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P359 Budesonide MMX in paediatric ulcerative colitis

M. Meglicka*1, M. Dadalski1, A. Adamczuk1, J. Kierkus1

1The Children’s Memorial Health Institute, Department of Gastroenterology, Hepatology, Feeding Disorders and Paediatrics, Warsaw, Poland

Background

Budesonide is a second generation steroid (CS) with high affinity for the glucocorticoid receptor, over 8.5 times greater than dexamethasone. Due to its low bioavailability, budesonide exhibits fewer side effects (AEs) than conventional CSs. Currently, available data on budesonide MMX concern the use of the preparation in adults with ulcerative colitis (UC). Data on the use of this preparation in children are single.

Methods

In total, 31 children with UC (K 18, M 13) and a median age of 13.2 years in whom budesonide MMX was used in 2014–2017 were enrolled in the retrospective study. Data from the results of laboratory tests: haematocrit (HT), platelets (PLT), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and severity of clinical disease in the PUCAI score before and after finished therapy were analysed. In 15/31 patients, endoscopic examinations before and after the treatment were also performed, the Mayo score was assessed. Data regarding to the duration of therapy and possible AEs were also collected. As a clinical response the reduction in the PUCAI score below 19 points was considered and as a clinical remission the PUCAI score below 10 points. The endoscopic response a reduction of the Mayo score was considered, while the endoscopic remission was Mayo = 0. The Wilcoxon test was used to assess statistical significance.

Results

There were none statistically significant improvement in analysed laboratory results found, compared with the condition before treatment. From among the study group, 55% of patients managed to achieve both a clinical response and a clinical remission (17/31) with p = 0.007. The endoscopic improvement was obtained by 73% (11/15) of the examined patients, and endoscopic remission by 40% (6/15). The median duration of therapy was 2 months, but 3 patients were treated with budesonide MMX for more than 10 months, of which one over 2 years. The percentage of AEs in the whole study group was 19% (6/31). All patients treated for over 10 months experienced AEs. In the remaining patients treated for a maximum of 3 months, the AEs percentage was 10% (3/31). The main AE observed in patients was the accumulation of adipose tissue on the face (cushingoidal face) and weight gain.

Conclusion

Budesonide MMX is an effective for the induction of remission in children with UC. In 55% of patients cause clinical remission, which is followed by a 40% endoscopic remission. Used in short-term therapy, it rarely causes AEs. Used in long-term treatment, like conventional CS, it causes AEs in children.