Objective   To evaluate the clinical efficiency and safety of combined diacerein and methotrexate(MTX) in treatment of rheumatoid arthritis(RA)

and the change in cytokines.  Methods   One hundred and twenty RA patients were randomly assigned to receive MTX(10 mg per week) or diacerein (50 mg/bid) plus MTX(10 mg per week) for 52 weeks. Therapeutic efficiency and safety as well as change in cytokines were evaluated after 2

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and 52 weeks of treatment respectively

with  ACR20 and ACR50 as the primary and secondary therapeutic efficiency indicators

respectively.  Results   The ACR 20 was 20.3% (35/39)

40.7%（24/59）

81.4%（48/59）

and 91.5%（54/59）respectively in diacerein plus MTX group

and was 1.7%（1/59）

22.0%（13/59）

59.3%（35/59）and 71.2%（42/59）respectively in MTX group after 2

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and 52 weeks of treatment (P0.05). The ACR 50 was 1.7%（1/59）

22.0%（13/59）

59.3%（35/59）and 71.2%（42/59）respectively in diacerein plus MTX group

and was 0%（0/59）

0%（0/59）

39.0%（23/59） and 59.3%（35/59）respectively in MTX group after 2

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and 52 weeks of treatment (P0.05). Both ACR 20 and ACR 50 were higher in diacerein plus MTX group than in MTX group. The changes in PGA

HAQ

ESR

CRP

IL-1

IL-6 and TNF-α were more significant in diacerein plus MTX group than in MTX group after 52 weeks of treatment（P 0.05）.  Conclusion   Diacerein plus MTX is better than diacerein in improving the signs and symptoms of RA patients

with a rapider efficiency

better safety and lower incidence of adverse events than MTX.