P432 Effects and safety of a colon-long absorbing budesonide product in patients with mild to moderate ulcerative colitis

• Published in: Journal of Crohn's and colitis Vol. 14; no. Supplement_1; pp. S393 - S394
• Main Authors: Pigniczki, D, Szántó, K, Rutka, M, Farkas, K, Bálint, A, Bor, R, Fábián, A, Szepes, Z, Molnár, T
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 15.01.2020
• ISSN: 1873-9946; 1876-4479
• DOI: 10.1093/ecco-jcc/jjz203.561

Abstract Background Budesonide is an oral corticosteroid, which is widely used in moderate-to-severe ulcerative colitis (UC) to obtain and maintain remission in those cases, where 5-aminosalicylic-acid was ineffective. Unlike previous forms of budesonide absorbing from the ileal and ascending colon region, the new-generation budesonide-MMX contains a formula, that allows absorption throughout the whole colon, and therefore in the whole potentially inflamed area in UC. We aimed to evaluate the effects and safety of budesonide-MMX in our UC patients who meet the above mentioned therapeutic demands in a real-life study. Methods We enrolled 22 patients with mild to severe UC in this single-centre prospective study until August of 2019. Patients received 9 mg oral budesonide-MMX once daily until 8 weeks. Laboratory parameters (cholesterol, triglyceride, CRP) and serum hormone levels (parathormone [PTH], dehydroepiandrosterone [DHEA] and cortisol) were monitored before and after the 8-week therapy to follow metabolic and hormonal changes. During these visits, body composition analysis was also performed with InBody 770 machine to observe the adverse steroid effects of budesonide-MMX in respect of body fat mass, body mass index, protein content of the body and bone mineral content. Disease activity was followed by the partial Mayo (pMayo) score. Statistical analysis was performed by paired t-test and Wilcoxon signed-rank test with SigmaPlot 1.25. Results The total of 22 patients (age: 44.4 ± 15.1 years, 6 male and 16 female patients) had received the 2-month budesonide-MMX therapy (2.0 ± 0.3 months). Mean disease duration was 8.3 years. By the end of follow-up, 15 (68.2%) patients experienced remission and 7 patients (31.8%) were primary non-responders. The disease activity decreased significantly from the mean of 3.95 to 1.64 (p < 0.001). No significant changes were observable in case of any body composition analysis parameter. Regarding the laboratory parameters, serum cholesterin level showed a significant increase (p < 0.001), while triglyceride and CRP showed did not show significant changes. Serum cortisol levels were elevated (p < 0.001), while PTH and DHEA showed no significant decrease. Only two patients experienced side effects: one of them hypertonia, headache and acnes, while the other patient experienced mild diarrhoea. One patient had a relapse during the treatment. Conclusion In our study, budesonide-MMX proved to be safe by bringing up a low number of side effects, while more than two-thirds of the patients could reach remission with this short-term therapy. Hormonal changes were not mentionable, although the drug’s effects on serum lipid content have to be examined further.