1Division 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. email@example.com.
2Center for Digestive and Liver Diseases, Mexico, MO, USA.
3Connecticut Gastroenterology Institute and Clinical Research Foundation, Bristol, CT, USA.
4Syracuse VA Medical Center, Syracuse, NY, USA.
5Gastroenterology Associates of Central Georgia, LLC, Macon, GA, USA.
6Nashville Medical Research Institute, The Maria Nathanson Center at Saint Thomas Hospital, Nashville, TN, USA.
7Salix, a Division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, USA.
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.
Efficacy and safety of MG 1.5 g once daily was evaluated in patients with UC in corticosteroid-induced remission.
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.
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.
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.