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Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Active Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study

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Abstract

Introduction

This study compared the efficacy and safety of two mesalazine formulations in the treatment of Chinese patients with mildly to moderately active ulcerative colitis (UC).

Methods

In this multicenter, single-blind, randomized controlled study of 251 patients with active UC conducted from November 2010 to January 2012, subjects were randomized to treatment with mesalazine modified-release tablets (MR group, n = 123) or enteric-coated tablets (EC group, n = 128) at 800 mg three-times daily for 8 weeks. The primary efficacy measure was the decrease in UC Disease Activity Index (UCDAI) at final evaluation. If the 95% confidence interval (CI) lower limit of the difference of the decrease in UCDAI between groups was over −1.0, mesalazine modified-release tablets were considered non-inferior to mesalazine enteric-coated tablets. The change in UCDAI in patients with mild and moderate (UCDAI 3–5 and 6–8 at enrollment, respectively) UC was analyzed. Secondary efficacy measures were remission and efficacy rates. Incidences of adverse drug reactions (ADRs) were calculated.

Results

The decreases in UCDAI at final evaluation were 2.84 and 2.56 in the MR and EC groups, respectively, with a difference of 0.27 between groups (95% CI −0.34, 0.88). The remission rates were 48.33% (58/120) and 55.65% (69/124), and the efficacy rates were 63.33% (76/120) and 66.94% (83/124) in the MR and EC groups, respectively (all P > 0.05). In patients with mild UC, the decreases in UCDAI were 2.16 and 2.05 in the MR and EC groups, respectively, while in patients with moderate UC they were 3.49 and 3.03, respectively (all P > 0.05). The incidences of ADRs in the MR and EC groups were 6.61% (8/121) and 10.24% (13/127), respectively (P > 0.05). No serious ADRs were reported during the study.

Conclusion

Mesalazine modified-release tablets are non-inferior to enteric-coated tablets and are an effective and safe treatment option in Chinese patients with mildly to moderately active UC.

Trial registration

ClinicalTrials.gov identifier: NCT01257386.

Funding

Tillotts Pharma AG.

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Acknowledgments

The general contents of this manuscript have been published in the Chinese Journal of Digestion 2015;35(4):252–5 [17], and are included here with permission. The funding for this study was provided by Tillotts Pharma AG. The article processing charges for this publication were funded by Tillotts Pharma AG. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. We thank Yuichi Takano (Zeria Pharmaceutical Co., Ltd., Tokyo, Japan) for providing assistance in writing this paper. Editorial assistance in the preparation of this manuscript was provided by Dr. Michelle Belanger on behalf of Springer Healthcare Communications. Support for this assistance was funded by Tillotts Pharma AG. We would like to thank the following doctors and hospitals for their contributions to this study: Prof. Ran Zhihua, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine; Prof. Li Zhaoshen, Changhai Hospital Affiliated to Second Military Medical University; Prof. Lu Lungen, Shanghai First People Hospital; Prof. Shen Xizhong, Zhongshan Hospital, Fudan University; Prof. Zhang Zhenyu, Nanjing First Hospital; Prof. Shi Ruihua, the First Hospital, Nanjing Medical University; Prof. Zou Xiaoping, Gulou Hospital, Nanjing University School of Medicine; Prof. Hou Xiaohua, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Prof. Luo Hesheng, Renmin Hospital of Wuhan University; Prof. Li Youming, The First Affiliated Hospital of College of Medicine, Zhejiang University; Prof. Cai Jianting, The Second Affiliated Hospital of College of Medicine, Zhejiang University; Prof. Xie Pengyan, Peking University First Hospital; Prof. Zhang Shutian, Prof. Wu Yongdong, Beijing Friendship Hospital, Capital Medical University; Prof. Hao Jianyu, Beijing Chao-Yang Hospital, Capital Medical University; Prof. Wang Bangmao, Tianjin Medical University General Hospital; Prof. Sheng Jianqiu, The Military General Hospital of Beijing PLA; and Prof. Li Liangping, Sichuan Provincial People’s Hospital.

Disclosures

Jing Sun has received honoraria from Tillotts Pharma AG. Yaozong Yuan has received honoraria from Tillotts Pharma AG. The authors declare no conflict of interest directly associated with the content of this manuscript.

Compliance with Ethics Guidelines

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised in 2013. Informed consent was obtained from all patients for being included in the study.

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Authors and Affiliations

  1. Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China

    Jing Sun & Yaozong Yuan

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  1. Jing Sun
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  2. Yaozong Yuan
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Correspondence to Jing Sun.

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Sun, J., Yuan, Y. Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Active Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study. Adv Ther 33, 400–409 (2016). https://doi.org/10.1007/s12325-016-0303-z

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  • DOI: https://doi.org/10.1007/s12325-016-0303-z

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