Biological therapy in a pediatric Crohn disease population at a referral center.

Abstract

OBJECTIVE:

The antitumor necrosis factor α (TNFα) antibodies infliximab and adalimumab are effective in inducing and maintaining remission in pediatric patients with Crohn disease (CD). The aim of the study was to evaluate the long-term efficacy and safety of biological therapy in pediatric patients with CD followed at a referral center.

METHODS:

This work is a retrospective observational study enrolling patients with CD treated with infliximab or adalimumab beyond the induction protocol. The patients' data were collected from the unit's IBD database (maximum follow-up evaluation after 36 months of treatment). The efficacy was evaluated by the Pediatric Crohn Disease Activity Index score and by analysis of the cumulative probability of continuing therapy; the safety was assessed in terms of adverse events.

RESULTS:

We enrolled 78 patients; the mean therapy duration was 27.2 ± 16.7 months, and the mean age at enrollment was 15 ± 3.1 years. The Kaplan-Meier analysis showed a cumulative probability of continuing therapy of 81%, 54%, and 33% at 1, 2, and 3 years, respectively, from the introduction of therapy. No association between the patients' baseline characteristics and the long-term outcome was found. The evaluation of the concomitant therapy with immunomodulators and anti-TNFα therapy versus anti-TNFα alone did not show a different outcome. No serious adverse events were recorded.

CONCLUSIONS:

The study indicates that biological therapy is effective and safe in pediatric patients with CD in a longer follow-up period. The response to treatment was not influenced by the patients' baseline characteristics or by the immunomodulator association.

• Authors: Federica Nuti, Franca Viola, Fortunata Civitelli, Claudia Alessandri, Marina Aloi, Anna Dilillo, Emanuela Del Giudice, Salvatore Cucchiara
• Journal: Journal of pediatric gastroenterology and nutrition (J Pediatr Gastroenterol Nutr) Vol. 58 Issue 5 Pg. 582-7 (May 2014) ISSN: 1536-4801 [Electronic] United States
• PMID: 24343280 (Publication Type: Journal Article)

Chemical References

• Anti-Inflammatory Agents
• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Gastrointestinal Agents
• Tumor Necrosis Factor-alpha
• Infliximab
• Adalimumab

Topics

• Adalimumab
• Adolescent
• Anti-Inflammatory Agents (therapeutic use)
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized (adverse effects, therapeutic use)
• Biological Therapy
• Child
• Cohort Studies
• Crohn Disease (drug therapy)
• Female
• Gastrointestinal Agents (therapeutic use)
• Humans
• Infliximab
• Male
• Retrospective Studies
• Time Factors
• Treatment Outcome
• Tumor Necrosis Factor-alpha (antagonists & inhibitors, immunology)