FOR ACTIVE MILD TO MODERATE ULCERATIVE COLITIS, TREATMENT AT THE SOURCE OF PROCTITIS AND PROCTOSIGMOIDITIS1,2
STUDY 1: 38.3% vs 25.8% (UCERIS rectal foam [n=133] vs placebo [n=132], respectively), P=.032
STUDY 2: 44.0% vs 22.4% (UCERIS rectal foam [n=134] vs placebo [n=147], respectively), P<.001
MMDAI, Modified Mayo Disease Activity Index.
STUDY DESIGN: Two identically designed, randomized, double-blind, placebo-controlled, multicenter studies were conducted in 546 adult patients with an endoscopy-confirmed diagnosis of active, mild to moderate distal colitis with disease extending at least 5 cm, but no further than 40 cm, from the anal verge. Primary endpoint was the proportion of patients who were in remission after 6 weeks of treatment.1
*Rectal bleeding score criteria: 0=no blood seen; 1=blood streaks in stool less than half of the time; 2=blood streaks in stool half the time or more; 3=blood alone passed.1,5
†Endoscopy score criteria: 0=normal/inactive disease; 1=erythema, decreased vascular pattern; 2=marked erythema, absent vascular pattern, friability, erosions; 3=spontaneous bleeding, ulceration.1
UCERIS rectal foam is designed with small volume and high viscosity, which promotes adhesion to the mucosal lining and helps minimize the potential for post-application leakage.6
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UCERIS® (budesonide) rectal foam is indicated for the induction of remission in patients with active, mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information for UCERIS rectal foam.
References: 1. UCERIS rectal foam [prescribing information]. Bridgewater, NJ: Salix Pharmaceuticals. 2. Langholz E, Munkholm P, Davidsen M, Nielsen OH, Binder V. Changes in extent of ulcerative colitis: a study on the course and prognostic factors. Scand J Gastroenterol. 1996;31(3):260-266. 3. Sandborn WJ, Bosworth B, Zakko S, et al. Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis.
Gastroenterology. 2015;148(4):740-750. 4. Brunner M, Vogelsang H, Greinwald R, et al. Colonic spread and serum pharmacokinetics of budesonide foam in patients with mildly to moderately active ulcerative colitis. Aliment Pharmacol Ther. 2005;22(5):463-470. 5. US Department of Health and Human Services. Ulcerative colitis: clinical trial endpoints: guidance for industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ulcerative-colitis-clinical-trial-endpoints-guidance-industry. Published August 2016. Accessed December 2, 2020. 6. Gross V, Bar-Meir S, Lavy A, et al. Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis. Aliment Pharmacol Ther. 2006;23(2):303-312.
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UCERIS® ((budesonide) rectal foam is indicated for the induction of remission in patients with active, mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.