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* = Presenting author

P540 Efficacy and safety of adalimumab in the treatment of inflammatory bowel disease in children

G. De Caro*, C. Madia, F. Gaiani, A. Fugazza, B. Bizzarri, A. Ghiselli, F. Fornaroli, F. Vincenzi, G.L. de’ Angelis

Azienda Ospedaliero Universitaria di Parma, Gastroenterologia ed Endoscopia Digestiva, Parma, Italy

Background

The objective of this study was to evaluate the efficacy (in term of clinical, laboratory and endoscopic response) and the safety of adlimumab in children with Crohn’s disease (CD) and ulcerative colitis (UC).

Methods

All paediatric patients with inflammatory bowel disease (IBD) treated with adalimumab at the gastroenterology unit (Parma) between January 2003 and November 2015 were included in a retrospective study. We included 33 children (12 male and 21 female): 27 with CD and 6 with UC. Disease activity was determined using Paediatric Crohn’s Disease Activity Index (PCDAI) for children with CD, and the Paediatric Ulcerative Colitis Activity Index (PUCAI) for those with UC. The degree of mucosa inflammation was studied by Simple Endoscopic Score for CD (SES-CD) and Mayo score for UC.

Results

The average age at diagnosis was 12.7 years for CD and 10.6 years for UC, with a median age of 14.7 years when ADA was started. Seventeen patients (15 CD patients and 2 UC patients) were naïve to anti-TNFα. After 12 weeks of ADA therapy, the PCDAI score was significantly reduced (10.25 vs 46.85), as well as the PUCAI score (14.65 vs 59.16). Further, 66% of children with CD achieved mucosal healing, and 81.4 % an endoscopic improvement. Moreover, 66% of children with showed mucosal healing, and 83.3 % an endoscopic response. Surgery was performed in 5 patients (1 with UC and 4 with CD) during the study period. Adverse events to ADA were reported in 4 patient: 1 patient with CD has developed eczema, oedema of the cheek, and oedema at the injection site 3 times. The treatment was then stopped with resolution of the symptoms. Three children affected by CD have shown psoriasis of the scalp and the trunk that have required discontinuation of treatment.

Conclusion

Our results confirm the safety and efficacy of ADA in paediatric patients with IBD. Indeed, we found significant mucosal healing and response rate in our group of children with both UC and CD. Treatment benefits should be weighed against side effects. Multicentre longitudinal studies with longer follow-up periods are required to determine the true efficacy and safety of long-term ADA treatment.