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

Abstract

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.

Comparison of efficacy of multimatrix mesalazine 4.8 g/day once-daily with other high-dose mesalazine in active ulcerative colitis: a randomized, double-blind study

“…Recently, the importance of mucosal healing has been emphasized. It has been reported that remission of UC is maintained for a longer period when the mucosal healing is achieved by induction therapy 121314. Furthermore, in the present study, the difference in the change in the rectal bleeding score, the main symptom of UC, was statistically significant between the 2 groups at week 2, as well as at subsequent visits.…”

Comparison of efficacies of once-daily dose multimatrix mesalazine and multiple-dose mesalazine for the maintenance of remission in ulcerative colitis: a randomized, double-blind study

“…The proportion of patients without rectal bleeding for 48 weeks was 76.9% in the pH-dependent delayed-release mesalazine 2.4 g/day TID group and 69.2% in the controlled-release mesalazine 2.25 g/day TID group. In another phase IIIb/IV open-label study of multimatrix mesalazine (the MOMENTUM trial), rectal bleeding was also investigated as one of the secondary endpoints during maintenance treatment with multimatrix mesalazine 2.4 g/day 14. The proportion of patients who maintained a rectal bleeding score of 0 for 12 months was 65.4% in patients with complete remission (modified UC-DAI score ≤1 with a score of 0 for both rectal bleeding and stool frequency, and ≥1-point reduction in endoscopy score from baseline) after induction treatment with multimatrix mesalazine 4.8 g/day for 8 weeks.…”

What is the real-life maintenance mesalazine dose in ulcerative colitis?

“…Long-term continuous treatment with high-dose MSZ (4.0 g/day) was more effective (relapsefree rate higher and mean time to relapse longer) than short-term treatment for maintenance of remission in UC patients (23). In a recent study (MOMENTUM Trial), patients achieving complete remission with a multimatrix MSZ 4.8 g/day once daily for eight weeks and then beginning dose reduction were more likely to remain in remission at month 12 than patients who began maintenance in partial remission (24). In our study, patients with flare-ups in the previous year more frequently maintained the higher dose of MSZ compared with patients without recent flare-ups (51% vs 27%, respectively).…”