Once-daily mesalamine granules for maintaining remission of ulcerative colitis: pooled analysis of efficacy, safety, and prognostic factors. Issue 3 (2nd April 2016)

• Record Type: Journal Article
• Authors: Zakko, Salam F.; Gordon, Glenn L.; Murthy, Uma; Sedghi, Shahriar; Pruitt, Ronald; Barrett, Andrew C.; Bortey, Enoch; Paterson, Craig; Forbes, William P.; Lichtenstein, Gary R.
• Is Part Of: Postgraduate medicine. Volume 128:Issue 3(2016)
• Page Start: 273
• Page End: 281
• Publication Date: 2016-04-02
• Subjects: Inflammatory bowel disease -- ulcerative colitis -- mesalamine -- remission; Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Periodicals; 610.5
• DOI: 10.1080/00325481.2016.1152876
• Languages: English
• ISSNs: 0032-5481

Abstract

ABSTRACT: Objectives: A capsule formulation of mesalamine granules (MG) was developed for once-daily dosing and better compliance. The study aim was to evaluate MG efficacy and tolerability in maintaining ulcerative colitis (UC) remission. Methods: Pooled analysis of 2 identical phase 3, randomized, double-blind trials of once-daily MG 1.5 g or placebo for up to 6 months. The primary endpoint was percentage of patients remaining relapse-free at month 6 versus placebo. Relapse was defined as revised Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, UC flare, or UC–related adverse event (AE). Results: Data were pooled for patients receiving MG ( n = 373) and placebo ( n = 189). Significantly more patients were relapse-free at 6 months with MG (79.4%) than placebo (62.4%; P < 0.001) and across subgroups based on select demographic and baseline characteristics ( P < 0.05). Secondary outcome measures including rectal bleeding, physician rating of disease activity, stool frequency, total SDAI score, and relapse-free duration favored MG ( P < 0.01). Common AEs with MG and placebo, respectively, were headache (10.9% and 7.6%), diarrhea (7.9% and 7.0%), and abdominal pain (6.3% and 6.5%). Conclusion: Once-daily MG was more efficacious than and as well tolerated as placebo in maintaining UC remission. ClinicalTrials.gov identifiers: NCT00744016 and NCT00767728.