Biological therapy In a Pediatric Crohn's disease population followed at a referral center

OBJECTIVES:: The anti-TNFα antibodies infliximab and adalimumab are effective in inducing and maintaining remission in pediatric Crohn's Disease (CD) patients. The aim of the study is to evaluate the long term efficacy and safety of biological therapy in pediatric CD patients followed at a referral center. METHODS:: This work is a retrospective observational study enrolling all of the CD patients 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 PCDAI 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 enrolment was 15 ± 3.1 yrs. The Kaplan-Meier analysis showed a cumulative probability of continuing therapy of 81%, 54% and 33% at 1, 2 and 3 yrs, 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 CD patients in a longer follow-up period. The response to treatment was not influenced by the patients' baseline characteristics or by the immunomodulator association.