Biological agents in paediatric inflammatory bowel disease: a clinical observation study from Greece.

Objectives: Biological agents have contributed significantly in controlling inflammatory bowel disease during the last 15 years. This study aimed at recording and evaluating paediatric data regarding the efficacy and safety of infliximab and adalimumab during the last decade. Patients and methods: A total of 31 patients (43% males) with a mean age of 13.5 ± 3.0 years were included and the majority (74%) had Crohn's disease (CD). Failure of previous treatment and steroid dependency were the main reasons for initiating anti-TNF-α therapy. Mean age at the first infusion was 11.0 ± 2.8 years, while the mean disease duration at the introduction of infliximab was 2.6 ± 2.7 years. The number of infusions per patient ranged from 1-25 (median 7, IQR: 4-13). Results: Initial response was achieved in 82.8% of patients. After one year of treatment the estimated rate of remission was 53%. The rate of surgery-free disease at 12, 36 and 60 months, after the first dose of infliximab, was 89.6%, 89.6% and 74.7% respectively. The incidence of serious anaphylaxis was 4/268 infusions (1.5%) or 4/31 patients (12.3%). At three months after the first infusion only 2 children were on steroids. Adalimumab was administered to 5 patients for a mean duration of 7.4 months, as a second option after infliximab failure or infusion reaction. Two out of five patients failed to achieve remission with adalimumab and these two patients were also infliximab failures. Conclusion: Biological agents are valuable and safe options for children with refractory IBD. The results, so far, have been satisfactory, although, long-term outcomes remain yet to be determined.