Efficacy of budesonide therapy in the early phase of treatment of adult celiac disease patients with malabsorption: An in vivo/in vitro pilot study

Budesonide is a glucocorticosteroid with local anti-inflammatory effect. Celiac disease is an immune-mediated disease caused, in intolerant patients, by gluten ingestion. 2. To investigate the efficacy of budesonide in malabsorptive celiac patients and its effect in an in vitro gliadin challenge. 3. We enrolled 20 celiac subjects with malabsorption that were assigned randomly to two 4-week treatments: one on gluten-free diet alone, the other on gluten-free diet plus 6 mg of budesonide daily. Intestinal biopsies from 5 celiac patients and 4 controls were challenged with gliadin and budesonide for 3 h and 24 h. Biopsies were tested by immunohistochemistry and immunofluorescence for known markers of inflammation. 4. Treatment with budesonide induced an increase of body weight, a decrease of the number of evacuations and of stool weight compared to those observed for a gluten-free diet alone. Well-being scores were higher in patients treated with both a gluten-free diet and budesonide when compared to those receiving a gluten-free diet alone. In vitro studies showed that budesonide reduced the expression of epithelial tyrosine-phosphorylation and the expression of the histocompatibility leukocyte antigen complex DR (HLA-DR) elicited by gliadin-derived peptides. Also, the expression in the lamina propria of cyclooxygenase type 2 (COX2) and intercellular adhesion molecule 1 (ICAM1) was reduced in patients treated with both a gluten-free diet and budesonide compared to those treated with gliadin alone. 5. Budesonide shows efficacy in the treatment of symptomatic adult celiac patients with overt malabsorption. Its effect is demonstrated by an in vitro gliadin challenge study.