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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, . ,
Language English Country England, Great Britain
Document type Clinical Trial, Phase III, Clinical Trial, Phase IV, Journal Article, Multicenter Study
- MeSH
- Anti-Inflammatory Agents, Non-Steroidal administration & dosage therapeutic use MeSH
- Adult MeSH
- Induction Chemotherapy * MeSH
- Middle Aged MeSH
- Humans MeSH
- Mesalamine administration & dosage therapeutic use MeSH
- Adolescent MeSH
- Young Adult MeSH
- Follow-Up Studies MeSH
- Prospective Studies MeSH
- Drug Administration Schedule MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Maintenance Chemotherapy * MeSH
- Colitis, Ulcerative drug therapy MeSH
- Treatment Outcome MeSH
- Dose-Response Relationship, Drug MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Clinical Trial, Phase IV MeSH
- Multicenter Study MeSH
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
University of Chicago Medicine Inflammatory Bowel Disease Center Chicago IL USA
University of Medicine and Pharmacy Târgu Mures Gastroenterology Department Târgu Mures Romania
References provided by Crossref.org
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- $a 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.
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