| Background:Juvenile idiopathic arthritis (JIA), the most common rheumatic disease in childhood, affects about 1.9-22.6/100.000 people worldwide, and is also a major cause of disabilities in children, accounting for a disability rate of about 11%-43%. The etiology of JIA has not been fully established yet, and is currently believed to be associated with the immunologic, genetic and exogenous factors (such as trauma, environment and infection). The conventional therapeutic options for JIA include NSAIDs, glucocorticoids and disease-modifying antirheumatic drugs (DMARDs), which have however resulted in unsatisfactory therapeutic effect in some patients as the disease remains active, leading to low quality of life or even disability of the patients. Despite the positive therapeutic effect achieved with targeted cytokine therapeutic agent-tumor necrosis factor blocker for adult rheumatoid arthritis, no indication has been established in China for use of such therapy in children with JIA. For etanercept and infliximab, which have been the earliest among the anti-TNF agents to be commonly used in Chinese JIA patients though, there have been varying reports on their efficacy and safety. In this regard, this paper will perform retrospective analysis on the clinical data from 50 pediatric JIA patients who had received anti-TNF therapy, and evaluate and compare the efficacy and safety of 2 different anti-TNF therapies, in an attempt to provide theoretical evidence for the clinical application of these therapies.Objective:To evaluate the short-term efficacy and safety of the TNF-a antagonists Yisaipu (a domestic etanercept product) and infliximab for treatment of juvenile idiopathic arthritis (JIA).Methods:An open-label, observationand cohort study was conducted in 50 patients with JIA treated with biological products in Children’s Hospital of Zhejiang University Medical College from November 2012 to May 2015. Among them,35 received Yisaipu (etanercept group, n=35) at the dose 0.4mg/kg twice weekly; and 15 received infliximab (infliximab group, n=15) at the dose 3-5mg/kg at 0,2 and 6 weeks and thereafter every 8 weeks, for a total of 7 doses comprising one treatment cycle. All patients also received combined treatment with oral MTX and conventional antirheumatic drugs. The efficacywas evaluated with ACR Pedi30/50/70 at 2,4,8,12 and 24 weeks, and the safety was also evaluated.Results:The ACR Pedi30/50/70 scores of the patient was 65.7/22.9/5.7 or 93.3/53.3/26.7 at the time of 2 weeks; 88.6/65.7/20.0 or 100.0/73.3/40.0 at 4 weeks,100/84.8/63.6 or 92.9/85.7/71.4, at 12 weeks 96.8/81.3/78.1 or 80.0/80.0/80.0 at 24 weeks in the etanerceptor infliximab group respectively. The ACR Pedi30/50 scores in infliximab group were significantly higher than etanercept at 2 weeks (both P=0.039),but there was no significant difference in ACR Pedi30/50/70 at any other points (all P>0.05). Compared to the group of etanercept, patients in the infliximab group had relatively higher incidence of lower blood pressure or chest distress (P=0.028 and 0.097, respectively). Over a maximum of 2-years follow-up, no serious adverse event was found in either group, no statistica difference was observed between the two groups in the incidences of recurrent respiratory tract infection, diarrhea, chicken pox, urinary tract infection, or urticaria.Conclusion:Both etanerceptand infliximab were effective for relieving symptoms in patients with JIA Althouh infliximab provided more effective at 2 weeks treatment. There was no difference in efficacy between both drugs at other points. No serious adverse event was found either during treatment or follow-up. |
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