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Uceris tablets induce remission in mesalamine-refractory, mild-to-moderate ulcerative colitis
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A phase 3 randomized controlled trial demonstrated the safety and efficacy of Uceris tablets for induction of clinical and endoscopic remission in patients with mild-to-moderate ulcerative colitis who were unresponsive to oral mesalamine monotherapy.
Systemic corticosteroids often prescribed to patients who fail to respond to mesalamine therapy are linked to potentially serious adverse events. Uceris (budesonide multimatrix, Salix Pharmaceuticals) is an extended-release oral glucocorticosteroid with low systemic bioavailability, designed to pass intact through the stomach and provide targeted delivery of active drug throughout the colon.
David T. Rubin
“The data suggest the efficacy and safety of Uceris in patients experiencing an active flare of UC despite initial oral 5-ASA therapy,” David T. Rubin, MD, professor and chief of gastroenterology at The University of Chicago Medicine, and Healio Gastroenterology Peer Perspective Board member, said in a press release.
Two previous phase 3 trials (CORE I and CORE II) demonstrated the safety and efficacy of budesonide multimatrix in patients who were not permitted to receive other UC therapies during the study, and a small phase 2 study showed safety and efficacy in patients who received concomitant oral mesalamine.
This double blind phase 3 trial aimed to further assess the safety, efficacy and tolerability of budesonide multimatrix in patients with active mild-to-moderate UC despite receiving mesalamine. Between December 2011 and December 2012, Rubin and colleagues randomly assigned 510 adult patients from outpatient settings in the U.S., Canada and Europe, to receive either 9 mg once daily or placebo for 8 weeks. There was also a 2-week screening phase and a 4-week post-treatment phase, and all patients continued treatment with at least 2.4 g oral mesalamine daily.
In the modified intention-to-treat population, 13% of the treatment group and 7.5% of the placebo group achieved the primary efficacy endpoint of combined clinical and endoscopic remission at week 8 (P = .049).
Similar proportions of patients in each group achieved clinical remission (24.3% vs. 22.8%), but significantly more patients in the treatment group achieved endoscopic remission (20% vs. 12.3%; P = .02) and histological healing (27% vs. 17.5%; P = .02).
Rates of adverse events were also comparable between groups (31.8% vs. 27.1%), with the most common being a UC flare. Small proportions of each group experienced a serious adverse event, but pancreatitis, bronchitis, anemia and hypokalemia each occurred in 0.4% of the treatment group and not in the placebo group. Overall, 4.7% of the treatment group vs. 3.5% of the placebo group stopped treatment due to an adverse event.
The researchers noted that patients in the treatment group showed reduced average morning cortisol levels at weeks 2, 4 and 8, but they stayed within the normal range.
They concluded that “once-daily oral budesonide [multimatrix] is a well-tolerated, efficacious therapeutic option for induction of combined endoscopic and clinical remission in mild to moderate UC, including in patients with UC not adequately controlled with oral mesalamine therapy alone.” – by Adam Leitenberger
Disclosures: This study was supported by Santarus, previously a subsidiary of Salix Pharmaceuticals. Rubin reports he has received research grants and served as a consultant for Salix and Santarus.
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