Effects of leflunomide combined with methotrexate in treatment of rheumatoid arthritis

AIM: To compare the efficacy and adverse reaction of leflunomide (Lef) plus methotrexate (MTX) (Group Lef+MTX) and Lef alone (Group Lef) in the treatment of active rheumatoid arthritis (RA). METHODS: It was an open controlled trial for 24 wk. Sixty patients with active RA were divided into two groups. Thirty patients of the control group (M 11,F 19; age(46±s10) a) administrated Lef 20 mg,po,qd. The other thirty patients of the experiment group (M 8,F 22; age (49±13) a), received Lef 10 mg,po,qd and MTX 7.5 mg po,qw as well. The status of patients have no significant difference between the two groups when they enrolled the trial. At the first 3 d, the dose of Lef for all patients was 50 mg·d -1. The indexes of the effeciency assessment included rest pain, morning stiffness, gripping strength, count of joint tenderness (TJC), count of joint swollen (SJC), activities of daily living, patient's assessment, physician's assessment, ESR, C-reactive protein (CRP), RF. RESULTS: No significant differences were found in efficiency assessment indexes between the two groups after 12 wk and 24 wk treatment. The efficacy rate of group Lef+MTX was 89 %, higher than that of group Lef (61 %) after 2 wk treatment, P0.05. It reached 89 %, 93 % respectively after 12 and 24 wk for group Lef+MTX and 86 %, 89 % for group Lef and there were no significant difference between the two groups again, P0.05. The rate of adverse reaction was 27 %(8/30) in group Lef+MTX and 20 % (6/30) in group Lef and no significant differences were found, P0.05. CONCLUSION: Lef combined with MTX in the treatment of rheumatoid arthritis asserted their efficacy more quickly than Lef alone. The efficacy was similar between the two groups after 12 wk. The rate of adverse reaction was a little higher in Lef and MTX combined therapy than in Lef alone.