title: Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission.
abstract: BACKGROUND
  Patients with ulcerative colitis (UC) who achieve remission with corticosteroids often relapse after tapering or discontinuation; alternative treatments limiting steroid exposure and UC relapse would be beneficial. It remains uncertain whether patients with corticosteroid-induced remission experience benefit with mesalamine granules (MG), a locally acting aminosalicylate extended-release capsule formulation for maintenance of UC remission in adults.
  
  
  OBJECTIVE
  Efficacy and safety of MG 1.5 g once daily was evaluated in patients with UC in corticosteroid-induced remission.
  
  
  METHODS
  Data from patients with previous corticosteroid use to achieve baseline UC remission were analyzed from two 6-month randomized, double-blind, placebo-controlled trials and a 24-month open-label extension (OLE). Six-month relapse-free rates were assessed using the revised Sutherland Disease Activity Index. UC-related adverse events (AEs) were recorded during the 30 months.
  
  
  RESULTS
  Included were 158 steroid-treated patients in UC remission (MG, n = 105; placebo, n = 53) and 74/105 MG-treated patients who continued MG in the OLE. A significantly larger percentage of patients remained relapse-free at 6 months with MG (77.1 %) versus placebo (54.7 %; P = 0.006), with a 55 % reduction in relapse risk (hazard ratio [HR] 0.45; 95 % CI 0.25-0.79). There was a similar (49.2 %) reduction in risk of UC-related AEs at 6 months (HR 0.51; 95 % CI 0.31-0.84; P = 0.009) that was sustained during the OLE.
  
  
  CONCLUSIONS
  MG 1.5 g once daily administered for maintenance of corticosteroid-induced remission was associated with low risk of relapse and UC-related AEs. CLINICALTRIALS.GOV: NCT00744016, NCT00767728, and NCT00326209.
authors.affiliation: Division of Gastroenterology, Hospital of the University of Pennsylvania, University of Pennsylvania School of Medicine, 7th Floor Perelman Center, Room 753, 3400 Civic Center Boulevard, Philadelphia, PA, 19104, USA. grl@uphs.upenn.edu.
authors.forename: Gary R
authors.initials: GR
authors.lastname: Lichtenstein
authors.affiliation: Center for Digestive and Liver Diseases, Mexico, MO, USA.
authors.forename: Glenn L
authors.initials: GL
authors.lastname: Gordon
authors.affiliation: Connecticut Gastroenterology Institute and Clinical Research Foundation, Bristol, CT, USA.
authors.forename: Salam
authors.initials: S
authors.lastname: Zakko
authors.affiliation: Syracuse VA Medical Center, Syracuse, NY, USA.
authors.forename: Uma
authors.initials: U
authors.lastname: Murthy
authors.affiliation: Gastroenterology Associates of Central Georgia, LLC, Macon, GA, USA.
authors.forename: Shahriar
authors.initials: S
authors.lastname: Sedghi
authors.affiliation: Nashville Medical Research Institute, The Maria Nathanson Center at Saint Thomas Hospital, Nashville, TN, USA.
authors.forename: Ron
authors.initials: R
authors.lastname: Pruitt
authors.affiliation: Salix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, USA.
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Barrett
authors.affiliation: Salix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, USA.
authors.forename: Enoch
authors.initials: E
authors.lastname: Bortey
authors.affiliation: Salix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, USA.
authors.forename: Craig
authors.initials: C
authors.lastname: Paterson
authors.affiliation: Salix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, USA.
authors.forename: William P
authors.initials: WP
authors.lastname: Forbes
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017326:Clinical Trials, Phase III as Topic; D003093:Colitis, Ulcerative / Q000175:diagnosis / Q000188:drug therapy*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011208:Powders; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D012074:Remission Induction; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D005765:Gastrointestinal Agents; D011208:Powders; D019804:Mesalamine
keywords: Inflammatory bowel diseases; Mesalamine; Remission; Steroids; Ulcerative colitis