Intestinal Research

Corrigenda and Errata

Corrigendum: Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies: 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; Intest Res 2018;16(3):499-501. Published online July 27, 2018; DOI: https://doi.org/10.5217/ir.2018.16.3.499

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Original Articles

IBD

Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies: 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; Intest Res 2018;16(2):233-245. Published online April 30, 2018; DOI: https://doi.org/10.5217/ir.2018.16.2.233

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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.

Citations

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Real-life effectiveness and safety of tofacitinib treatment in patients with ulcerative colitis: a KASID multicenter cohort study
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Factors predicting clinical and endoscopic remission with placebo therapy in East Asian patients with ulcerative colitis: a systematic review and meta-analysis
Jian Zeng, Zhong Wang, Xiao-Jun Yang
European Journal of Clinical Pharmacology.2022; 78(7): 1069. CrossRef
Personalized medicine in inflammatory bowel disease: Perspectives on Asia
Su Hyun Park, Sang Hyoung Park
Journal of Gastroenterology and Hepatology.2022; 37(8): 1434. CrossRef
Safety and efficacy of long‐term tofacitinib treatment in East Asian patients with ulcerative colitis in OCTAVE Open
Katsuyoshi Matsuoka, Tadakazu Hisamatsu, Hyo Jong Kim, Byong Duk Ye, Shoko Arai, Masato Hoshi, Hirotoshi Yuasa, Junichi Tabira, Shigeyuki Toyoizumi, Nanzhi Shi, Joon‐suk Woo, Toshifumi Hibi
Journal of Gastroenterology and Hepatology.2022; 37(10): 1884. CrossRef
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Tofacitinib, the First Oral Janus Kinase Inhibitor Approved for Adult Ulcerative Colitis
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Long-Term Clinical Outcomes of Korean Patient With Crohn's Disease Following Early Use of Infliximab: Nam Hee Kim, Yoon Suk Jung, Chang Mo Moon, Shin Yeong Lee, Eun Ran Kim, Young Ho Kim, Chang Kyun Lee, Suck Ho Lee, Jae Hak Kim, Kyu Chan Huh, Soon Man Yoon, Hyun Joo Song, Sun-Jin Boo, Hyun Joo Jang, You Sun Kim, Kang-Moon Lee, Jeong Eun Shin, Dong Il Park; Intest Res 2014;12(4):281-286. Published online October 27, 2014; DOI: https://doi.org/10.5217/ir.2014.12.4.281

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Background/Aims

Several recent studies have reported that the early use of infliximab (IFX) improves the prognosis of Crohn's disease (CD). However, no data are available from Asian populations, as the forementioned studies have all been conducted in Western countries. The aim of the current study was to evaluate the impact of early use of IFX on the prognosis of Korean patients with CD.

Methods

Patients with a diagnosis of CD established between July 1987 and January 2012 were investigated in 12 university hospitals in Korea. Because insurance coverage for IFX treatment began in August 2005, patients were assigned to either of 2 groups based on diagnosis date. The first group included patients diagnosed from July 1987 to December 2005, and the second from January 2006 to January 2012. We compared the cumulative probabilities of operation and reoperation between the two groups using the Kaplan-Meier method and a log-rank test.

Results

Of the 721 patients investigated, 443 (61.4%) comprized the second group. Although the cumulative probabilities of immunosuppressant (P<0.001) and IFX use (P<0.001) after diagnosis were significantly higher in the second group, there were no significant differences in cumulative probabilities of operation (P=0.905) or reoperation (P=0.418) between two groups.

Conclusions

The early use of IFX did not reduce CD-related surgery requirements in Korean patients with CD. These study results suggest that the early use of IFX may have little impact on the clinical outcome of CD in Korean patients in the setting of a conventional step-up algorithm.

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Commentary

Crohn's Disease Clinical Network and Cohort (CONNECT) Study: The First Step Toward Nationwide Multicenter Research of Crohn's Disease in Korea: Jae Hee Cheon, You Sun Kim, Byong Duk Ye, Kang Moon Lee, Young Ho Kim, Joo Sung Kim, Dong Soo Han, Won Ho Kim; Intest Res 2014;12(3):173-175. Published online July 25, 2014; DOI: https://doi.org/10.5217/ir.2014.12.3.173

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Original Article

Usefulness of Polyp Detection Rate as a Quality Indicator in Colonoscopy: Su Hee Lee, Dong Il Park, Jun Mo Sung, Jae Hyun Jang, Seung Ho Ryu, Young Ho Kim, Suck-Ho Lee, Chang Kyun Lee, Chang Soo Eun, Dong Soo Han; Intest Res 2011;9(2):105-111. Published online August 30, 2011; DOI: https://doi.org/10.5217/ir.2011.9.2.105

Abstract PDF

Background/Aims
The adenoma detection rate (ADR) has been proposed as a quality indicator of colonoscopy; however, ADR cannot be measured easily with commonly used endoscopy reporting systems because substantial time and effort is required to acquire data from histologic assessments. The purpose of this study was to determine if polyp detection rate (PDR) could be used as a valid proxy for ADR. Methods: A total of 1,156 consecutive, asymptomatic, individuals of average risk between 50 and 75 years-of-age who underwent screening colonoscopies at four tertiary medical centers by 27 gastroenterologists were included in this study. Each individual endoscopist performed at least 10 colonoscopies during the study period. The ADR and PDR were calculated as the proportion of an endoscopist's cases with an adenoma or polyp divided by the total number of colonoscopies. Pearson's correlation coefficient and the intraclass correlation coefficient were used to determine the level of agreement between ADR and PDR. Results: The mean PDR and ADR for endoscopists was 47.4% (range, 21.7-75.0) and 36.5% (range, 13.0-66.7), respectively. There was a strong correlation between PDR and ADR (Pearson's correlation coefficient 0.94, P＜0.001) and there was also good agreement between performance quintiles defined by ADR and PDR (intraclass correlation coefficient 0.94, P＜0.001). Conclusions: PDR is a valid proxy for ADR and may be useful for quality assurance at centers where ADR cannot be easily measured. (Intest Res 2011;9:105-111)

Citations

Citations to this article as recorded by

Usefulness of Polyp and Adenoma Detection Rate in the Proximal and Distal Colon
Sung Youn Choi, Dong Il Park, Chang Kyun Lee, Jae Myung Cha, Suck Ho Lee, Young Whangbo, Chang Soo Eun, Dong Soo Han, Bo In Lee, Jeong Eun Shin
The Korean Journal of Gastroenterology.2014; 63(1): 11. CrossRef
Correlation between Adenoma Detection Rate and Advanced Adenoma Detection Rate
Shin Yeoung Lee, Nam Hee Kim, Hyun Beom Chae, Ki Joong Han, Tae Hoon Lee, Choel Min Jang, Kyung Mo Yoo, Yoon Suk Jung, Jung Ho Park, Hong Joo Kim, Yong Kyun Cho, Chong Il Sohn, Woo Kyu Jeon, Byung Ik Kim, Dong Il Park
The Korean Journal of Gastroenterology.2014; 64(1): 18. CrossRef
The Correlation between Polyp Detection Rate and Adenoma Detection Rate: Mainly Determined by the Colon Segment
Geom Seog Seo
The Korean Journal of Gastroenterology.2014; 63(1): 1. CrossRef

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Case Report

A Case of Degos' Disease Presenting with Abdominal Angina and Widespread Skin Lesions: Bon-Ho Ku, Yeun Jung Lim, Hyo Kyung Choi, Young Ho Kim, Jongwook Park, Chi Hoon Kim, Tae-Hoon Jang, Yong Woo Seo, Young Cheol Jo, Kee-Taek Jang, Chang Ohk Sung, Dong-Kyung Chang; Intest Res 2010;8(1):70-74. Published online June 30, 2010; DOI: https://doi.org/10.5217/ir.2010.8.1.70

Abstract PDF: Malignant atrophic papulosis (MAP), also known as Degos' disease, is a rare and often fatal occlusive thrombotic vasculopathy, with fewer than seven cases reported in Korea. MAP is characterized by porcelain-white, atrophic, papular skin lesions and multi-organ system involvement, especially the gastrointestinal (GI) tract and nervous system. Involvement of the GI tract is usually associated with a poor prognosis. To date, no treatment has been shown to be effective in the treatment of MAP. We describe a 52-year-old man who presented with a 5-month history of abdominal angina and a 2-year history of multiple skin lesions on the trunk and extremities. The skin lesions were papules, 4-6 mm in diameter, with a porcelain-white center and a slightly raised erythematous telangiectatic rim. A biopsy of a skin lesion showed a wedge-shaped degeneration of collagen in the dermis and atrophic epidermis. An explorative laparoscopy revealed multiple, yellow-white plaques scattered throughout the small bowel. A biopsy of the small bowel showed sclerotic vascular alterations containing intravascular fibrin thrombi. He was started on aspirin (100 mg daily) and has survived for 24 months since the onset of gastrointestinal symptoms. (Intest Res 2010;8:70-74)

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Original Article

The Effectiveness of Audiovisual Aids Education in Preparing Patients for Colonoscopy: Byung Hoon Min, Dong Kyung Chang, Young Ho Kim, Poong-Lyul Rhee, Jae J. Kim, Jong Chul Rhee; Published online June 30, 2007

Abstract PDF: Background/Aims
The purpose of this study is to investigate how effectively audiovisual aids education can improve patients' bowel preparation and their satisfaction during colonoscopic examination. Methods: The control group consisted of 116 patients and the experimental group consisted of 109 patients. The control group was given the existing test guidebooks and the experimental group was offered audiovisual aids education immediately before the test. After the test, the patients assessed. Results: In regard to the organization and consistency of colonoscopic education, the experimental group showed a statistically significant score (p=0.000). In regard to satisfaction with the colonoscopy, the average score of the control group was 7.50⁑2.02, while that of the experimental group was 8.63⁑1.76 (p=0.000). In regard to bowel preparation, the experimental group showed a statistically meaningful score compared to that of the control group (p=0.002). In terms of examination time comparison, the experimental group returned a statistically meaningful score (p=0.005). In regard to the nurses' task satisfaction, according to the information offered, the experimental group showed a statistically significant score (8.47⁑1.32) compared to the control group (6.49⁑2.23)(p=0.000). Conclusions: The audiovisual aids education enhanced the patients' satisfaction. Therefore these aids are worth incorporating within nursing methods. (Intest Res 2007;5:52-59)

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Case Report

A Case of C1 Esterase Inhibitor Deficiency Presenting as Recurrent Abdominal Pain and Ascites: Byung Hoon Min, Dong Kyung Chang, Young Ho Kim, Poong-Lyul Rhee, Jae J. Kim, Jong Chul Rhee; Published online June 30, 2007

Abstract PDF: C1 esterase inhibitor deficiency is a disorder resulting from a qualitative or functional defect of the C1 esterase inhibitor. It is characterized by recurrent episodes of subcutaneous and submucosal swellings in any part of the skin and the respiratory and gastrointestinal tracts. Gastrointestinal symptoms such as abdominal pain are the dominant symptoms in about 25% of cases and sometimes make this condition misunderstood as surgical emergency, especially when ascites is accompanied. We experienced a case of C1 esterase inhibitor deficiency in a 35-year-old woman presenting with recurrent abdominal pain, ascites, and lower extremities edema. Her symptoms first occurred 8 years ago, and used to spontaneously resolve within 3 days. In laboratory finding, serum C4 and serum C1 esterase inhibitor showed reduced level of 3.2 mg/dL and 5 mg/dL, respectively. After treatment with danazol and tranexamic acid, no more recurrence of symptoms was observed during 2 months of follow-up period. (Intest Res 2007;5:73-76)

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Original Article

Acute Diarrhea after Bone Marrow Transplantation: Hyun Joo Suh, Young Ho Kim, Ji Hyang Kim, Yong Sung Choi, Jeong Kim, Poong Lyul Rhee, Jae J. Kim, Seung Woon Paik, Jong Chul Rhee; Intest Res 2005;3(2):104-109. Published online December 30, 2005

Abstract PDF: Background/Aims
A few study have performed the cause of acute diarrhea in patients undergoing bone marrow transplantation (BMT) so far. We analyzed the prevalence of acute diarrhea after BMT, its etiology and its risk factors. Methods: We retrospectively evaluated records of 132 patients undergoing BMT between September 1999 and Jun 2003. Diarrhea had to get its onset from day of admission to day of 100 posttransplant. Results: 95 patients developed acute diarrhea in 132 patients (72% of incidence). The total episodes of diarrhea were 117. Infection was found in 16 of 117 episodes (13.7%). Acute Graft versus host disease was responsible for 9 of 117 episodes (10.3%). Possible etiology of diarrhea was composed of 19 episodes of medication-induced diarrhea (16.2%), 11 episodes of mucositis (9.4%) and 5 episodes of infection (4.3%). Unknown originated diarrhea were 56 episodes (47.9%). Development of diarrhea was not significantly associated with age, sex, underlying disease, BMT conditions and prophylaxis of CMV virus. Conclusions: Acute diarrhea was common in patients undergoing BMT. However, etiology have not clearly evaluated in half of the cases. Further tests to evaluate etiology of acute diarrhea should be investigated. (Intest Res 2005;3:104-109)

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Case Report

A Case of Mesenteric Vasculitis Induced by Norpal Cactus Extract: Jung Su Ha, Dong Kyung Chang, Jun Haeng Lee, Young Ho Kim, Hee Jung Son, Poong Lyul Rhee, Jae J. Kim, Seung Woon Paik, Jong Chul Rhee; Intest Res 2005;3(1):85-88. Published online June 30, 2005

Abstract PDF: Herbs are inadvertently regarded safe and harmless because of their natural origin and the experience of long-term use as a folk medicine. However, some herbal medicines are associated with toxicities in the organs such as liver, kidney, skin, or heart. Norpal cactus extract is a kind of herbs which is used for ordinary food in Mexico, and has effects on hypergylcemia and hypercholesterolemia, and inflammation. There has been no particular reports of drug-induced vasculitis by herbal medicine. Here, we present a case of vasculitis that was initially manifestated as acute diarrhea and abdominal pain after ingestion of Norpal cactus extract. (Intest Res 2005;3:85-89)

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