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3. Correction: Association of ulcerative colitis symptom severity and proctocolectomy with multidimensional patient-reported outcomes: a cross-sectional study

Author

Matsuoka, Katsuyoshi, Yamazaki, Hajime, Nagahori, Masakazu, Kobayashi, Taku, Omori, Teppei, Mikami, Yohei, Fujii, Toshimitsu, Shinzaki, Shinichiro, Saruta, Masayuki, Matsuura, Minoru, Yamamoto, Takayuki, Motoya, Satoshi, Hibi, Toshifumi, Watanabe, Mamoru, Fernandez, Jovelle, Fukuhara, Shunichi, and Hisamatsu, Tadakazu

Published
2024
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6. Association of ulcerative colitis symptom severity and proctocolectomy with multidimensional patient-reported outcomes: a cross-sectional study

Author

Matsuoka, Katsuyoshi, Yamazaki, Hajime, Nagahori, Masakazu, Kobayashi, Taku, Omori, Teppei, Mikami, Yohei, Fujii, Toshimitsu, Shinzaki, Shinichiro, Saruta, Masayuki, Matsuura, Minoru, Yamamoto, Takayuki, Motoya, Satoshi, Hibi, Toshifumi, Watanabe, Mamoru, Fernandez, Jovelle, Fukuhara, Shunichi, and Hisamatsu, Tadakazu

Published
2023
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14. AJM300 (carotegrast methyl), an oral antagonist of α4-integrin, as induction therapy for patients with moderately active ulcerative colitis: a multicentre, randomised, double-blind, placebo-controlled, phase 3 study

Author

Motoya, Satoshi, Maemoto, Atsuo, Fujiya, Mikihiro, Ashida, Toshifumi, Goto, Mitsuru, Matsumoto, Takayuki, Suzuki, Yasuo, Hamahata, Yukihiro, Nakagawa, Tomoo, Kato, Naoya, Kato, Jun, Endo, Yutaka, Suzuki, Ryoichi, Matsuda, Koichiro, Ohmiya, Naoki, Katsushima, Shinji, Hosomi, Shuhei, Tarumi, Ken-ichi, Watanabe, Chiyuki, Saito, Mitsuru, Yokoyama, Yuichiro, Inaba, Tomoki, Sakata, Yasuhisa, Hongo, Hitoshi, Shibuya, Tomoyoshi, Kawakami, Kazuhiko, Kakuta, Yoichi, Irisawa, Atsushi, Yoshimura, Naoki, Fukuda, Katsuyuki, Shirai, Takayuki, Ichikawa, Hitoshi, Nagata, Junko, Suzuki, Takayoshi, Yokoyama, Kaoru, Tomidokoro, Takashi, Kojima, Yuichiro, Yamada, Masahiro, Yamamoto, Hideko, Yamamoto, Takayuki, Horiki, Noriyuki, Obata, Hirozumi, Inoue, Satoko, Tanaka, Shinji, Toyokawa, Tatsuya, Kunihiro, Masaki, Hisabe, Takashi, Ogata, Shinichi, Takeshima, Fuminao, Matsushima, Kayoko, Matsuhashi, Nobuyuki, Sakuraba, Hirotake, Iwabuchi, Masahiro, Tsuchiya, Akihiko, Uchiyama, Kan, Kanai, Takanori, Nakamura, Masanao, Yokoyama, Tadashi, Hida, Nobuyuki, Mitsuyama, Keiichi, Osada, Taro, Hiraoka, Sakiko, Tsuzuki, Tomoyuki, Masuo, Takashige, Hokari, Ryota, Kobayashi, Taku, Saruta, Masayuki, Araki, Masao, Araki, Hiroshi, Shimizu, Masahito, Kikuchi, Masakazu, Nishikawa, Takahiro, Takedatsu, Hidetoshi, Aoyagi, Kunihiko, Ochiai, Toshiaki, Toda, Nobuo, Mizokami, Yuji, Nagahori, Masakazu, Matsueda, Kazuhiro, Kino, Hitoshi, Kanamori, Akira, Suzuki, Tsunehiro, Sakurai, Toshiharu, Kudo, Masatoshi, Kitano, Atsuo, Hisamatsu, Tadakazu, Kumagai, Shinji, Ninomiya, Tomoyuki, Mori, Kenichiro, Yoshida, Shun-ichi, Goto, Mitsuhide, Matsuoka, Katsuyoshi, Watanabe, Mamoru, Ohmori, Toshihide, Nakajima, Koichi, Ishida, Tetsuya, Ishiguro, Yoh, Kanke, Kazunari, Kobayashi, Kiyonori, Hirai, Fumihito, Watanabe, Kenji, Mizusawa, Hidehiro, Kishida, Shuji, Miura, Yoshiharu, Ohta, Akira, Kajioka, Toshifumi, and Hibi, Toshifumi

Published
2022
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20. Efficacy and safety of mirikizumab as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a subgroup analysis of the global phase 3 LUCENT-1 and LUCENT-2 studies

Author

Kobayashi, Taku, primary, Matsuoka, Katsuyoshi, additional, Watanabe, Mamoru, additional, Hisamatsu, Tadakazu, additional, Hirai, Fumihito, additional, Milata, Joe, additional, Li, Xingyuan, additional, Morris, Nathan, additional, Arora, Vipin, additional, Ishizuka, Tomoko, additional, Matsuo, Koji, additional, Satoi, Yoichi, additional, Milch, Catherine, additional, and Hibi, Toshifumi, additional

Published
2024
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21. Add-on multiple submucosal injections of the RNA oligonucleotide GUT-1 to anti-TNF antibody treatment in patients with moderate-to-severe ulcerative colitis: An open-label, proof-of concept study

Author

Suzuki, Kenji, primary, Sameshima, Yukinori, additional, Yokoyama, Junji, additional, Terai, Shuji, additional, Yoneyama, Hiroyuki, additional, Atreya, Raja, additional, Neurath, Markus F., additional, Hibi, Toshifumi, additional, and Asakura, Hitoshi, additional

Published
2024
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23. Discontinuation of infliximab in patients with ulcerative colitis in remission (HAYABUSA): a multicentre, open-label, randomised controlled trial

Author

Kato, Shingo, Maemoto, Atsushi, Matsuura, Minoru, Sakemi, Ryosuke, Sasaki, Makoto, Tsujikawa, Tomoyuki, Esaki, Motohiro, Fukata, Norimasa, Kitamura, Kazuya, Hiraoka, Sakiko, Hokari, Ryota, Ishihara, Shunji, Mizoshita, Tsutomu, Naito, Yuji, Omata, Fumio, Saruta, Masayuki, Yoshino, Takuya, Kobayashi, Taku, Motoya, Satoshi, Nakamura, Shiro, Yamamoto, Takayuki, Nagahori, Masakazu, Tanaka, Shinji, Hisamatsu, Tadakazu, Hirai, Fumihito, Nakase, Hiroshi, Watanabe, Kenji, Matsumoto, Takayuki, Tanaka, Masanori, Abe, Takayuki, Suzuki, Yasuo, Watanabe, Mamoru, and Hibi, Toshifumi

Published
2021
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26. Impact of Concomitant Thiopurine on the Efficacy and Safety of Filgotinib in Patients with Ulcerative Colitis: Post hoc Analysis of the Phase 2b/3 SELECTION Study

Author

Watanabe, Kenji; https://orcid.org/0000-0002-3781-4724, Peyrin-Biroulet, Laurent, Danese, Silvio; https://orcid.org/0000-0001-7341-1351, Fujitani, Yasushi, Faes, Margaux, Oortwijn, Alessandra, Lindsay, James O, Rogler, Gerhard; https://orcid.org/0000-0002-1733-9188, Hibi, Toshifumi, Watanabe, Kenji; https://orcid.org/0000-0002-3781-4724, Peyrin-Biroulet, Laurent, Danese, Silvio; https://orcid.org/0000-0001-7341-1351, Fujitani, Yasushi, Faes, Margaux, Oortwijn, Alessandra, Lindsay, James O, Rogler, Gerhard; https://orcid.org/0000-0002-1733-9188, and Hibi, Toshifumi

Abstract

BACKGROUND AND AIMS: SELECTION is the first study to assess the impact of concomitant thiopurine and other immunomodulator [IM] use on the efficacy and safety of a Janus kinase inhibitor, filgotinib, in patients with ulcerative colitis. METHODS: Data from the phase 2b/3 SELECTION study were used for this post hoc analysis. Patients were randomized [2:2:1] to two induction studies [biologic-naive, biologic-experienced] to filgotinib 200 mg, 100 mg, or placebo. At week 10, patients receiving filgotinib were re-randomized [2:1] to continue filgotinib or switch to placebo until week 58 [maintenance]. Outcomes were compared between subgroups with and without concomitant IM use. RESULTS: At week 10, a similar proportion of patients in +IM and -IM groups treated with filgotinib 200 mg achieved Mayo Clinic Score [MCS] response [biologic-naive: 65.8% vs 66.9%; biologic-experienced: 61.3% vs 50.5%] and clinical remission [biologic-naive: 26.0% vs 26.2%; biologic-experienced: 11.3% vs 11.5%]. At week 58, a similar proportion of patients in +IM and -IM groups treated with filgotinib 200 mg achieved MCS response [biologic-naive: 74.2% vs 75.0%; biologic-experienced: 45.5% vs 61.4%] and clinical remission [biologic-naive: 51.6% vs 47.4%; biologic-experienced: 22.7% vs 24.3%]. The probability of protocol-specified disease worsening during the maintenance study in patients treated with filgotinib 200 mg did not differ between +IM and -IM groups [p = 0.6700]. No differences were observed in the incidences of adverse events between +IM and -IM groups in induction/maintenance studies. CONCLUSIONS: The efficacy and safety profiles of filgotinib treatment in SELECTION did not differ with or without concomitant IM use.

Published
2024

27. Adrenomedullin for steroid-resistant ulcerative colitis: a randomized, double-blind, placebo-controlled phase-2a clinical trial

Author

Kita, Toshihiro, Ashizuka, Sinya, Ohmiya, Naoki, Yamamoto, Takayuki, Kanai, Takanori, Motoya, Satoshi, Hirai, Fumihito, Nakase, Hiroshi, Moriyama, Tomohiko, Nakamura, Masanao, Suzuki, Yasuo, Kanmura, Shuji, Kobayashi, Taku, Ohi, Hidehisa, Nozaki, Ryoichi, Mitsuyama, Keiichi, Yamamoto, Shojiro, Inatsu, Haruhiko, Watanabe, Koji, Hibi, Toshifumi, and Kitamura, Kazuo

Published
2021
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28. Non-adherence to Medications in Pregnant Ulcerative Colitis Patients Contributes to Disease Flares and Adverse Pregnancy Outcomes

Author

Watanabe, Chikako, Nagahori, Masakazu, Fujii, Toshimitsu, Yokoyama, Kaoru, Yoshimura, Naoki, Kobayashi, Taku, Yamagami, Hirokazu, Kitamura, Kazuya, Takashi, Kagaya, Nakamura, Shiro, Naganuma, Makoto, Ishihara, Shunji, Esaki, Motohiro, Yonezawa, Maria, Kunisaki, Reiko, Sakuraba, Atsushi, Kuji, Naoaki, Miura, Soichiro, Hibi, Toshifumi, Suzuki, Yasuo, and Hokari, Ryota

Published
2021
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29. Recent steroid use and the relapse risk in ulcerative colitis patients with endoscopic healing.

Author

Fukuda, Tomohiro, Yamazaki, Hajime, Miyatani, Yusuke, Sawada, Tsunaki, Shibuya, Naoki, Fukuo, Yuka, Kiyohara, Hiroki, Morikubo, Hiromu, Tominaga, Keiichi, Kakimoto, Kazuki, Imai, Takayuki, Yaguchi, Katsuki, Yamamoto, Shojiro, Ando, Katsuyoshi, Nishimata, Nobuaki, Yoshihara, Takeo, Andoh, Akira, Hibi, Toshifumi, Matsuoka, Katsuyoshi, and Sugiyama, Tomoya

Subjects
ULCERATIVE colitis, STEROID drugs, ODDS ratio, LOGISTIC regression analysis
Abstract

Summary: Background: Endoscopic healing (EH) is a therapeutic target in ulcerative colitis (UC). However, even patients who have achieved EH relapse frequently. Aims: To investigate the association between recent steroid use and relapse risk in UC patients with EH. Methods: This multi‐centre cohort study included 1212 UC patients with confirmed EH (Mayo endoscopic subscore ≤1). We excluded patients with current systemic steroid use or history of advanced therapy. We divided patients into a recent steroid group (last systemic steroid use within 1 year; n = 59) and a non‐recent or steroid‐naïve group (n = 1153). We followed the patients for 2 years to evaluate relapse, defined as induction of systemic steroids or advanced therapy. We used logistic regression to estimate the odds ratio (OR) of relapse. Results: Relapse occurred in 28.8% of the recent steroid group and 5.6% of the non‐recent/steroid‐naïve group (multi‐variable‐adjusted OR 5.53 [95% CI 2.85–10.7]). The risk of relapse decreased with time since the last steroid use: 28.8% for less than 1 year after steroid therapy, 22.9% for 1 year, 16.0% for 2 years and 7.9% beyond 3 years, approaching 4.0% in steroid‐naïve patients. (ptrend <0.001). Conclusions: Even for patients with UC who achieved EH, the risk of relapse remains high following recent steroid therapy. Physicians need to consider the duration since last steroid use to stratify the relapse risk in UC patients with EH. [ABSTRACT FROM AUTHOR]

Published
2024
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30. Impact of Concomitant Thiopurine on the Efficacy and Safety of Filgotinib in Patients with Ulcerative Colitis: Post Hoc Analysis of the Phase 2b/3 SELECTION Study.

Author

Watanabe, Kenji, Peyrin-Biroulet, Laurent, Danese, Silvio, Fujitani, Yasushi, Faes, Margaux, Oortwijn, Alessandra, Lindsay, James O, Rogler, Gerhard, and Hibi, Toshifumi

Abstract

Background and Aims SELECTION is the first study to assess the impact of concomitant thiopurine and other immunomodulator [IM] use on the efficacy and safety of a Janus kinase inhibitor, filgotinib, in patients with ulcerative colitis. Methods Data from the phase 2b/3 SELECTION study were used for this post hoc analysis. Patients were randomised [2:2:1] to two induction studies [biologic-naive, biologic-experienced] to filgotinib 200 mg, 100 mg, or placebo. At Week 10, patients receiving filgotinib were re-randomised [2:1] to continue filgotinib or to switch to placebo until Week 58 [maintenance]. Outcomes were compared between subgroups with and without concomitant IM use. Results At Week 10, similar proportions of patients in the +IM and −IM groups treated with filgotinib 200 mg achieved Mayo Clinic Score [MCS] response [biologic-naive: 65.8% vs 66.9%; biologic-experienced: 61.3% vs 50.5%] and clinical remission [biologic-naive: 26.0% vs 26.2%; biologic-experienced: 11.3% vs 11.5%]. At Week 58, similar proportion of patients in the +IM and −IM groups treated with filgotinib 200 mg achieved MCS response [biologic-naive: 74.2% vs 75.0%; biologic-experienced: 45.5% vs 61.4%] and clinical remission [biologic-naive: 51.6% vs 47.4%; biologic-experienced: 22.7% vs 24.3%]. The probability of protocol-specified disease worsening during the maintenance study in patients treated with filgotinib 200 mg did not differ between +IM and −IM groups [ p  = 0.6700]. No differences were observed in the incidences of adverse events between +IM and −IM groups in the induction/maintenance studies. Conclusions The efficacy and safety profiles of filgotinib treatment in SELECTION did not differ with or without concomitant IM use. ClinicalTrials.gov identifier NCT02914522. [ABSTRACT FROM AUTHOR]

Published
2024
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33. Significance of Conducting 2 Types of Fecal Tests in Patients With Ulcerative Colitis

Author

Naganuma, Makoto, Kobayashi, Taku, Nasuno, Masanao, Motoya, Satoshi, Kato, Shingo, Matsuoka, Katsuyoshi, Hokari, Ryota, Watanabe, Chikako, Sakamoto, Hirotsugu, Yamamoto, Hironori, Sasaki, Makoto, Watanabe, Kenji, Iijima, Hideki, Endo, Yutaka, Ichikawa, Hitoshi, Ozeki, Keiji, Tanida, Satoshi, Ueno, Nobuhiro, Fujiya, Mikihiro, Sako, Minako, Takeuchi, Ken, Sugimoto, Shinya, Abe, Takayuki, Hibi, Toshifumi, Suzuki, Yasuo, and Kanai, Takanori

Published
2020
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34. Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies

Author

Long, Millie D, primary, Schreiber, Stefan, additional, Hibi, Toshifumi, additional, Gibble, Theresa Hunter, additional, Fisher, Deborah A, additional, Park, Gina, additional, Moses, Richard E, additional, Higgins, Peter D R, additional, Lindsay, James O, additional, Lee, Scott D, additional, Escobar, Rodrigo, additional, and Jairath, Vipul, additional

Published
2024
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35. Endoscopic and clinical evaluation of treatment and prognosis of Cronkhite–Canada syndrome: a Japanese nationwide survey

Author

Watanabe, Chikako, Komoto, Shunsuke, Tomita, Kengo, Hokari, Ryota, Tanaka, Masanori, Hirata, Ichiro, Hibi, Toshifumi, Kaunitz, Jonathan D, and Miura, Soichiro

Subjects
Clinical Trials and Supportive Activities, Digestive Diseases, Prevention, Rare Diseases, Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Oral and gastrointestinal, Administration, Oral, Adrenal Cortex Hormones, Adult, Aged, Aged, 80 and over, Endoscopy, Gastrointestinal, Female, Humans, Intestinal Mucosa, Intestinal Polyposis, Japan, Male, Middle Aged, Nutritional Support, Prognosis, Recurrence, Remission Induction, Retrospective Studies, Surveys and Questionnaires, Time Factors, Acquired gastrointestinal polyposis syndrome, Malnutrition, Gastric cancer, Colon cancer, Clinical Sciences, Gastroenterology & Hepatology
Abstract

BackgroundFirst reported in 1955, Cronkhite-Canada syndrome (CCS), a rare syndrome characterized by ectodermal abnormalities and inflammatory changes of the gastrointestinal tract mucosa, has been associated with a poor prognosis and life-threatening malignant complications. In a large population survey, we endeavored to characterize the course and treatment outcome of CCS through clinical and endoscopic assessment, and to explore its optimal treatment and surveillance strategy.MethodsA retrospective analysis of 210 patients with CCS was conducted via a questionnaire-based nationwide survey of 983 teaching hospitals located throughout Japan. We assessed clinical features, endoscopic findings, treatments used, and short- and long-term outcomes.ResultsThe average age at diagnosis was 63.5 years. In all cases, upper or lower gastrointestinal tract polyposis was confirmed, accompanied by characteristic ectodermal abnormalities. Of the treatments used, oral corticosteroids (30-49 mg/day) were the most effective treatment for active disease, with adjunctive nutritional support considered beneficial. With corticosteroid treatment, abdominal symptoms were relieved within a few months, whereas polyp regression often required more than 6 months. Maintenance of endoscopic remission with or without steroids for 3 years significantly lowered the development of CCS-related cancer, compared with relapsers or nonresponders, underscoring the importance of sustained endoscopic remission for cancer prevention.ConclusionsThe prognosis of CCS has greatly improved through the use of improved medical treatment. Although CCS continues to be relentlessly progressive, carrying a high cancer risk, a sufficient dose and duration of corticosteroid therapy accompanied by nutritional support and periodic endoscopic surveillance appears to improve its natural history.

Published
2016

36. S25 Communicating Needs and Features of IBD Experiences (CONFIDE) Survey: Impact of Moderate to Severe Crohn’s Disease Symptoms on Health Care Professional Treatment Decisions in the United States and Europe

Author

Dubinsky, Marla C., primary, Gibble, Theresa H., additional, Travis, Simon, additional, Panaccione, Remo, additional, Hibi, Toshifumi, additional, Bleakman, Alison Potts., additional, Panni, Tommaso, additional, Kayhan, Cem, additional, Favia, Angelo D., additional, Atkinson, Christian, additional, Schreiber, Stefan, additional, and Rubi, David T., additional

Published
2023
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37. S3 Communicating Needs and Features of IBD Experiences (CONFIDE) Survey: United States and European Patient Perspectives on the Impact of Moderate to Severe Crohn’s Disease on Sexual Activity

Author

Rubin, David T., primary, Gibble, Theresa H., additional, Travis, Simon, additional, Panaccione, Remo, additional, Hibi, Toshifumi, additional, Bleakman, Alison Potts, additional, Panni, Tommaso, additional, Kayhan, Cem, additional, Favia, Angelo D., additional, Atkinson, Christian, additional, Schreiber, Stefan, additional, and Dubinsky, Marla C., additional

Published
2023
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39. Single Nucleotide Polymorphisms of the MEFV Gene E148Q Are Highly Associated With Disease Phenotype in Crohn’s Disease

Author

Yamada, Satoshi, primary, Honzawa, Yusuke, additional, Yamamoto, Shuji, additional, Matsuura, Minoru, additional, Kitamoto, Hiroki, additional, Okabe, Makoto, additional, Kakiuchi, Nobuyuki, additional, Toyonaga, Takahiko, additional, Kobayashi, Taku, additional, Hibi, Toshifumi, additional, Seno, Hiroshi, additional, and Nakase, Hiroshi, additional

Published
2023
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41. A nationwide, multi-center, retrospective study of symptomatic small bowel stricture in patients with Crohn’s disease

Author

Bamba, Shigeki, Sakemi, Ryosuke, Fujii, Toshimitsu, Takeda, Teruyuki, Fujioka, Shin, Takenaka, Kento, Kitamoto, Hiroki, Umezawa, Shotaro, Sakuraba, Hirotake, Inokuchi, Toshihiro, Fukata, Norimasa, Mizuno, Shinta, Yamashita, Masaki, Shinzaki, Shinichiro, Tanaka, Hiroki, Takedatsu, Hidetoshi, Ozaki, Ryo, Moriya, Kei, Ishii, Manabu, Kinjo, Tetsu, Ozeki, Keiji, Ooi, Makoto, Hayashi, Ryohei, Kakimoto, Kazuki, Shimodate, Yuichi, Kitamura, Kazuya, Yamada, Akihiro, Sonoda, Akira, Nishida, Yu, Yoshioka, Kyouko, Ashizuka, Shinya, Takahashi, Fumiaki, Shimokawa, Toshio, Kobayashi, Taku, Andoh, Akira, and Hibi, Toshifumi

Published
2020
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43. Somatic inflammatory gene mutations in human ulcerative colitis epithelium

Author

Nanki, Kosaku, Fujii, Masayuki, Shimokawa, Mariko, Matano, Mami, Nishikori, Shingo, Date, Shoichi, Takano, Ai, Toshimitsu, Kohta, Ohta, Yuki, Takahashi, Sirirat, Sugimoto, Shinya, Ishimaru, Kazuhiro, Kawasaki, Kenta, Nagai, Yoko, Ishii, Ryota, Yoshida, Kosuke, Sasaki, Nobuo, Hibi, Toshifumi, Ishihara, Soichiro, Kanai, Takanori, and Sato, Toshiro

Published
2020
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45. Submucosal Injection of the RNA Oligonucleotide GUT-1 in Active Ulcerative Colitis Patients: A Randomized, Double-Blind, Placebo-Controlled Phase 2a Induction Trial.

Author

Atreya, Raja, Kühbacher, Tanja, Waldner, Maximilian J, Hirschmann, Simon, Drvarov, Oliver, Hashem, Raed Abu, Maaser, Christian, Kucharzik, Torsten, Dinter, Johanna, Mertens, Jessica, Schramm, Christoph, Holler, Babett, Mössner, Joachim, Suzuki, Kenji, Yokoyama, Junji, Terai, Shuji, Uter, Wolfgang, Yoneyama, Hiroyuki, Asakura, Hitoshi, and Hibi, Toshifumi

Abstract

Background and Aims Carbohydrate sulfotransferase 15 [CHST15] biosynthesizes sulphated matrix glycosaminoglycans and is implicated in intestinal inflammation and fibrosis. Here, we evaluate the efficacy and safety of the double-stranded RNA oligonucleotide GUT-1, a specific blocker of CHST15, as induction therapy in patients with ulcerative colitis [UC]. Methods In this randomized, double-blind, placebo-controlled, phase 2a study, we enrolled endoscopically active UC patients, refractory to conventional therapy, in five hospital centres across Germany. Patients were randomized 1:1:1 using a block randomized technique to receive a single dosing of 25 nM GUT-1, 250 nM GUT-1, or placebo by endoscopic submucosal injections. The primary outcome measure was improvement of endoscopic lesions at weeks 2 or 4. The secondary outcome measures included clinical and histological responses. Safety was assessed in all patients who received treatment. Results Twenty-eight patients were screened, 24 were randomized, and 21 were evaluated. Endoscopic improvement at weeks 2 or 4 was achieved by 71.4% in the GUT-1 250 nM, 0% in the GUT-1 25 nM, and 28.6% in the placebo group. Clinical remission was shown by 57.1% in the GUT-1 250 nM, 0% in the GUT-1 25 nM, and 14.3% in the placebo groups. Histological improvement was shown by 42.9% in the GUT-1 250 nM, 0% in the GUT-1 25 nM, and 0% in the placebo groups. GUT-1 250 nM reduced CHST15 expression significantly and suppressed mucosal inflammation and fibrosis. GUT-1 application was well tolerated. Conclusion Single dosing by submucosal injection of GUT-1 repressed CHST15 mucosal expression and may represent a novel induction therapy by modulating tissue remodelling in UC. [ABSTRACT FROM AUTHOR]

Published
2024
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47. S1070 Communication Gap Between Patients and Health Care Professionals on Bowel Urgency With Focus on Crohn's Disease: Results From the Communicating Needs and Features of IBD Experiences (CONFIDE) Survey

Author

Schreiber, Stefan, primary, Gibble, Theresa Hunter, additional, Dubinsky, Marla C., additional, Rubin, David T., additional, Panaccione, Remo, additional, Hibi, Toshifumi, additional, Kayhan, Cem, additional, Bleakman, Alison Potts, additional, Panni, Tommaso, additional, Favia, Angelo D., additional, Atkinson, Christian, additional, and Travis, Simon, additional

Published
2023
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48. S912 The Effect of Patients’ Current Ulcerative Colitis Disease Severity Perception on Prevalence and Experiences of Bowel Urgency: Results from the Communicating Needs and Features of IBD Experiences (CONFIDE) Survey

Author

Rubin, David T., primary, Dubinsky, Marla C., additional, Gibble, Theresa Hunter, additional, Schreiber, Stefan, additional, Panaccione, Remo, additional, Hibi, Toshifumi, additional, Panni, Tommaso, additional, Kayhan, Cem, additional, Bleakman, Alison Potts, additional, Flynn, Eoin, additional, Atkinson, Christian, additional, and Travis, Simon, additional

Published
2023
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49. S855 Communicating Needs and Features of IBD Experiences (CONFIDE) Survey: Burden and Impact of Bowel Urgency is Similar in Patients With Moderate-to-Severe Crohn’s Disease and Ulcerative Colitis

Author

Schreiber, Stefan, primary, Gibble, Theresa Hunter, additional, Dubinsky, Marla C., additional, Rubin, David T., additional, Panaccione, Remo, additional, Hibi, Toshifumi, additional, Kayhan, Cem, additional, Bleakman, Alison Potts, additional, Panni, Tommaso, additional, Favia, Angelo D., additional, Atkinson, Christian, additional, and Travis, Simon, additional

Published
2023
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