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P523. Efficacy and safety of adalimumab (ADA) therapy in pediatric Crohn's disease (CD) patients who failed infliximab (IFX): a multicenter experience of the Italian Society of Pediatric Gastroenterology Hepatology and Nutrition (SIGENP)

P. Alvisi1, A. Barabino2, S. Cucchiara3, E. Miele4, C. Romano5, A. Ravelli6, D. Knafelz7, P. Lionetti8, G. Guariso9, M. Aloi3, S. Arrigo2, L. Balzani10, S. Martellossi11, 1Maggiore hospital, Pediatric unit, Bologna, Italy, 2Gaslini hospital, Gastroenterology and Endoscopy unit, Genua, Italy, 3Sapienza University of Rome, Pediatric Gastroenterology and Liver unit, Rome, Italy, 4University of Naples Federico II, Pediatric unit, Naples, Italy, 5University of Messina, Pediatric Gastroenterology and Liver unit, Messina, Italy, 6Children's hospital, Gastroenterology and GI Endoscopy unit, Brescia, Italy, 7Bambino Gesù Hospital, Hepatology and Gastroenterology unit, Rome, Italy, 8Meyer Pediatric Hospital, Gastroenterology and Nutrition unit, Florence, Italy, 9University of Padua, Pediatric Gastroenterology unit, Padua, Italy, 10Bologna Hospitals, Directional Staff, Bologna, Italy, 11Institute of Child Health, IRCSS Burlo Garofolo, Department Of Pediatrics, Trieste, Italy

Background

The published experience of ADA treatment in pediatric CD is limited. Aim of the present report was to evaluate ADA efficacy and safety after IFX failure in pediatric CD.

Methods

A retrospective study involving CD pts <18 y of age after IFX failure was carried out by SIGENP. Demographic data, growth parameters, clinical response (PCDAI score), endoscopic findings (CDEIS score) and adverse events at 6 m and at the patient's last follow up were recorded.

Results

37 pts (19 F, mean age 10.9 y) from 10 IBD centers. At diagnosis 86% had moderate-severe disease, 49% extensive disease, 18% ileum cecal disease, 33% ileum or colonic disease. 11% of pts received IFX as first line therapy and 22% pts associated immunomodulator (IM). Reasons of IFX discontinuation were loss of response (53%), and infusion reaction (47%). At the ADA start the mean age was 14.6 y, 70.2% pts had moderate-severe disease (30.2% PCDAI >30). 46% CRP value was positive. The mean time from diagnosis was 3 y (range 3–11 y). Nobody needed steroids. At 6 months, 35/37 pts were evaluable. 63% in complete clinical remission, 12% in partial clinical remission and 25% had active disease. 39% had CRP positive values. Mean follow up time after ADA start was 13.2 m. At the last follow up, 62% pts were in clinical complete remission, 6% in partial clinical remission and 32% pts had active disease. The mean PCDAI value at the ADA start was 20.8 (median 22.5), at 6 m was 11.4 (median 10) and at the last follow up 10.9 (median 10). PCDAI decrements were statistically significant (p < 0.01). In 29% of pts CRP values were positive. At the last follow up endoscopic evaluation was available in 54% pts and documented mucosal healing in 65%, mild-moderate lesions in 10% and severe disease in 25%. In univariate analysis no prognostic factors were found (disease duration and extension, reasons for IFX stop) except for the combined therapy IFX+ IM that was negatively correlated with the PCDAI values (p < 0.01). At last follow up the growth parameters were not significantly different. Adverse events were one case of meningitis and one of medulloblastoma in a boy treated with IFX (12 m) and ADA (6m) without IM.

Conclusion

According to our data ADA is an effective therapy for pediatric CD who failed IFX. Despite the severity of disease, more than 60% of pts showed clinical and endoscopic remission. Treatment efficacy with anti-TNF alfa agents should be balanced against infection risk and possible onset of cancer.