Objective: To evaluate the efficacy and safety of humanized anti-IL-6 receptor monoclonal antibody (tocilizumab) in treatment of systemic juvenile idiopathic arthritis (sJIA).
Methods: Thirteen sJIA patients admitted between December 2015 and November 2016 and received tocilizumab treatment were enrolled in the study. The complete blood count (CBC), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), interleukin-6 (IL-6) and ferritin levels were measured; American College of Rheumatology Pediatric(ACR Pedi)30/50/70/90 scores were assessed; and the use of glucocorticosteroid and adverse events were documented.
Results: Compared with the baseline levels, the CRP and ESR at d3 were decreased (all P<0.05); hemoglobin was increased and platelet was decreased at week 2 (all P<0.05), ferritin decreased at week 4, white blood cell (WBC) decreased at week 8 after treatment with tocilizumab (all P<0.05). The level of IL-6 was rising at d3 and week 2 and descending at week 4, but no significant difference was observed compared with the baseline level (all P>0.05). All 13 patients achieved ACR Pedi 30 remission at week 4, 61.5% achieved ACR Pedi 90 remission and glucocorticosteroids were withdrawn at week 20. Twenty two adverse events occurred, and infection accounted for 54.5% (12/22); no severe adverse reactions were observed during 20-week follow-up.
Conclusions: Tocilizumab is safe and effective in treatment of sJIA, with decreasing inflammation, improving disease activity and reducing glucocorticosteroid use.
目的: 探讨人源化IL-6受体抗体（托珠单抗注射液）治疗全身型幼年特发性关节炎（sJIA）的临床疗效及安全性。
方法: 回顾性分析2015年12月-2016年11月在浙江大学医学院附属儿童医院应用托珠单抗治疗的13例sJIA患儿的临床资料，包括血常规、C反应蛋白（CRP）、红细胞沉降率（ESR）、IL-6、血清铁蛋白、美国风湿病学儿科（ACR Pedi）30/50/70/90评分、激素使用情况以及治疗期间的不良反应。
结果: 与治疗前比较，治疗后第3天患儿的CRP和ESR明显下降（均 P < 0.05）；治疗后第2周血红蛋白增加和血小板减少（均 P < 0.05）；第4周血清铁蛋白水平下降（ P < 0.05）；白细胞在治疗后第8周时减少（ P < 0.05）。IL-6水平在治疗后先上升，第4周时下降，但与治疗前比较差异均无统计学意义（均 P＞0.05）。治疗第4周ACR Pedi 30或以上达100%；第20周时，61.5%的患儿达到ACR Pedi 90和停用糖皮质激素。随访至20周，所有患儿共发生不良反应22例次，其中感染发生率占54.5%（12/22），无严重不良反应发生。
结论: 托珠单抗能快速控制sJIA炎症，改善疾病活动度，有助于糖皮质激素的顺利减量及停药，且安全有效。