A 2-year follow-up study on the recombinant human tumor necrosis factor receptor-Fc fusion protein treatment of juvenile idiopathic arthritis / 中华风湿病学杂志

ABSTRACT

Objective To analyze the outcome of children with juvenile idiopathic arthritis (JIA) treated with recombinant human tumor necrosis factor receptor antibody fusion protein (rhTNFRFc) for 2 years,and to evaluate the long-term efficacy and safety as well as the related factors that affect the curative effect of rhTNFRFc.Methods Fifty-seven JIA patients treated with rhTNFRFc were followed up for 2 years.Clinical data were registered including age of onset,disease duration before rhTNFRFc treatment,disease activity assessment,medication before treatment,dosage regimen of infection or adverse reactions.Pearson Chi-Square statistical test and logistic regression model of binomial classification were used for statistical analysis.Results ①Twenty-two JIA cases completed 2-year therapy.Some were in the process of dosage tapering.Eight cases reached ACR Pedi 50,14 cases reached ACR Pedi 70.All of them were included in the clinical effectiveness analysis.Thirty-five cases withdrawal in 2 years because of disease remission or treatment failure or side effects or infection.Seven who withdrew and then maintained with DMARDs under the supervision of doctors were evaluated by assessment of ACR Pedi 70.They were stable at the end of 2 years,and were included for the clinical effectiveness analysis group.Nineteen cases were withdrew by the doctor because they failed to reach ACR Pedi 30 within 3 months.They were included in the treatment failure analysis.Seven cases were lost during the follow up.② The remission rate (ACR Pedi 50,70) of SO-J1A in 2 years was 33％.Oligoarthritis rate was 60％,while that of polyarthritis rate was 79％.The statistical analysis showed that different categories and RF level were significantly different in effectiveness and treatment failure (x2=31.6,P＜0.05; x2=5.488,P＜0.05).There was no significant difference in age,sex,duration before treatment,AKA,CCP,ANA between the two groups (P＞0.05).③ Logistic regression analysis showed that different categories of JIA and RF levels were correlated with therapy,P＜0.05.The relative risk (OR) value of different categories of JIA was 2.983 (P＜0.05).Negative RF might be the predictive factor for treatment response (OR =0.029,P＜0.05).④ Eight cases (2％) had recurrence and other adverse reations during treatment,the majority (7 cases) was SO-JIA.Conclusions ① The long-term therapeutic effect and safety for oligoarthritis and Polyarthritis by rhTNFRFc are better than SO-JIA.② Negative RF maybe the factor associated with favourable rhTNFRFc efficacy.③ The long-term safety of rhTNFRFc for SO-JIA is good.Physicians should be cautious to infection and other adverse reactions.