title: Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis.
abstract: OBJECTIVE
  Budesonide is a high-potency, second-generation corticosteroid designed to minimize systemic adverse consequences of conventional corticosteroids. We performed 2 randomized, phase 3 trials to evaluate the ability of budesonide rectal foam, formulated to optimize retention and provide uniform delivery of budesonide to the rectum and distal colon, to induce remission in patients with ulcerative proctitis or ulcerative proctosigmoiditis.
  
  
  METHODS
  Two identically designed, randomized, double-blind, placebo-controlled trials evaluated the efficacy of budesonide foam for induction of remission in 546 patients with mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis who received budesonide foam 2 mg/25 mL twice daily for 2 weeks, then once daily for 4 weeks, or placebo.
  
  
  RESULTS
  Remission at week 6 occurred significantly more frequently among patients receiving budesonide foam than placebo (Study 1: 38.3% vs 25.8%; P = .0324; Study 2: 44.0% vs 22.4%; P < .0001). A significantly greater percentage of patients receiving budesonide foam vs placebo achieved rectal bleeding resolution (Study 1: 46.6% vs 28.0%; P = .0022; Study 2: 50.0% vs 28.6%; P = .0002) and endoscopic improvement (Study 1: 55.6% vs 43.2%; P = .0486; Study 2: 56.0% vs 36.7%; P = .0013) at week 6. Most adverse events occurred at similar frequencies between groups, although events related to changes in cortisol values were reported more frequently with budesonide foam. There were no cases of clinically symptomatic adrenal insufficiency.
  
  
  CONCLUSIONS
  Budesonide rectal foam was well tolerated and more efficacious than placebo in inducing remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. ClinicalTrials.gov ID: NCT01008410 and NCT01008423.
authors: Division of Gastroenterology, University of California-San Diego, La Jolla, California. Electronic address: wsandborn@ucsd.edu.
authors: William J
authors: WJ
authors: Sandborn
authors: New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.
authors: Brian
authors: B
authors: Bosworth
authors: Connecticut Gastroenterology Institute, Bristol, Connecticut.
authors: Salam
authors: S
authors: Zakko
authors: Center for Digestive and Liver Diseases, Inc, Mexico, Missouri.
authors: Glenn L
authors: GL
authors: Gordon
authors: University of North Carolina School of Medicine, Chapel Hill, North Carolina.
authors: David R
authors: DR
authors: Clemmons
authors: Salix Pharmaceuticals, Inc, Raleigh, North Carolina.
authors: Pamela L
authors: PL
authors: Golden
authors: Salix Pharmaceuticals, Inc, Raleigh, North Carolina.
authors: Robert L
authors: RL
authors: Rolleri
authors: Salix Pharmaceuticals, Inc, Raleigh, North Carolina.
authors: Jing
authors: J
authors: Yu
authors: Salix Pharmaceuticals, Inc, Raleigh, North Carolina.
authors: Andrew C
authors: AC
authors: Barrett
authors: Salix Pharmaceuticals, Inc, Raleigh, North Carolina.
authors: Enoch
authors: E
authors: Bortey
authors: Salix Pharmaceuticals, Inc, Raleigh, North Carolina.
authors: Craig
authors: C
authors: Paterson
authors: Salix Pharmaceuticals, Inc, Raleigh, North Carolina.
authors: William P
authors: WP
authors: Forbes
mesh_terms: D000285:Administration, Rectal; D000287:Administration, Topical; D000328:Adult; D019819:Budesonide / Q000008:administration & dosage*; D012809:Colon, Sigmoid; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011349:Proctitis / Q000188:drug therapy; D011350:Proctocolitis / Q000188:drug therapy*; D012074:Remission Induction / Q000379:methods; D016896:Treatment Outcome; D014456:Ulcer / Q000188:drug therapy*
chemical_list: D005938:Glucocorticoids; D019819:Budesonide
keywords: Budesonide; Inflammatory Bowel Disease; Ulcerative Colitis; Ulcerative Proctosigmoiditis