Santarus Announces Publication of Results from UCERIS Pivotal Study in Gastroenterology
UCERIS 9 mg statistically more effective than placebo for inducing remission in patients with active, mild to moderate ulcerative colitis
The results from CORE I indicate that the investigational drug UCERIS 9
mg had a statistically significant benefit over placebo in the primary
endpoint of combined clinical and endoscopic remission at week 8 among
patients with active, mild to moderate ulcerative colitis.
The percentage of patients achieving the primary endpoint of combined clinical and endoscopic remission at week 8 in the UCERIS 9 mg group was significantly greater than that seen in the placebo group (17.9% vs. 7.4%, p= 0.0143; odds ratio (OR): 2.71). The combined clinical and endoscopic remission rate for UCERIS 6 mg (13.2% vs 7.4%, p= 0.1393; OR: 1.90) and for the reference drug Asacol® (mesalamine) 2.4 g (12.1% vs 7.4%, p= 0.2200; OR: 1.71) were numerically greater than placebo, but the differences were not statistically significant. These results are summarized in the table below.
|
|
Placebo n= 121 |
Uceris
9 mg n= 123 |
Uceris
6 mg n= 121 |
Asacol
2.4 g n= 124 |
|||||||||
| Combined Clinical and Endoscopic Remission, % | 7.4% | 17.9% | 13.2% | 12.1% | |||||||||
| P-value | 0.0143* | 0.1393 | 0.2200 | ||||||||||
| Odds ratio | 2.71 | 1.90 | 1.71 |
*Statistically significant (p < 0.025)
Efficacy analyses were done in the modified intent to treat population under a prespecified statistical analysis plan, which included all randomized patients who received at least one dose of a study drug and excluded patients with major good clinical practice or entry criteria violations and those with normal histology at baseline as determined by central histopathology review.
"In this study, UCERIS 9 mg was well tolerated, and significantly more
effective than placebo in inducing remission in patients with active,
mild to moderate ulcerative colitis," said
UCERIS 9 mg and 6 mg were generally well tolerated and the frequency of treatment emergent adverse events was similar to placebo. The most frequent treatment emergent adverse events (experienced by ≥ 5.0% of patients in any treatment group) were worsening ulcerative colitis, headache, pyrexia, insomnia, back pain, nausea, abdominal pain, diarrhea and flatulence. Potential glucocorticoid effects occurred in similar percentages of patients across all treatment groups. Potential glucocorticoid effects were observed in 10.1% of patients in the placebo group, 11.8% of patients in the UCERIS 9 mg group, 5.6% of patients in the UCERIS 6 mg group and 7.9% of patients in the Asacol group.
Phase III Study (CORE* I and II) Design
*COlonic RElease budesonide for the treatment of mild to moderate ulcerative colitis
UCERIS was evaluated for the treatment of active, mild to moderate ulcerative colitis in two multicenter, randomized, double-blind, double-dummy, placebo-controlled four-arm Phase III clinical studies. The primary endpoint was the induction of combined clinical and endoscopic remission, defined as an overall UCDAI score ≤ 1 after 8 weeks of treatment with subscores of 0 for both rectal bleeding and stool frequency, a normal colonic mucosa without any sign of friability, and ≥ 1 point reduction from baseline in the endoscopic score.
-
CORE I was conducted in
North America andIndia and compared UCERIS 9 mg or 6 mg dosed once daily to placebo. The study included a reference arm utilizing a dose of two Asacol (mesalamine) 400 mg delayed-release tablets dosed three times a day resulting in a total of 2.4 grams daily. The trial enrolled a total of 509 patients. -
CORE II was conducted in
Europe ,Australia ,Israel , andRussia and compared UCERIS 9 mg or 6 mg dosed once daily to placebo. The study included a reference arm that utilized a dose of three Entocort® EC 3 mg capsules resulting in a once daily dose of 9 mg. The trial enrolled a total of 511 patients.
The CORE I and CORE II clinical studies were powered to show a statistical difference between the two UCERIS treatment arms and placebo. The trials were not powered to show statistical differences between UCERIS and the reference arms (Asacol in the CORE I study and Entocort EC in CORE II).
About UCERIS (budesonide)
UCERIS is an investigational drug that contains budesonide, a
corticosteroid, in a novel oral tablet formulation that utilizes
proprietary MMX® multi-matrix system technology, which is
designed to result in the controlled release and distribution of
budesonide throughout the length of the colon. UCERIS is being developed
in collaboration with
About Ulcerative Colitis
Ulcerative colitis is a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements. It is believed that as many as 700,000 people in the U.S. suffer from ulcerative colitis.
About
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forward-looking statements, which speak only as of the date hereof. All
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