OBJECTIVE To assess the net benefit of biological agents (BA) used in JIA. METHODS We systematically searched databases up to March 2019 for randomized controlled trials (RCT) performed in JIA disease. Separate random-effects meta-analyses were conducted for efficacy (ACR paediatric score 30%, ACRpedi30) and serious adverse events for safety. In order to standardize the baseline risk, we performed a meta-analysis of baseline risk in the control group (for both efficacy and safety meta-analysis). The net benefit was determined as the risk difference of efficacy subtracted by the risk difference of safety. RESULTS We included 19 trials: 11 parallel RCTs (754 patients) and 8 withdrawal RCTs (704 patients). The net benefit ranged from 2.4% (adalimumab) to 17.6% (etanercept), and from 2.4% (etanercept) to 36.7%, (abatacept) in parallel and withdrawal trials assessing non-systemic JIA, respectively. In the systemic JIA category, the net benefit ranged from 22.8% (rilonacept) to 70.3% (canakinumab), and from 32.3% (canakinumab) to 58.2% (tocilizumab) in parallel and withdrawal trials, respectively. CONCLUSION The results suggest that a greater number of patients experienced therapeutic success without serious adverse events in the systemic onset JIA category compared with the BAs for non-systemic JIA categories. Baseline risk, design of trial and JIA categories impact the measure of net benefit of BAs in JIA patients.

中文翻译：

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幼年特发性关节炎生物制剂的获益-风险平衡：随机临床试验的荟萃分析

目的 评估 JIA 中使用的生物制剂 (BA) 的净收益。方法 我们系统地搜索了截至 2019 年 3 月的数据库，以查找在 JIA 疾病中进行的随机对照试验 (RCT)。对疗效（ACR 儿科评分 30%，ACRpedi30）和严重不良事件的安全性进行了单独的随机效应荟萃分析。为了标准化基线风险，我们对对照组的基线风险进行了荟萃分析（针对有效性和安全性的荟萃分析）。净收益确定为疗效风险差异减去安全性风险差异。结果 我们纳入了 19 项试验：11 项平行 RCT（754 名患者）和 8 项退出 RCT（704 名患者）。净收益范围从 2.4%（阿达木单抗）到 17.6%（依那西普），从 2.4%（依那西普）到 36.7%，（abatacept）分别在评估非系统性 JIA 的平行试验和停药试验中进行。在全身性 JIA 类别中，平行试验和停药试验中的净获益范围分别为 22.8%（rilonacept）至 70.3%（canakinumab）和 32.3%（canakinumab）至 58.2%（tocilizumab）。结论 结果表明，与非全身性 JIA 类别的 BA 相比，在全身性 JIA 类别中，更多的患者在没有严重不良事件的情况下获得了治疗成功。基线风险、试验设计和 JIA 类别会影响 JIA 患者 BA 净获益的衡量标准。分别。结论 结果表明，与非全身性 JIA 类别的 BA 相比，在全身性 JIA 类别中，更多的患者在没有严重不良事件的情况下获得了治疗成功。基线风险、试验设计和 JIA 类别会影响 JIA 患者 BA 净获益的衡量标准。分别。结论 结果表明，与非全身性 JIA 类别的 BA 相比，在全身性 JIA 类别中，更多的患者在没有严重不良事件的情况下获得了治疗成功。基线风险、试验设计和 JIA 类别会影响 JIA 患者 BA 净获益的衡量标准。