Ulcerative Colitis Remission Status After Induction With Mesalazine Predicts Maintenance Outcomes: the MOMENTUM Trial
Authors:
- David T. RubinDavid T. Rubin
- Libor GabalecLGLibor Gabalec
- Daniela DobruDaniela Dobru
- Juan MárquezJMJuan Márquez
- Geert D’hAensGeert D’hAens
- on behalf of the Ulcerative Colitis Remission Study GroupOGon behalf of the Ulcerative Colitis Remission Study Group
Open Access
- 23 February 2016
- journal article
- research article
- Published by Oxford University Press (OUP) in Journal of Crohn's and Colitis
- Vol. 10 (8) , 925-933
Abstract
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. 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. 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. Patients achieving complete remission before dose reduction were more likely to remain in remission at Month 12.Keywords
This publication has 17 references indexed in Scilit:
- Ulcerative colitis: prevention of relapseExpert Review of Gastroenterology & Hepatology, 2013
- Prognostic significance of endoscopic remission in patients with active ulcerative colitis treated with oral and topical mesalazine: A prospective, multicenter studyInflammatory Bowel Diseases, 2012
- Early Mucosal Healing With Infliximab Is Associated With Improved Long-term Clinical Outcomes in Ulcerative ColitisGastroenterology, 2011
- Epidemiology and Natural History of Inflammatory Bowel DiseasesGastroenterology, 2011
- Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters CommitteeAmerican Journal of Gastroenterology, 2010
- Quality of life of patients with ulcerative colitis: Past, present, and futureInflammatory Bowel Diseases, 2008
- European evidence-based Consensus on the management of ulcerative colitis: Current managementJournal of Crohn's and Colitis, 2008
- Effect of Once- or Twice-Daily MMX Mesalamine (SPD476) for the Induction of Remission of Mild to Moderately Active Ulcerative ColitisClinical Gastroenterology and Hepatology, 2007
- Once-Daily, High-Concentration MMX Mesalamine in Active Ulcerative ColitisGastroenterology, 2007
- Systematic review: adherence issues in the treatment of ulcerative colitisAlimentary Pharmacology & Therapeutics, 2006