Uceris Evaluated in Mesalamine-Refractory Ulcerative Colitis – Monthly Prescribing Reference (registration)

May 18, 2017

A total of 510 patients with mild-to-moderate ulcerative colitis took part in the randomized, placebo-controlled trial

Salix announced the publication of study data for budesonide multimatrix (MMX), also known as Uceris extended-release tablets, in theJournal of Crohn's & Colitis.

In the randomized, double-blind, placebo-controlled, multicenter study, budesonide MMX was evaluated for the induction of remission in 510 patients withmild to moderate ulcerative colitis (UC)refractory to baseline mesalamine therapy. Study patients were randomized to oral budesonide MMX 9mg daily or placebo for 8 weeks. Baseline treatment with oral mesalamine 2.4g daily was continued.

Clinical remission was defined as UC disease activity index rectal bleeding and stool frequency subscale scores of 0. Endoscopic remission was defined as UC disease activity index mucosal appearance subscale score of 0.

At Week 8, combined clinical and endoscopic remission was obtained in 13.0% of budesonide MMX patients vs. 7.5% of placebo patients in the modified intent-to-treat population (P=0.049). Clinical remission was similar for both study arms (P=0.70). More patients in the budesonide MMX group vs. the patients in the placebo group achieved endoscopic remission (20.0% vs. 12.3%;P=0.02) and histological healing (27.0% vs. 17.5%;P=0.02).

Study authors reported that the rates of adverse events were comparable between the budesonide MMX and placebo arms: 31.8% vs. 27.1%. A reduction in mean morning cortisol concentrations was noted at Weeks 2, 4, and 8 with budesonide MMX, but concentrations remained in the normal range.

David T. Rubin, MD, lead author, from the University of Chicago Medicine, added, "The data suggest the efficacy and safety of Uceris in patients experiencing an active flare of UC despite initial oral 5-ASA therapy."

Uceris, a second-generation extended-release corticosteroid, is currently approved for the induction of remission in patients with active, mild to moderate ulcerative colitis. It is available as 9mg extended-release tablets in 30-count bottles.

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Excerpt from:
Uceris Evaluated in Mesalamine-Refractory Ulcerative Colitis - Monthly Prescribing Reference (registration)