Greenberg S¹, Herfarth HH^2,3,4, Barnes EL^2,3,4. Inflamm Intest Dis. 2019 Aug;4(3):115-122. doi: 10.1159/000501004. Epub 2019 Jul 10.

Author information

1 Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

2 Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

3 Multidisciplinary Center for Inflammatory Bowel Diseases, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

4 Center for Gastrointestinal Biology and Disease, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Abstract

BACKGROUND: Budesonide multimatrix (MMX) system has been approved for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC), and offers potential safety benefits over more commonly utilized corticosteroid therapies.

OBJECTIVES: In a real-world setting we aimed to evaluate the proportion of UC patients treated with budesonide MMX who had an inadequate clinical response, defined as requiring transition to prednisone, and to identify any predictors of inadequate response.

METHODS: We performed a single-center retrospective cohort study evaluating adult patients with UC, ≥18 years of age, who were treated with budesonide MMX. We used bivariate and multivariable analyses to identify predictors of inadequate response to budesonide MMX.

RESULTS: Ninety-six patients were treated with budesonide MMX. Before initiation of budesonide MMX 55, 35, and 8% were on aminosalicylate, immunomodulator, and/or biologic therapy or no therapy for UC respectively. While 54% (52/96) of patients responded to budesonide MMX, 46% (44/96) required a transition to prednisone. Patients who required transition to prednisone were more likely to be male (39 vs. 19%, p = 0.035) and younger at the time of diagnosis (median age 23.5 vs. 29.0 years, p = 0.034). Age ≤29 years at diagnosis (adjusted OR 3.10, 95% CI 1.21-7.95) and male sex (adjusted OR 2.96, 95% CI 1.12-7.77) but not concomitant therapy with biologics and/or immunomodulators or disease extent were associated with increased odds of requiring transition to prednisone.

CONCLUSIONS: Budesonide MMX is effective in more than half of patients with mild-to-moderate UC. Predictors of budesonide non-response and need to transition to prednisone include male sex and younger age at diagnosis.