Intest Res.  2018 Apr;16(2):255-266. 10.5217/ir.2018.16.2.255.

Comparison of efficacy of once daily multimatrix mesalazine 2.4 g/day and 4.8 g/day with other 5-aminosalicylic acid preparation in active ulcerative colitis: a randomized, double-blind study

Affiliations
  • 1Center for Diagnostic and Therapeutic Endoscopy, Keio University Hospital, Tokyo, Japan. hogata@z8.keio.jp
  • 2Yokoyama Hospital for Gastroenterological Diseases, Nagoya, Japan.
  • 3Clinical Development Department, Mochida Pharmaceutical Co., Ltd., Tokyo, Japan.
  • 4Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan.

Abstract

BACKGROUND/AIMS
This study compared the efficacy of multimatrix mesalazine 2.4 g/day and 4.8 g/day with controlled-release mesalazine 2.25 g/day.
METHODS
In this multicenter, randomized, double-blind study, 251 patients with mildly to moderately active ulcerative colitis received multimatrix mesalazine 2.4 g/day once daily (Multimatrix-2.4), 4.8 g/day once daily (Multimatrix-4.8), or controlled-release (time-dependent) mesalazine 2.25 g/day 3 times daily (Time-2.25) for 8 weeks. The primary efficacy endpoint was the change in the ulcerative colitis-disease activity index (UC-DAI) score.
RESULTS
The mean change in the UC-DAI score and standard deviation in the per protocol set was −1.9±2.5 for Multimatrix-2.4 and −2.4±2.8 for Time-2.25. The difference between Multimatrix-2.4 and Time-2.25 was 0.3 (two-sided 95% confidence interval [CI], −0.5 to 1.1), thus non-inferiority was not demonstrated based on the pre-defined non-inferiority margin (1.0). In the full analysis set, the difference between Multimatrix-4.8 and Time-2.25 was −1.2 (two-sided 95% CI, −2.0 to −0.5), and the mean change in UC-DAI score in the FAS was −3.3 (two-sided 95% CI, −3.9 to −2.8) for Multimatrix-4.8 and −1.9 (two-sided 95% CI, −2.5 to −1.3) for Multimatrix-2.4, indicating that Multimatrix-4.8 was more effective than Time-2.25 and Multimatrix-2.4. There was no difference among the treatment groups in terms of safety.
CONCLUSIONS
This study showed that the efficacy of multimatrix mesalazine 2.4 g/day was comparable to controlled release mesalazine 2.25 g/day, although non-inferiority was not demonstrated. Importantly, this was the first study to indicate that multimatrix mesalazine 4.8 g/day was more effective than 2.4g/day with no associated safety concerns.

Keyword

Colitis, ulcerative; Active; Mesalazine; Multimatrix

MeSH Terms

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

Figure

  • Fig. 1 Patients disposition. aMultiple selection is allowed as the reason for discontinuation. Multimatrix-2.4, multimatrix mesalazine 2.4 g/day once daily; Multimatrix-4.8, multimatrix mesalazine 4.8 g/day once daily; Time-2.25, time-dependent (controlled-release) mesalazine 2.25 g/day 3 times daily. FAS, full analysis set; UC-DAI, UC Disease Activity Index; PPS, per protocol set.

  • Fig. 2 Change in UC Disease Activity Index (UC-DAI) score. The mean change in UC-DAI score and two-sided 95% CI in the full analysis set (FAS) was −3.3 (−3.9 to −2.8) in the Multimatrix-4.8 group, −1.9 (−2.5 to −1.3) in the Multimatrix-2.4 group, and −2.4 (−3.0 to −1.7) in Time-2.25 group. Error bars indicate 95% CI. Multimatrix-4.8, multimatrix mesalazine 4.8 g/day once daily; Multimatrix-2.4, multimatrix mesalazine 2.4 g/day once daily; Time-2.25, time-dependent (controlled-release) mesalazine 2.25 g/day 3 times daily.


Cited by  1 articles

Is once daily multimatrix mesalazine therapy effective regardless of the dose in patients with mild to moderate ulcerative colitis?
Seong Ran Jeon
Intest Res. 2018;16(2):163-165.    doi: 10.5217/ir.2018.16.2.163.


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