Intest Res.  2017 Jul;15(3):358-367. 10.5217/ir.2017.15.3.358.

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

Affiliations
  • 1Center for Diagnostic and Therapeutic Endoscopy, Keio University Hospital, Tokyo, Japan. hogata@z8.keio.jp
  • 2Inogashiradori Proctology and Gastroenterology Clinic, Tokyo, Japan.
  • 3Matsushima Clinic, Kanagawa, Japan.
  • 4Clinical Development Department, Mochida Pharmaceutical Co., Ltd., Tokyo, Japan.
  • 5Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan.

Abstract

BACKGROUND/AIMS
This study compared the efficacy of once-daily administration of multimatrix mesalazine 2.4 g/day with multiple-dose mesalazine for the maintenance of remission.
METHODS
In this multicenter, randomized, double-blind study, 203 patients with ulcerative colitis in remission received multimatrix mesalazine 2.4 g/day once-daily or time-dependent (controlled-release) mesalazine 2.25 g/day 3 times-daily for 48 weeks. The primary efficacy endpoint was the proportion of patients without rectal bleeding.
RESULTS
The proportion of patients without rectal bleeding during the 48-week treatment period in the per protocol set was 84.8% (84/99) in the multimatrix mesalazine 2.4 g/day group and 78.0% (78/100) in the controlled-release mesalazine 2.25 g/day group. The difference between the 2 treatment groups was 6.8% (two-sided 95% confidence interval, −3.9% to 17.6%). The noninferiority margin of −10% was met in the comparison of multimatrix mesalazine 2.4 g/day once-daily with controlled-release mesalazine 2.25 g/day. Multimatrix mesalazine 2.4 g/day once-daily demonstrated consistent efficacy in all subgroups. There was no difference between the 2 treatment groups with regard to safety.
CONCLUSIONS
A once-daily dose of 2 multimatrix mesalazine tablets (2.4 g) was not inferior to controlled-release mesalazine 2.25 g/day 3 times-daily in maintaining absence of rectal bleeding in ulcerative colitis.

Keyword

Colitis, ulcerative; Mesalazine; Maintenance; Once-daily

MeSH Terms

Colitis, Ulcerative*
Double-Blind Method*
Hemorrhage
Humans
Mesalamine*
Tablets
Ulcer*
Mesalamine
Tablets

Figure

  • Fig. 1 Patient disposition. aMultiple options are allowed as reasons for discontinuation. FAS, full analysis set; PPS, per protocol set.

  • Fig. 2 The proportion of patients without rectal bleeding during the treatment period in the per protocol set. The difference between the multimatrix mesalazine 2.4 g/day group and the controlled-release mesalazine 2.25 g/day group was 6.8% (two-sided 95% CI, –3.9% to 17.6%).

  • Fig. 3 The Kaplan-Meier plot of time to rectal bleeding (rectal bleeding score ≥1) in the per protocol set.

  • Fig. 4 The proportion of patients who relapsed (UC-Disease Activity Index score ≥3 and rectal bleeding score ≥1) at week 48 or at the discontinuation of treatment in the per protocol set. The difference between the multimatrix mesalazine 2.4 g/day group and the controlled-release mesalazine 2.25 g/day group was −4.8% (two-sided 95% CI, −15.6% to 5.9%) at week 48 and −4.9% (two-sided 95% CI, −14.9% to 5.2%) at the end of treatment period.


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