Servicio de Medicina Preventiva y Gestión de Calidad, Hospital General Universitario Gregorio Marañón, Madrid, España.
Departamento de Historia de la Ciencia y Documentación, Universidad de Valencia, Valencia, España.
Med Clin (Barc). 2023 Jun 9;160(11):501-516. doi: 10.1016/j.medcli.2023.02.006. Epub 2023 Mar 24.
Inflammatory bowel disease includes two chronic inflammatory diseases, ulcerative colitis and Crohn's disease. The burden of disease is increasing worldwide. A few reviews evaluating the paediatric use of tumour necrosis factor (TNF) antagonists have been published, although these mostly include observational studies and do not consider economic evaluations. This systematic review evaluated the available evidence regarding the efficacy, safety, and cost-effectiveness of TNF antagonist therapy for paediatric inflammatory bowel disease. We searched PubMed/MEDLINE, Embase, and Cochrane Central (up to May 2022). Nine randomized clinical trials and four economic evaluations that examined any anti-TNF drugs (e.g., infliximab, adalimumab, golimumab, and certolizumab) against different alternatives were included. In studies evaluating the efficacy of anti-TNF drugs in Crohn's disease, most assessed the efficacy of maintenance regimen in patients who had previously responded to induction (response=28%-63%, and clinical remission=17%-83% depending on dose, drug, and follow-up). In ulcerative colitis, maintenance treatment with anti-TNF drugs reported clinical remission rates between 17% and 44%. Nine studies reported information on adverse events. No clinical trials comparing different anti-TNF drugs were found. The findings from this review suggest that maintenance treatment with anti-TNF drugs (such as infliximab and adalimumab) in paediatric inflammatory bowel disease is probably effective and safe. However, the economic evaluations reported contradictory results of the cost-effectiveness ratios. Protocol registry: Open Science Framework: https://osf.io/wjmvf.
炎症性肠病包括两种慢性炎症性疾病,溃疡性结肠炎和克罗恩病。疾病负担在全球范围内呈上升趋势。虽然已经发表了一些评估肿瘤坏死因子(TNF)拮抗剂在儿科应用的综述,但这些综述大多包括观察性研究,不考虑经济评估。本系统评价评估了 TNF 拮抗剂治疗儿科炎症性肠病的疗效、安全性和成本效益的现有证据。我们检索了 PubMed/MEDLINE、Embase 和 Cochrane Central(截至 2022 年 5 月)。纳入了 9 项随机临床试验和 4 项经济评估,这些研究考察了任何抗 TNF 药物(如英夫利昔单抗、阿达木单抗、古利昔单抗和 Certolizumab)与不同替代药物的比较。在评估抗 TNF 药物治疗克罗恩病疗效的研究中,大多数评估了既往对诱导治疗有反应的患者维持治疗的疗效(缓解率为 28%-63%,临床缓解率为 17%-83%,取决于剂量、药物和随访)。在溃疡性结肠炎中,抗 TNF 药物维持治疗报告的临床缓解率在 17%-44%之间。9 项研究报告了不良事件的信息。未发现比较不同抗 TNF 药物的临床试验。本综述的结果表明,在儿科炎症性肠病中使用抗 TNF 药物(如英夫利昔单抗和阿达木单抗)进行维持治疗可能是有效和安全的。然而,报告的成本效益比的经济评估结果却相互矛盾。方案注册:开放科学框架:https://osf.io/wjmvf。