Intest Res.  2017 Jul;15(3):368-379. 10.5217/ir.2017.15.3.368.

Comparison of efficacy of multimatrix mesalazine 4.8 g/day once-daily with other high-dose mesalazine in active ulcerative colitis: a randomized, double-blind study

• Ogata H
• Aoyama N
• Mizushima
• Hagino A
• Hibi T

• KMID: 2382381
• DOI: http://doi.org/10.5217/ir.2017.15.3.368

Abstract

BACKGROUND/AIMS
This study assessed the efficacy and safety of high-dose multimatrix mesalazine once-daily (QD) compared to another form of high-dose mesalazine.
METHODS
In this multicenter, randomized, double-blind study, 280 patients with mildly to moderately active ulcerative colitis (UC) received multimatrix mesalazine 4.8 g/day QD or pH-dependent-release mesalazine 3.6 g/day three times daily for 8 weeks. The primary endpoint was the change in the UC-Disease Activity Index (UC-DAI) at the end of the treatment period.
RESULTS
The change in the UC-DAI (mean±standard deviation) in the per-protocol set was −2.6±2.47 in the multimatrix mesalazine 4.8 g/day group (n=134) and −1.8±2.64 in the pH-dependent-release mesalazine 3.6 g/day group (n=129). The difference in the mean change between the 2 groups was −0.7 (two-sided 95% confidence interval, −1.3 to −0.1). The noninferiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/day was verified within the noninferiority margin (1.1). The superiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/day was also investigated and confirmed in the full analysis set, according to the study protocol. In subgroup analyses, the effectiveness of multimatrix mesalazine 4.8 g/day was consistent in all subgroups. There was no difference in safety between the 2 treatment groups.
CONCLUSIONS
Multimatrix mesalazine 4.8 g/day has higher efficacy and shows no difference in safety in mildly to moderately active UC, in comparison with pH-dependent-release mesalazine 3.6 g/day.

Keyword

Ulcerative colitis; Mesalazine; High-dose

MeSH Terms

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

Figure

• 

  Fig. 1 Patient disposition. aMultiple options are allowed as reasons for discontinuation. FAS, full analysis set; UC-DAI, UC-Disease Activity Index; PPS, per protocol set.

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  Fig. 2 The proportion of patients who achieved remission, clinical remission, endoscopic remission, and improvement at the end of the treatment period in the per protocol set. The differences in each endpoint between the multimatrix mesalazine 4.8 g/day group and pH-dependent−release mesalazine 3.6 g/day group were 12.8% (two-sided 95% CI, 1.4% to 24.3%) for remission, 10.6% (two-sided 95% CI, −0.8% to 22.1%) for clinical remission, 5.4% (two-sided 95% CI, −3.5% to 14.2%) for endoscopic remission, and 9.0% (two-sided 95% CI, −2.7% to 20.8%) for improvement. aThe difference in the remission rate between the treatment groups was statistically significant.

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