Cong-Zhu Ding1, Yao Yao2, Xue-Bing Feng1, Yun Fang2, Cheng Zhao1, Yue Wang3. 1. Department of Rheumatology and Immunology, Nanjing Drum Tower Hospital Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China. 2. Department of Pharmacy, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China. 3. The First Clinical Medical School, Nanjing University of Chinese Medicine, Nanjing, China.
Abstract
OBJECTIVE: To analyze the safety of combined leflunomide (LEF), methotrexate (MTX), and glucocorticoid (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 receivingLEF 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 χ(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.
RCT Entities:
OBJECTIVE: To analyze the safety of combined leflunomide (LEF), methotrexate (MTX), and glucocorticoid (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 χ(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.
Authors: David N Juurlink; Muhammad Mamdani; Alexander Kopp; Andreas Laupacis; Donald A Redelmeier Journal: JAMA Date: 2003-04-02 Impact factor: 56.272
Authors: J R Curtis; T Beukelman; A Onofrei; S Cassell; J D Greenberg; A Kavanaugh; G Reed; V Strand; J M Kremer Journal: Ann Rheum Dis Date: 2010-01 Impact factor: 19.103