Efficacy and Safety of Adalimumab for Paediatric Crohn's Disease: A Systematic Review

Piotr Dziechciarz1, Andrea Horvath2, Jaroslaw Kierkuś3

  • 1Department of Paediatrics Medical University of Warsaw, Warsaw, Poland piotrdz@hotmail.com.

Insights

Adalimumab therapy shows approximately 50% remission rates in children with Crohn's disease within the first year. While generally safe, further high-quality studies are needed to confirm effectiveness and safety in pediatric patients.

Area of Science:

  • Pediatric Gastroenterology
  • Immunology
  • Pharmacology

Background:

  • Adalimumab is an established therapy for adult Crohn's disease (CD).
  • Evidence on its use in pediatric CD populations is less established.
  • This study systematically reviews existing literature on adalimumab for pediatric CD.

Purpose of the Study:

  • To systematically assess the published evidence on the efficacy and safety of adalimumab for Crohn's disease in children.
  • Evaluate remission rates and adverse events in pediatric patients treated with adalimumab.
  • Identify gaps in the current research for pediatric Crohn's disease treatment.

Main Methods:

  • Systematic literature search of MEDLINE, EMBASE, and Cochrane Library up to July 2015.
  • Included randomized controlled trials and observational studies on adalimumab for pediatric Crohn's disease.
  • Analyzed 14 studies encompassing 664 patients aged 1.9 to 21 years.

Main Results:

  • Pooled remission rates varied, with approximately 44% at 12 months.
  • Primary non-response was observed in 6% of patients.
  • Severe adverse events were reported in 12%, including 2 deaths and 1 medulloblastoma; withdrawal due to adverse events was 35% in one study.

Conclusions:

  • Low-quality evidence suggests adalimumab achieves remission in about half of pediatric Crohn's disease patients within a year.
  • The safety profile appears reasonable, but significant adverse events and withdrawals occurred.
  • High-quality evidence is still needed to definitively establish the effectiveness and safety of adalimumab in pediatric Crohn's disease.
Abstract

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