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MMX MESALAMINE INDUCES COMPLETE MUCOSAL HEALING IN PATIENTS WITH MILD-TO-MODERATE ULCERATIVE COLITIS

WJ Sandborn¹, GR Lichtenstein², MA Kamm³, K Barrett⁴, RE Joseph⁵
¹Mayo Clinic, Rochester; ²University of Pennsylvania, Philadelphia, Pennsylvania, USA; ³St Mark's Hospital, London; ⁴Shire Pharmaceutical Inc, Basingstoke, UK; ⁵Shire Pharmaceuticals Inc, Wayne, Pennsylvania, USA

INTRODUCTION: MMX^TM mesalamine, a high-strength formulation of 5-ASA designed for once-daily (QD) dosing, combines a gastro-resistant film (to delay drug release until the terminal ileum) and MMX Multi Matrix System^TM technology (to provide extended drug delivery throughout the colon). Incomplete mucosal healing in patients with symptomatic remission has been linked with higher ulcerative colitis (UC) relapse rates relative to patients who also have complete mucosal healing.¹ We report here an analysis of complete mucosal healing (sigmoidoscopy score of 0) during MMX mesalamine therapy.
METHODS: Two randomized, double-blind, placebo-controlled, phase III studies (SPD476-301 and -302) were pooled to examine complete mucosal healing following treatment in patients with active mild-to-moderate UC. Patients received MMX mesalamine 2.4g/day given QD (study 302) or twice-daily (1.2g BID, study 301), 4.8g/day (QD in both studies) or placebo. The primary endpoint was clinical and endoscopic remission at week 8. For the purposes of this analysis, mucosal healing (assessed by sigmoidoscopy) was evaluated at week 8 or early withdrawal.
RESULTS: After up to 8 weeks, higher complete mucosal healing rates were observed with MMX mesalamine 2.4g/day (55/172 [32.0%]) and 4.8g/day (56/174 [32.2%]) than with placebo (27/171 [15.8%]).
CONCLUSIONS: MMX mesalamine effectively induces complete mucosal healing - an important indicator of treatment efficacy - in patients with active mild-to-moderate UC.
This study was funded by Shire Pharmaceuticals Inc, Wayne, PA, USA
Reference
1. Meucci G, et al. Gastroenterology 2006;130:S1302

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