Safety and efficacy of tocilizumab, an anti-IL-6-receptor monoclonal antibody, in patients with polyarticular-course juvenile idiopathic arthritis
Safety and efficacy of tocilizumab, an anti-IL-6-receptor monoclonal antibody, in patients with polyarticular-course juvenile idiopathic arthritis
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DOI：
10.1007/s10165-011-0481-0
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发表时间：
2012-02-01
影响因子：
2.2
通讯作者：
Kishimoto, Tadamitsu
中科院分区：
文献类型：
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作者：
Imagawa, Tomoyuki;Yokota, Shumpei;Kishimoto, Tadamitsu
我们评估了托珠单抗治疗多关节或少关节起病的多关节病程幼年特发性关节炎（pJIA）的安全性和有效性。在开放标签研究中，患者每4周一次接受8 mg/kg托珠单抗治疗：初始研究（至第12周），然后是扩展研究（至少48周）。19例常规甲氨蝶呤治疗难治性患者入组。17例患者有多关节发作的pJIA; 2例有少关节发作的pJIA。平均年龄为11.6岁;平均病程为5.3年。美国儿科流变学会（ACR Pedi）30、50、70和90应答率在第12周分别为94.7%、94.7%、57.9%和10.5%，在第48周分别为100%、94.1%、88.2%和64.7%。从第24周开始，平均疾病活动性评分（DAS 28）保持低于缓解水平（2.6）。在扩展研究期间，2例患者停止给药，因为ACR Pedi 50应答被判定为不足（1例患者），并且产生了抗托珠单抗抗体（1例患者）。不良事件一般为轻度，4例严重不良事件自行消退或经治疗消退。总之，托珠单抗显示出治疗难治性pJIA的早期和持续的疗效和耐受性，这表明它是一种有希望的治疗这种疾病的新方法。
We evaluated the safety and efficacy of tocilizumab in polyarticular-course juvenile idiopathic arthritis (pJIA) with polyarticular or oligoarticular onset. Patients received 8 mg/kg tocilizumab every 4 weeks in the open-label studies: initial study (to week 12) and then an extension study (at least 48 weeks). Nineteen patients intractable to conventional methotrexate therapy were enrolled. Seventeen patients had polyarticular-onset pJIA; two had oligoarticular-onset pJIA. Mean age was 11.6 years; mean disease duration 5.3 years. American College of Rheumatology Pediatric (ACR Pedi) 30, 50, 70, and 90 response rates, respectively, were 94.7%, 94.7%, 57.9%, and 10.5% at week 12, and 100%, 94.1%, 88.2%, and 64.7% at week 48. Mean disease activity score (DAS28) remained below the remission level (2.6) from week 24. Administration was discontinued in two patients during the extension study because the ACR Pedi 50 response was judged insufficient (one patient) and antitocilizumab antibodies developed (one patient). Adverse events were generally mild, and the four serious adverse events resolved spontaneously or with treatment. In conclusion, tocilizumab showed early and sustained efficacy and tolerability for treating intractable pJIA, which suggests that it is a promising new treatment for this disease.