High-dose mesalazine treatment for ulcerative colitis patients who relapse under low-dose maintenance therapy

Abstract

Background Mesalazine is often used to maintain remission in patients with ulcerative colitis. Aim To investigate if increasing the dose of mesalazine is safe and effective for patients with ulcerative colitis who relapse under low-dose maintenance therapy. Methods Ninety consecutive patients who relapsed during maintenance therapy with oral mesalazine at 1.5–2.25 g/day were included. All patients had mildly or moderately active ulcerative colitis at entry, and were treated with oral mesalazine at 4.0 g/day for the following 8 weeks. At entry and week 8, endoscopic examinations were carried out to assess the severity of endoscopic inflammation. The primary as well as the secondary endpoints were clinical and endoscopic improvements at week 8. Results No patient experienced any serious side effect, and the treatment with 4.0 g/day mesalazine over the 8 week period was well tolerated by all patients. Fifty-nine patients (66%) achieved clinical improvement in stool frequency and/or rectal bleeding including 40 (44%) with clinical remission (normal stool frequency and no rectal bleeding). Forty-three patients (48%) showed endoscopic improvement including 25 (28%) with endoscopic remission. Conclusions Increasing the dose of mesalazine up to 4.0 g/day appeared to be safe and effective for patients who relapsed under low-dose, 1.5–2.25 g/day maintenance therapy.