Abstract

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. Conclusions: 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.

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