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Leflunomide, a new disease-modifying drug for treating active rheumatoid arthritis in methotrexate-controlled phase II clinical trial

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单位: [1]Shanghai Med Univ 2, Shanghai Renji Hosp, Dept Clin Immunol, Shanghai 200001, Peoples R China [2]Shanghai Guanghua Hosp, Dept Rheumatol, Shanghai 200000, Peoples R China [3]Shanghai Med Univ, Shanghai Zhongshan Hosp, Dept Rheumatol, Shanghai 200032, Peoples R China [4]Anhui Med Univ, Affiliated Hosp, Dept Clin Immunol, Hefei 230022, Peoples R China [5]Anhui Provincial Hosp, Dept Rheumatol, Hefei 230001, Peoples R China [6]Nanjing Med Univ, Affiliated Hosp, Dept Rheumatol, Nanjing 210029, Peoples R China [7]Nanjing Gulou Hosp, Dept Rheumatol, Nanjing 210008, Peoples R China [8]Tongji Med Univ, Tongji Hosp, Dept Rheumatol, Wuhan 430003, Peoples R China [9]Beijing Friendship Hosp, Dept Rheumatol, Beijing 100050, Peoples R China [10]Anhui Med Univ, Inst Clin Pharmacol, Hefei 230022, Peoples R China [*1]Shanghai Renji Hosp, Dept Rheumatol, 145 Shandong Middle Rd, Shanghai 200001, Peoples R China
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关键词: leflunomide rheumatoid arthritis methotrexate clinical trial

摘要:
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 eificacy 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.

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大类 | 2 区 医学
小类 | 2 区 医学:内科
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出版当年[2001]版:
Q4 MEDICINE, GENERAL & INTERNAL
最新[2024]版:
Q1 MEDICINE, GENERAL & INTERNAL

影响因子: 最新[2024版] 最新五年平均[2021-2025] 出版当年[2001版] 出版当年五年平均[1997-2001] 出版前一年[2000版] 出版后一年[2002版]

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第一作者单位: [*1]Shanghai Renji Hosp, Dept Rheumatol, 145 Shandong Middle Rd, Shanghai 200001, Peoples R China
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通讯机构: [*1]Shanghai Renji Hosp, Dept Rheumatol, 145 Shandong Middle Rd, Shanghai 200001, Peoples R China
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