Twice-daily budesonide foam best for distal ulcerative colitis

Last Updated: 2015-12-10

By Reuters Staff

NEW YORK (Reuters Health) - Twice-daily budesonide foam is better than once-daily budesonide foam for inducing complete mucosal healing in patients with distal ulcerative colitis (UC), researchers from Japan report.

Mucosal healing has recently been recognized as the most important therapeutic goal for UC.

While healing is often defined as a Mayo endoscopic score of 1 or less, Dr. Makoto Naganuma from Keio University School of Medicine in Tokyo and colleagues contend that complete mucosal healing should be defined as a Mayo endoscopic score of 0.

They performed a phase 2, placebo-controlled trial to compare the efficacy and safety of once-daily (QD) versus twice-daily (BID) budesonide 2-mg foam treatment for 165 Japanese patients with distal UC.

Significantly more patients in the BID group (46.6%) than in the QD group (23.6%, p<0.01) and placebo group (5.6%, p<0.0001) achieved complete mucosal healing, the team reports in the Journal of Crohn's and Colitis, online November 17.

BID treatment also yielded superior results when the analysis was restricted to patients with no prior use of 5-ASA enema or suppository (58.1% complete mucosal healing with BID treatment versus 34.4% with QD treatment and 6.1% with placebo).

Clinical remission rates were similar after six weeks of BID and QD treatment, both of which were significantly better than with placebo.

Although study drug-related adverse events were more common with BID (50.9%) or QD (48.2%) budesonide than with placebo (20.4%), few patients discontinued treatment because of adverse events, and there was no increase in glucocorticoid-related symptoms such as moon face and fluid retention in either treatment group.

"Our new results suggest that BID administration of budesonide foam effectively induced complete mucosal healing," the researchers conclude. "BID administration of budesonide foam was not associated with any serious problems related with safety and application. BID budesonide foam has the possibility to be a potentially therapeutic option for achieving complete mucosal healing in patients with mild to moderate UC."

The study was supported by Ajinomoto Pharmaceuticals Co., Ltd. Dr. Naganuma did not respond to a request for comment.

SOURCE: http://bit.ly/1U6BjN3

J Crohns Colitis 2015.