MMX Mesalamine for the Treatment of Active Mild-to-Moderate Ulcerative Colitis

Abstract

Purpose: Current mesalamine (5-ASA) treatments for ulcerative colitis (UC) are often associated with complex dosing regimens that may lead to poor compliance and reduced efficacy. SPD476–302, a randomized, placebo-controlled, phase III study recently demonstrated the efficacy of MMX™ mesalamine (SPD476), a high-strength (1.2g/tablet) 5-ASA formulation designed for once-daily dosing, in inducing remission in patients with mild-to-moderately active UC. Given the importance of evidence-based medicine for patient care, number needed to treat (NNT) analyses are frequently used for making treatment decisions in clinical practice. The purpose of this analysis is to assess the NNT associated with MMX mesalamine-related induction of remission in UC. Methods: In study SPD476–302, patients with mild-to-moderate UC received MMX mesalamine 2.4g/day given once daily (QD), MMX mesalamine 4.8g/day given QD, Asacol® given three times daily (TID) or placebo. The primary endpoint was clinical and endoscopic remission (modified UC-disease activity index score of ≤1, with a rectal bleeding and stool frequency score of 0, no mucosal friability, and ≥1 point reduction in sigmoidoscopy score from baseline) after 8 weeks' treatment. An NNT analysis was completed for remission at 8 weeks. Results: See table.Table: Evidence-based analysis of remission.Conclusions: NNT analysis shows that, versus placebo, for one patient with mild-to-moderately active UC to achieve clinical and endoscopic remission (using stringent criteria) at week 8, six patients need to be treated with MMX mesalamine (2.4g/day or 4.8g/day given QD) while 10 patients need to be treated with Asacol 2.4g/day given TID. This research was funded by Shire Pharmaceuticals Inc., Wayne, PA, USA