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214 MMX MESALAMINE EFFECTIVELY INDUCES REMISSION OF MILD-TO-MODERATE ULCERATIVE COLITIS REGARDLESS OF AGE WJ Sandborn1, GR Lichtenstein2, MA Kamm3, K Barrett4, RE Joseph5 INTRODUCTION: MMXTM mesalamine, a high-strength (1.2g/tablet) formulation of 5-ASA designed for once-daily (QD) dosing, combines a gastro-resistant film (to delay drug release until pH>7, usually in the terminal ileum) and MMX Multi Matrix SystemTM technology (to provide extended drug delivery in the colon). We report here the effect of age on clinical outcome with MMX mesalamine therapy.
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
METHODS: Two randomized, double-blind, placebo-controlled, phase III studies (SPD476-301 and -302) were pooled to examine efficacy according to age group in patients with active mild-to-moderate ulcerative colitis (UC). Patients received MMX mesalamine 2.4g/day given either as 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 using stringent criteria (modified UC-disease activity index score <=1, with a rectal bleeding and stool frequency score of 0, no mucosal friability and =>1 point reduction in sigmoidoscopy score from baseline).
RESULTS: In patients aged <55 years, significantly higher remission rates were observed following treatment with MMX mesalamine 2.4g/day (51/143 [35.7%]; p<0.001) and 4.8g/day (48/138 [34.8%]; p<0.001) than with placebo (24/138 [17.4%]). For patients aged 55 years and over, similar increases in remission rate were observed with MMX mesalamine 2.4g/day (13/29 [44.8%]) and 4.8g/day (13/36 [36.1%]) compared with placebo (6/33 [18.2%]), although due to the low numbers of patients in this group, only the 2.4g/day dose demonstrated statistical significance versus placebo (p=0.02). Logistic regression analysis confirmed there was no significant interaction between age and treatment (p=0.801).
CONCLUSIONS: MMX mesalamine effectively induces remission of active mild-to-moderate UC regardless of age. QD dosing with MMX mesalamine may increase compliance and therapeutic success in patients with UC.
This study was funded by Shire Pharmaceuticals Inc, Wayne, PA, USA