Prospective Evaluation of the Achievement of Mucosal Healing with Anti-TNF-α Therapy in a Paediatric Crohn's Disease Cohort

J Crohns Colitis. 2016 Jan;10(1):5-12. doi: 10.1093/ecco-jcc/jjv126. Epub 2015 Jul 17.

Abstract

Background and aims: There is growing evidence that in Crohn's disease the achievement and maintenance of mucosal healing (MH) through anti-TNFα antibodies may change the natural history of the disease. Few studies evaluating such outcome as a therapeutic goal are available in paediatrics. The primary aim of the study was to assess the efficacy of biologics in obtaining MH in a paediatric Crohn's disease cohort. The secondary aims were: (1) to assess response based on early or late treatment introduction and on combination therapy with immunomodulators versus biologics alone; and (2) to evaluate clinical outcome 2 years after the second endoscopy.

Methods: Biologic-naive paediatric Crohn's disease patients starting anti-tumour necrosis factor α (TNFα) treatment were enrolled. Patients' demographic and treatment data were recorded. Clinical [Pediatric Crohn's Disease Activity Index (PCDAI)] and endoscopic [Simple Endoscopic Score for Crohn's Disease (SES-CD)] evaluations were performed at time 0 (T0) and after 9-12 months (follow-up). Appropriate induction and maintenance therapeutic schemes were applied.

Results: Thirty-seven patients were enrolled. At enrolment, mean age was 12.3 ± 3.4 years and mean disease duration was 13.0 ± 16 months. At follow-up there was a significant decrease in PCDAI and SES-CD compared with T0 (p < 0.01). No statistical difference in frequency of MH between the early and late treatment introduction groups was found. Combination therapy was superior in obtaining complete plus partial MH (p < 0.01). One and 2 years after the second endoscopy, all and 79% of patients with complete MH and 75 and 67% of those with partial MH were still in clinical remission, respectively.

Conclusions: Biologics improve mucosal lesions, apparently more effectively if given in combination with immunomodulators. MH appears to sustain a better disease course.

Keywords: Anti-TNFα; agents; mucosal healing; paediatric Crohn’s disease.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adalimumab / administration & dosage
  • Adalimumab / adverse effects
  • Adolescent
  • Biological Products / administration & dosage*
  • Child
  • Cohort Studies
  • Crohn Disease / diagnosis*
  • Crohn Disease / drug therapy*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Immunologic Factors / administration & dosage
  • Infliximab / administration & dosage
  • Infliximab / adverse effects
  • Intestinal Mucosa / drug effects*
  • Intestinal Mucosa / physiopathology
  • Kaplan-Meier Estimate
  • Male
  • Odds Ratio
  • Prospective Studies
  • Risk Assessment
  • Severity of Illness Index
  • Statistics, Nonparametric
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / administration & dosage
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*

Substances

  • Biological Products
  • Immunologic Factors
  • Tumor Necrosis Factor-alpha
  • Infliximab
  • Adalimumab

Supplementary concepts

  • Pediatric Crohn's disease