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( Satoshi Motoya ),( Mamoru Watanabe ),( Hyo Jong Kim ),( Young Ho Kim ),( Dong Soo Han ),( Hirotoshi Yuasa ),( Junichi Tabira ),( Naoki Isogawa ),( Shoko Arai ),( Isao Kawaguchi ),( Toshifumi Hibi ) 대한장연구학회 2018 Intestinal Research Vol.16 No.2
Background/Aims: Tofacitinib is an oral, small-molecule Janus kinase inhibitor being investigated for ulcerative colitis (UC). In OCTAVE Induction 1 and 2, patients with moderately to severely active UC received placebo or tofacitinib 10 mg twice daily (BID) for 8 weeks. Clinical responders in OCTAVE Induction were re-randomized to 52 weeks’ therapy with placebo, tofacitinib 5 mg BID, or tofacitinib 10 mg BID. Methods: We conducted post-hoc efficacy and safety analyses of East Asian patients in OCTAVE Induction 1 and 2 and OCTAVE Sustain. Results: A total of 121 East Asian (Japan, Korea, and Taiwan) patients were randomized in OCTAVE Induction 1 and 2 (placebo, n=26; tofacitinib 10 mg BID, n=95), and 63 in OCTAVE Sustain (placebo, n=20; tofacitinib 5 mg BID, n=22; tofacitinib 10 mg BID, n=21). At week 8 of OCTAVE Induction 1 and 2, 18.9% of patients (18/95) achieved remission with tofacitinib 10 mg BID versus 3.8% (1/26) with placebo. In OCTAVE Sustain, the week 52 remission rates were 45.5% (10/22), 47.6% (10/21), and 15.0% (3/20) with 5 mg BID, 10 mg BID, and placebo, respectively. Adverse event rates were similar between groups in OCTAVE Induction and numerically higher with tofacitinib in OCTAVE Sustain. Serious adverse event rates were similar across groups in all studies. Infections were numerically more frequent with tofacitinib than placebo. Increases in serum lipid levels were observed with tofacitinib. Conclusions: In East Asian patients with UC, tofacitinib demonstrated numerically greater efficacy versus placebo as induction and maintenance therapy, with a safety profile consistent with the global study population. ClinicalTrials.gov: NCT01465763; NCT01458951; NCT01458574. (Intest Res 2018;16:233-245)
REVIEW : Pathogenesis of Inflammatory Bowel Diseases
( Masakazu Nagahori ),( Yasuhiro Nemoto ),( Mamoru Watanabe ) 대한장연구학회 2010 Intestinal Research Vol.8 No.1
Our understanding of IBD pathogenesis has been increasing rapidly. The genetically determined interplay between the commensal microbiota, intestinal epithelial cells, and the immune system has been appreciated deeply. The interplay is also considered to be modified by specific environmental factors. This review examines the recent findings from the animal and human studies on IBD pathogenesis and the implications for future effective therapies. (Intest Res 2010;8:9-17)
A SUPERNOVA SEARCH WITH PUBLIC ASTRONOMICAL OBSERVATORIES IN JAPAN
YAMAOKA HITOSHI,DOI MAMORU,SHiGEYAMA TOSHIKAZU,WATANABE MASARU,YASUDA NAOKI The Korean Astronomical Society 1996 Journal of The Korean Astronomical Society Vol.29 No.suppl1
We are promoting a supernova(SN) search project with medium size (60cm-105cm) telescopes belonging to public observatories in Japan. The main purpose is to measure the SNe Ia rate, which plays an important role in the chemical and dynamical evolution of galaxies. We expect to measure the SN rate in E/SO galaxies within the $35\%$ error after 2 years run, and the longer run will give the smaller error.
( Taku Kobayashi ),( Katsuyoshi Matsuoka ),( Mamoru Watanabe ),( Tadakazu Hisamatsu ),( Fumihito Hirai ),( Joe Milata ),( Xingyuan Li ),( Nathan Morris ),( Vipin Arora ),( Tomoko Ishizuka ),( Koji Mat 대한장연구학회 2024 Intestinal Research Vol.22 No.2
Background/Aims: Mirikizumab is a p19-directed anti-interleukin-23 antibody with potential efficacy against ulcerative colitis (UC). We evaluated the efficacy and safety of mirikizumab in a Japanese subpopulation with moderately to severely active UC from the LUCENT-1 and LUCENT-2 studies. Methods: LUCENT-1 and LUCENT-2 were phase 3, randomized, double-blind, placebo-controlled trials of mirikizumab therapy in adults with moderately to severely active UC. LUCENT-1 was a 12-week induction trial where patients were randomized 3:1 to receive intravenous mirikizumab 300 mg or placebo every 4 weeks (Q4W). Patients achieving a clinical response with mirikizumab following the induction study were re-randomized 2:1 to double-blind treatment with either mirikizumab 200 mg or placebo subcutaneously Q4W during the 40-week maintenance study. The primary outcomes were clinical remission at week 12 of LUCENT-1 and week 40 of LUCENT-2. Results: A total of 137 patients enrolled in Japan were randomized to mirikizumab (n = 102) or placebo (n = 35). Compared with placebo, patients who received mirikizumab showed numerically higher clinical remission at week 12 of induction (32.4% [n = 33] vs. 2.9% [n = 1]) and at week 40 of maintenance (48.9% [n = 23] vs. 28.0% [n = 7]). A greater number of patients achieved key secondary endpoints in the mirikizumab group compared with placebo. The frequency of treatment-emergent adverse events was similar across mirikizumab and placebo groups. Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population. Conclusions: Mirikizumab induction and maintenance treatments were effective in Japanese patients with moderately to severely active UC. No new safety concerns were identified. (Intest Res 2024;22:172-185)
Stem cell-based therapy for inflammatory bowel disease
Hiromichi Shimizu,Kohei Suzuki,Mamoru Watanabe,Ryuichi Okamoto 대한장연구학회 2019 Intestinal Research Vol.17 No.3
Inflammatory bowel disease (IBD) is an idiopathic, multi-etiological disease characterized by inflammation and mucosal destruction of the gastrointestinal tract. Despite the remarkable advance in immunomodulating therapies, there still remains a certain population of patients who are refractory to conventional as well as biologic therapies and fail to achieve mucosal healing. To improve the prognosis of those patients, at least 2 types of stem cells have been tested for their potential therapeutic use. Transplantation of hematopoietic stem cells or mesenchymal stem cells have been tested in several clinical studies, but their beneficial effect still remains controversial. In this review, we would like to overview the recent clinical challenges of stem cell-based therapies in IBD and also introduce our new therapeutic plan of intestinal stem cell transplantation for IBD, based on our ex vivo intestinal organoid culture technique.
Artificial intelligence for endoscopy in inflammatory bowel disease
( Kento Takenaka ),( Ami Kawamoto ),( Ryuichi Okamoto ),( Mamoru Watanabe ),( Kazuo Ohtsuka ) 대한장연구학회 2022 Intestinal Research Vol.20 No.2
Inflammatory bowel disease (IBD), with its 2 subtypes, Crohn’s disease and ulcerative colitis, is a complex chronic condition. A precise definition of disease activity and appropriate drug management greatly improve the clinical course while minimizing the risk or cost. Artificial intelligence (AI) has been used in several medical diseases or situations. Herein, we provide an overview of AI for endoscopy in IBD. We discuss how AI can improve clinical practice and how some components have already begun to shape our knowledge. There may be a time when we can use AI in clinical practice. As AI systems contribute to the exact diagnosis and treatment of human disease, we should continue to learn best practices in health care in the field of IBD. (Intest Res 2022;20:165-170)
( Toshifumi Hibi ),( Makoto Naganuma ),( Eisei Oda ),( Yoji Yamada ),( Yoshitomo Chujoh ),( Ryoichi Yoshihara ),( Mamoru Watanabe ) 대한장연구학회 2020 Intestinal Research Vol.18 No.1
Background/Aims: Mucosal healing (MH) of distal lesions in ulcerative colitis (UC) has recently been confirmed with budesonide 2-mg foam (BF) treatment in 2 clinical trials; however, few studies have investigated the predictive factors for complete MH. Methods: We conducted a post hoc analysis using pooled data from phase II and III clinical trials evaluating the efficacy and safety of BF for UC. Additionally, we analyzed the relationships between complete MH and baseline factors and clinical symptoms from baseline to week 6. Results: Among the 291 Japanese patients from the 2 pooled clinical studies, 119 patients in the BF twice a day group and 117 in the placebo group were included in the full analysis set. The proportion of patients with a rectal bleeding (RB) subscore of 0 was significantly higher in the BF group than in the placebo group after a 5-day treatment (P<0.05). After a 2-day treatment, significantly more patients in the BF group had a stool frequency (SF) subscore of 0 than patients in the placebo group (P<0.05). Multivariate analysis showed that complete MH at week 6 was influenced by baseline SF subscore and 5-aminosalicylic acid (5-ASA) enema or suppository use (P=0.0086 and P=0.0015, respectively). The relationship between complete MH at week 6 and RB subscore after week 2 was also confirmed. Conclusions: Normal SF at baseline, history of 5-ASA topical product use, and elimination of RB after week 2 are suggested predictors of complete MH at week 6 with twice-daily BF treatment. (Intest Res 2020;18:56-68)
( Tadakazu Hisamatsu ),( Yasuo Suzuki ),( Mariko Kobayashi ),( Takashi Hagiwara ),( Takeshi Kawaberi ),( Haruhiko Ogata ),( Toshiyuki Matsui ),( Mamoru Watanabe ),( Toshifumi Hibi ) 대한장연구학회 2021 Intestinal Research Vol.19 No.4
Background/Aims: Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings. Methods: This was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remis-sion, mucosal healing, and Work Productivity and Activity Impairment (WPAI). Results: The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malig-nancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained >70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years >2 to ≤3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n=102) at baseline to 26.9 (n=84) at 4 weeks. Conclusions: Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting. (Intest Res 2021;19:408-418)
Magnetic resonance enterography for the evaluation of the deep small intestine in Crohn`s disease
( Kazuo Ohtsuka ),( Kento Takenaka ),( Yoshio Kitazume ),( Toshimitsu Fujii ),( Katsuyoshi Matsuoka ),( Masakazu Nagahori ),( Maiko Kimura ),( Takashi Nagaishi ),( Mamoru Watanabe ) 대한장연구학회 2016 Intestinal Research Vol.14 No.2
For the control of Crohn`s disease (CD) a thorough assessment of the small intestine is essential; several modalities may be utilized, with cross-sectional imaging being important. Magnetic resonance (MR) enterography, i.e., MRE is recommended as a modality with the highest accuracy for CD lesions. MRE and MR enteroclysis are the two methods performed following distension of the small intestine. MRE has sensitivity and specificity comparable to computed tomography enterography (CTE); although images obtained using MRE are less clear compared with CTE, MRE does not expose the patient to radiation and is superior for soft-tissue contrast. Furthermore, it can assess not only static but also dynamic and functional imaging and reveals signs of CD, such as abscess, comb sign, fat edema, fistula, lymph node enhancement, less motility, mucosal lesions, stricture, and wall enhancement. Several indices of inflammatory changes and intestinal damage have been proposed for objective evaluation. Recently, diffusion-weighted imaging has been proposed, which does not need bowel preparation and contrast enhancement. Comprehension of the characteristics of MRE and other modalities is important for better management of CD. (Intest Res 2016;14:120-126)