P136 - Efficacy and safety of adalimumab in children with active Crohn's disease: a prospective, open-label, single-centre trial

s of the 4th Congress of ECCO the European Crohn’s and Colitis Organisation S65 P136 Efficacy and safety of adalimumab in children with active Crohn’s disease: a prospective, open-label, single-centre trial F. Civitelli *, F. Viola, S. Oliva, F. Nuti, E. Romeo, G. Di Nardo, V. Pannone, O. Borrelli, S. Cucchiara. Sapienza University, Rome, Italy Adalimumab (ADA) (HUMIRA, Abbott ®), a fully human IGG1 anti-TNFa monoclonal antibody, is effective in inducing and maintaining remission in adult patients (pts) with active Chron’s Disease (CD), regardless of previous experience with anti-TNFa therapy. There are only few data on its use in pediatric pts with CD. Aim: To prospectively evaluate efficacy and safety of ADA in pediatric pts with moderate to severe CD. Patients and Methods: 23 CD pts, median age 16.1 years (range 9 20), naive to (9 pts) or who had failed prior Infliximab (IFX) therapy (14 pts) received ADA. The induction schedule at week (wk) 0 and 2 was 160mg/80mg in 13 pts, 80mg/40mg in 8 pts, followed respectively by 80mg or 40mg every other week (eow) during the 44 wks maintenance phase. Two pts received an induction dose of 120mg/80mg, followed by 80mg eow. Primary outcomes were: clinical remission (PCDAI score 10), clinical response (decrease in PCDAI score of 50% versus baseline), safety of the therapeutic course at wk 2, 4, 12, 24 and 48. ITT analysis including all pts who received at least 1 dose of ADA was performed. Results: mean disease duration at the beginning of ADA course was 52.2±42.5 months (mts). Fourteen pts had previously received IFX therapy (9.2±8.2 doses), discontinued due to loss of efficacy (11 pts) or intolerance (3 pts). Mean time between the last IFX dose and the beginning of ADA was 19.2±15.5 mts. At baseline 13 pts were receiving concomitant immumnomodulators (IM); only 2 pts at wk 48. Mean oral corticosteroids dose (mg/kg/day) was 0.9±0.2mg at the beginning of the trial, 0.07±0.1 at wk 48 (p < 0.001). The mean PCDAI, ESR, CRP values at each study point are shown in the table. Rates of remission at wk 2, 4, 12, 24 and 48 were: 36.3%; 60.8%; 30.5%; 50% and 65.2%. Rates of response were respectively: 54.5%; 34.8%; 39.1%; 40.9%; 30.4%. During the maintenance phase 5/8 pts receiving 40mg eow had to increase ADA dose to 80mg eow in order to maintain clinical remission; 6/13 pts receiving 80mg eow were able to shift to 40mg eow without CD exacerbation. Only 2 pts presented a serious adverse event requiring temporary cessation of ADA: 1 within wk 24 (abdominal abscess), 1 through wk 48 (severe cutaneous infection).