Intestinal Research

Review

What to do when traditional rescue therapies fail in acute severe ulcerative colitis: Christopher F. D. Li Wai Suen, Matthew C. Choy, Peter De Cruz; Received January 7, 2024 Accepted March 22, 2024 Published online May 16, 2024; DOI: https://doi.org/10.5217/ir.2024.00003 [Epub ahead of print]

Abstract PDF PubReader ePub: Acute severe ulcerative colitis (ASUC) is a medical emergency that affects approximately 25% of patients with ulcerative colitis at some point in time in their lives. Outcomes of ASUC are highly variable. Approximately 30% of patients do not respond to corticosteroids and up to 50% of patients do not respond to rescue therapy (infliximab or cyclosporin) and require emergency colectomy. Data are emerging on infliximab dosing strategies, use of cyclosporin as a bridge to slower acting biologic agents and Janus kinase inhibition as primary and sequential therapy. In this review, we outline contemporary approaches to clinical management of ASUC in the setting of failure to respond to traditional rescue therapies.

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Original Articles

Defining management strategies for acute severe ulcerative colitis using predictive models: a simulation-modeling study: Danny Con, Peter De Cruz; Received November 17, 2023 Accepted February 15, 2024 Published online May 7, 2024; DOI: https://doi.org/10.5217/ir.2023.00175 [Epub ahead of print]

Abstract PDF PubReader ePub: Background/Aims
Robust management algorithms are required to reduce the residual risk of colectomy in acute severe ulcerative colitis (ASUC) refractory to standard infliximab salvage therapy. The aim of this study was to evaluate the performance and benefits of alternative ASUC management strategies using simulated prediction models of varying accuracy.
Methods
This was a simulation-based modeling study using a hypothetical cohort of 5,000 steroid-refractory ASUC patients receiving standard infliximab induction. Simulated predictive models were used to risk-stratify patients and escalate treatment in patients at high risk of failing standard infliximab induction. The main outcome of interest was colectomy by 3 months.
Results
The 3-month colectomy rate in the base scenario where all 5,000 patients received standard infliximab induction was 23%. The best-performing management strategy assigned high-risk patients to sequential Janus kinase inhibitor inhibition and mediumrisk patients to accelerated infliximab induction. Using a 90% area under the curve (AUC) prediction model and optimistic treatment efficacy assumptions, this strategy reduced the 3-month colectomy rate to 8% (65% residual risk reduction). Using an 80% AUC prediction model with only modest treatment efficacy assumptions, the 3-month colectomy rate was reduced to 15% (35% residual risk reduction). Overall management strategy efficacy was highly dependent on predictive model accuracy and underlying treatment efficacy assumptions.
Conclusions
This is the first study to simulate predictive model-based management strategies in steroid-refractory ASUC and evaluate their effect on short-term colectomy rates. Future studies on predictive model development should incorporate simulation studies to better understand their expected benefit.

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IBD

Long-term clinical and real-world experience with Crohn’s disease treated with anti-tumor necrosis factor-α antibodies: Haruka Otake, Satohiro Matsumoto, Hirosato Mashima; Intest Res 2022;20(4):464-474. Published online March 31, 2022; DOI: https://doi.org/10.5217/ir.2021.00139

Abstract PDF PubReader ePub

Background/Aims
Although anti-tumor necrosis factor (TNF)-α agents are important therapeutic drugs for Crohn’s disease (CD), data regarding their long-term sustained effects are limited. Herein, we evaluated the long-term loss of response (LOR) to anti-TNF-α agents in patients with CD.
Methods
This retrospective study included patients with CD who started treatment with infliximab or adalimumab as a first-line therapeutic approach. The cumulative event-free, retention, and surgery-free rates after the start of biological therapy were analyzed. Secondary LOR was analyzed in patients who achieved corticosteroid-free clinical remission after the start of biological therapy. Cox proportional hazards models were used to analyze the predictive factors of secondary LOR.
Results
The cumulative event-free rates at 1, 2, 5, and 10 years were 83.3%, 75.1%, 37.4%, and 23.3%, respectively. The incidence of LOR was 10.6% per patient-year of follow-up. At 12–14 weeks after the start of biological therapy, the proportion of patients with a C-reactive protein to albumin (CRP/ALB) ratio ≥0.18 was significantly higher in patients with LOR (P<0.001). Multivariate analysis indicates that a CRP/ALB ratio ≥0.18 (hazard ratio [HR], 5.86; 95% confidence interval [CI], 1.56–22.0; P=0.009) and upper gastrointestinal tract inflammation (HR, 3.00; 95% CI, 1.26–7.13; P=0.013) were predictive factors of secondary LOR.
Conclusions
Although anti-TNF-α agents contributed to long-term clinical remission of CD, the annual incidence of secondary LOR was 10.6%. The CRP/ALB ratio at 3 months after the start of biological therapy and upper gastrointestinal tract inflammation were identified as predictive factors of secondary LOR.

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Jihye Park, Jaeyoung Chun, Soo Jung Park, Jae Jun Park, Tae Il Kim, Hyuk Yoon, Jae Hee Cheon
Digestive Diseases and Sciences.2024; 69(3): 901. CrossRef
Developing a Machine-Learning Prediction Model for Infliximab Response in Crohn’s Disease: Integrating Clinical Characteristics and Longitudinal Laboratory Trends
Yun Qiu, Shixian Hu, Kang Chao, Lingjie Huang, Zicheng Huang, Ren Mao, Fengyuan Su, Chuhan Zhang, Xiaoqing Lin, Qian Cao, Xiang Gao, Minhu Chen
Inflammatory Bowel Diseases.2024;[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
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Comparative real-world outcomes between ustekinumab, infliximab, and adalimumab in bio-naïve and bio-experienced Crohn’s disease patients: a retrospective multicenter study
Ji Eun Na, Yong Eun Park, Jongha Park, Tae-Oh Kim, Jong Hoon Lee, Su Bum Park, Soyoung Kim, Seung Bum Lee
BMC Gastroenterology.2024;[Epub] CrossRef
Usefulness of Serum Leucine-rich Alpha 2 Glycoprotein in Crohn’s Disease: Is There Any Difference between Small Intestine and Colonic Lesions?
Satohiro Matsumoto, Hirosato Mashima
Crohn's & Colitis 360.2023;[Epub] CrossRef
Enrichment of Activated Fibroblasts as a Potential Biomarker for a Non-Durable Response to Anti-Tumor Necrosis Factor Therapy in Patients with Crohn’s Disease
Soo-Kyung Park, Gi-Young Lee, Sangsoo Kim, Chil-Woo Lee, Chang-Hwan Choi, Sang-Bum Kang, Tae-Oh Kim, Jaeyoung Chun, Jae-Myung Cha, Jong-Pil Im, Kwang-Sung Ahn, Seon-Young Kim, Min-Suk Kim, Chang-Kyun Lee, Dong-Il Park
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IBD

Maintaining infliximab induced clinical remission with azathioprine and 5-aminosalicylates in acute severe steroid-refractory ulcerative colitis has lower cost and high efficacy (MIRACLE): a multicenter study: Ramit Mahajan, Arshdeep Singh, Saurabh Kedia, Kirandeep Kaur, Vandana Midha, Pabitra Sahu, Varun Mehta, Dharmatma Singh, Namita Bansal, Khushdeep Dharni, Sandeep Kaushal, Vineet Ahuja, Ajit Sood; Intest Res 2022;20(1):64-71. Published online February 3, 2021; DOI: https://doi.org/10.5217/ir.2020.00100

Abstract PDF PubReader ePub

Background/Aims
Infliximab (IFX) has been used to induce and maintain remission in patients with severe steroid-refractory ulcerative colitis (UC). Long-term use of biologics in developing countries is limited by high cost and frequent side effects. An optimal maintenance strategy in these patients needs to be established.
Methods
A retrospective analysis of maintenance of clinical remission with combination of azathioprine (AZA) and 5-aminosalicylates (5-ASA) in patients with severe steroidrefractory UC where IFX (5 mg/kg intravenously at weeks 0, 2, 6) had been used only as an induction therapy was done at 2 centers in India. Primary outcome was the proportion of patients maintaining corticosteroid-free sustained clinical remission (SCR) at the end of study period. Rates of relapse and cost of therapy were also analyzed.
Results
Of the 137 patients who received rescue IFX induction therapy, 77 (56.2%) achieved clinical remission (mean age 34.81 ± 13.32 years, 68.83% males, median follow-up 4 years, range 3 months to 6 years) and were included. Cumulative corticosteroid-free SCR was maintained in 68%, 59%, 42%, and 35% patients at 1, 2, 4, and 6 years respectively. Sixty-seven relapses were observed in 33 patients. Majority of the relapses (45/67, 67.16%) occurred within first 2 years of follow-up. Two relapses were managed with re-induction with IFX, one required colectomy, whereas all other responded to repeat course(s) of corticosteroids. Annual per capita maintenance therapy with 5-ASA and AZA was cheaper by US$ 4,526 compared to maintaining remission with IFX.
Conclusions
Clinical remission achieved with IFX induction therapy in severe steroid-refractory UC can be sustained over long time with a combination of AZA and 5-ASA.

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Tao Wang, Junquan Tian, Wenxuan Su, Fan Yang, Jie Yin, Qian Jiang, Yuying Li, Kang Yao, Tiejun Li, Yulong Yin
Nutrients.2023; 15(11): 2476. CrossRef
Management of Ulcerative Colitis: A Review of Indian Literature
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Soo-Young Na
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Identifying Care Challenges as Opportunities for Research and Education in Inflammatory Bowel Disease in South Asia
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Inflammatory Bowel Diseases

Is there a correlation between infliximab trough levels and the development of adverse events in patients with inflammatory bowel disease?: Eirini Theodoraki, Eleni Orfanoudaki, Kalliopi Foteinogiannopoulou, Evangelia Legaki, Maria Gazouli, Ioannis E. Koutroubakis; Intest Res 2021;19(4):461-467. Published online August 18, 2020; DOI: https://doi.org/10.5217/ir.2020.00042

Abstract PDF PubReader ePub

Background/Aims
The measurement of infliximab trough levels (IFX-TLs) in patients with inflammatory bowel disease (IBD) is performed to optimize treatment. However, the association between the development of adverse events (AEs) and IFX-TLs has not been sufficiently studied thus far. To investigate the possible association of IFX-TLs with AEs in Greek patients with IBD receiving maintenance treatment with IFX.
Methods
A retrospective analysis of the registry data of the Gastroenterology Department of the University Hospital of Heraklion, from IBD patients with at least one available IFX-TL measurement during the years 2016 to 2017 was conducted. AEs reported 4 months before and 4 months after the measured IFX-TLs were recorded. The IFX-TLs of patients with or without AEs were compared.
Results
Of a total of 83 IBD patients (61 Crohn’s disease [73%]; 52 men [63%]; mean age ± standard deviation, 43.3 ± 16.0 years), 147 measurements of IFX-TLs were available (median 4.69 μg/ mL [1.32–9.16]), and 99 AEs (67.3%, 14 severe) were registered. The median IFX-TL of patients with AEs was 5.79 μg/mL (1.36– 10.25), higher than the median IFX-TL of patients without AEs (3.40 μg/mL [1.30–5.92]), but the difference was not significant (P= 0.97). The presence of infections or dermatologic reactions was not correlated with IFX-TLs. There was no difference in the prevalence of the total AEs (66.7% vs. 73.3%, P= 0.77) or in the analysis of AEs by group between patients with IFX-TLs ≥ 15 μg/ mL and patients with IFX-TLs < 15 μg/mL.
Conclusions
IFX-TLs are not significantly associated with the development of AEs in IBD patients receiving maintenance treatment with IFX.

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Inflammatory Bowel Diseases

Long-term outcomes of infliximab in a real-world multicenter cohort of patients with acute severe ulcerative colitis: Shin Ju Oh, Ga Young Shin, Hosim Soh, Jae Gon Lee, Jong Pil Im, Chang Soo Eun, Kang-Moon Lee, Dong Il Park, Dong Soo Han, Hyo Jong Kim, Chang Kyun Lee; Intest Res 2021;19(3):323-331. Published online August 18, 2020; DOI: https://doi.org/10.5217/ir.2020.00039

Abstract PDF PubReader ePub

Background/Aims
Infliximab (IFX) has proven effective as rescue therapy in steroid-refractory acute severe ulcerative colitis (ASUC), however, the long-term real-world data are scarce. Our study aimed to assess the long-term treatment outcomes of IFX in a real-life cohort.
Methods
We established a multicenter retrospective cohort of hospitalized patients with ASUC, who met Truelove and Witt’s criteria and received intravenous corticosteroid (IVCS) or IFX during index hospitalization between 2006 and 2016 in 5 university hospitals in Korea. The cohort was systematically followed up until colectomy, death or last follow-up visit.
Results
A total of 296 patients were followed up for a mean of 68.9 ± 44.0 months. During index hospitalization, 49 patients were treated with IFX; as rescue therapy for IVCS failure in 37 and as first-line medical therapy for ASUC in 12. All patients treated with IFX avoided colectomy during index hospitalization. The cumulative rates of rehospitalization and colectomy were 20.4% and 6.1% at 3 months and 39.6% and 18.8% at the end of follow-up, respectively. Patients treated with IFX presented with significantly shorter colectomy-free survival than IVCS responders (P= 0.04, log-rank test). Both cytomegalovirus colitis and Clostridioides difficile infection (CDI) were the significant predictors of colectomy in the overall study cohort (hazard ratios of 6.57 and 4.61, respectively). There were no fatalities.
Conclusions
Our real-world cohort study demonstrated that IFX is an effective therapeutic option in Korean patients with ASUC, irrespective of IFX indication. Aggressive vigilance for cytomegalovirus colitis and CDI is warranted for hospitalized patients with ASUC.

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Javier P Gisbert, María José García, María Chaparro
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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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Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn’s disease in Asia: Choon Jin Ooi, Ida Hilmi, Rupa Banerjee, Sai Wei Chuah, Siew Chien Ng, Shu Chen Wei, Govind K Makharia, Pises Pisespongsa, Min Hu Chen, Zhi Hua Ran, Byong Duk Ye, Dong Il Park, Khoon Lin Ling, David Ong, Vineet Ahuja, Khean Lee Goh, Jose Sollano, Wee Chian Lim, Wai Keung Leung, Raja Affendi Raja Ali, Deng Chyang Wu, Evan Ong, Nazri Mustaffa, Julajak Limsrivilai, Tadakazu Hisamatsu, Suk Kyun Yang, Qin Ouyang, Richard Geary, Janaka H De Silva, Rungsun Rerknimitr, Marcellus Simadibrata, Murdani Abdullah, Rupert WL Leong, the Asia Pacific Association of Gastroenterology (APAGE) Working Group on Inflammatory Bowel Disease and Asian Organization for Crohn’s and Colitis; Intest Res 2019;17(3):285-310. Published online May 31, 2019; DOI: https://doi.org/10.5217/ir.2019.00026

Abstract PDF PubReader ePub

The Asia-Pacific Working Group on inflammatory bowel disease (IBD) was established in Cebu, Philippines, under the auspices of the Asian Pacific Association of Gastroenterology with the goal of improving IBD care in Asia. This consensus is carried out in collaboration with Asian Organization for Crohn’s and Colitis. With biologic agents and biosimilars becoming more established, it is necessary to conduct a review on existing literature and establish a consensus on when and how to introduce biologic agents and biosimilars in the conjunction with conventional treatments for ulcerative colitis (UC) and Crohn’s disease (CD) in Asia. These statements also address how pharmacogenetics influence the treatments of UC and CD and provide guidance on response monitoring and strategies to restore loss of response. Finally, the review includes statements on how to manage treatment alongside possible hepatitis B and tuberculosis infections, both common in Asia. These statements have been prepared and voted upon by members of IBD workgroup employing the modified Delphi process. These statements do not intend to be all-encompassing and future revisions are likely as new data continue to emerge.

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Original Articles

IBD

Long-term prognosis of Japanese patients with biologic-naïve Crohn’s disease treated with anti-tumor necrosis factor-α antibodies: Rintaro Moroi, Katsuya Endo, Katsutoshi Yamamoto, Takeo Naito, Motoyuki Onodera, Masatake Kuroha, Yoshitake Kanazawa, Tomoya Kimura, Yoichi Kakuta, Atsushi Masamune, Yoshitaka Kinouchi, Tooru Shimosegawa; Intest Res 2019;17(1):94-106. Published online December 3, 2018; DOI: https://doi.org/10.5217/ir.2018.00048

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Few reports have described the long-term treatment outcomes of the anti-tumor necrosis factor-α antibody for Japanese Crohn’s disease (CD) patients. The aim of this study was to evaluate them and clarify the clinical factors that affect the long-term prognosis of the anti-tumor necrosis factor-α treatments.
Methods
This was a retrospective, observational, single-center cohort study. Japanese CD patients treated with either infliximab or adalimumab as a first-line therapy were analyzed. The cumulative retention rates of the biologics, relapse-free survival, and surgery-free survival were analyzed using Kaplan-Meier methods. The clinical factors associated with the long-term outcomes were estimated by both the log-rank test and Cox proportional hazard model.
Results
The cumulative retention rate was significantly higher in the group with a concomitant elemental diet of ≥900 kcal/day, baseline C-reactive protein (CRP) levels <2.6 mg/dL, and baseline serum albumin levels ≥3.5 g/dL, respectively. The baseline serum albumin levels were also associated with both relapse-free and surgery-free survival. The lack of concomitant use of an elemental diet ≥900 kcal/day was identified as the only independent risk factor for the withdrawal of the biologics.
Conclusions
Baseline CRP levels and serum albumin levels could affect the long-term outcomes in CD patients. Concomitant elemental diet of ≥900 kcal/day could have a positive influence on clinical treatment course.

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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
Long-term clinical and real-world experience with Crohn’s disease treated with anti-tumor necrosis factor-α antibodies
Haruka Otake, Satohiro Matsumoto, Hirosato Mashima
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Natural history of inflammatory bowel disease: a comparison between the East and the West
Eun Mi Song, Suk-Kyun Yang
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Hyo Yeop Song, Geom Seog Seo
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Eun Ae Kang, Jung Won Park, Yehyun Park, Soo Jung Park, Tae Il Kim, Won Ho Kim, Min Soo Cho, Jae Hee Cheon
BMC Gastroenterology.2021;[Epub] CrossRef
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Ji Young Chang, Jae Hee Cheon
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Fumihito Hirai, Teruyuki Takeda, Yasumichi Takada, Masahiro Kishi, Tsuyoshi Beppu, Noritaka Takatsu, Masaki Miyaoka, Takashi Hisabe, Kenshi Yao, Tosiharu Ueki
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TL1A (TNFSF15) genotype affects the long‐term therapeutic outcomes of anti‐TNFα antibodies for Crohn's disease patients
Katsuya Endo, Yoichi Kakuta, Rintaro Moroi, Katsutoshi Yamamoto, Hisashi Shiga, Masatake Kuroha, Takeo Naito, Yoshitaka Kinouchi, Atsushi Masamune
JGH Open.2020; 4(6): 1108. CrossRef

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WITHDRAWN:Knowledge and viewpoints on biosimilar monoclonal antibodies from members of the Asian Organization of Crohn’s and Colitis: comparison with European Crohn’s and Colitis members: Soo-Kyung Park, Tadakazu Hisamatsu, Zhihua Ran, Shu-Chen Wei, Dong Il Park; Received June 12, 2018 Accepted October 6, 2018 Published online November 12, 2018; DOI: https://doi.org/10.5217/ir.2018.00084

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Awareness and Knowledge of Pharmacists toward Biosimilar Medicines: A Survey in Jordan
Muna Oqal, Bushra Hijazi, Abdelrahim Alqudah, Ahmad Al-Smadi, Basima A Almomani, Roaa Alnajjar, Majd Abu Ghunaim, Mohammad Irshaid, Aroob Husam, Gergely Feher
International Journal of Clinical Practice.2022; 2022: 1. CrossRef

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IBD

Trough level of infliximab is useful for assessing mucosal healing in Crohn's disease: a prospective cohort study: Akihiro Koga, Toshiyuki Matsui, Noritaka Takatsu, Yasumichi Takada, Masahiro Kishi, Yutaka Yano, Takahiro Beppu, Yoichiro Ono, Kazeo Ninomiya, Fumihito Hirai, Takashi Nagahama, Takashi Hisabe, Yasuhiro Takaki, Kenshi Yao, Hirotsugu Imaeda, Akira Andoh; Intest Res 2018;16(2):223-232. Published online April 30, 2018; DOI: https://doi.org/10.5217/ir.2018.16.2.223

Abstract PDF Supplementary Material PubReader ePub

Background/Aims

Decreased trough levels of infliximab (TLI) and antibodies to infliximab (ATI) are associated with loss of response (LOR) in Crohn's disease. Two prospective studies were conducted to determine whether TLI or ATI better correlates with LOR (Study 1), and whether TLI could become a predictor of mucosal healing (MH) (Study 2).

Methods

Study 1 was conducted in 108 patients, including those with LOR and remission to compare ATI and TLI in discriminating the 2 conditions based on receiver operating characteristic (ROC) curve analyses. Study 2 involved 35 patients who were evaluated endoscopically.

Results

In Study 1, there were no differences between the 2 assays in ROC curve analyses; the TLI cutoff value for LOR was 2.6 µg/mL (sensitivity, 70.9%; specificity, 79.2%), and the ATI cutoff value was 4.9 µg/mL (sensitivity, 65.5%; specificity, 67.9%). The AUROC (area under the ROC curve) of TLI was greater than that of ATI. AUROC was useful for discriminating between the 2 conditions. In Study 2, the TLI was significantly higher in the colonic MH group than in the non-MH group (2.7 µg/mL vs. 0.5 µg/mL, P=0.032).

Conclusions

TLI is better than ATI for clinically diagnosing LOR, and a correlation was observed between TLI and colonic MH.

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T. L. Alexandrov, B. A. Vykova
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Bruce E Sands, Silvio Danese, J Casey Chapman, Khushboo Gurjar, Stacy Grieve, Deepika Thakur, Jenny Griffith, Namita Joshi, Kristina Kligys, Axel Dignass
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Expression of inflammatory mediators in biofilm samples and clinical association in inflammatory bowel disease patients—a preliminary study
Mayte Buchbender, Jakob Fehlhofer, Peter Proff, Tobias Möst, Jutta Ries, Matthias Hannig, Markus F. Neurath, Madline Gund, Raja Atreya, Marco Kesting
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Martina Franzin, Katja Stefančič, Marianna Lucafò, Giuliana Decorti, Gabriele Stocco
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Post-Induction High Adalimumab Drug Levels Predict Biological Remission at Week 24 in Patients With Crohn's Disease
Eran Zittan, A. Hillary Steinhart, Pavel Goldstein, Raquel Milgrom, Ian M. Gralnek, Mark S. Silverberg
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Potential Utility of Therapeutic Drug Monitoring of Adalimumab in Predicting Short-Term Mucosal Healing and Histologic Remission in Pediatric Crohn's Disease Patients
So Yoon Choi, Young Ok Choi, Yon Ho Choe, Ben Kang
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Clinical efficacy of adalimumab versus infliximab and the factors associated with recurrence or aggravation during treatment of anal fistulas in Crohn's disease: Cheng-Chun Ji, Shota Takano; Intest Res 2017;15(2):182-186. Published online April 27, 2017; DOI: https://doi.org/10.5217/ir.2017.15.2.182

Abstract PDF PubReader ePub

Background/Aims

Infliximab has proven to be effective in the treatment of perianal fistulas in Crohn's disease (CD) but the efficacy of adalimumab is still unclear. The aim of this study is to assess the clinical efficacy of adalimumab and compare the results with those for infliximab.

Methods

Forty-seven CD patients treated for perianal fistulas with infliximab from September 2005 to December 2010 (n=31), or with adalimumab from November 2010 to May 2012 (n=16), were enrolled in this retrospective study. The following patient characteristics were analyzed; intestinal lesion site, fistula classification, seton placement, index of inflammatory bowel disease, C-reactive protein level, follow-up period, and the cumulative rate of nonrecurrence or aggravation of fistula.

Results

There were no significant differences in the intestinal lesion site, fistula classification, inflammatory bowel disease index, C-reactive protein level, and the frequency of injection between the infliximab group and the adalimumab group. The cumulative rate of nonrecurrence or aggravation of fistula was 62.5% in the adalimumab group and 83.9% in the infliximab group at 24 months after treatment (P=0.09). The risk factors for recurrence or aggravation may be related to seton placement (P=0.02), gender (P=0.06), and fistula classification (P=0.07).

Conclusions

There was no significant difference in the clinical efficacy of adalimumab and infliximab in the treatment of perianal fistulas in CD. However, fistula classification may be an important risk factor for recurrence or aggravation. The preliminary findings in this study show that further research is warranted.

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Clinical features of active tuberculosis that developed during anti-tumor necrosis factor therapy in patients with inflammatory bowel disease: Jang Wook Lee, Chang Hwan Choi, Ji Hoon Park, Jeong Wook Kim, Sang Bum Kang, Ja Seol Koo, Young-Ho Kim, You Sun Kim, Young Eun Joo, Sae Kyung Chang; Intest Res 2016;14(2):146-151. Published online April 27, 2016; DOI: https://doi.org/10.5217/ir.2016.14.2.146

Abstract PDF PubReader ePub

Background/Aims

Anti-tumor necrosis factor (TNF) therapy for active ulcerative colitis (UC) and Crohn's disease (CD) is associated with increased risks of tuberculosis (TB) infection. We analyzed the incidence and clinical features of Korean patients with inflammatory bowel disease (IBD) who developed active TB during anti-TNF therapy.

Methods

Ten cases of active TB developed in patients treated with infliximab (n=592) or adalimumab (n=229) for UC (n=160) or CD (n=661) were reviewed. We analyzed demographics, interval between start of anti-TNF therapy and active TB development, tests for latent TB infection (LTBI), concomitant medications, and the details of diagnosis and treatments for TB.

Results

The incidence of active TB was 1.2% (10/821): 1.5% (9/592) and 0.4% (1/229) in patients receiving infliximab and adalimumab, respectively. The median time to the development of active TB after initiation of anti-TNF therapy was three months (range: 2–36). Three patients had past histories of treatment for TB. Positive findings in a TB skin test (TST) and/or interferon gamma releasing assay (IGRA) were observed in three patients, and two of them received anti-TB prophylaxis. Two patients were negative by both TST and IGRA. The most common site of active TB was the lungs, and the active TB was cured in all patients.

Conclusions

Active TB can develop during anti-TNF therapy in IBD patients without LTBI, and even in those with histories of TB treatment or LTBI prophylaxis. Physicians should be aware of the potential for TB development during anti-TNF therapy, especially in countries with a high prevalence of TB.

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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

Abstract PDF PubReader ePub

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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The Potential of Molecular Remission: Tissue Neutrophil Elastase Is Better Than Histological Activity for Predicting Long-Term Relapse in Patients With Ulcerative Colitis in Endoscopic Remission
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Association of Perianal Fistulas with Clinical Features and Prognosis of Crohn's Disease in Korea: Results from the CONNECT Study
Jaeyoung Chun, Jong Pil Im, Ji Won Kim, Kook Lae Lee, Chang Hwan Choi, Hyunsoo Kim, Jae Hee Cheon, Byong Duk Ye, Young-Ho Kim, You Sun Kim, Yoon Tae Jeen, Dong Soo Han, Won Ho Kim, Joo Sung Kim
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Physicians Should Provide Shared Decision-Making for Anti-TNF Therapy to Inflammatory Bowel Disease Patients
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Long-Term Outcomes of Infliximab Treatment in 582 Korean Patients with Crohn’s Disease: A Hospital-Based Cohort Study
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The Effect of Infliximab on Patients with Ulcerative Colitis in Korea: Hyun Il Seo, Dong Il Park, Tae Oh Kim, You Sun Kim, Suck-Ho Lee, Ji Won Kim, Jae Hak Kim, Jeong Eun Shin; Intest Res 2014;12(3):214-220. Published online July 25, 2014; DOI: https://doi.org/10.5217/ir.2014.12.3.214

Abstract PDF PubReader ePub

Background/Aims

Infliximab was introduced recently as a rescue therapy for ulcerative colitis (UC) patients refractory to conventional treatments such as therapy with 5-amiono salicylic acids (5-ASA), immune modulators, and corticosteroids. However, there is insufficient data about its efficacy and safety in Korea.

Methods

From 7 tertiary referral hospitals, 33 patients who were treated with infliximab for moderate to severe (Mayo score 6-12) UC refractory to conventional treatment were recruited to this study. Clinical remission was defined as a total Mayo score of 2 or lower and every subscore less than 2. Partial response was defined as a decrease of Mayo score at least 3 points from baseline.

Results

Twenty-three patients (69.7%) showed clinical remission and 29 patients (87.8%) showed partial response in the observation period. When the remission and non-remission groups were compared in univariate analysis, only a higher total Mayo score at base line (11.0±0.9 vs. 9.9±1.5; P=0.04) was related to remission. The remission maintenance rate decreased with time in the Kaplan-Meier analysis. Two patients experienced re-remission after the first remission followed by aggravation during infliximab treatment. Three patients stopped infliximab treatment owing to adverse events including rhabdomyolysis, pneumonia, and fever of unknown origin.

Conclusions

If there is no choice except surgery for UC patients refractory to conventional treatment, infliximab is an effective and relatively safe treatment option for these patients in Korea.

Citations

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Efficacy of Anti-TNF Therapy for the Treatment of Patients with Moderate-to-Severe Inflammatory Bowel Disease; a First Iranian Report
Samaneh Mohagheghi Darehranj, Sudabeh Alatab, Homayoon Vahedi, Anahita Sadeghi, Alireza Sima, Masoud Malekzadeh, Amir Anoshiravani, Hafez Fakheri, Nasser Ebrahimi Daryani, Abdolhamid Mousavi, Fariborz Mansour-Ghanaei, Mohammad Javad Zahedi, Reza Malekzade
Middle East Journal of Digestive Diseases.2019; 12(1): 12. CrossRef
Novel treatments for inflammatory bowel disease
Hyo Sun Lee, Soo-Kyung Park, Dong Il Park
The Korean Journal of Internal Medicine.2018; 33(1): 20. CrossRef
Long-term outcomes of infliximab treatment and predictors of response in 195 patients with ulcerative colitis: a hospital-based cohort study from Korea
Hyungil Seo, Kiju Chang, Sun-Ho Lee, Eun-Mi Song, Gwang-Un Kim, Myeongsook Seo, Ho-Su Lee, Sung-Wook Hwang, Dong-Hoon Yang, Kyung-Jo Kim, Byong Duk Ye, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Sang Hyoung Park
Scandinavian Journal of Gastroenterology.2017; 52(8): 857. CrossRef
Colectomy rates in patients with ulcerative colitis following treatment with infliximab or ciclosporin
Kymberley Thorne, Laith Alrubaiy, Ashley Akbari, David G. Samuel, Sian Morrison-Rees, Stephen E. Roberts
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Efficacy and safety of CT‐P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study
Yoon Suk Jung, Dong Il Park, Young Ho Kim, Ji Hyun Lee, Pyoung Ju Seo, Jae Hee Cheon, Hyoun Woo Kang, Ji Won Kim
Journal of Gastroenterology and Hepatology.2015; 30(12): 1705. CrossRef
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Jung Won Lee, Jong Pil Im, Jae Hee Cheon, You Sun Kim, Joo Sung Kim, Dong Soo Han
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Circulating Ghrelin Levels and Obestatin/Ghrelin Ratio as a Marker of Activity in Ulcerative Colitis
Ja Young Jung, Ji Bong Jeong, Ji Won Kim, Su Hwan Kim, Seong-Joon Koh, Byeong Gwan Kim, Kook Lae Lee
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Sung Chul Park, Yoon Tae Jeen
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Case Reports

Successful Treatment of Postoperative Fistula with Infliximab in a Patient with Crohn's Disease: Seong Yeon Jeong, Jeong Seop Moon, Kyu Joo Park, You Sun Kim; Intest Res 2014;12(1):74-77. Published online January 28, 2014; DOI: https://doi.org/10.5217/ir.2014.12.1.74

Abstract PDF PubReader

Nearly 80% of patients with Crohn's disease (CD) require surgical treatment for complications or failure of medical management. We managed a 31-year-old man with CD who presented with a post-operative fistula. The patient had undergone surgery due to multiple strictures and a fistula. However, a new fistula developed that connected to the intraperitoneal abscess. Intravenous antibiotics were started and multiple percutaneous drainage tubes were inserted to treat the abdominal abscess. However, the amount of drainage was consistently high, even one month after the operation. To treat the postoperative fistula, 5 mg/kg of infliximab was started, and the amount of drainage decreased dramatically to less than 10 cc a day. Some studies have reported that infliximab decreases the recurrence of CD after surgery. The effect of infliximab on post-operative fistulas in patients with CD has not been sufficiently studied. Our results indicated that the use of infliximab to treat post-operative fistula should be explored further in future clinical studies.

Citations

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Treatment of abdominal fistulas in Crohn�s disease and monitoring with abdominal ultrasonography
Nadia Moreno Sánchez, José María Paredes, Tomas Ripollés, Javier Sanz de la Vega, Patricia Latorre, María Jesús Martínez, José Richart, José Vizuete, Eduardo Moreno-Osset
Revista Española de Enfermedades Digestivas.2020;[Epub] CrossRef
Factors Associated with Anxiety and Depression in Korean Patients with Inactive Inflammatory Bowel Disease
Min Chul Kim, Yoon Suk Jung, Young Seok Song, Jung In Lee, Jung Ho Park, Chong Il Sohn, Kyu Yong Choi, Dong Il Park
Gut and Liver.2016;[Epub] CrossRef
Efficacy and safety of CT‐P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study
Yoon Suk Jung, Dong Il Park, Young Ho Kim, Ji Hyun Lee, Pyoung Ju Seo, Jae Hee Cheon, Hyoun Woo Kang, Ji Won Kim
Journal of Gastroenterology and Hepatology.2015; 30(12): 1705. CrossRef
The clinical characteristics of patients with free perforation in Korean Crohn’s disease: results from the CONNECT study
Young Seok Doh, You Sun Kim, Song I Bae, Jong Pil Im, Jae Hee Cheon, Byong Duk Ye, Ji Won Kim, Young Sook Park, Ji Hyun Lee, Young-Ho Kim, Joo Sung Kim, Dong Soo Han, Won Ho Kim
BMC Gastroenterology.2015;[Epub] CrossRef

4,675 View
58 Download
4 Web of Science
4 Crossref

Refractory Duodenal Crohn's Disease Successfully Treated with Infliximab: You Lim Kim, Young Sook Park, Eun Kyoung Park, Dae Rim Park, Gyu Sik Choi, Sang Bong Ahn, Seong Hwan Kim, Yun Ju Jo; Intest Res 2014;12(1):66-69. Published online January 28, 2014; DOI: https://doi.org/10.5217/ir.2014.12.1.66

Abstract PDF PubReader

Crohn's disease (CD) may involve any part of the gastrointestinal tract, from the mouth to the anus. Approximately >90% of cases occur in the small bowel and colon. Upper gastrointestinal involvement, especially duodenal manifestation, is relatively rare. Therefore, adequate medical treatment for duodenal CD has not yet been established. We report a case of CD with duodenal involvement. A 46-year-old man with Crohn's ileocolitis presented to our hospital with right upper quadrant pain. An endoscopy showed a deep excavated ulcer with deformity at the duodenal bulb, and he was initially treated with azathioprine (1 mg/kg), Pentasa (3.0 g/day), and a proton pump inhibitor for 1 year. However, the deep ulcer did not heal. Therefore, infliximab infusion therapy was initiated, and the duodenal lesion completely resolved on follow-up esophagogastroduodenoscopy. We report a case of duodenal CD that completely resolved following infliximab infusion, with a review of the literature.

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Amy L Lightner
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Review

Diagnosis and Treatment of Latent Tuberculosis Infection in Patients with Inflammatory Bowel Diseases due to Initiation of Anti-Tumor Necrosis Factor Therapy: Tae Sun Shim; Intest Res 2014;12(1):12-19. Published online January 28, 2014; DOI: https://doi.org/10.5217/ir.2014.12.1.12

Abstract PDF PubReader

Patients with intractable inflammatory bowel diseases (IBD) are increasingly being treated with anti-tumor necrosis factor (TNF) agents and are at increased risk of developing tuberculosis (TB). Therefore, diagnosis and treatment of latent TB infection (LTBI) is recommended in patients due to the initiation of anti-TNF therapy. Traditionally, LTBI has been diagnosed on the basis of clinical factors and a tuberculin skin test. Recently, interferon-gamma releasing assays (IGRAs) that can detect TB infection have become available. Considering the high-risk of developing TB in patients on anti-TNF therapy, the use of both a tuberculin skin test and an IGRA should be considered to detect and treat LTBI in patients with IBD due to the initiation of anti-TNF therapy. The traditional LTBI treatment regimen has consisted of isoniazid monotherapy for 9 months. However, shorter regimens such as 4 months of rifampicin or 3 months of isoniazid/rifampicin have been used increasingly to improve treatment completion rates. In this review, the incidence of TB and the prevalence of LTBI in patients with IBD will be briefly described, as well as methods for diagnosing latent and active TB before anti-TNF therapy, current LTBI treatment regimens, recommendations for managing TB that develops during anti-TNF therapy, the necessity of regular monitoring to detect new TB infection, and the re-initiation of anti-TNF therapy in patients who develop TB.

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