P510 Assessment of study group – patients with inflammatory bowel disease, treated with monoclonal anti-TNF alpha: a multicenter, prospective cohort observational study, Satimos – preliminary report in pediatric population

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Background: The incidence of the inflammatory bowel disease (IBD) is increasing in the pediatric population. Anti-TNF treatment is used more often. Because of this, a multicenter, prospective cohort observational study was started to prospectively evaluate the safety of anti-TNF alpha in adults and pediatric patients with IBD. Data collection began in January 2014. This preliminary report is based on the analysis of data collected until September 2016. From the database the information about pediatric population was analized in this report. The aim of the study is characteristic of pediatric population qualified to anti-TNF therapy in Poland.

Methods: Authors analyzed the data of 667 patients - 307 women (45.9%) and 360 men (54.1%).

Among the respondents, there were 270 patients aged below 18 years old (40.4%) and 397 adults (59.6%). The analysis omitted 74 patients for whom complete date were lacking.

Results: The pediatric group consisted of 214 patients suffering from Crohn's disease (CD) and 56 with ulcerative colitis (UC). The time between the first symptoms and diagnosis depends on the type of disease, UC was diagnosed after mean 8.1 months, CD after mean 11.8 months. Among children with UC, 60.4% of patients had extensive colitis (E3), 32.1% had left side colitis and 7.5% had proctitis. For pediatric patients with CD localisation of the disease was: upper gastrointestinal tract 27.1%, ileum terminale 38.3%, colon 40.2%, small intestine 22.0%, perianal changes were seen in 23.4% children. The most often, regards to CD 75.4% of children were qualified to biologic therapy because of luminal active disease and 24.6% of children with severe perianal changes. Among children with CU, 73.1% of patients were qualified to the therapy because chronic refraktory course of disease, 26.9% because exacerbation of disease. Mean disease activity at the beginning was PCDAI 40.4, PUCAI 53.7.

80.3% of patients with CD and 87.8% with UC were qualified to treatment with Infliximab, 19.7% of children with CD and 12.1% with UC were qualified to treatment with Adalimumab. The response to treatment in the CD by decrease in PCDAI score was observed in 70.8% of children. In turn, the UC response to treatment was defined as a decrease in the PUCAI scale and was recorded in the case of 78.8% of children.

Among children with UC adverse events was observed in 58.9% of cases, with CD in 46.7%.

The most common adverse events which were reported could be classified as gastrointestinal disorders (24.3%) and mild infections (19.2%).

Conclusions: This preliminary report shows important data about pediatric population with IBD. Data also shows how large number of patients require biological treatment.

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