|
A multicenter clinical study of tocilizumab in the treatment of systemic-onset juvenile idiopathic arthritis
LIANG Fang-fang, LIU Da-wei, FAN Zhi-dan, et al
2022, 37(5):
379-384.
DOI: 10.19538/j.ek2022050613
Objective To explore the critical time points of tocilizumab in treating systemic-onset juvenile idiopathic arthritis (SJIA) and evaluate the short-term and long-term efficacy and safety of early use of tocilizumab. Methods It is a multicenter prospective cohort study. We enrolled 88 children with first-onset moderate to severe active SJIA from 5 research centers,including Shenzhen Childrens Hospital,Childrens Hospital of Chongqing Medical University,Peking Union Medical College Hospital,Childrens Hospital of Fudan University,and Childrens Hospital of Nanjing Medical University,from November 1,2017,to November 1,2020. The patients were divided into tocilizumab group(n=51) and control group(n=37). After short-term (three months and six months) and long-term (one year and two years) treatment,we compared analyzed the clinical effects between the two groups. Results The two groups C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) decreased significantly after 3 and 6 months of treatment,respectively. In the tocilizumab group,the two indices in more than 90% of patients decreased to the normal level,which had significant difference (P<0.05) compared with the control group. There were significant differences between the two groups in the dosage of hormone use at the initial stage(P<0.05),as well as after three and six months of treatment (P<0.05). The hormone dosage was significantly reduced,and the proportion of the patients who successfully stopped using hormone in half a year increased significantly. The short-term compliance rates of ACRPedi 30/50/70/90 in tocilizumab group and control group were significantly different (P<0.05),being 100.0%/94.0%/70.0%/36.0% and 97.2%/77.8%/50.0%/8.3% after 3 months,and 100.0%/95.5%/84.4%/57.8% and 96.4%/64.3%/42.9%/10.7% after 6 months,respectively. Comparing the long-term efficacy between the two groups,the compliance rate of ACRPedi 70/90 in the tocilizumab group was significantly higher than that in the control group (P<0.05). The most common adverse reaction was respiratory tract infections in the two groups,and no other serious adverse events occurred. Conclusion The early use of tocilizumab in moderate and severe SJIA is effective. Tocilizumab can efficiently relieve the inflammatory index and reduce the hormone dosage,achieving the goal of rapidly reducing the dosage or even stopping the use of hormone. It provides a good effect on improving disease activity in the long time.
|