ข้ามไปยังเนื้อหาหลัก

What are the benefits and risks of tumor necrosis factor-alpha antagonists for treating Crohn’s disease in children?

Key messages

• Infliximab may result in a slight increase in induction of clinical remission (absence of noticeable symptoms) and endoscopic remission (absence of inflammation seen during examination of the colon) when compared to conventional treatment.

• There is limited evidence to support the use of tumor necrosis factor-alpha antagonists (anti-TNF) therapy for induction of remission in children with Crohn's disease.

• More well-designed studies are needed to compare anti-TNF with other treatments and to explore timing, dosing, and other details related to this treatment.

How is Crohn’s disease treated in children?

Initial treatment options for Crohn’s disease in children are steroids, enteral nutrition (special liquid food mixture containing all the nutrients required to meet nutrition needs), immunomodulators (substances that modify the immune system's activity), and sometimes biologics (drugs made from living organisms) such as anti-TNF.

Due to the more aggressive course of Crohn's disease in children and sometimes extensive inflammation, anti-TNF are frequently used.

What did we want to find out?

We wanted to find out if anti-TNF are safe and effective for induction treatment of Crohn’s disease in children. Induction treatment refers to the initial phase of medication used to reduce inflammation and therefore symptoms to bring about remission (when disease symptoms lessen or go away completely).

What did we do?

We searched for studies that looked at anti-TNF as induction treatment compared with conventional treatment (steroids or enteral nutrition), placebo (dummy treatment), or no treatment in children with Crohn’s disease. We summarized the results of the studies and rated our confidence in the evidence based on factors such as study methods and sizes.

What did we find?

We found only one study including 100 children with Crohn’s disease, aged 3 to 17 years, treated with first-line (first step in managing the disease) infliximab (anti-TNF) (50 children) or conventional treatment (steroids [oral prednisolone] or exclusive enteral nutrition) (50 children). The study was conducted in three European countries. Children were followed for one year.

The results suggest that infliximab may result in a slight increase in induction of clinical remission (absence of noticeable symptoms) and endoscopic remission (absence of inflammation seen during examination of the colon) when compared to conventional treatment. The included study did not look at morbidity (disease) or death related to Crohn's disease due to any cause, or serious or mild unwanted effects.

What are the limitations of the evidence?

We have little confidence in the evidence because it is possible that people in the studies knew which treatment they were getting; the included study was small; and there are not enough studies to be certain about the results.

Larger studies looking at the benefits and harms of anti-TNF compared with conventional treatment for children with active Crohn's disease are needed. Among the important outcomes to be included are morbidity, death, and serious unwanted effects.

How up-to-date is this evidence?

The evidence is current to June 2024.

วัตถุประสงค์

To assess the efficacy and safety of TNF-alpha antagonists for induction of remission in children and adolescents with active Crohn's disease.

วิธีการสืบค้น

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, PubMed, Embase (Elsevier), LILACS (Latin American and Caribbean Health Science Information database) (BIREME), and Science Citation Index Expanded and Conference Proceedings Citation Index-Science (Web of Science). We applied no language or document type restrictions. The last update of evidence was on 1 June 2024.

ข้อสรุปของผู้วิจัย

There is limited evidence to support the use of anti-TNF therapy for induction of remission in pediatric Crohn's disease.

Only one randomized clinical trial at high risk of bias suggests that FL-IFX may result in a slight increase in induction of clinical remission and endoscopic remission when compared to conventional treatment. The results of this trial need to be interpreted with caution.

Several important questions remain regarding the optimal timing of anti-TNF therapy, the preference between step-up versus top-down strategies, and other related issues. Further RCTs are needed to achieve stronger evidence, address these questions, and provide clearer guidance.

There is a need for larger randomized clinical trials following the SPIRIT and CONSORT statements, assessing the benefits and harms of using anti-TNF versus conventional therapy for pediatric Crohn's disease induction treatment.

แหล่งทุน

This Cochrane review had no dedicated funding.

การลงทะเบียน

The intervention protocol was published on Cochrane Database of Systematic Reviews 2022, DOI: 10.1002/14651858.CD014497.

การอ้างอิง
Sepúlveda A, de la Piedra Bustamante MJ, Orlanski-Meyer E, Villarroel del Pino LA, Olivares Labbe MT, Gana JC. Tumor necrosis factor-alpha antagonists for treatment of pediatric Crohn’s disease. Cochrane Database of Systematic Reviews 2025, Issue 8. Art. No.: CD014497. DOI: 10.1002/14651858.CD014497.pub2.

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