BACKGROUND AND AIMS: This study assessed the efficacy of maintenance treatment with multimatrix mesalazine following achievement of complete or partial remission after induction treatment with high-dose multimatrix mesalazine. METHODS: In this phase 3b/4, open-label, multicentre, prospective, single-arm study, patients with mild-to-moderate ulcerative colitis were treated with multimatrix mesalazine 4.8g/day once daily for 8 weeks [induction phase]. At Week 8, those who achieved complete or partial remission, based on predefined clinical and endoscopic criteria, were eligible to receive 12 months of multimatrix mesalazine 2.4g/day once daily maintenance therapy. The primary endpoint was the proportion of patients in complete remission at Month 12. RESULTS: A total of 717 patients received induction treatment; 25.9% and 39.3% of patients achieved complete and partial remission, respectively, at Week 8. A total of 461 patients entered the maintenance phase. The likelihood of remaining in/achieving complete remission at Month 12 was higher for patients who entered the maintenance phase in complete remission compared with those who began maintenance in partial remission [47.8% vs 26.0%; p < 0.001]. At Month 12, mucosal healing [endoscopy score ≤ 1] was demonstrated in 76.4% [139/182] and 63.5% [176/277] of those who were in complete and partial remission, respectively, at the end of induction. CONCLUSION: Patients achieving complete remission before dose reduction were more likely to remain in remission at Month 12.

Academic Medical Centre Department of Gastroenterology and Hepatology Amsterdam The Netherlands

CHUQ Research Center L'Hôtel Dieu de Québec Québec Canada

Department of Colorectal Surgery Clínica Las Américas Medellin Columbia

Orlickoustecka Nemocnice a s Department of Internal Medicine Ústí nad Orlicí Czech Republic

Shire Basingstoke UK

Shire Wayne PA USA

University of Chicago Medicine Inflammatory Bowel Disease Center Chicago IL USA

University of Medicine and Pharmacy Târgu Mures Gastroenterology Department Târgu Mures Romania

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