Safety and efficacy study of Uceris (budesonide multimatrix MMX) in ulcerative colitis published in Journal of Crohn's & Colitis- Salix Pharmaceuticals

Salix Pharmaceuticals announced the peer-reviewed publication of a study in the Journal of Crohn's & Colitis evaluating the safety and efficacy of Uceris (budesonide multimatrix MMX), which was examined for induction of remission in patients with mild to moderate ulcerative colitis (UC) refractory to baseline mesalamine therapy. The study evaluated budesonide MMX 9 mg administered once daily for eight weeks for the induction of remission of mild to moderate UC not adequately controlled by stable, oral mesalamine therapy. The results of this randomized, double-blind, placebo-controlled study evaluated the efficacy, safety, and tolerability of once-daily, oral budesonide MMX 9 mg for the induction of remission of patients with mild to moderate UC unresponsive to oral mesalamine monotherapy. Combined clinical and endoscopic remission at Week 8 was achieved by 13.0% and 7.5% of patients receiving budesonide multimatrix or placebo, respectively, in the modified intention-to-treat population. Clinical remission [ulcerative colitis disease activity index rectal bleeding and stool frequency subscale scores of 0] was similar in both groups. More patients receiving budesonide multimatrix vs placebo achieved endoscopic remission [ulcerative colitis disease activity index mucosal appearance subscale score of 0; 20.0% vs 12.3%; p = 0.02] and histological healing [27.0% vs 17.5%; p = 0.02]. Adverse event rates were similar [budesonide multimatrix, 31.8%; placebo, 27.1%]. Mean morning cortisol concentrations decreased at Weeks 2, 4, and 8 with budesonide multimatrix but remained within the normal range.

See: "Budesonide Multimatrix Is Efficacious for Mesalamine-refractory, Mild to Moderate Ulcerative Colitis: A Randomised, Placebo-controlled Trial." David T. Rubin et al. J Crohns Colitis jjx032 4 March 2017 DOI: https://doi.org/10.1093/ecco-jcc/jjx032