Intestinal Research

Reviews

Colorectal neoplasia

Summary and comparison of recently updated post-polypectomy surveillance guidelines: Yoon Suk Jung; Intest Res 2023;21(4):443-451. Published online October 26, 2023; DOI: https://doi.org/10.5217/ir.2023.00107

Recently, updated guidelines for post-polypectomy surveillance have been published by the U.S. Multi‐Society Task Force (USMSTF), the British Society of Gastroenterology/Association of Coloproctology of Great Britain and Ireland/Public Health England (BSG/ACPGBI/PHE), the European Society of Gastrointestinal Endoscopy (ESGE), the Japan Gastroenterological Endoscopy Society (JGES), and the Korean Multi-Society Taskforce Committee. This review summarizes and compares the updated recommendations of these 5 guidelines. There are some differences between the guidelines for the recommended post-polypectomy surveillance intervals. In particular, there are prominent differences between the guidelines for 1–4 tubular adenomas < 10 mm with low-grade dysplasia (nonadvanced adenomas [NAAs]) and tubulovillous or villous adenomas. The USMSTF, JGES, and Korean guidelines recommend colonoscopic surveillance for patients with 1–4 NAAs and those with tubulovillous or villous adenomas, whereas the BSG/ACPGBI/PHE and ESGE guidelines do not recommend endoscopic surveillance for such patients. Surveillance recommendations for patients with serrated polyps (SPs) are limited. Although the USMSTF guidelines provide specific recommendations for patients who have undergone SPs removal, these are weak and based on very lowquality evidence. Future studies should examine this topic to better guide the surveillance recommendations for patients with SPs. For countries that do not have separate guidelines, we hope that this review article will help select the most appropriate guidelines as per each country’s healthcare environment.

Citations

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Causal association between telomere length and colorectal polyps: A bidirectional two-sample Mendelian randomization study
Yin Zhang, Jiaying Wang, Mingyu Zheng, Huanwei Qu, Shuya Yang, Fuzhou Han, Nan Yao, Wenqiang Li, Jun Qu
Medicine.2024; 103(1): e36867. CrossRef
Screening and surveillance for hereditary colorectal cancer
Hee Man Kim, Tae Il Kim
Intestinal Research.2024; 22(2): 119. CrossRef
Screening and Surveillance of Colorectal Cancer: A Review of the Literature
Marcello Maida, Dushyant Singh Dahiya, Yash R. Shah, Angad Tiwari, Harishankar Gopakumar, Ishaan Vohra, Aqsa Khan, Fouad Jaber, Daryl Ramai, Antonio Facciorusso
Cancers.2024; 16(15): 2746. CrossRef

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Cancer

Korean Guidelines for Postpolypectomy Colonoscopic Surveillance: 2022 revised edition: Su Young Kim, Min Seob Kwak, Soon Man Yoon, Yunho Jung, Jong Wook Kim, Sun-Jin Boo, Eun Hye Oh, Seong Ran Jeon, Seung-Joo Nam, Seon-Young Park, Soo-Kyung Park, Jaeyoung Chun, Dong Hoon Baek, Mi-Young Choi, Suyeon Park, Jeong-Sik Byeon, Hyung Kil Kim, Joo Young Cho, Moon Sung Lee, Oh Young Lee, Korean Society of Gastrointestinal Endoscopy, Korean Society of Gastroenterology, Korean Association for the Study of Intestinal Diseases; Intest Res 2023;21(1):20-42. Published online January 31, 2023; DOI: https://doi.org/10.5217/ir.2022.00096

Abstract PDF Supplementary Material PubReader ePub

Colonoscopic polypectomy is effective in decreasing the incidence and mortality of colorectal cancer (CRC). Premalignant polyps discovered during colonoscopy are associated with the risk of metachronous advanced neoplasia. Postpolypectomy surveillance is the most important method for managing advanced metachronous neoplasia. A more efficient and evidence-based guideline for postpolypectomy surveillance is required because of the limited medical resources and concerns regarding colonoscopy complications. In these consensus guidelines, an analytic approach was used to address all reliable evidence to interpret the predictors of CRC or advanced neoplasia during surveillance colonoscopy. The key recommendations state that the high-risk findings for metachronous CRC following polypectomy are as follows: adenoma ≥10 mm in size; 3 to 5 (or more) adenomas; tubulovillous or villous adenoma; adenoma containing high-grade dysplasia; traditional serrated adenoma; sessile serrated lesion containing any grade of dysplasia; serrated polyp of at least 10 mm in size; and 3 to 5 (or more) sessile serrated lesions. More studies are needed to fully comprehend the patients who are most likely to benefit from surveillance colonoscopy and the ideal surveillance interval to prevent metachronous CRC.

Citations

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The histologic features, molecular features, detection and management of serrated polyps: a review
Jin-Dong Wang, Guo-Shuai Xu, Xin-Long Hu, Wen-Qiang Li, Nan Yao, Fu-Zhou Han, Yin Zhang, Jun Qu
Frontiers in Oncology.2024;[Epub] CrossRef
Screening and surveillance for hereditary colorectal cancer
Hee Man Kim, Tae Il Kim
Intestinal Research.2024; 22(2): 119. CrossRef
Prediction of Lymph Node Metastasis in T1 Colorectal Cancer Using Artificial Intelligence with Hematoxylin and Eosin-Stained Whole-Slide-Images of Endoscopic and Surgical Resection Specimens
Joo Hye Song, Eun Ran Kim, Yiyu Hong, Insuk Sohn, Soomin Ahn, Seok-Hyung Kim, Kee-Taek Jang
Cancers.2024; 16(10): 1900. CrossRef
Strategies to improve screening colonoscopy quality for the prevention of colorectal cancer
Joo Hye Song, Eun Ran Kim
The Korean Journal of Internal Medicine.2024; 39(4): 547. CrossRef
Korean Guidelines for Postpolypectomy Colonoscopic Surveillance: 2022 Revision
Su Young Kim
The Korean Journal of Medicine.2023; 98(3): 102. CrossRef
Clinical characteristics and risk factors related to polyposis recurrence and advanced neoplasm development among patients with non-hereditary colorectal polyposis
Jihun Jang, Jihye Park, Soo Jung Park, Jae Jun Park, Jae Hee Cheon, Tae Il Kim
Intestinal Research.2023; 21(4): 510. CrossRef
Summary and comparison of recently updated post-polypectomy surveillance guidelines
Yoon Suk Jung
Intestinal Research.2023; 21(4): 443. CrossRef
Strategy for post-polypectomy colonoscopy surveillance: focus on the revised Korean guidelines
Yong Soo Kwon, Su Young Kim
Journal of the Korean Medical Association.2023; 66(11): 652. CrossRef

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Original Articles

IBD

Real-world data for golimumab treatment in patients with ulcerative colitis in Japan: interim analysis in post-marketing surveillance: Shiro Nakamura, Teita Asano, Hiroaki Tsuchiya, Kanami Sugimoto, Yuya Imai, Seiji Yokoyama, Yasuo Suzuki; Intest Res 2022;20(3):329-341. Published online August 4, 2021; DOI: https://doi.org/10.5217/ir.2021.00032

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Golimumab (GLM) is an anti-tumor necrosis factor-α drug approved for treating moderate-to-severe active ulcerative colitis (UC). A 52-week post-marketing surveillance (PMS) was initiated to evaluate its safety and effectiveness in patients with UC in Japan. We present an interim report of the ongoing PMS.
Methods
Patients received 200 mg of subcutaneous GLM at week 0, 100 mg at week 2, and 100 mg 4 weekly thereafter. The safety analysis set included 392 patients with UC, and the effectiveness analysis set 387 patients. Safety and effectiveness were assessed at week 6.
Results
Adverse drug reactions (ADRs) were reported in 8.2% (32/392) and serious ADRs in 4.6% (18/392). The most frequent ADRs were infection and infestation (3.3%), with herpes zoster being the most common. ADRs were significantly higher in patients with concomitant corticosteroid use (odds ratio [OR], 3.45; 95% confidence interval [CI], 1.40–9.68). No significant difference in ADR incidence was observed between patients aged ≥65 and <65 years (OR, 1.23; 95% CI, 0.35–3.47). Six-week effectiveness of GLM was confirmed by a decrease in the partial Mayo score (–2.3; 95% CI, –2.6 to –2.1) and C-reactive protein levels (–0.64; 95% CI, –0.92 to –0.36), including in the biologics-experienced population.
Conclusions
The safety and effectiveness of GLM at week 6 in a real-world setting were demonstrated in patients with UC in Japan. ADR patterns were consistent with previous reports with no new safety signals. Concomitant corticosteroid use may be associated with increased ADR incidence. The final results of the ongoing PMS are necessary for further evaluation.

Citations

Citations to this article as recorded by

Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review
Peter M. Irving, Peter Hur, Raju Gautam, Xiang Guo, Severine Vermeire
Journal of Managed Care & Specialty Pharmacy.2024; 30(9): 1026. CrossRef
Reviewing not Homer’s Iliad, but “Kai Bao Ben Cao”: indigo dye—the past, present, and future
Yusuke Yoshimatsu, Tomohisa Sujino, Takanori Kanai
Intestinal Research.2023; 21(2): 174. CrossRef
Golimumab for Ulcerative Colitis: One More Option to SAVE the Colon
Sang Hyoung Park
Crohn's & Colitis 360.2023;[Epub] CrossRef
Advancements in the Management of Moderate-to-Severe Ulcerative Colitis: A Revised 2023 Korean Treatment Guidelines
Soo-Young Na
The Korean Journal of Medicine.2023; 98(5): 223. CrossRef
Pharmacogenetics-based personalized treatment in patients with inflammatory bowel disease: A review
Ji Young Chang, Jae Hee Cheon
Precision and Future Medicine.2021; 5(4): 151. CrossRef

5,010 View
659 Download
3 Web of Science
5 Crossref

Inflammatory Bowel Diseases

Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn’s disease: 3-year results from a real-world study: Tadakazu Hisamatsu, Yasuo Suzuki, Mariko Kobayashi, Takashi Hagiwara, Takeshi Kawaberi, Haruhiko Ogata, Toshiyuki Matsui, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2021;19(4):408-418. Published online November 20, 2020; DOI: https://doi.org/10.5217/ir.2020.00025

Abstract PDF PubReader ePub

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 remission, 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. Malignancy 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.

Citations

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Effect of Perianal Fistula on the Quality of Life and Work Productivity of Patients with Crohn's Disease: Report of a Questionnaire Survey
Naoto Saigusa, Takeshi Inaba
Nippon Daicho Komonbyo Gakkai Zasshi.2024; 77(2): 89. CrossRef
Real-world effectiveness and safety of adalimumab in Korean patients with intestinal Behcet’s disease: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter study
Seung Bum Lee, Hee Seung Hong, Chang Kyun Lee, Bo-In Lee, Sol Kim, Seong-Joon Koh, Hosun Yu, Jung-Bin Park, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Sang Hyoung Park
The Korean Journal of Internal Medicine.2023; 38(5): 661. CrossRef
Clinical features of enteric and colo-duodenal fistula in patients with Crohn’s disease
Jun Su Lee, Sang-Bum Kang, Kwangbeom Park, Yong Sik Yoon, Chang Sik Yu, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Jong Lyul Lee, Sang Hyoung Park
Intestinal Research.2023; 21(3): 406. CrossRef
TNF-Alpha Inhibitors and Ustekinumab for the Treatment of Psoriasis: Therapeutic Utility in the Era of IL-17 and IL-23 Inhibitors
Julie J. Hong, Edward K. Hadeler, Megan L. Mosca, Nicholas D. Brownstone, Tina Bhutani, Wilson J. Liao
Journal of Psoriasis and Psoriatic Arthritis.2022; 7(2): 79. CrossRef
Infliximab versus Adalimumab: Can We Choose the Right One for the Right Patients with Ulcerative Colitis?
Sang Hyoung Park, Byong Duk Ye, Suk-Kyun Yang
Gut and Liver.2022; 16(1): 138. CrossRef
Biological Therapies for the Management of Enteric Disease: Considerations for the Clinician
Adam Saleh, Usman Ansari, Shaadi Abughazaleh, Kerri Glassner, Bincy P Abraham
Biologics: Targets and Therapy.2022; Volume 16: 67. CrossRef
Prevention of postoperative recurrence in Crohn’s disease: the never-ending story
Jung-Bin Park, Sang Hyoung Park
Intestinal Research.2022; 20(3): 279. CrossRef
Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α
Jihye Park, Jae Hee Cheon
The Korean Journal of Internal Medicine.2022; 37(5): 895. CrossRef
Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef
Adalimumab for induction of remission in patients with Crohn's disease: a systematic review and meta-analysis
Juntao Yin, Yang Li, Yangyang Chen, Chaoyang Wang, Xiaoyong Song
European Journal of Medical Research.2022;[Epub] CrossRef
Natural history of inflammatory bowel disease: a comparison between the East and the West
Eun Mi Song, Suk-Kyun Yang
Intestinal Research.2022; 20(4): 418. CrossRef
Can Anti-Tumor Necrosis Factor Agents Be Discontinued in Patients with Inflammatory Bowel Disease?
Jihye Park, Jae Hee Cheon
Gut and Liver.2021; 15(5): 641. CrossRef
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Ji Young Chang, Jae Hee Cheon
Precision and Future Medicine.2021; 5(4): 151. CrossRef

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Colorectal neoplasia

Postgastrectomy gastric cancer patients are at high risk for colorectal neoplasia: a case control study: Tae-Geun Gweon, Kyu-Tae Yoon, Chang Hyun Kim, Jin-Jo Kim; Intest Res 2021;19(2):239-246. Published online November 13, 2020; DOI: https://doi.org/10.5217/ir.2020.00009

Abstract PDF PubReader ePub

Background/Aims
Several studies have shown that colorectal neoplasms (CRN) including colorectal cancer (CRC) may be prevalent in patients with gastric cancer. However, in most of these studies, colonoscopy to investigate the prevalence of CRN was performed prior to surgery. We aimed to investigate whether CRN was more prevalent in postgastrectomy gastric cancer patients than in healthy individuals.
Methods
We reviewed the medical records of those patients within a cohort of gastric cancer patients with gastrectomy who underwent colonoscopy between 2016 and 2017. Controls age- and sex-matched with gastric cancer patients at a 2:1 ratio were identified among those who underwent colonoscopy at a health-promotion center. The frequencies of CRN, advanced CRN (ACRN), and CRC among patients with gastrectomy were compared with those in the control subjects. A total of 744 individuals (gastric cancer, 248; control, 496) were included.
Results
The rates of CRN and ACRN in the gastric cancer group were higher than those in the healthy individuals (CRN, 47.6% vs. 34.7%, P< 0.001; ACRN, 16.9% vs. 10.9%, P= 0.020). The rate of CRC was comparable between the 2 groups (2.0% vs. 0.6%, P= 0.125). Multivariate analysis identified previous gastrectomy for gastric cancer and male sex as significant risk factors for (A)CRN.
Conclusions
CRN and ACRN were more prevalent in patients who underwent surgery for gastric cancer than in the control group. Regular surveillance colonoscopy at appropriate intervals is indicated after gastrectomy.

Citations

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Hye Min Kim, Hyo Suk Kim, Young Eun An, Jae Hyuck Chang, Tae Ho Kim, Chang Whan Kim, Tae‐Geun Gweon
Digestive Endoscopy.2024;[Epub] CrossRef
Calcium, Vitamin D, and Colorectal Cancer
Young-Jo Wi, Soo-Young Na
The Korean Journal of Gastroenterology.2023; 82(2): 47. CrossRef
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Sung Hoon Jung, Chul-Hyun Lim, Tae-Geun Gweon, Jinsu Kim, Jung Hwan Oh, Kyu-Tae Yoon, Jee Young An, Jeong‑Seon Ji, Hwang Choi
Digestive Diseases and Sciences.2022; 67(10): 4841. CrossRef
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Jae Hyun Kim, Youn Jung Choi, Hye Jung Kwon, Gyu Man Oh, Kyoungwon Jung, Sung Eun Kim, Won Moon, Moo In Park, Seun Ja Park
Digestive Diseases and Sciences.2022; 67(9): 4533. CrossRef
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Seong-Jung Kim, Jun Lee, Dae Youb Baek, Jun Hyung Lee, Ran Hong
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American Journal of Gastroenterology.2022; 117(11): 1877. CrossRef

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Inflammatory Bowel Diseases

Safety and effectiveness of adalimumab in the treatment of ulcerative colitis: results from a large-scale, prospective, multicenter, observational study: Haruhiko Ogata, Takashi Hagiwara, Takeshi Kawaberi, Mariko Kobayashi, Toshifumi Hibi; Intest Res 2021;19(4):419-429. Published online November 10, 2020; DOI: https://doi.org/10.5217/ir.2020.00033

Abstract PDF PubReader ePub

Background/Aims
Adalimumab has been shown to induce and maintain clinical remission in patients with moderate to severe ulcerative colitis (UC). However, no large-scale population-based studies have been performed in Japan. This study was conducted to evaluate the safety and effectiveness of adalimumab in clinical practice in Japanese patients with UC.
Methods
In this 52-week, prospective, multicenter, single-cohort, noninterventional, observational, postmarketing surveillance study, patients with moderate to severe UC received an initial subcutaneous injection of adalimumab 160 mg, followed by 80 mg at 2 weeks, and then 40 mg every other week. Safety assessments were the incidence of adverse drug reactions (ADRs) and serious ADRs. Effectiveness assessments were clinical remission, corticosteroid-free remission, mucosal healing, and change in C-reactive protein (CRP) levels from baseline.
Results
Of 1,593 registered patients, 1,523 (male, 57.6%; mean age, 41.8 years) and 1,241 patients were included in the safety and effectiveness populations, respectively. ADRs were reported in 18.1% and serious ADRs in 4.9% of patients. Clinical remission was achieved in 49.7% of patients at week 4, increasing to 74.4% at week 52. Corticosteroid-free remission rates increased over time, from 10.4% at week 4 to 53.1% at week 52. More than 60% of patients demonstrated mucosal healing at weeks 24 and 52. Mean CRP levels (mg/dL) decreased from 1.2 at baseline to 0.6 at week 4 and 0.3 at week 52.
Conclusions
This large real-world study confirmed the safety and effectiveness of adalimumab in patients with UC in Japan. No new safety concerns were identified.

Citations

Citations to this article as recorded by

Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review
Peter M. Irving, Peter Hur, Raju Gautam, Xiang Guo, Severine Vermeire
Journal of Managed Care & Specialty Pharmacy.2024; 30(9): 1026. CrossRef
Real‐world experience of adalimumab therapy for patients with ulcerative colitis: A single tertiary medical center experience in Central Taiwan
Hsu‐Heng Yen, Yu‐Chun Hsu, Chu‐Hsuan Kuo, Tsui‐Chun Hsu, Yang‐Yuan Chen
Advances in Digestive Medicine.2023; 10(1): 28. CrossRef
Reviewing not Homer’s Iliad, but “Kai Bao Ben Cao”: indigo dye—the past, present, and future
Yusuke Yoshimatsu, Tomohisa Sujino, Takanori Kanai
Intestinal Research.2023; 21(2): 174. CrossRef
Safety of Adalimumab: An Analysis of the FDA Adverse Event Reporting System (FAERS) Database
Buthainah Ghanem
Jordan Journal of Pharmaceutical Sciences.2023; 16(3): 517. CrossRef
Infliximab versus Adalimumab: Can We Choose the Right One for the Right Patients with Ulcerative Colitis?
Sang Hyoung Park, Byong Duk Ye, Suk-Kyun Yang
Gut and Liver.2022; 16(1): 138. CrossRef
Adalimumab Efficacy for Management of Inflammatory Bowel Disease in Southwest Region of Iran
Pezhman Alavinejad, Sana Delavari, Abazar Parsi, Ali Akbar Shayesteh
Modern Care Journal.2022;[Epub] CrossRef
Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study
Seung Yong Shin, Soo Jung Park, Young Kim, Jong Pil Im, Hyo Jong Kim, Kang-Moon Lee, Ji Won Kim, Sung-Ae Jung, Jun Lee, Sang-Bum Kang, Sung Jae Shin, Eun Sun Kim, You Sun Kim, Tae Oh Kim, Hyun-Soo Kim, Dong Il Park, Hyung Kil Kim, Eun Soo Kim, Young-Ho Ki
Intestinal Research.2022; 20(3): 350. CrossRef
Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α
Jihye Park, Jae Hee Cheon
The Korean Journal of Internal Medicine.2022; 37(5): 895. CrossRef
Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef
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Suhyun Park, Sang Hyoung Park
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Latent and Active Tuberculosis Infection in Patients with Inflammatory Bowel Disease
Byung Chul Jin, Hee Jin Moon, Sang Wook Kim
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Jongwook Yu, Soo Jung Park, Hyung Wook Kim, Yun Jeong Lim, Jihye Park, Jae Myung Cha, Byong Duk Ye, Tae Oh Kim, Hyun-Soo Kim, Hyun Seok Lee, Su Young Jung, Youngdoe Kim, Chang Hwan Choi
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Katarzyna Komosinska-Vassev, Aleksandra Kałużna, Agnieszka Jura-Półtorak, Alicja Derkacz, Krystyna Olczyk
Journal of Clinical Medicine.2022; 11(19): 5618. CrossRef
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Inflammatory bowel diseases

Infliximab biosimilar CT-P13 is interchangeable with its originator for patients with inflammatory bowel disease in real world practice: Tomoo Nakagawa, Taku Kobayashi, Kiyohiro Nishikawa, Fumika Yamada, Satoshi Asai, Yukinori Sameshima, Yasuo Suzuki, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2019;17(4):504-515. Published online August 23, 2019; DOI: https://doi.org/10.5217/ir.2019.00030

Abstract PDF PubReader ePub

Background/Aims
An interim analysis of post-marketing surveillance of CT-P13, an infliximab biosimilar, was performed to evaluate its safety and efficacy in Japanese patients with inflammatory bowel disease.
Methods
Patients were prospectively enrolled between November 2014 and March 2017, after the launch of CT-P13 in Japan, and case report forms of patients followed for at least 4 months were analyzed as of July 2018.
Results
Of 523 patients in the analysis set, 372 remained on CT-P13 therapy, while 54 (20.2%) of 267 patients with Crohn’s disease, and 97 (37.9%) of 256 patients with ulcerative colitis were withdrawn during follow-up. A total of 144 adverse drug reactions (ADRs) were reported in 106 patients (20.3%). Infusion reaction was the most frequent ADR observed in 49 patients (9.4%). Efficacy parameters decreased immediately after the start of treatment in naïve patients to anti-tumor necrosis factor-α antibody. In the patients switched from originator infliximab for nonmedical reasons, the decreased parameters due to proceeded treatment with the originator were maintained in low ranges, and the treatment continuation rate was high with low ADR incidence. In contrast, in patients switched for medical reasons such as adverse event or loss of response, the incidence of ADRs was high. However, the efficacy parameters were improved, and the treatment continuation rate was not significantly different from that of the naïve patient group.
Conclusions
In this interim analysis, CT-P13 was comparable to the originator infliximab with respect to ADRs and efficacy, and is therefore considered to be a cost-efficient interchangeable biosimilar for Japanese patients with inflammatory bowel disease.

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Arab Journal of Gastroenterology.2024; 25(3): 257. CrossRef
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Gary R. Lichtenstein, Arif Soonasra, Mark Latymer, Sheena Singh, Brian G. Feagan
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Clinical experience of using biosimilars in Crohn’s disease and their effectiveness
Léa Sequier, Bénédicte Caron, Silvio Danese, Laurent Peyrin-Biroulet
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Journal of Clinical Gastroenterology.2023; 57(6): 601. CrossRef
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Tomoe Kazama, Katsuyoshi Ando, Nobuhiro Ueno, Mikihiro Fujiya, Takahiro Ito, Atsuo Maemoto, Keisuke Ishigami, Masanori Nojima, Hiroshi Nakase, Shintaro Sagami
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Tsutomu Takeuchi, Kiyohiro Nishikawa, Fumika Yamada, Akimichi Morita, Mamitaro Ohtsuki, Yasuo Suzuki, Mamoru Watanabe, Hisashi Yamanaka, Toshifumi Hibi
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Safety, efficacy, and drug survival of the infliximab biosimilar CT‐P13 in post‐marketing surveillance of Japanese patients with psoriasis
Akimichi Morita, Kiyohiro Nishikawa, Fumika Yamada, Keiichi Yamanaka, Hideki Nakajima, Mamitaro Ohtsuki
The Journal of Dermatology.2022; 49(10): 957. CrossRef
Post‐marketing analysis for biosimilar CT‐P13 in inflammatory bowel disease compared with external data of originator infliximab in Japan
Shintaro Sagami, Kiyohiro Nishikawa, Fumika Yamada, Yasuo Suzuki, Mamoru Watanabe, Toshifumi Hibi
Journal of Gastroenterology and Hepatology.2021; 36(8): 2091. CrossRef
Current utilization patterns for long-acting insulin analogues including biosimilars among selected Asian countries and the implications for the future
Brian Godman, Mainul Haque, Santosh Kumar, Salequl Islam, Jaykaran Charan, Farhana Akter, Amanj Kurdi, Eleonora Allocati, Muhammed Abu Bakar, Sagir Abdur Rahim, Nusrat Sultana, Farzana Deeba, M. A. Halim Khan, A. B. M Muksudul Alam, Iffat Jahan, Zubair Ma
Current Medical Research and Opinion.2021; 37(9): 1529. CrossRef
Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness
Jae Hee Cheon, Seongsu Nah, Hyoun Woo Kang, Yun Jeong Lim, Sang-Hoon Lee, Sang Joon Lee, Sung Hyun Kim, Na Hyun Jung, Jeong Eun Park, Yeo Jin Lee, Da Bee Jeon, Yeon Mi Lee, Jong Min Kim, Sung-Hwan Park
Advances in Therapy.2021; 38(8): 4366. CrossRef
The Great Debate With IBD Biosimilars
Jimmy K Limdi, Francis A Farraye
Crohn's & Colitis 360.2021;[Epub] CrossRef
Treatment of inflammatory bowel diseases: focusing on biologic agents and new therapies
Hyo Yeop Song, Geom Seog Seo
Journal of the Korean Medical Association.2021; 64(9): 605. CrossRef
Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study
Stephanie L. Ho, Fang Niu, Suresh Pola, Fernando S. Velayos, Xian Ning, Rita L. Hui
BioDrugs.2020; 34(3): 395. CrossRef
Post-Marketing Pooled Safety Analysis for CT-P13 Treatment of Patients with Immune-Mediated Inflammatory Diseases in Observational Cohort Studies
Sang Joon Lee, KyungMin Baek, Sujin Lee, Yoon Jee Lee, Jeong Eun Park, Seul Gi Lee
BioDrugs.2020; 34(4): 513. CrossRef
Hepatotoxicty of Agents Used in the Management of Inflammatory Bowel Disease: a 2020 Update
Michele S. Barnhill, Joshua M. Steinberg, Joseph J. Jennings, James H. Lewis
Current Gastroenterology Reports.2020;[Epub] CrossRef

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Endoscopy

Three-year colonoscopy surveillance after polypectomy in Korea: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter prospective study: Won Seok Choi, Dong Soo Han, Chang Soo Eun, Dong Il Park, Jeong-Sik Byeon, Dong-Hoon Yang, Sung-Ae Jung, Sang Kil Lee, Sung Pil Hong, Cheol Hee Park, Suck-Ho Lee, Jeong-Seon Ji, Sung Jae Shin, Bora Keum, Hyun Soo Kim, Jung Hye Choi, Sin-Ho Jung; Intest Res 2018;16(1):126-133. Published online January 18, 2018; DOI: https://doi.org/10.5217/ir.2018.16.1.126

Abstract PDF PubReader ePub

Background/Aims

Colonoscopic surveillance is currently recommended after polypectomy owing to the risk of newly developed colonic neoplasia. However, few studies have investigated colonoscopy surveillance in Asia. This multicenter and prospective study was undertaken to assess the incidence of advanced adenoma based on baseline adenoma findings at 3 years after colonoscopic polypectomy.

Methods

A total of 1,323 patients undergoing colonoscopic polypectomy were prospectively assigned to 3-year colonoscopy surveillance at 11 tertiary endoscopic centers. Relative risks for advanced adenoma after 3 years were calculated according to baseline adenoma characteristics.

Results

Among 1,323 patients enrolled, 387 patients (29.3%) were followed up, and the mean follow-up interval was 31.0±9.8 months. The percentage of patients with advanced adenoma on baseline colonoscopy was higher in the surveillance group compared to the non-surveillance group (34.4% vs. 25.7%). Advanced adenoma recurrence was observed in 17 patients (4.4%) at follow-up. The risk of advanced adenoma recurrence was 2 times greater in patients with baseline advanced adenoma than in those with baseline non-advanced adenoma, though the difference was not statistically significant (6.8% [9/133] vs. 3.1% [8/254], P=0.09). Advanced adenoma recurrence was observed only in males and in subjects aged ≥50 years. In contrast, adenoma recurrence was observed in 187 patients (48.3%) at follow-up. Male sex, older age (≥50 years), and multiple adenomas (≥3) at baseline were independent risk factors for adenoma recurrence.

Conclusions

A colonoscopy surveillance interval of 3 years in patients with baseline advanced adenoma can be considered appropriate.

Citations

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When should patients take simethicone orally before colonoscopy for avoiding bubbles: A single-blind, randomized controlled study
Woohyuk Jung, Gyu Man Oh, Jae Hyun Kim, Youn Jung Choi, Min Young Son, Kyoungwon Jung, Sung Eun Kim, Won Moon, Moo In Park, Seun Ja Park
Medicine.2023; 102(19): e33728. CrossRef
Comparison of the efficacy and safety between oral sulfate tablet and polyethylene glycol for bowel preparation before colonoscopy according to age
Jae Hyun Kim, Yong Eun Park, Tae Oh Kim, Jongha Park, Gyu Man Oh, Won Moon, Seun Ja Park
Medicine.2022; 101(27): e29884. CrossRef
Optimization of the surveillance strategy in patients with colorectal adenomas: A combination of clinical parameters and index colonoscopy findings
Chan Hyuk Park, Yoon Suk Jung, Nam Hee Kim, Jung Ho Park, Dong Il Park, Chong Il Sohn
Journal of Gastroenterology and Hepatology.2021; 36(4): 974. CrossRef
Postgastrectomy gastric cancer patients are at high risk for colorectal neoplasia: a case control study
Tae-Geun Gweon, Kyu-Tae Yoon, Chang Hyun Kim, Jin-Jo Kim
Intestinal Research.2021; 19(2): 239. CrossRef
Risk of developing metachronous advanced colorectal neoplasia after resection of low-risk diminutive versus small adenomas
Nam Hee Kim, Yoon Suk Jung, Jung Ho Park, Dong Il Park, Chong Il Sohn
Gastrointestinal Endoscopy.2020; 91(3): 622. CrossRef
Optimal Colonoscopic Surveillance Interval After Normal Baseline Screening Colonoscopy
Jian Dong, Minman Wu, Jiarong Miao, Rana Sami Ullah Khan, Tao Zhi, Tianmei Zhang, Xue Li, Yashi Peng, Gang Yang, Qiong Nan
Gastroenterology Nursing.2020; 43(3): 225. CrossRef
Comparative systematic review and meta-analysis of 1- to 5-mm versus 6- to 9-mm adenomas on the risk of metachronous advanced colorectal neoplasia
Yoon Suk Jung, Tae Jun Kim, Eunwoo Nam, Chan Hyuk Park
Gastrointestinal Endoscopy.2020; 92(3): 692. CrossRef
Appropriate Surveillance Interval after Colonoscopic Polypectomy in Patients Younger than 50 Years
Yoon Suk Jung, Nam Hee Kim, Jung Ho Park, Dong Il Park, Chong Il Sohn
Journal of Korean Medical Science.2019;[Epub] CrossRef
Impact of obesity and metabolic abnormalities on the risk of metachronous colorectal neoplasia after polypectomy in men
Nam Hee Kim, Yoon Suk Jung, Jung Ho Park, Dong Il Park, Chong Il Sohn
Journal of Gastroenterology and Hepatology.2019; 34(9): 1504. CrossRef
What Is Appropriate Upper Endoscopic Interval Among Dyspeptic Patients With Previously Normal Endoscopy? A Multicenter Study With Bayesian Change Point Analysis
Jong Wook Kim, Kee Wook Jung, Joong Goo Kwon, Jung Bok Lee, Jong Kyu Park, Ki Bae Bang, Chung Hyun Tae, Jung Hwan Oh
Journal of Neurogastroenterology and Motility.2019; 25(4): 544. CrossRef
Risk of Developing Metachronous Advanced Colorectal Neoplasia After Polypectomy in Patients With Multiple Diminutive or Small Adenomas
Nam Hee Kim, Yoon Suk Jung, Mi Yeon Lee, Jung Ho Park, Dong Il Park, Chong Il Sohn
American Journal of Gastroenterology.2019; 114(10): 1657. CrossRef

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Determining the optimal surveillance interval after a colonoscopic polypectomy for the Korean population?: Jung Lok Lee, Jae Myung Cha, Hye Min Lee, Jung Won Jeon, Min Seob Kwak, Jin Young Yoon, Hyun Phil Shin, Kwang Ro Joo, Joung Il Lee, Dong Il Park; Intest Res 2017;15(1):109-117. Published online January 31, 2017; DOI: https://doi.org/10.5217/ir.2017.15.1.109

Abstract PDF PubReader ePub

Background/Aims

Western surveillance strategies cannot be directly adapted to the Korean population. The aim of this study was to estimate the risk of metachronous neoplasia and the optimal surveillance interval in the Korean population.

Methods

Clinical and pathological data from index colonoscopy performed between June 2006 and July 2008 and who had surveillance colonoscopies up to May 2015 were compared between low- and high-risk adenoma (LRA and HRA) groups. The 3- and 5-year cumulative risk of metachronous colorectal neoplasia in both groups were compared.

Results

Among 895 eligible patients, surveillance colonoscopy was performed in 399 (44.6%). Most (83.3%) patients with LRA had a surveillance colonoscopy within 5 years and 70.2% of patients with HRA had a surveillance colonoscopy within 3 years. The cumulative risk of metachronous advanced adenoma was 3.2% within 5 years in the LRA group and only 1.7% within 3 years in the HRA group. The risk of metachronous neoplasia was similar between the surveillance interval of <5 and ≥5 years in the LRA group; however, it was slightly higher at surveillance interval of ≥3 than <3 years in the HRA group (9.4% vs. 2.4%). In multivariate analysis, age and the ≥3-year surveillance interval were significant independent risk factors for metachronous advanced adenoma (P=0.024 and P=0.030, respectively).

Conclusions

Patients had a surveillance colonoscopy before the recommended guidelines despite a low risk of metachronous neoplasia. However, the risk of metachronous advanced adenoma was increased in elderly patients and those with a ≥3-year surveillance interval.

Citations

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Risk of developing metachronous colorectal neoplasia after the resection of proximal versus distal adenomas
Yoon Suk Jung, Nam Hee Kim, Youngwoo Kim, Dong Il Park
Digestive and Liver Disease.2022; 54(4): 537. CrossRef
Post-polypectomy surveillance interval and advanced neoplasia detection rates: a multicenter, retrospective cohort study
Amanda J. Cross, Emma C. Robbins, Kevin Pack, Iain Stenson, Matthew D. Rutter, Andrew M. Veitch, Brian P. Saunders, Stephen W. Duffy, Kate Wooldrage
Endoscopy.2022; 54(10): 948. CrossRef
Comparison of Risk of Metachronous Advanced Colorectal Neoplasia in Patients with Sporadic Adenomas Aged < 50 Versus ≥ 50 years: A Systematic Review and Meta-Analysis
Yoon Suk Jung, Jung Ho Park, Chan Hyuk Park
Journal of Personalized Medicine.2021; 11(2): 120. CrossRef
British Society of Gastroenterology/Association of Coloproctology of Great Britain and Ireland/Public Health England post-polypectomy and post-colorectal cancer resection surveillance guidelines
Matthew D Rutter, James East, Colin J Rees, Neil Cripps, James Docherty, Sunil Dolwani, Philip V Kaye, Kevin J Monahan, Marco R Novelli, Andrew Plumb, Brian P Saunders, Siwan Thomas-Gibson, Damian J M Tolan, Sophie Whyte, Stewart Bonnington, Alison Scope,
Gut.2020; 69(2): 201. CrossRef
Urine-NMR metabolomics for screening of advanced colorectal adenoma and early stage colorectal cancer
Eun Ran Kim, Hyuk Nam Kwon, Hoonsik Nam, Jae J. Kim, Sunghyouk Park, Young-Ho Kim
Scientific Reports.2019;[Epub] CrossRef
A Comparison of the Cumulative Incidences of Metachronous Colorectal Adenoma and Cancer According to the Initial FindingsAmong Colonoscopically Followed-up Patients
Seiji Kimura, Masanori Tanaka, Shinsaku Fukuda
Nippon Daicho Komonbyo Gakkai Zasshi.2019; 72(6): 395. CrossRef
Impact of obesity and metabolic abnormalities on the risk of metachronous colorectal neoplasia after polypectomy in men
Nam Hee Kim, Yoon Suk Jung, Jung Ho Park, Dong Il Park, Chong Il Sohn
Journal of Gastroenterology and Hepatology.2019; 34(9): 1504. CrossRef
Risk of developing metachronous advanced colorectal neoplasia after colonoscopic polypectomy in patients aged 30 to 39 and 40 to 49 years
Nam Hee Kim, Yoon Suk Jung, Jung Ho Park, Dong Il Park, Chong Il Sohn
Gastrointestinal Endoscopy.2018; 88(4): 715. CrossRef
Quality is the Key for Emerging Issues of Population-Based Colonoscopy Screening
Jin Young Yoon, Jae Myung Cha, Yoon Tae Jeen
Clinical Endoscopy.2018; 51(1): 50. CrossRef
Histologic discrepancy between endoscopic forceps biopsy and endoscopic mucosal resection specimens of colorectal polyp in actual clinical practice
Moon Joo Hwang, Kyeong Ok Kim, A Lim Kim, Si Hyung Lee, Byung Ik Jang, Tae Nyeun Kim
Intestinal Research.2018; 16(3): 475. CrossRef
Quality is the key for emerging issues of population-based colonoscopy screening
Jin Young Yoon, Jae Myung Cha, Yoon Tae Jeen
Intestinal Research.2018; 16(1): 48. CrossRef

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Role of random biopsies in surveillance of dysplasia in ulcerative colitis patients with high risk of colorectal cancer: Sawan Bopanna, Maitreyee Roy, Prasenjit Das, S Dattagupta, V Sreenivas, V Pratap Mouli, Saurabh Kedia, Rajan Dhingra, Rajesh Pradhan, N Suraj Kumar, Dawesh P Yadav, Govind Makharia, Vineet Ahuja; Intest Res 2016;14(3):264-269. Published online June 27, 2016; DOI: https://doi.org/10.5217/ir.2016.14.3.264

Abstract PDF PubReader ePub

Background/Aims

Recent data suggest that the incidence of ulcerative colitis (UC) related colorectal cancer (CRC) in India is similar to that of West. The optimum method for surveillance is still a debate. Surveillance with random biopsies has been the standard of care, but is a tedious process. We therefore undertook this study to assess the yield of random biopsy in dysplasia surveillance.

Methods

Between March 2014 and July 2015, patients of UC attending the Inflammatory Bowel Disease clinic at the All India Institute of Medical Sciences with high risk factors for CRC like duration of disease >15 years and pancolitis, family history of CRC, primary sclerosing cholangitis underwent surveillance colonoscopy for dysplasia. Four quadrant random biopsies at 10 cm intervals were taken (33 biopsies). Two pathologists examined specimens for dysplasia, and the yield of dysplasia was calculated.

Results

Twenty-eight patients were included. Twenty-six of these had pancolitis with a duration of disease greater than 15 years, and two patients had associated primary sclerosing cholangis. No patient had a family history of CRC. The mean age at onset of disease was 28.89±8.73 years and the duration of disease was 19.00±8.78 years. Eighteen patients (64.28%) were males. A total of 924 biopsies were taken. None of the biopsies revealed any evidence of dysplasia, and 7/924 (0.7%) were indefinite for dysplasia.

Conclusions

Random biopsy for surveillance in longstanding extensive colitis has a low yield for dysplasia and does not suffice for screening. Newer techniques such as chromoendoscopy-guided biopsies need greater adoption.

Citations

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JGH Open.2024;[Epub] CrossRef
Low prevalence of primary sclerosing cholangitis in patients with inflammatory bowel disease in India
Arshdeep Singh, Vandana Midha, Vikram Narang, Saurabh Kedia, Ramit Mahajan, Pavan Dhoble, Bhavjeet Kaur Kahlon, Ashvin Singh Dhaliwal, Ashish Tripathi, Shivam Kalra, Narender Pal Jain, Namita Bansal, Rupa Banerjee, Devendra Desai, Usha Dutta, Vineet Ahuja
Intestinal Research.2023; 21(4): 452. CrossRef
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Roberto Gabbiadini, Ferdinando D’Amico, Alessandro De Marco, Maria Terrin, Alessandra Zilli, Federica Furfaro, Mariangela Allocca, Gionata Fiorino, Silvio Danese
Journal of Clinical Medicine.2022; 11(3): 509. CrossRef
Endoscopic Surveillance in Inflammatory Bowel Diseases: Selecting a Suitable Technology
Arianna Dal Buono, Roberto Gabbiadini, Federica Furfaro, Marjorie Argollo, Thaís Viana Tavares Trigo, Alessandro Repici, Giulia Roda
Frontiers in Medicine.2022;[Epub] CrossRef
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Federica Gaiani, Federica Marchesi, Francesca Negri, Luana Greco, Alberto Malesci, Gian Luigi de’Angelis, Luigi Laghi
International Journal of Molecular Sciences.2021; 22(10): 5246. CrossRef
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Manjiri N Karandikar, Purva Kulkarni, Smita Mulay, R C Nimbergi, N S Mani
Indian Journal of Pathology and Oncology.2021; 8(3): 340. CrossRef
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Oleg V. Knyazev, Anna V. Kagramanova, Sergei G. Khomeriki, Asfold I. Parfenov
Terapevticheskii arkhiv.2021; 93(8): 975. CrossRef
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Hadis Najafimehr, Hamid Asadzadeh Aghdaei, Mohamad Amin Pourhoseingholi, Hamid Mohaghegh Shalmani, Amir Vahedian-Azimi, Matthew Kroh, Mohammad Reza Zali, Amirhossein Sahebkar, Muhammad Naeem
Gastroenterology Research and Practice.2021; 2021: 1. CrossRef
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Haruhiko Ogata, Takashi Hagiwara, Takeshi Kawaberi, Mariko Kobayashi, Toshifumi Hibi
Intestinal Research.2021; 19(4): 419. CrossRef
Histological remission of ulcerative colitis with combined anti-cytokine and cell therapy
Oleg V. Knyazev, Sergey G. Khomeriki, Аnna V. Kagramanova, Albina A. Lishchinskaya, Olga A. Smirnova, Karina K. Noskova, Asfold I. Parfenov
Terapevticheskii arkhiv.2021; 93(12): 1435. CrossRef
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Andrew D Beggs, Jonathan James, Germaine Caldwell, Toby Prout, Mark P Dilworth, Phillipe Taniere, Tariq Iqbal, Dion G Morton, Glenn Matthews
Inflammatory Bowel Diseases.2018; 24(7): 1503. CrossRef
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Hyo Jun Ahn, Sang-Bum Kang
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Louise C. Connell, José Mauricio Mota, Maria Ignez Braghiroli, Paulo M. Hoff
Current Treatment Options in Oncology.2017;[Epub] CrossRef
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Dong Soo Han
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