Intestinal Research

Original Articles

IBD

Serum albumin is the strongest predictor of anti-tumor necrosis factor nonresponse in inflammatory bowel disease in resource-constrained regions lacking therapeutic drug monitoring: Peeyush Kumar, Sudheer K. Vuyyuru, Prasenjit Das, Bhaskar Kante, Mukesh Kumar Ranjan, David Mathew Thomas, Sandeep Mundhra, Pabitra Sahu, Pratap Mouli Venigalla, Saransh Jain, Sandeep Goyal, Rithvik Golla, Shubi Virmani, Mukesh K. Singh, Karan Sachdeva, Raju Sharma, Nihar Ranjan Dash, Govind Makharia, Saurabh Kedia, Vineet Ahuja; Intest Res 2023;21(4):460-470. Published online March 17, 2023; DOI: https://doi.org/10.5217/ir.2022.00128

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Background/Aims
Evidence on predictors of primary nonresponse (PNR), and secondary loss of response (SLR) to anti-tumor necrosis factor (anti-TNF) agents in inflammatory bowel disease is scarce from Asia. We evaluated clinical/biochemical/molecular markers of PNR/SLR in ulcerative colitis (UC) and Crohn’s disease (CD).
Methods
Inflammatory bowel disease patients treated with anti-TNF agents (January 2005–October 2020) were ambispectively included. Data concerning clinical and biochemical predictors was retrieved from a prospectively maintained database. Immunohistochemistry for expression of oncostatin M (OSM), OSM receptor (OSM-R), and interleukin-7 receptor (IL-7R) were done on pre anti-TNF initiation mucosal biopsies.
Results
One-hundred eighty-six patients (118 CD, 68 UC: mean age, 34.1±13.7 years; median disease duration at anti-TNF initiation, 60 months; interquartile range, 28–100.5 months) were included. PNR was seen in 17% and 26.5% and SLR in 47% and 28% CD and UC patients, respectively. In CD, predictors of PNR were low albumin (P<0.001), postoperative recurrence (P=0.001) and high IL-7R expression (P<0.027) on univariate; and low albumin alone (hazard ratio [HR], 0.09; 95% confidence interval [CI], 0.03–0.28; P<0.001) on multivariate analysis respectively. Low albumin (HR, 0.31; 95% CI, 0.15–0.62; P=0.001) also predicted SLR. In UC, predictors of PNR were low albumin (P<0.001), and high C-reactive protein (P<0.001), OSM (P<0.04) and OSM-R (P=0.07) stromal expression on univariate; and low albumin alone (HR, 0.11; 95% CI, 0.03–0.39; P=0.001) on multivariate analysis respectively.
Conclusions
Low serum albumin at baseline significantly predicted PNR in UC and PNR/SLR in CD patients. Mucosal markers of PNR were high stromal OSM/OSM-R in UC and high IL-7R in CD patients.

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Population Pharmacokinetic Model for the Use of Intravenous or Subcutaneous Infliximab in Patients with Inflammatory Bowel Disease: Real-World Data from a Prospective Cohort Study
Joo Hye Song, Sung Noh Hong, Myeong Gyu Kim, Minjung Kim, Seong Kyung Kim, Eun Ran Kim, Dong Kyung Chang, Young-Ho Kim
Gut and Liver.2025; 19(3): 376. CrossRef
The efficacy of infliximab combined with partial enteral nutrition in the treatment of Crohn’s disease: a cohort study
Chen Huang, Chao Chen, Hao Wu, Hanyu Yin, Weixiang Yao, Susu Bai, Baixue Zhuo, Xiaoli Wu
Frontiers in Nutrition.2025;[Epub] CrossRef
Effectiveness of Switching to Subcutaneous Infliximab in Ulcerative Colitis Patients Experiencing Intravenous Infliximab Failure
June Hwa Bae, Jung-Bin Park, Ji Eun Baek, Seung Wook Hong, Sang Hyoung Park, Dong-Hoon Yang, Byong Duk Ye, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Sung Wook Hwang
Gut and Liver.2024; 18(4): 667. CrossRef
Tofacitinib in Steroid-Refractory Acute Severe Ulcerative Colitis: A Retrospective Analysis
Sayan Malakar, Srikanth Kothalkar, Umair Shamsul Hoda, Uday C Ghoshal
Cureus.2023;[Epub] CrossRef

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IBD

Influence of anti-tumor necrosis factor-alpha therapy to pregnant inflammatory bowel disease women and their children’s immunity: Ko Eun Lee, Sung-Ae Jung, Sang Hyoung Park, Chang Mo Moon, So Yeon Shim, Eun Soo Kim, Su Jin Cho, Seong-Eun Kim, Kwang Bum Cho, Suk-Kyun Yang; Intest Res 2019;17(2):237-243. Published online February 8, 2019; DOI: https://doi.org/10.5217/ir.2018.00071

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Background/Aims
The onset of inflammatory bowel disease (IBD) usually occurs at young age, and therefore, women IBD patients experience pregnancy during their disease progression. Recently, the use of anti-tumor necrosis factor-α (anti-TNF-α) has been rapidly increasing. The aim of this study was to evaluate pregnancy related outcomes in women with IBD who were treated with anti-TNF-α during pregnancy and immunity of their children.
Methods
Korean women with IBD who had been treated with anti-TNF-α during pregnancy had been enrolled. Medical records were reviewed and a survey was performed for each patient. For the patients who agreed on additional examination for their children, children’s growth, medical history and antibody to hepatitis B surface antigen (anti-HBs) titer were checked.
Results
All 18 patients had been diagnosed with Crohn’s disease. There was not any case of preterm delivery, low birth-weight infant, congenital anomaly, nor stillbirth. All 12 children had followed the regular vaccination schedule for hepatitis B and 4 of them showed negative results for anti-HBs. After the 1 booster vaccination, all children demonstrated seroconversion. Regarding live vaccines, 4 children had bacillus Calmette-Guerin and 4 had rotavirus vaccine before 6 months, without any specific side effects.
Conclusions
This was the first study of immunity of the children born from IBD women who had been treated with anti-TNF-α medication during their pregnancy. IBD women had comparable pregnancy outcomes with the general women population, suggesting that the disease activity rather than the administered medication would be more important in healthy pregnancy. Considering the history of vaccination and anti-HBs titers, immunity seems to be intact in the children.

Citations

Citations to this article as recorded by

Family Planning and Rheumatoid Arthritis
Catherine Sims, Mahret Birru Talabi
Current Rheumatology Reports.2025;[Epub] CrossRef
Safety of Rotavirus Vaccination in Infants That Were Exposed to Biologics In Utero: A Systematic Review
Trevor L Schell, Lucas Fass, Mary E Hitchcock, Francis A Farraye, Mary S Hayney, Sumona Saha, Freddy Caldera
Inflammatory Bowel Diseases.2024;[Epub] CrossRef
Navigating Reproductive Care in Patients With Inflammatory Bowel Disease: A Comprehensive Review
Paula Sousa, Javier P Gisbert, Mette Julsgaard, Christian Philipp Selinger, María Chaparro
Journal of Crohn's and Colitis.2024; 18(Supplement): ii16. CrossRef
2022 American College of Rheumatology Guideline for Vaccinations in Patients With Rheumatic and Musculoskeletal Diseases
Anne R. Bass, Eliza Chakravarty, Elie A. Akl, Clifton O. Bingham, Leonard Calabrese, Laura C. Cappelli, Sindhu R. Johnson, Lisa F. Imundo, Kevin L. Winthrop, Reuben J. Arasaratnam, Lindsey R. Baden, Roberta Berard, S. Louis Bridges, Jonathan T. L. Cheah,
Arthritis & Rheumatology.2023; 75(3): 333. CrossRef
2022 American College of Rheumatology Guideline for Vaccinations in Patients With Rheumatic and Musculoskeletal Diseases
Anne R. Bass, Eliza Chakravarty, Elie A. Akl, Clifton O. Bingham, Leonard Calabrese, Laura C. Cappelli, Sindhu R. Johnson, Lisa F. Imundo, Kevin L. Winthrop, Reuben J. Arasaratnam, Lindsey R. Baden, Roberta Berard, S. Louis Bridges, Jonathan T. L. Cheah,
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Society for Maternal-Fetal Medicine Consult Series #64: Systemic lupus erythematosus in pregnancy
Robert Silver, Sabrina Craigo, Flint Porter, Sarah S. Osmundson, Jeffrey A. Kuller, Mary E. Norton
American Journal of Obstetrics and Gynecology.2023; 228(3): B41. CrossRef
Vaccines in Children Exposed to Biological AgentsIn Uteroand/or During Breastfeeding: Are They Effective and Safe?
Javier P Gisbert, María Chaparro
Journal of Crohn's and Colitis.2023; 17(6): 995. CrossRef
Vaccination for rheumatic diseases: Current issues (based on ACR guidelines)
B. S. Belov, N. V. Muravyeva, E. L. Nasonov
Rheumatology Science and Practice.2023; 61(2): 151. CrossRef
Pregnancy Outcomes Associated With Biologic Agent Exposure in Patients With Several Rheumatic Diseases and Inflammatory Bowel Diseases
Soo Min Ahn, Young Bin Joo, Yun Jin Kim, So-Young Bang, Hye-Soon Lee
Journal of Korean Medical Science.2023;[Epub] CrossRef
Modern Ideas about Vaccination of Patients with Rheumatic Diseases: the View of ACR Experts
B. S. Belov, N. V. Muravyeva
Antibiotics and Chemotherapy.2023; 68(5-6): 77. CrossRef
Suboptimal Vaccination Administration in Mothers With Inflammatory Bowel Disease and Their Biologic-Exposed Infants
Helene Chiarella-Redfern, Sangmin Lee, Bellal Jubran, Nastaran Sharifi, Remo Panaccione, Cora Constantinescu, Eric I Benchimol, Cynthia H Seow
Inflammatory Bowel Diseases.2022; 28(1): 79. CrossRef
A systematic review of live vaccine outcomes in infants exposed to biologic disease modifying anti-rheumatic drugs in utero
Bethan Goulden, Nicole Chua, Elaine Parker, Ian Giles
Rheumatology.2022; 61(10): 3902. CrossRef
The Risk of Adverse Neonatal Outcomes With Maternal Inflammatory Bowel Disease: A Systematic Review and Meta-analysis
Kristel K Leung, Parul Tandon, Vivek Govardhanam, Cynthia Maxwell, Vivian Huang
Inflammatory Bowel Diseases.2021; 27(4): 550. CrossRef
The Influence of Disease Activity on Pregnancy Outcomes in Women With Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis
Min-A Kim, Young-Han Kim, Jaeyoung Chun, Hye Sun Lee, Soo Jung Park, Jae Hee Cheon, Tae Il Kim, Won Ho Kim, Jae Jun Park
Journal of Crohn's and Colitis.2021; 15(5): 719. CrossRef
Biologics During Pregnancy and Breastfeeding Among Women With Rheumatic Diseases: Safety Clinical Evidence on the Road
Asmaa Beltagy, Azin Aghamajidi, Laura Trespidi, Wally Ossola, Pier Luigi Meroni
Frontiers in Pharmacology.2021;[Epub] CrossRef
ECCO Guidelines on the Prevention, Diagnosis, and Management of Infections in Inflammatory Bowel Disease
T Kucharzik, P Ellul, T Greuter, J F Rahier, B Verstockt, C Abreu, A Albuquerque, M Allocca, M Esteve, F A Farraye, H Gordon, K Karmiris, U Kopylov, J Kirchgesner, E MacMahon, F Magro, C Maaser, L de Ridder, C Taxonera, M Toruner, L Tremblay, M Scharl, N
Journal of Crohn's and Colitis.2021; 15(6): 879. CrossRef
Canadian Association of Gastroenterology Clinical Practice Guideline for Immunizations in Patients With Inflammatory Bowel Disease (IBD)—Part 1: Live Vaccines
Eric I. Benchimol, Frances Tse, Matthew W. Carroll, Jennifer C. deBruyn, Shelly A. McNeil, Anne Pham-Huy, Cynthia H. Seow, Lisa L. Barrett, Talat Bessissow, Nicholas Carman, Gil Y. Melmed, Otto G. Vanderkooi, John K. Marshall, Jennifer L. Jones
Gastroenterology.2021; 161(2): 669. CrossRef
Canadian Association of Gastroenterology Clinical Practice Guideline for Immunizations in Patients With Inflammatory Bowel Disease (IBD)—Part 1: Live Vaccines
Eric I Benchimol, Frances Tse, Matthew W Carroll, Jennifer C deBruyn, Shelly A McNeil, Anne Pham-Huy, Cynthia H Seow, Lisa L Barrett, Talat Bessissow, Nicholas Carman, Gil Y Melmed, Otto G Vanderkooi, John K Marshall, Jennifer L Jones
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Systematic review with meta‐analysis: risk of adverse pregnancy‐related outcomes in inflammatory bowel disease
Parul Tandon, Vivek Govardhanam, Kristel Leung, Cynthia Maxwell, Vivian Huang
Alimentary Pharmacology & Therapeutics.2020; 51(3): 320. CrossRef
Safety and Optimal Timing of BCG Vaccination in Infants Born to Mothers Receiving Anti-TNF Therapy for Inflammatory Bowel Disease
Sang Hyoung Park, Hyo Jong Kim, Chang Kyun Lee, Eun Mi Song, Sang-Bum Kang, Byung Ik Jang, Eun Soo Kim, Kyeong Ok Kim, Yoo Jin Lee, Eun Young Kim, Yun Jin Jung, Soo-Kyung Park, Dong Il Park, Byong Duk Ye, Sung-Ae Jung, Suk-Kyun Yang
Journal of Crohn's and Colitis.2020; 14(12): 1780. CrossRef
Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review
N. Ghalandari, R. J. E. M. Dolhain, J. M. W. Hazes, E. P. van Puijenbroek, M. Kapur, H. J. M. J. Crijns
Drugs.2020; 80(16): 1699. CrossRef

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IBD

Efficacy of restarting anti-tumor necrosis factor α agents after surgery in patients with Crohn's disease: Sakiko Hiraoka, Shiho Takashima, Yoshitaka Kondo, Toshihiro Inokuchi, Yuusaku Sugihara, Masahiro Takahara, Seiji Kawano, Keita Harada, Jun Kato, Hiroyuki Okada; Intest Res 2018;16(1):75-82. Published online January 18, 2018; DOI: https://doi.org/10.5217/ir.2018.16.1.75

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Background/Aims

The efficacy of anti-tumor necrosis factor α (anti-TNFα) antibodies for postoperative Crohn's disease (CD) in patients who were treated with these agents prior to surgery is largely unknown.

Methods

CD patients who underwent intestinal resection and received anti-TNFα agents after surgery were divided into 2 groups according to the presence or absence of preoperative anti-TNFα treatment: anti-TNFα restart group or anti-TNFα naïve group. Endoscopic recurrence after surgery was examined according to the preoperative conditions, including administration of anti-TNFα agents before surgery.

Results

Thirty-six patients received anti-TNFα antibody after surgery: 22 in the anti-TNFα restart group and 14 in the anti-TNFα naïve group. Endoscopic recurrence after surgery was more frequently observed in the anti-TNFα restart group than in the anti-TNFα naïve group (68% vs. 14%, P<0.001). Multivariate analysis revealed the following significant risk factors of endoscopic recurrence after surgery: anti-TNF restart group (odds ratio [OR], 28.10; 95% CI, 3.08–722.00), age at diagnosis <23 years (OR, 24.30; 95% CI, 1.67–1,312.00), serum albumin concentration at surgery <3.3 g/dL (OR, 34.10; 95% CI, 1.72–2,804.00), and presence of inflammation outside of the surgical site (OR, 21.40; 95% CI, 1.02–2,150.00). Treatment intensification for patients with endoscopic recurrence in the anti-TNFα restart group showed limited responses, with only 1 of 12 patients achieving endoscopic remission.

Conclusions

The efficacy of restarting anti-TNFα antibody treatment after surgery was limited, and treatment intensification or a change to different classes of biologics should be considered for those patients.

Citations

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Influence of preoperative anti TNF alpha antibody therapy on postoperative recurrence of Crohn’s disease
Yuki Sekido, Takayuki Ogino, Takashi Takeda, Mitsunobu Takeda, Tsuyoshi Hata, Atsushi Hamabe, Hidekazu Takahashi, Norikatsu Miyoshi, Mamoru Uemura, Yuichiro Doki, Hidetoshi Eguchi, Tsunekazu Mizushima
Scientific Reports.2025;[Epub] CrossRef
Common Mistakes in Managing Patients with Inflammatory Bowel Disease
Javier P. Gisbert, María Chaparro
Journal of Clinical Medicine.2024; 13(16): 4795. CrossRef
Anti-TNF Agents and New Biological Agents (Vedolizumab and Ustekinumab) in the Prevention and Treatment of Postoperative Recurrence After Surgery in Crohn’s Disease
Javier P. Gisbert, María Chaparro
Drugs.2023; 83(13): 1179. CrossRef
Nutrition, Nutritional Status, Micronutrients Deficiency, and Disease Course of Inflammatory Bowel Disease
Marco Valvano, Annalisa Capannolo, Nicola Cesaro, Gianpiero Stefanelli, Stefano Fabiani, Sara Frassino, Sabrina Monaco, Marco Magistroni, Angelo Viscido, Giovanni Latella
Nutrients.2023; 15(17): 3824. CrossRef
Patient sex does not affect endoscopic outcomes of biologicals in inflammatory bowel disease but is associated with adverse events
Mitchell R. K. L. Lie, Emma Paulides, C. Janneke van der Woude
International Journal of Colorectal Disease.2020; 35(8): 1489. CrossRef
Adalimumab or Infliximab for the Prevention of Early Postoperative Recurrence of Crohn Disease: Results From the ENEIDA Registry
Fiorella Cañete, Míriam Mañosa, María José Casanova, Ramiro C González-Sueyro, Jesús Barrio, Fernando Bermejo, Pilar Nos, Eva Iglesias-Flores, Esther García-Planella, José Lázaro Pérez-Calle, Raquel Vicente, Maribel Vera, Laura Ramos, Montserrat Rivero, R
Inflammatory Bowel Diseases.2019; 25(11): 1862. CrossRef
Maneuvering Clinical Pathways for Crohn’s Disease
Thomas X. Lu, Russell D. Cohen
Current Gastroenterology Reports.2019;[Epub] CrossRef
Author's Reply
Sakiko Hiraoka, Jun Kato, Hiroyuki Okada
Intestinal Research.2018; 16(2): 321. CrossRef
The old versus the new: which do you keep in postoperative Crohn's disease?
Paulo Gustavo Kotze, Christopher Ma, Miguel Regueiro, Remo Panaccione
Intestinal Research.2018; 16(2): 319. CrossRef

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Special Review

IBD

Asian Organization for Crohn's and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 1: risk assessment: Dong Il Park, Tadakazu Hisamatsu, Minhu Chen, Siew Chien Ng, Choon Jin Ooi, Shu Chen Wei, Rupa Banerjee, Ida Normiha Hilmi, Yoon Tae Jeen, Dong Soo Han, Hyo Jong Kim, Zhihua Ran, Kaichun Wu, Jiaming Qian, Pin-Jin Hu, Katsuyoshi Matsuoka, Akira Andoh, Yasuo Suzuki, Kentaro Sugano, Mamoru Watanabe, Toshifumi Hibi, Amarender S. Puri, Suk-Kyun Yang; Intest Res 2018;16(1):4-16. Published online January 18, 2018; DOI: https://doi.org/10.5217/ir.2018.16.1.4

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Because anti-tumor necrosis factor (anti-TNF) therapy has become increasingly popular in many Asian countries, the risk of developing active tuberculosis (TB) among anti-TNF users may raise serious health problems in this region. Thus, the Asian Organization for Crohn's and Colitis and the Asia Pacific Association of Gastroenterology have developed a set of consensus statements about risk assessment, detection and prevention of latent TB infection, and management of active TB infection in patients with inflammatory bowel disease (IBD) receiving anti-TNF treatment. Twenty-three consensus statements were initially drafted and then discussed by the committee members. The quality of evidence and the strength of recommendations were assessed by using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Web-based consensus voting was performed by 211 IBD specialists from 9 Asian countries concerning each statement. A consensus statement was accepted if at least 75% of the participants agreed. Part 1 of the statements comprised 2 parts: risk of TB infection Recommendaduring anti-TNF therapy, and screening for TB infection prior to commencing anti-TNF therapy. These consensus statements will help clinicians optimize patient outcomes by reducing the morbidity and mortality related to TB infections in patients with IBD receiving anti-TNF treatment.

Citations

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Thomas Theo Brehm, Maja Reimann, Niklas Köhler, Christoph Lange
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Ten missteps in the management of inflammatory bowel disease in Asia: An expert report by the Asian Pacific Association of Gastroenterology Working Group on Inflammatory Bowel Disease
Vineet Ahuja, Ida Hilmi, Byong Duk Ye, Khoon Lin Ling, Siew C. Ng, Rupert W. Leong, Peeyush Kumar, Xin Hui Khoo, Govind K. Makharia, Jose Sollano, Pises Pisespongsa, Nazri Mustaffa, Rupa Banerjee, Alex Hwong‐Ruey Leow, Raja Affendi Raja Ali, Sai Wei Chuah
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Korean clinical practice guidelines on biologics and small molecules for moderate-to-severe ulcerative colitis
Soo-Young Na, Chang Hwan Choi, Eun Mi Song, Ki Bae Bang, Sang Hyoung Park, Eun Soo Kim, Jae Jun Park, Bora Keum, Chang Kyun Lee, Bo-In Lee, Seung-Bum Ryoo, Seong-Joon Koh, Miyoung Choi, Joo Sung Kim
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Flora Maria Lorenzo Fortes, Raquel Rocha, Genoile Oliveira Santana
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Bronchoesophageal fistula in a patient with Crohn’s disease receiving anti-tumor necrosis factor therapy
Kyunghwan Oh, Kee Don Choi, Hyeong Ryul Kim, Tae Sun Shim, Byong Duk Ye, Suk-Kyun Yang, Sang Hyoung Park
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Pooja KC, Madhur Bhattarai, Subodh Adhikari, Prakriti Parajuli, Sujata Bhandari, Himal Bikram Bhattarai, Niraj Kumar Sharma, Shailendra Karki, Suryakiran Acharya, Bibhusan Basnet
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Yuya Sugiyama, Nobuhiro Ueno, Shion Tachibana, Yu Kobayashi, Yuki Murakami, Takahiro Sasaki, Aki Sakatani, Keitaro Takahashi, Katsuyoshi Ando, Shin Kashima, Kentaro Moriichi, Hiroki Tanabe, Toshikatsu Okumura, Mikihiro Fujiya
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Tofacitinib in Steroid-Refractory Acute Severe Ulcerative Colitis: A Retrospective Analysis
Sayan Malakar, Srikanth Kothalkar, Umair Shamsul Hoda, Uday C Ghoshal
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Andreia Guimarães, João Gama, Luis Curvo-Semedo, António Canaveira Manso
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Development of Spinal Tuberculosis in an Adolescent With Crohn's Disease After Infliximab Therapy: A Case Report With Literature Review
Jae Hoon Jung, Sujin Choi, Youra Kang, Dae-Chul Cho, So Mi Lee, Tae In Park, Byung-Ho Choe, Dongsub Kim, Ben Kang
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Suprabhat Giri, Harish Darak
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Chan Hyuk Park, Jung Ho Park, Yoon Suk Jung
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Frequency of Positive Conversion of Interferon-Gamma Release Assay Results Among Patients With Inflammatory Bowel Disease Treated With Non-tumor Necrosis Factor Inhibitors
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Targeted versus universal tuberculosis chemoprophylaxis in 1968 patients with inflammatory bowel disease receiving anti‐TNF therapy in a tuberculosis endemic region
Lingna Ye, Thomas P. Chapman, Zhenzhen Wen, Lang Lin, Yun Qiu, Zhanju Liu, Zhihua Ran, Jiaming Qian, Kaichun Wu, Xiang Gao, Pinjin Hu, Minhu Chen, Simon P. L. Travis, Qian Cao
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Biologics for the Management of Inflammatory Bowel Disease: A Review in Tuberculosis-Endemic Countries
Rupa Banerjee, Raja Affendi Raja Ali, Shu Chen Wei, Shashi Adsul
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Increased Risk of Herpes Zoster in Young and Metabolically Healthy Patients with Inflammatory Bowel Disease: A Nationwide Population-Based Study
Hosim Soh, Jaeyoung Chun, Kyungdo Han, Seona Park, Gukhwan Choi, Jihye Kim, Jooyoung Lee, Jong Pil Im, Joo Sung Kim
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Evidence-based consensus on opportunistic infections in inflammatory bowel disease (republication)

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High risk of tuberculosis during infliximab therapy despite tuberculosis screening in inflammatory bowel disease patients in India
Ashish Agarwal, Saurabh Kedia, Saransh Jain, Vipin Gupta, Sawan Bopanna, Dawesh P Yadav, Sandeep Goyal, Venigalla Pratap Mouli, Rajan Dhingra, Govind Makharia, Vineet Ahuja
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Risk of infection associated with anti-TNF-α therapy
Mario Fernández-Ruiz, José María Aguado
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Special Review: Consensus on TB in IBD

IBD

Asian Organization for Crohn's and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 2: management: Dong Il Park, Tadakazu Hisamatsu, Minhu Chen, Siew Chien Ng, Choon Jin Ooi, Shu Chen Wei, Rupa Banerjee, Ida Normiha Hilmi, Yoon Tae Jeen, Dong Soo Han, Hyo Jong Kim, Zhihua Ran, Kaichun Wu, Jiaming Qian, Pin-Jin Hu, Katsuyoshi Matsuoka, Akira Andoh, Yasuo Suzuki, Kentaro Sugano, Mamoru Watanabe, Toshifumi Hibi, Amarender S. Puri, Suk-Kyun Yang; Intest Res 2018;16(1):17-25. Published online January 18, 2018; DOI: https://doi.org/10.5217/ir.2018.16.1.17

Abstract PDF PubReader ePub

Because anti-tumor necrosis factor (anti-TNF) therapy has become increasingly popular in many Asian countries, the risk of developing active tuberculosis (TB) among anti-TNF users may raise serious health problems in this region. Thus, the Asian Organization for Crohn's and Colitis and the Asia Pacific Association of Gastroenterology have developed a set of consensus statements about risk assessment, detection and prevention of latent TB infection, and management of active TB infection in patients with inflammatory bowel disease (IBD) receiving anti-TNF treatment. Twenty-three consensus statements were initially drafted and then discussed by the committee members. The quality of evidence and the strength of recommendations were assessed by using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Web-based consensus voting was performed by 211 IBD specialists from 9 Asian countries concerning each statement. A consensus statement was accepted if at least 75% of the participants agreed. Part 2 of the statements comprised 3 parts: management of latent TB in preparation for anti-TNF therapy, monitoring during anti-TNF therapy, and management of an active TB infection after anti-TNF therapy. These consensus statements will help clinicians optimize patient outcomes by reducing the morbidity and mortality related to TB infections in patients with IBD receiving anti-TNF treatment.

Citations

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Case Report

Fatal infections in older patients with inflammatory bowel disease on anti-tumor necrosis factor therapy: Way-Seah Lee, Najib Azmi, Ruey-Terng Ng, Sik-Yong Ong, Sasheela Sri La Ponnampalavanar, Sanjiv Mahadeva, Ida Hilmi; Intest Res 2017;15(4):524-528. Published online October 23, 2017; DOI: https://doi.org/10.5217/ir.2017.15.4.524

Abstract PDF PubReader ePub

Anti-tumor necrosis factor (anti-TNF) is highly effective in inflammatory bowel disease (IBD); however, it is associated with an increased risk of infections, particularly in older adults. We reviewed 349 patients with IBD, who were observed over a 12-month period, 74 of whom had received anti-TNF therapy (71 patients were aged <60 years and 3 were aged ≥60 years). All the 3 older patients developed serious infectious complications after receiving anti-TNFs, although all of them were also on concomitant immunosuppressive therapy. One patient developed disseminated tuberculosis, another patient developed cholera diarrhea followed by nosocomial pneumonia, while the third patient developed multiple opportunistic infections (Pneumocystis pneumonia, cryptococcal septicemia and meningitis, Klebsiella septicemia). All 3 patients died within 1 year from the onset of the infection(s). We recommend that anti-TNF, especially when combined with other immunosuppressive therapy, should be used with extreme caution in older adult patients with IBD.

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Original Article

Adalimumab induction and maintenance therapy achieve clinical remission and response in Chinese patients with Crohn's disease: Kai-Chun Wu, Zhi Hua Ran, Xiang Gao, Minhu Chen, Jie Zhong, Jian-Qiu Sheng, Michael A Kamm, Simon Travis, Kori Wallace, Nael M Mostafa, Marisa Shapiro, Yao Li, Roopal B Thakkar, Anne M Robinson; Intest Res 2016;14(2):152-163. Published online April 27, 2016; DOI: https://doi.org/10.5217/ir.2016.14.2.152

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Background/Aims

This was a Phase 2 study (NCT02015793) to evaluate the pharmacokinetics, safety, and efficacy of adalimumab in Chinese patients with Crohn's disease (CD).

Methods

Thirty, adult Chinese patients with CD (CD Activity Index [CDAI] 220–450; high-sensitivity [hs]-C-reactive protein [CRP] ≥3 mg/L) received double-blind adalimumab 160/80 mg or 80/40 mg at weeks 0/2, followed by 40 mg at weeks 4 and 6. An open-label extension period occurred from weeks 8–26; patients received 40 mg adalimumab every other week. Serum adalimumab concentration and change from baseline in fecal calprotectin (FC) were measured during the double-blind period. Clinical remission (CDAI <150), response (decrease in CDAI ≥70 points from baseline), and change from baseline in hs-CRP were assessed through week 26. Nonresponder imputation was used for missing categorical data and last observation carried forward for missing hs-CRP/FC values. No formal hypothesis was tested. Adverse events were monitored.

Results

Mean adalimumab serum concentrations during the induction phase were 13.9–18.1 µg/mL (160/80 mg group) and 7.5−9.5 µg/mL (80/40 mg group). During the double-blind period, higher remission/response rates and greater reductions from baseline in hs-CRP and FC were observed with adalimumab 160/80 mg compared to that with 80/40 mg. Adverse event rates were similar among all treatment groups.

Conclusions

Adalimumab serum concentrations in Chinese patients with CD were comparable to those observed previously in Western and Japanese patients. Clinically meaningful remission rates and improvement in inflammatory markers were achieved with both dosing regimens; changes occurred rapidly with adalimumab 160/80 mg induction therapy. No new safety signals were reported.

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