The efficacy and safety of combination therapy with methotrexate and leflunomide in patients with active rheumatoid arthritis

Objective To observe the efficacy and safety of combination therapy with methotrexate( MTX) and leflunomide in patients with active rheumatoid arthritis( RA). Methods 80 patients with active RA were randomly divided into two groups,one group with MTX 10 mg / week,the other group with MTX 10 mg once a week plus leflunomide 20 mg once a day. At baseline and after 4 weeks,6 weeks,12 weeks,18 weeks,24 weeks of treatment,swollen joint count,tender joint count,duration of morning stiffness,doctor and patient evaluation,disease activity score( DAS28),erythrocyte sedimentation rate( ESR),ultra- sensitivity C- reactive protein( CRP) level were documented. χ2test and the t test were used for statistical analysis. Results After 24 weeks of treatment,ACR20 improvement in the combination therapy group was better than that in the control group( 78% vs 53%,P 0. 05),and there was no difference in DAS28 score and the incidence of adverse reactions between two groups. Conclusion Compared with MTX monothrapy,the combination therapy with MTX and leflunomide can better and safely control the disease.