Colon to Rectum
United European Gastroenterol J. 2023;11(8):775–83
Mesalazine granules promote disease clearance in patients with mild-to-moderate ulcerative colitis
Background: Over the past decade, treatment targets for ulcerative colitis (UC) have become more stringent, incorporating multiple parameters. Recently, the concept of “disease clearance” – defined as combined clinical, endoscopic, and histological remission – has been proposed as an ultimate end point in treating UC.
Objective: To determine the rates of disease clearance in patients with mild-to-moderate UC treated with different doses of mesalazine granules as induction therapy.
Methods: In a post-hoc analysis, data were pooled from 4 randomized, active-controlled, phase 3 clinical trials in patients with mild-to-moderate UC receiving 8-week induction therapy with mesalazine granules at daily doses of 1.5, 3.0 or 4.5 g. Rates of clinical, endoscopic, and histological remission were determined using stringent criteria and used to calculate rates of the composite end points of clinical plus endoscopic remission, endoscopic plus histological remission, and disease clearance (clinical plus endoscopic plus histological remission).
Results: A total of 860 patients were included in the analysis. Among the total population, 20.0% achieved disease clearance with mesalazine granules: 13.1% in patients receiving 1.5 g mesalazine granules/day, 21.8% in those receiving 3.0 g/day and 18.9% in those receiving 4.5 g/day. Among patients with moderate UC, 16.8% achieved disease clearance: 7.1% with 1.5 g/day, 18.8% with 3.0 g/day and 16.2% with 4.5 g/day.
Conclusion: Disease clearance, proposed to be predictive of improved long-term outcomes, can be achieved in a clinically meaningful proportion of mild-to-moderate ulcerative colitis patients treated with mesalazine granules. A daily dose of 3.0 g appears optimal to reach this target.
DOI: 10.1002/ueg2.12435