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Ulcerative Colitis Remission Status After Induction With Mesalazine Predicts Maintenance Outcomes: the MOMENTUM Trial

DT. Rubin, M. Bradette, L. Gabalec, D. Dobru, J. Márquez, S. Inglis, E. Magee, D. Solomon, G. D'Haens, . ,

. 2016 ; 10 (8) : 925-33. [pub] 20160223

Jazyk angličtina Země Anglie, Velká Británie

Typ dokumentu klinické zkoušky, fáze III, klinické zkoušky, fáze IV, časopisecké články, multicentrická studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc17024152

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.

Citace poskytuje Crossref.org

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$a Dobru, Daniela $u University of Medicine and Pharmacy Târgu Mures, Gastroenterology Department, Târgu Mures, Romania.
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