Abstract:

Objective To observe the therapeutic effects of different doses of recombinant human tumor necrosis factor-receptor Ⅱ:IgG Fc fusion protein (rhTNFR:Fc) on rheumatoid arthritis (RA）. Methods Seventy-six patients with RA were randomly divided into rhTNFR:Fc treatment group A (n=22; rhTNFR:Fc 25 mg, twice/week and methotrexate 10 mg/week）, rhTNFR:Fc treatment group B (n=24; rhTNFR:Fc 12.5mg, twice/week and methotrexate 10 mg/week） and control group (n=30; methotrexate 10 mg/week). Joint function related parameters including number of swollen joints, number of tenderness, pain degree, time of morning stiffness, Health Assessment Questionnaire (HAQ) score, erythrocyte sedimentation rate, C-reactive protein and rheumatoid factor were detected before and 2, 4, 6, 8, 12, 16 and 24 weeks after treatment in all the patients. After being treated for 3 months, the changes of joint function related paramters were evaluated and compared among groups. ACR20, ACR50 and ACR70 criteria were employed to evaluate the therapeutic effects. Results There was no significant difference in joint function related parameters among three groups before treatment (P＞0.05), while those improved significantly after treatment for 3 months (P<0.05), with more favorable results in rhTNFR:Fc treatment group A and B than in control group (P<0.05). The percent of patients with ACR50 in rhTNFR:Fc treatment group A was significantly higher than that in rhTNFR:Fc treatment group B 2 and 4 weeks after treatment (P<0.05), while there was no significant difference in total effect between these two groups 8, 12, 16 and 24 weeks after treatment(P＞0.05). Conclusion Small dose of rhTNFR:Fc in combination with methotrexate may yield effective and economical results for treatment of RA.

Key words: recombinant human tumor necrosis factor-receptorⅡ:IgG Fc fusion protein, rheumatoid arthritis, methotrexate