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Background and aimsThis 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.MethodsIn 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.ResultsA 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.ConclusionPatients achieving complete remission before dose reduction were more likely to remain in remission at Month 12.

Original publication

DOI

10.1093/ecco-jcc/jjw049

Type

Journal article

Journal

Journal of Crohn's & colitis

Publication Date

08/2016

Volume

10

Pages

925 - 933

Addresses

University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL, USA.

Keywords

Ulcerative Colitis Remission Study Group, Humans, Colitis, Ulcerative, Mesalamine, Anti-Inflammatory Agents, Non-Steroidal, Treatment Outcome, Drug Administration Schedule, Follow-Up Studies, Prospective Studies, Dose-Response Relationship, Drug, Adolescent, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Young Adult, Maintenance Chemotherapy, Induction Chemotherapy