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Mesalazine granules 1.5 g once-daily maintain remission in patients with ulcerative colitis who switch from other 5-ASA formulations: a pooled analysis from two randomised controlled trials
Alimentary Pharmacology and Therapeutics, 05/25/2012
Clinical Article
Lichtenstein GR et al. – Mesalazine granules 1.5 g once–daily is effective for maintenance of remission in ulcerative colitis (UC) patients who switch from other 5–aminosalicylic acid (5–ASA) formulations.
Methods- Data from two independent multicenter, randomised, double–blind, placebo–controlled, 6–month trials evaluating patients with UC in remission were combined for analysis of a subpopulation of patients who switched from other 5–ASA formulations to MG 1.5 g or placebo upon randomisation.
- The primary endpoint was the percentage of patients who remained relapse–free at Month 6 or end of treatment.
- Relapse was defined as a Sutherland Disease Activity Index (SDAI) rectal bleeding score ≥1 and mucosal appearance score ≥2, a UC flare or medication used to treat a UC flare.
- Of the 487 patients who received 5–ASA maintenance therapy at enrolment, 322 were in the MG group and 165 were in the placebo group.
- The percentage of patients who remained relapse–free (based on Sutherland Disease Activity Index scores) after 6 months was significantly higher with MG than placebo (78.3% vs. 58.8%, P < 0.001).
- Rectal bleeding, stool frequency and the physician's rating of disease activity remained unchanged after 6 months in a higher percentage of patients using MG compared with those on placebo (P < 0.004 for each endpoint).
