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Long-term Safety and Tolerability of Once-daily Mesalamine Granules in the Maintenance of Remission of Ulcerative Colitis

Lichtenstein, Gary R. MD*; Barrett, Andrew C. PhD; Bortey, Enoch PhD; Paterson, Craig MD; Forbes, William P. PharmD

doi: 10.1097/MIB.0000000000000076
Original Clinical Articles

Background: Ulcerative colitis (UC), a chronic, relapsing, and remitting inflammatory bowel disease, requires long-term treatment to maintain remission. In this study, the long-term safety and tolerability of mesalamine granules (MG) therapy was evaluated in the maintenance of UC remission. Previous prospective studies evaluating different oral mesalamine formulations have not exceeded a duration of 14 months.

Methods: A phase 3, multicenter, 24-month, open-label extension study evaluating MG 1.5 g once daily in patients who achieved previous remission from mild to moderate UC was performed. Eligible patients had successfully participated in 1 of 2 previous 6-month double-blind, placebo-controlled trials or were new patients in remission. Safety assessments included monitoring of adverse events (AEs) and clinical laboratory tests. Risk of UC recurrence was assessed by the occurrence of UC-related AEs.

Results: Of the 393 patients enrolled (280 from the double-blind studies; 113 new patients), 388 were included in the safety population. The most common AEs included nasopharyngitis (13.9%), headache (11.6%), and diarrhea (10.8%), and the incidence of these events was generally lower in the MG group versus historical placebo group from the double-blind studies. Pancreatic, renal, and hepatic AEs occurred in 23 patients (5.9%). The risk of UC-related AEs was low and was maintained for 24 months during the open-label study.

Conclusions: Once-daily MG has a favorable safety profile for the maintenance of remission for up to 2 years in patients with UC.

Article first published online 28 May 2014.

*Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania; and

Salix Pharmaceuticals Inc., Raleigh, NC.

Reprints: Gary R. Lichtenstein, MD, Division of Gastroenterology, Department of Medicine, University of Pennsylvania Health System, 9th Floor Penn Tower, One Convention Avenue, Philadelphia, PA 19104-4283 (e-mail: grl@uphs.upenn.edu).

Funding for technical editorial and medical writing assistance was provided by Salix Pharmaceuticals Inc., Raleigh, NC.

G. R. Lichtenstein has served as a consultant for Abbott Corporation/AbbVie; Elan Corporation, plc.; Hospira Inc.; Millennium Pharmaceuticals Inc.; Ono Pharmaceutical Co. Ltd.; Pfizer Inc.; Santarus Inc.; Schering-Plough Corp.; and Takeda Pharmaceutical Company Limited. He has served as a research consultant for Alaven Pharmaceutical LLC; Ferring Pharmaceuticals; Janssen Ortho Biotech; Prometheus Laboratories Inc.; Salix Pharmaceuticals Inc.; Shire plc.; UCB Inc.; and Warner Chilcott. Additionally, he has served as a researcher for Bristol-Myers Squibb Company and has received honoraria from Ironwood Pharmaceuticals Inc., for participation in the company's continuing medical education program. A. C. Barrett, E. Bortey, and C. Paterson are employees of and shareholders in Salix Pharmaceuticals Inc. W. P. Forbes is an officer and employee of and shareholder in Salix Pharmaceuticals Inc.

Received March 04, 2014

Accepted April 11, 2014

© Crohn's & Colitis Foundation of America, Inc.
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