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Leflunomide, a new disease-modifying drug for treating active rheumatoid arthritis in methotrexate-controlled phase Ⅱ clinical trial
作者姓名:Bao C  Chen S  Gu Y  Lao Z  Ni L  Yu Q  Xu J  Li X  Liu J  Sun L  He P  Ma J  Xu S  Ding C
作者单位:Department of Clinical Immunology,Shanghai Renji Hospital Shanghai Second Medical University,Department of Clinical Immunology,Shanghai Renji Hospital Shanghai Second Medical University,Department of Clinical Immunology,Shanghai Renji Hospital Shanghai Second Medical University,Department of Rheumatology,Shanghai Guanghua Hospital,Department of Rheumatology,Shanghai Guanghua Hospital,Department of Rheumatology,Shanghai Zhongshan Hospital,Shanghai Medical University,Department of Clinical Immunology,Affiliated Hospital of Anhui Medical University,Department of Rheumatology,Anhui Provincial Hospital,Department of Rheumatology,Affiliated Hospital of Nanjing Medical University,Department of Rheumatology,Nanjing Gulou Hospital,Department of Rheumatology,Tongji Hospital Tongji Medical University,Department of Rheumatology,Beijing Friendship Hospital,Institute of Clinical Pharmacology,Anhui Medical University Shanghai 200001,China,Shanghai 200001,China,Shanghai 200001,China,Shanghai 200000,China,Shanghai 200000,China,Shanghai 200032,China,Hefei 230022,China,Hefei 230001,China,Nanjing 210029,China,Nanjing 210008,China,Wuhan 430003,China,Beijing 100050,China,Hefei 230022,China
摘    要:Leflunomide ,anovelimmunoinhibitorwithimmunosupressiveandantiproliferativeproperties ,hasbeendemonstratedtobeeffectiveintreatingrheumatoidarthritis(RA)inanimalexperimentsandinforeignclinicaltrials ItimmediatelytransformsintotheactivemetaboliteA77172 6invivobyoraladministrationandactsthroughDHODHinhibition,preventingpyrimideoverproduction 1 Inexperimentalmodelsofchronicgraft versus hostdiseaseandsolidorgantransplantation ,leflunomidecanpreventrejectionorreverseongoingrejection 2 ,3 Bytheap…

关 键 词:风湿性关节炎  甲氨蝶蛉  来氟诺胺  自身免疫性疾病  药物疗法  临床研究

Leflunomide,a new disease-modifying drug for treating active rheumatoid arthritis in methotrexate-controlled phase II clinical trial
Bao C,Chen S,Gu Y,Lao Z,Ni L,Yu Q,Xu J,Li X,Liu J,Sun L,He P,Ma J,Xu S,Ding C.Leflunomide,a new disease-modifying drug for treating active rheumatoid arthritis in methotrexate-controlled phase II clinical trial[J].Chinese Medical Journal,2003,116(8):1228-1234.
Authors:Bao Chunde  Chen Shunle  Gu Yueying  Lao Zhiying  Ni Liqing  Yu Qiang  Xu Jianhua  Li Xiangpei  Liu Jialing  Sun Lingyun  He Peigen  Ma Jiliang  Xu Shuyun  Ding Changhai
Institution:1. Department of Clinical Immunology, Shanghai Renji Hospital Shanghai Second Medical University, Shanghai 200001, China
2. Department of Rheumatology, Shanghai Guanghua Hospital, Shanghai 200000, China
3. Department of Rheumatology, Shanghai Zhongshan Hospital, Shanghai Medical University, Shanghai 200032, China
4. Department of Clinical Immunology, Affiliated Hospital of Anhui Medical University, Hefei 230022, China
5. Department of Rheumatology, Anhui Provincial Hospital, Hefei 230001, China
6. Department of Rheumatology, Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China
7. Department of Rheumatology, Nanjing Gulou Hospital, Nanjing 210008, China
8. Department of Rheumatology, Tongji Hospital Tongji Medical University, Wuhan 430003, China
9. Department of Rheumatology, Beijing Friendship Hospital, Beijing 100050, China
10. Institute of Clinical Pharmacology, Anhui Medical University, Hefei 230022, China
Abstract:Objective To evaluate the efficacy and safety of leflunomide in comparison with methotrexate (MTX) on patients with rheumatoid arthritis (RA) in China.Methods Five hundred and sixty-six patients with active rheumatoid arthritis were randomly assigned to receive leflunomide at 20 mg once daily or MTX at 15 mg once weekly in a controlled trial. Five hundred and four patients completed the 12-week treatment and some patients continued the treatment for 24 weeks.Results Both leflunomide and MTX could improve the symptoms, signs, and joint function, but there were no changes in X-ray observations of patients with rheumatoid arthritis. In the leflunomide group, the overall rates of effectiveness at 12 weeks and 24 weeks were 86.94% and 92.31% respectively; the rates of remarkable improvement were 64.95% and 79.81% respectively. In the MTX group, the overall rates of effectiveness at 12 weeks and 24 weeks were 84.04% and 83.15% respectively; the rates of remarkable improvement were 56.81% and 75.28% respectively. According to intent-to-treat analysis, the ACR 20% response rates at 12 weeks and 24 weeks in the leflunomide group were 62.54% and 67.18% respectively, compared with 60.08% and 61.32% respectively in MTX group. No statistical differences were shown in the efficacy between the two groups (P>0.05). The adverse events in the leflunomide group were gastrointestinal symptoms, skin rash, alopecia, nervous system symptoms, decreased leukocyte count, and elevation of alanine aminotransferase (ALT). Most of these side effects were mild and transient. The incidence of adverse events in the leflunomide group was 16.84%, significantly lower than that in MTX group (28.17%, P=0.002).Conclusions Leflunomide is effective in the treatment of RA with less adverse events than MTX. Its efficacy is similar to MTX, but the incidence of adverse events and the rate of withdrawal due to adverse events were lower in the leflunomide group than in MTX group.
Keywords:leflunomide  rheumatoid arthritis  methotrexate  clinical trial
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