Intestinal Research

Statement

IBD

Consensus recommendations for patient-centered therapy in mild-to-moderate ulcerative colitis: the i Support Therapy–Access to Rapid Treatment (iSTART) approach: Silvio Danese, Rupa Banerjee, JR Fraser Cummings, Iris Dotan, Paulo G Kotze, Rupert Wing Loong Leong, Kristine Paridaens, Laurent Peyrin-Biroulet, Glyn Scott, Gert Van Assche, Jan Wehkamp, Jesús K Yamamoto-Furusho; Intest Res 2018;16(4):522-528. Published online October 16, 2018; DOI: https://doi.org/10.5217/ir.2018.00073

Abstract PDF Supplementary Material PubReader ePub

Symptomatic ulcerative colitis (UC) can be a chronic, disabling condition. Flares in disease activity are associated with many of the negative impacts of mild-to-moderate UC. Rapid resolution of flares can provide benefits to patients and healthcare systems. i Support Therapy–Access to Rapid Treatment (iSTART) introduces patient-centered care for mild-to-moderate UC. iSTART provides patients with the ability to self-assess symptomology and self-start a short course of second-line treatment when necessary. An international panel of experts produced consensus statements and recommendations. These were informed by evidence from systematic reviews on the epidemiology, mesalazine (5-ASA) treatment, and patient use criteria for second-line therapy in UC. Optimized 5-ASA is the first-line treatment in all clinical guidelines, but may not be sufficient to induce remission in all patients. Corticosteroids should be prescribed as second-line therapy when needed, with budesonide MMX® being a preferred steroid option. Active involvement of suitable patients in management of UC flares has the potential to improve therapy, with patients able to show good accuracy for flare self-assessment using validated tools. There is a place in the UC treatment pathway for an approach such as iSTART, which has the potential to provide patient, clinical and economic benefits.

Citations

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Original Articles

IBD

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: Haruhiko Ogata, Tadashi Yokoyama, Seiichi Mizushima, Atsushi Hagino, Toshifumi Hibi; Intest Res 2018;16(2):255-266. Published online April 30, 2018; DOI: https://doi.org/10.5217/ir.2018.16.2.255

Abstract PDF Supplementary Material PubReader ePub

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.

Citations

Citations to this article as recorded by

Efficacy and Safety of High-Dose Multimatrix Mesalazine in Pediatric Patients with Mild-to-Moderate Active Ulcerative Colitis
Toshiaki Shimizu, Itaru Iwama, Toshihiko Kakiuchi, Daiki Abukawa, Hideki Kumagai, Naomi Iwata, Masahiro Takatsu, Kanako Nishimura, Akiko Matsuda, Koichi Hayashi, Tatsuki Mizuochi
Pediatric Gastroenterology, Hepatology & Nutrition.2026; 29(3): 220. CrossRef
The gut wall’s potential as a partner for precision oncology in immune checkpoint treatment
Sara Hone Lopez, Mathilde Jalving, Rudolf S.N. Fehrmann, Wouter B. Nagengast, Elisabeth G.E. de Vries, Jacco J. de Haan
Cancer Treatment Reviews.2022; 107: 102406. CrossRef
Differential effects of mesalazine formulations on thiopurine metabolism through thiopurine S‐methyltransferase inhibition
Hiromu Morikubo, Taku Kobayashi, Ryo Ozaki, Shinji Okabayashi, Satoshi Kuronuma, Osamu Takeuchi, Tenyo Shiba, Hiroki Kiyohara, Mao Matsubayashi, Shintaro Sagami, Masaru Nakano, Osamu Ikezaki, Tadakazu Hisamatsu, Yoichi Tanaka, Toshifumi Hibi
Journal of Gastroenterology and Hepatology.2021; 36(8): 2116. CrossRef
Efficacy of Oral, Topical, or Combined Oral and Topical 5-Aminosalicylates, in Ulcerative Colitis: Systematic Review and Network Meta-analysis
Brigida Barberio, Jonathan P Segal, M Nabil Quraishi, Christopher J Black, Edoardo V Savarino, Alexander C Ford
Journal of Crohn's and Colitis.2021; 15(7): 1184. CrossRef
Evidence-based clinical practice guidelines for inflammatory bowel disease 2020
Hiroshi Nakase, Motoi Uchino, Shinichiro Shinzaki, Minoru Matsuura, Katsuyoshi Matsuoka, Taku Kobayashi, Masayuki Saruta, Fumihito Hirai, Keisuke Hata, Sakiko Hiraoka, Motohiro Esaki, Ken Sugimoto, Toshimitsu Fuji, Kenji Watanabe, Shiro Nakamura, Nagamu I
Journal of Gastroenterology.2021; 56(6): 489. CrossRef
Outcomes of a drug shortage requiring switching in patients with ulcerative colitis
Daniel R van Langenberg, Richard Kai-Yuan Cheng, Mayur Garg
World Journal of Gastrointestinal Pathophysiology.2020; 11(2): 32. CrossRef
Comparative assessment of budesonide‐MMX and mesalamine in active, mild‐to‐moderate ulcerative colitis: A systematic review and network meta‐analysis
Stefanos Bonovas, Georgios K. Nikolopoulos, Daniele Piovani, Marien González‐Lorenzo, Katerina Pantavou, Theodore Lytras, Laurent Peyrin‐Biroulet, Silvio Danese
British Journal of Clinical Pharmacology.2019; 85(10): 2244. CrossRef
Switching between Three Types of Mesalazine Formulation and Sulfasalazine in Patients with Active Ulcerative Colitis Who Have Already Received High-Dose Treatment with These Agents
Eriko Yasutomi, Sakiko Hiraoka, Shumpei Yamamoto, Shohei Oka, Mami Hirai, Yasushi Yamasaki, Toshihiro Inokuchi, Hideaki Kinugasa, Masahiro Takahara, Keita Harada, Jun Kato, Hiroyuki Okada
Journal of Clinical Medicine.2019; 8(12): 2109. CrossRef
Is once daily multimatrix mesalazine therapy effective regardless of the dose in patients with mild to moderate ulcerative colitis?
Seong Ran Jeon
Intestinal Research.2018; 16(2): 163. CrossRef

8,459 View
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7 Web of Science
9 Crossref

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: Haruhiko Ogata, Nobuo Aoyama, Seiichi Mizushima, Atsushi Hagino, Toshifumi Hibi; Intest Res 2017;15(3):368-379. Published online June 12, 2017; DOI: https://doi.org/10.5217/ir.2017.15.3.368

Abstract PDF PubReader ePub

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.

Citations

Citations to this article as recorded by

Long-Term Efficacy and Safety of Multi-Matrix Mesalazine Maintenance Therapy in Pediatric Patients with Ulcerative Colitis
Toshiaki Shimizu, Daisuke Tokuhara, Shigeo Nishimata, Takashi Ishige, Takahiro Kudo, Masahiro Takatsu, Kanako Nishimura, Akiko Matsuda, Koichi Hayashi, Katsuhiro Arai
Pediatric Gastroenterology, Hepatology & Nutrition.2026; 29(1): 44. CrossRef
Efficacy and Safety of High-Dose Multimatrix Mesalazine in Pediatric Patients with Mild-to-Moderate Active Ulcerative Colitis
Toshiaki Shimizu, Itaru Iwama, Toshihiko Kakiuchi, Daiki Abukawa, Hideki Kumagai, Naomi Iwata, Masahiro Takatsu, Kanako Nishimura, Akiko Matsuda, Koichi Hayashi, Tatsuki Mizuochi
Pediatric Gastroenterology, Hepatology & Nutrition.2026; 29(3): 220. CrossRef
Analysis of the Medication Persistence Rate for and Adherence to Oral 5-Aminosalicylic Acid Preparations in Japanese Patients with Ulcerative Colitis: Study Using a Nationwide Claims Database
Takumi Ota, Takahiro Takebe, Yutaka Shimizu, Takashi Orido, Hiroyuki Tanaka, Shiro Nakamura
Digestion.2024; 105(3): 232. CrossRef
5-Aminosalicylic Acid Distribution into the Intestinal Membrane Along the Gastrointestinal Tract After Oral Administration in Rats
Yorinobu Maeda, Yuta Goto, Fumiya Ohnishi, Syoutarou Koga, Satoshi Kawano, Yuhzo Hieda, Takeshi Goromaru, Teruo Murakami
Pharmaceutics.2024; 16(12): 1567. CrossRef
Differential effects of mesalazine formulations on thiopurine metabolism through thiopurine S‐methyltransferase inhibition
Hiromu Morikubo, Taku Kobayashi, Ryo Ozaki, Shinji Okabayashi, Satoshi Kuronuma, Osamu Takeuchi, Tenyo Shiba, Hiroki Kiyohara, Mao Matsubayashi, Shintaro Sagami, Masaru Nakano, Osamu Ikezaki, Tadakazu Hisamatsu, Yoichi Tanaka, Toshifumi Hibi
Journal of Gastroenterology and Hepatology.2021; 36(8): 2116. CrossRef
Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child-bearing female with active ulcerative colitis
Tong Wang, Hua Lu, Fangyuan Li, Qi Zhang
Medicine.2021; 100(5): e23915. CrossRef
Evidence-based clinical practice guidelines for inflammatory bowel disease 2020
Hiroshi Nakase, Motoi Uchino, Shinichiro Shinzaki, Minoru Matsuura, Katsuyoshi Matsuoka, Taku Kobayashi, Masayuki Saruta, Fumihito Hirai, Keisuke Hata, Sakiko Hiraoka, Motohiro Esaki, Ken Sugimoto, Toshimitsu Fuji, Kenji Watanabe, Shiro Nakamura, Nagamu I
Journal of Gastroenterology.2021; 56(6): 489. CrossRef
Efficacy of Multi Matrix System Mesalazine for the Induction of Remission in Patients with Ulcerative Colitis who Insufficiently Respond toother Mesalazine Formulations: A Japanese Single-center Study
Masaki Kato, Kohei Sugiyama, Maki Miyakawa, Masanao Nasuno, Hiroki Tanaka, Satoshi Motoya
Nippon Daicho Komonbyo Gakkai Zasshi.2021; 74(6): 357. CrossRef
pH‑dependent vs. constant release of mesalazine in the treatment of ulcerative colitis: Do drug delivery concepts determine therapeutic efficacy? (Review)
Helmut Deissler, Heinrich Krammer, Anton Gillessen
Biomedical Reports.2021;[Epub] CrossRef
Optimizing the Use of Current Treatments and Emerging Therapeutic Approaches to Achieve Therapeutic Success in Patients with Inflammatory Bowel Disease
Hiroshi Nakase
Gut and Liver.2020; 14(1): 7. CrossRef
Inflammatory Bowel Disease – Non-biological treatment
Fernando Magro, Gonçalo Cordeiro, Andreia Martins Dias, Maria Manuela Estevinho
Pharmacological Research.2020; 160: 105075. CrossRef
Systematic review: safety of mesalazine in ulcerative colitis
P. Sehgal, J.‐F. Colombel, A. Aboubakr, N. Narula
Alimentary Pharmacology & Therapeutics.2018; 47(12): 1597. CrossRef

10,043 View
91 Download
10 Web of Science
12 Crossref

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: Haruhiko Ogata, Akihiro Ohori, Haruo Nishino, Seiichi Mizushima, Atsushi Hagino, Toshifumi Hibi; Intest Res 2017;15(3):358-367. Published online June 12, 2017; DOI: https://doi.org/10.5217/ir.2017.15.3.358

Abstract PDF PubReader ePub

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.

Citations

Citations to this article as recorded by

Long-Term Efficacy and Safety of Multi-Matrix Mesalazine Maintenance Therapy in Pediatric Patients with Ulcerative Colitis
Toshiaki Shimizu, Daisuke Tokuhara, Shigeo Nishimata, Takashi Ishige, Takahiro Kudo, Masahiro Takatsu, Kanako Nishimura, Akiko Matsuda, Koichi Hayashi, Katsuhiro Arai
Pediatric Gastroenterology, Hepatology & Nutrition.2026; 29(1): 44. CrossRef
Culture-based characterization of gut microbiota in inflammatory bowel disease
Hyunjoon Park, Soyoung Yeo, Taekyu Lee, Yumin Han, Chang Beom Ryu, Chul Sung Huh
Frontiers in Microbiology.2025;[Epub] CrossRef
A review on the current status and definitions of activity indices in inflammatory bowel disease: how to use indices for precise evaluation
Masahiro Kishi, Fumihito Hirai, Noritaka Takatsu, Takashi Hisabe, Yasumichi Takada, Tsuyoshi Beppu, Ken Takeuchi, Makoto Naganuma, Kazuo Ohtsuka, Kenji Watanabe, Takayuki Matsumoto, Motohiro Esaki, Kazutaka Koganei, Akira Sugita, Keisuke Hata, Kitarou Fut
Journal of Gastroenterology.2022; 57(4): 246. CrossRef
Inflammatory Bowel Disease – Non-biological treatment
Fernando Magro, Gonçalo Cordeiro, Andreia Martins Dias, Maria Manuela Estevinho
Pharmacological Research.2020; 160: 105075. CrossRef
Systematic review: safety of mesalazine in ulcerative colitis
P. Sehgal, J.‐F. Colombel, A. Aboubakr, N. Narula
Alimentary Pharmacology & Therapeutics.2018; 47(12): 1597. CrossRef
How to Optimally Use Currently Available Drugs in a Therapeutic Algorithm?
You Sun Kim
The Korean Journal of Gastroenterology.2018; 71(2): 74. CrossRef

8,152 View
64 Download
5 Web of Science
6 Crossref

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