group 3 received 15 mg prednisone. Adverse effects were analyzed using the chi(2) test at week 4 or the Fisher exact test at week 12. RESULTS: Patients in group 1 had a higher incidence of skin rash, oral ulcers, leukopenia, and liver damage than did those in groups 2 and 3 (all, P <= 0.05). However, the rates of osteoporosis, diabetes, hyperlipidemia, and hypertension in group 3 were statistically higher than in groups 1 and 2 (P <= 0.05). CONCLUSION: In the treatment of RA, the incidence of skin rash, liver dysfunction, and oral ulcers may be decreased with combination therapy using LEF, MTX, and 7.5 mg prednisone, and blood pressure, blood glucose concentration, and bone density are not increased. Most important, 7.5 mg prednisone was synergistic with LEF and MTX, and such combination therapy could be a useful option as initial treatment of early active RA. (Curr Ther Res Clin Exp. 2012;73:123-133) (c) 2012 Elsevier HS Journals, Inc. All rights reserved.