Issue 09

Clinical Question

Does budesonide foam, a second generation corticosteroid, induce adrenal suppression when used to treat proctitis or proctosigmoiditis?

Editor’s Bottom Line

Using adrenocorticotropic hormone (ACTH) challenge testing, there was no evidence of adrenal suppression with budesonide foam when used for up to 8 weeks in patients with proctitis or proctosigmoiditis.

Reference

Rubin DT, Sandborn WJ, Bosworth B, et al. Budesonide foam has a favorable safety profile for inducing remission in mild-to-moderate ulcerative proctitis or proctosigmoiditis. Dig Dis Sci. 2015 Nov;60(11):3408–17.
https://www.ncbi.nlm.nih.gov/pubmed/26386854

Synopsis

A total of 5 phase III clinical trials were included in this meta-analysis (Table 1). Studies #1–4 included patients with endoscopically and/or histologically confirmed mild-moderate proctitis or proctosigmoiditis. All studies permitted oral 5-ASA drugs at stable doses except for #4. Adverse events were documented. Standard morning ACTH challenge tests were performed to assess adrenal insufficiency.

Of the 719 patients enrolled in studies #1–4, 85% completed them. Drug-related adverse event (AE) rate was 15.6% versus 5.8% in the budesonide foam and placebo groups, respectively. Serious AEs in both groups were the same (1.1%). The most common AEs in the budesonide versus placebo groups were decreased blood cortisol (9.2% vs. 2.2%), headache (6.3% vs. 2.5%), and abdominal pain (3.6% vs. 1.4%). The ACTH test found that that tested patients were within the normal range for up to 8 weeks using budesonide foam therapy and there was a low systemic exposure after administration.

Table 1: Study designs

Details

Study Design: Meta-analysis
Funding: Salix, a division of Valeant Pharmaceuticals North America LLC
Allocation: n/a
Setting: n/a
Level of Evidence: 1a (Oxford Levels of Evidence)

The summary and conclusion in this issue of E-mentoring in IBD pertains to the manuscript(s) being reviewed, and should be considered in the context of what is already known surrounding the topic and incorporated into practice as deemed appropriate by the individual learner.