title: Budesonide Foam Has a Favorable Safety Profile for Inducing Remission in Mild-to-Moderate Ulcerative Proctitis or Proctosigmoiditis.
abstract: BACKGROUND
  Budesonide foam, a rectally administered, second-generation corticosteroid with extensive hepatic first-pass metabolism, is efficacious for the treatment of mild-to-moderate ulcerative proctitis and ulcerative proctosigmoiditis.
  
  
  OBJECTIVE
  The aim of this study was to comprehensively assess the safety and pharmacokinetic profile of budesonide foam.
  
  
  METHODS
  Data from five phase III studies were pooled to further evaluate safety, including an open-label study (once-daily treatment for 8 weeks), an active-comparator study (once-daily treatment for 4 weeks), and two placebo-controlled studies and an open-label extension study (twice-daily treatment for 2 weeks, then once daily for 4 weeks). Data from the placebo-controlled studies and two phase I studies (i.e., patients with mild-to-moderate ulcerative colitis and healthy volunteers) were pooled to evaluate the pharmacokinetics of budesonide foam.
  
  
  RESULTS
  A similar percentage of patients reported adverse events in the budesonide foam and placebo groups, with the majority of adverse events being mild or moderate in intensity (93.3 vs 96.0%, respectively). Adverse events occurred in 41.4 and 36.3% of patients receiving budesonide foam and placebo, respectively. Mean morning cortisol concentrations remained within the normal range for up to 8 weeks of treatment; there were no clinically relevant effects of budesonide foam on the hypothalamic-pituitary-adrenal axis. Population pharmacokinetic analysis demonstrated low systemic exposure after budesonide foam administration.
  
  
  CONCLUSIONS
  This integrated analysis demonstrated that budesonide foam for the induction of remission of distal ulcerative colitis is safe overall, with no clinically relevant effects on the hypothalamic-pituitary-adrenal axis.
authors.affiliation: University of Chicago Medicine, 5841 S. Maryland Avenue, MC 4076, Chicago, IL, 60637, USA. drubin@medicine.bsd.uchicago.edu.
authors.forename: David T
authors.initials: DT
authors.lastname: Rubin
authors.affiliation: Division of Gastroenterology, Department of Medicine, University of California San Diego, 9500 Gilman Drive, La Jolla, CA, 92093, USA. wsandborn@ucsd.edu.
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.affiliation: Jill Roberts Center for Inflammatory Bowel Disease, New York-Presbyterian Hospital/Weill Cornell Medical Center, 1315 York Avenue, Mezzanine, New York, NY, 10021, USA. bpb9002@med.cornell.edu.
authors.forename: Brian
authors.initials: B
authors.lastname: Bosworth
authors.affiliation: Connecticut Gastroenterology Institute, Bristol Hospital, 41 Brewster Road, Bristol, CT, 06010, USA. szakko@bristolhospital.org.
authors.forename: Salam
authors.initials: S
authors.lastname: Zakko
authors.affiliation: Center for Digestive and Liver Diseases, Inc., 714 Medical Park Drive, Mexico, MO, 65265, USA. glgordonmd@gutdoc.us.
authors.forename: Glenn L
authors.initials: GL
authors.lastname: Gordon
authors.affiliation: Nuventra Pharma Sciences, Inc., 2525 Meridian Parkway, Research Triangle Park, NC, 27713, USA. msale@nuventra.com.
authors.forename: Mark E
authors.initials: ME
authors.lastname: Sale
authors.affiliation: Salix, a Division of Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd, Bridgewater, NJ, 08807, USA. rrolleri1@nc.rr.com.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Rolleri
authors.affiliation: Salix, a Division of Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd, Bridgewater, NJ, 08807, USA. goldenpl@hotmail.com.
authors.forename: Pamela L
authors.initials: PL
authors.lastname: Golden
authors.affiliation: Salix, a Division of Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd, Bridgewater, NJ, 08807, USA. andrewcbarrett@yahoo.com.
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Barrett
authors.affiliation: Salix, a Division of Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd, Bridgewater, NJ, 08807, USA. Enoch.bortey@yahoo.com.
authors.forename: Enoch
authors.initials: E
authors.lastname: Bortey
authors.affiliation: Salix, a Division of Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate Blvd, Bridgewater, NJ, 08807, USA. bill.forbes@earthlink.net.
authors.forename: William P
authors.initials: WP
authors.lastname: Forbes
mesh_terms: D000285:Administration, Rectal; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D002986:Clinical Trials as Topic; D004304:Dosage Forms; D016903:Drug Monitoring; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; D008875:Middle Aged; D011350:Proctocolitis / Q000175:diagnosis / Q000188:drug therapy*; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D004304:Dosage Forms; D005938:Glucocorticoids; D019819:Budesonide
keywords: Budesonide foam; Pharmacokinetics; Safety; Ulcerative colitis; Ulcerative proctitis; Ulcerative proctosigmoiditis