Extended-release budesonide safe in ulcerative colitis

Last Updated: 2015-07-22

By David Douglas

NEW YORK (Reuters Health) - A form of extended-release budesonide using multi-matrix (MMX) technology is safe and well tolerated in patients with mild to moderate ulcerative colitis, according to pooled trial data.

As Dr. Gary R. Lichtenstein told Reuters Health by email, "Our analysis demonstrated that the short-term use of Budesonide MMX in two large clinical trials was well tolerated and was effective for treatment of patients with active mild to moderate ulcerative colitis and was associated with an incidence of adverse events that was comparable to placebo."

The analysis, funded by Santarus, Inc., a subsidiary of Salix Pharmaceuticals, Inc., was published online June 20 in the Journal of Crohn's and Colitis.

Dr. Lichtenstein, from the University of Pennsylvania, Philadelphia, and colleagues combined findings from two large randomized trials, one small randomized trial and an open-label trial.

In all, 631 patients received budesonide MMX 6 or 9 mg/day, 17 received 3 mg/day and 293 got placebo for up to eight weeks.

Rates of treatment-related adverse events (AEs) were similar for 9 mg (27.1%), 6 mg (24.8%) and placebo (23.9%). This was also true of serious AEs (2.4%, 2.0%, and 2.7%). The fewest adverse events were reported in the 3 mg group. However as the researchers point out, "this treatment group also included the fewest patients."

Thus, although the studies included did not contribute equally to the analysis, the team observes that "it is reassuring that a low incidence of AEs were reported in the 2 large, randomized, controlled trials."

Mean morning plasma cortisol concentrations were normal from baseline to final visit across the randomized groups. In the open-label group, mean cortisol concentration was 129.9 nmol/L after four weeks, returning to normal concentrations at the final visit.

The drug was not associated with an overall increased risk for glucocorticoid-related adverse effects, the researchers say.

Given these findings, the researchers conclude that "budesonide MMX is a second-generation glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and may be an alternative to conventional corticosteroids in such patients."

Commenting on the findings by email, gastroenterologist Dr. Darrell S. Pardi from the Mayo Clinic in Rochester, Minnesota, told Reuters Health the "Bottom line is that this drug appears to be safe at the doses and durations studied, and probably safer than other steroids such as prednisone (although that was not addressed in this paper)."

The clinical trials included in the analysis were funded by Cosmo Pharmaceuticals, S.p.A. and Santarus. Several of the authors are Santarus employees, and two are from Cosmo.

Dr. Lichtenstein reported ties to Santarus and Salix.

SOURCE: http://bit.ly/1MobKG8

J Crohns Colitis 2015.