Steroid Foam Diminishes Inflammatory Bowel Disease

Patients with distal ulcerative colitis had significantly higher rates of remission when treated with rectally administered steroid foam, according to two new studies.

Researchers at the University of California San Diego (UCSD; USA) reported the results of two phase III, randomized, placebo-controlled trials of a budesonide foam preparation. Both studies involved patients with endoscopy-confirmed mild or moderate ulcerative proctitis or proctosigmoiditis. The patients were randomized to budesonide foam or matching placebo, applied twice daily for 2 weeks and then daily for 4 weeks. All study participants underwent endoscopic assessments at baseline and after 6 weeks of treatment, with the primary efficacy endpoint being the proportion of patients achieving remission at 6 weeks.

The analysis of the individual trials showed that 38.3% and 44% of patients in the budesonide arm achieved remission at 6 weeks, as compared with 25.8% and 22.4% of the placebo groups. The combined results showed a remission rate of 41.2% with budesonide foam and 24% with placebo. Separate analysis of the individual components of the remission criteria showed that significantly more patients in the budesonide arm had endoscopic healing and resolution of rectal bleeding. Adverse event rates were similar between the budesonide and placebo groups. The studies were presented as a poster session at the American College of Gastroenterology (ACG) meeting, held during October 2013 in San Diego (CA, USA).

“In general, topical therapies have demonstrated efficacy, but enemas often prove difficult to administer and maintain, and can lead to fecal incontinence and urgency. Suppositories are better tolerated but generally limited to treatment of rectal disease,” concluded lead author William Sandborn, MD, and colleagues. “Experience with foam preparations has demonstrated better retention and adherence, as well as more uniform distribution of medication in the distal colon and rectum, as compared with enemas and suppositories.”

Budesonide is a synthetic glucocorticoid steroid that has an anti-inflammatory effect. It is used to reduce inflammation associated with inflammatory bowel diseases by controlling the rate of protein synthesis, depressing the migration of polymorphonuclear leukocytes and fibroblasts, and reversing capillary permeability and lysosomal stabilization at the cellular level. In rectal foam formulation, it is administered to reduce inflammation associated with ulcerative colitis affecting the lower end of the bowel and rectum.

Related Links:
University of California San Diego