Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine, Shanghai, China.
Front Immunol. 2022 Aug 19;13:896550. doi: 10.3389/fimmu.2022.896550. eCollection 2022.
Biological agents have been used with extreme caution in children because of their possible adverse effects.
This study used high-quality randomized controlled trials (RCTs) to provide high-level evidence to assess the effectiveness and safety of biological agents for treating children with psoriasis.
We searched PubMed, Embase, Cochrane, and Web of Science databases through October 31, 2021. We included trials reporting at least one adverse event after treatment with biological agents of patients less than 18-year-old diagnosed with psoriasis. RevMan 5.3 and Stata 15.0 software were used for meta and Bayesian analyses.
Six trials with 864 participants were included in the analysis. The results showed a 2.37-fold higher response rate in all biologics groups than in the control group for psoriasis area and severity index 75 (PASI75) (RR= 2.37, value < 0.01, 95% confidence interval [CI] [1.22, 4.62]). Compared with placebo, the PASI75 response rates of etanercept (RR= 2.82, 95% [CI] [1.10, 7.21]), ustekinumab low dose (RR= 7.45, 95%[CI] [1.25, 44.58]), and ustekinumab high dose (RR= 7.25, 95%[CI] [1.21, 43.41]) were superior. Additionally, the incidence of total adverse reactions was 1.05 times higher for biologics than for controls, indicating a good safety profile (RR= 1.05, value = 0.53, 95%[CI] [0.92, 1.19]). Overall, these six high-quality randomized controlled trials suggest that biologics are effective and safe for pediatric patients with psoriasis.
Inclusion of few relevant, high-quality RCTs.
The results of this study indicate that biologics can be used to treat children with moderate-to-severe psoriasis without the risk of adverse effects. Ustekinumab showed the best efficacy and the fewest adverse effects.
由于生物制剂可能产生不良反应，因此在儿童中使用时需极其谨慎。
本研究采用高质量随机对照试验（RCT），为评估生物制剂治疗儿童银屑病的有效性和安全性提供高级别证据。
我们检索了 PubMed、Embase、Cochrane 以及 Web of Science 数据库，检索时间截至 2021 年 10 月 31 日。我们纳入了报道至少有 1 例治疗后不良反应的研究，这些研究对象为诊断为银屑病且年龄小于 18 岁的患者，他们接受生物制剂治疗。使用 RevMan 5.3 和 Stata 15.0 软件进行荟萃分析和贝叶斯分析。
纳入的 6 项研究共 864 名参与者。结果显示，所有生物制剂组的银屑病面积和严重程度指数 75 （PASI75）应答率均显著高于对照组（RR=2.37，P<0.01，95%置信区间[CI] [1.22, 4.62]）。与安慰剂相比，依那西普（RR=2.82，95%CI[1.10, 7.21]）、低剂量乌司奴单抗（RR=7.45，95%CI[1.25, 44.58]）和高剂量乌司奴单抗（RR=7.25，95%CI[1.21, 43.41]）的 PASI75 应答率更高。此外，生物制剂组总不良反应发生率比对照组高 1.05 倍，表明安全性良好（RR=1.05，P=0.53，95%CI[0.92, 1.19]）。总体而言，这 6 项高质量随机对照试验表明，生物制剂治疗儿童银屑病有效且安全。
纳入的相关高质量 RCT 较少。
本研究结果表明，生物制剂可用于治疗中重度银屑病儿童，且无不良反应风险。乌司奴单抗疗效最佳，不良反应最少。
