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P546. Biological therapy in children and adolescents: infliximab and adalimumab, a comparison of their side effects

F. Calzolari, F. Vincenzi, F. Fornaroli, B. Bizzarri, A. Ghiselli, C. Calzolari, A. Salerno, G. Nervi, G.L. de' Angelis, University Hospital of Parma, Gastroenterology and Digestive Endoscopy Unit, Parma, Italy

Background

Infliximab (IFX) and Adalimumab (ADA) have recently been approved for the treatment of IBD in children and adolescents (ADA only for Crohn's disease in pediatric age).

The aim of this study was to evaluate and compare adverse events and side effects arising during IFX or ADA therapy in a cohort of 63 pediatric patients affected by IBD in the period between January 2008 and June 2013.

Methods

Forty-five patients were treated only with IFX, 8 only with ADA and 10 with both of them at different times. 801 intravenous IFX infusions were administered to 55 patients (27 M and 28 F, average age 15.46 years); 38 of them were affected by CD, 14 by UC, 2 by indeterminate colitis and one by Behçet's syndrome. 948 subcutaneous ADA injections were administered to 18 patients (6 M and 12 F, average age 15.02); among them, 15 were affected by CD and 3 by UC.

Results

In our study, the main serious adverse events observed were: infections, acute infusion reactions to IFX and drug-induced psoriasis.

Infections were the most severe adverse event reported and involved 9.09% of IFX-treated patients and 27.78% of ADA-treated patients. They were mostly opportunistic (HSV, HPV, VZV and TB). As regards non-opportunistic infections, there was only one case of pneumonia caused by Mycoplasma. All infections were successfully treated, without other complications. The concomitant treatment with azathioprine didn't increase the risk of infection in our sample.

Acute infusion reactions were observed only with IFX, in 18.18% of the patients treated with this drug. The subjects involved were 2 males and 8 females: in our cohort female gender resulted as a risk factor for developing acute infusion reactions (p = 0.04191). No case required resuscitator's intervention nor ICU admission. In 4 patients it was possible to switch to a slow infusion schedule; in the remaining 6, biological therapy was definitively suspended to avoid more serious subsequent reactions.

Drug-induced psoriasis occurred in 3 males and 7 females. Our experience showed that this adverse event is a class effect, regarding mainly female patients and involving atypical areas for psoriasis, such as hands, feet, scalp and groin region. Half of the cases had a familiar history of idiopathic psoriasis: these were the most severe and invalidating forms and required definitive interruption of the therapy.

Conclusion

This study shows that long-term treatment with IFX and ADA was safe and well tolerated in most cases. Considering the remarkable benefits of this new form of medical therapy for IBD in pediatric age, the decision to use an anti-TNFalpha agent should be individualized and based upon specific clinical features and unique risk profile of a given patient.