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.
Highlights
Ulcerative colitis [UC] is an inflammatory disease of the large bowel characterised by relapsing and/or remitting gastrointestinal and systemic symptoms, which include bloody diarrhoea and rectal urgency.[1,2] Primary goals of UC management are induction and maintenance of disease remission, including healing of the mucosa, to improve patients’ health and quality of life.[3,4] With no known cure for UC, most patients will need lifelong maintenance medical therapy to help prevent disease relapse.[4,5] In a prospective trial by Meucci and colleagues,[6] patients with mild-to-moderate UC relapse received induction treatment with a combination of oral and topical mesalazine
Patients achieving complete remission before dose reduction were more likely to remain in remission at Month 12
In patients with moderate-to-severe UC relapse who were treated with infliximab in the Active Ulcerative Colitis Trial [ACT]-1 and ACT-2,7 colectomy risk was significantly lower if patients had a Mayo endoscopy subscore ≤ 1 than if the mucosa was more severely affected [Mayo score ≥ 2]
Summary
Ulcerative colitis [UC] is an inflammatory disease of the large bowel characterised by relapsing and/or remitting gastrointestinal and systemic symptoms, which include bloody diarrhoea and rectal urgency.[1,2] Primary goals of UC management are induction and maintenance of disease remission, including healing of the mucosa, to improve patients’ health and quality of life.[3,4] With no known cure for UC, most patients will need lifelong maintenance medical therapy to help prevent disease relapse.[4,5] In a prospective trial by Meucci and colleagues,[6] patients with mild-to-moderate UC relapse received induction treatment with a combination of oral and topical 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 4.8 g/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 2.4 g/day once daily maintenance therapy. 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. 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
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