title: Budesonide MMX for the Induction of Remission of Mild to Moderate Ulcerative Colitis: A Pooled Safety Analysis.
abstract: OBJECTIVE
  Cumulative safety and tolerability of budesonide MMX, a once-daily oral corticosteroid for inducing mild to moderate ulcerative colitis remission, was examined.
  
  
  METHODS
  Data from three randomized, double-blind, placebo-controlled, phase II or III studies [budesonide MMX 9 mg, 6 mg, or 3mg for 8 weeks]; one phase II study [randomisation to budesonide MMX 9 mg or placebo for 4 weeks, then open-label budesonide MMX 9 mg for 4 weeks]; and one open-label study [budesonide MMX 9 mg for 8 weeks] were pooled.
  
  
  RESULTS
  Patients randomised to budesonide MMX 9 mg [n = 288], 6 mg [n = 254], or placebo [n = 293] had similar rates of adverse events [AEs] [27.1%, 24.8%, and 23.9%, respectively] and serious AEs [2.4%, 2.0%, and 2.7%, respectively]; treatment-related AEs and serious AEs were reported by 11.8% and 13.5%, and 5.9% and 2.2%, respectively, of patients receiving budesonide MMX 3mg [n = 17] or open-label budesonide MMX 9 mg [n = 89]. Mean morning plasma cortisol concentrations were normal from baseline to final visit across randomised groups; in patients receiving open-label budesonide, mean cortisol concentration was 129.9 nmol/l after 4 weeks, returning to normal concentrations at final visit. Budesonide MMX was not associated with an overall increased risk for glucocorticoid-related adverse effects.
  
  
  CONCLUSIONS
  Budesonide MMX 9 mg was associated with normal mean cortisol concentrations at final visit and an AE incidence comparable to placebo. Overall, budesonide MMX was safe and well tolerated for inducing remission of patients with mild to moderate ulcerative colitis.
authors.affiliation: Division of Gastroenterology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA grl@uphs.upenn.edu.
authors.forename: Gary R
authors.initials: GR
authors.lastname: Lichtenstein
authors.affiliation: Translational Gastroenterology Unit, Oxford University Hospitals, Oxford, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Travis
authors.affiliation: Instituto Clinico Humanitas, Milan, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Danese
authors.affiliation: Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Geert
authors.initials: G
authors.lastname: D'Haens
authors.affiliation: Cosmo Technologies Ltd, Dublin, Ireland.
authors.forename: Luigi
authors.initials: L
authors.lastname: Moro
authors.affiliation: Cosmo Technologies Ltd, Dublin, Ireland.
authors.forename: Richard
authors.initials: R
authors.lastname: Jones
authors.affiliation: Santarus, Inc., San Diego, CA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Huang
authors.affiliation: Santarus, Inc., San Diego, CA, USA.
authors.forename: E David
authors.initials: ED
authors.lastname: Ballard
authors.affiliation: Santarus, Inc., San Diego, CA, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Bagin
authors.affiliation: Santarus, Inc., San Diego, CA, USA.
authors.forename: Yun
authors.initials: Y
authors.lastname: Hardiman
authors.affiliation: Santarus, Inc., San Diego, CA, USA.
authors.forename: Raul
authors.initials: R
authors.lastname: Collazo
authors.affiliation: University of California San Diego, La Jolla, CA, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D019819:Budesonide / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000097:blood / Q000188:drug therapy*; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D060828:Induction Chemotherapy; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D015415:Biomarkers; D019819:Budesonide; D006854:Hydrocortisone
keywords: Budesonide MMX; safety; tolerability; ulcerative colitis