Intestinal Research

Original Articles

IBD

Filgotinib induction-study baseline characteristics of patients with ulcerative colitis who achieve sustained corticosteroid-free remission: post hoc analysis of the phase 2b/3 SELECTION study: Taku Kobayashi, Axel Dignass, Xavier Roblin, Yoshie Takatori, Toshihiko Kaise, Alessandra Oortwijn, Corinne Jamoul, Toshifumi Hibi; Intest Res 2025;23(1):65-75. Published online June 14, 2024; DOI: https://doi.org/10.5217/ir.2024.00007

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Background/Aims
Obtaining and maintaining corticosteroid-free remission are important goals of treatment for ulcerative colitis (UC). Characteristics associated with achieving corticosteroid-free remission were assessed in filgotinib-treated patients in SELECTION, a 58-week, phase 2b/3 trial in moderately to severely active UC.
Methods
This post hoc analysis used data from filgotinib-treated patients receiving corticosteroids at maintenance baseline in SELECTION. Univariate logistic regression was performed to assess induction baseline characteristics associated with 6 months of corticosteroid-free remission at week 58, defined as clinical remission without using corticosteroids for at least 6 months.
Results
At maintenance baseline, 92 and 81 patients were receiving corticosteroids in the filgotinib 200 mg and filgotinib 100 mg groups, respectively. Age, body mass index, history of pancolitis, disease duration, fecal calprotectin levels, C-reactive protein levels, Mayo Clinic Score, concomitant corticosteroids, immunomodulators, and aminosalicylates had no statistically significant effect on the likelihood of achieving corticosteroid-free remission. Baseline characteristics associated with increased odds of corticosteroid-free remission were Mayo Clinic Endoscopic Subscore of 2 (vs. 3) in the filgotinib 200 mg and filgotinib 100 mg groups, and female (vs. male) sex, current (vs. former or never) smoking, and being biologic‑naive (vs. experienced) in the filgotinib 200 mg group.
Conclusions
Steroid tapering can be achieved in patients with UC receiving filgotinib 200 mg independently of baseline characteristics such as clinical activity and duration of illness. However, the likelihood of achieving corticosteroid-free remission was higher among patients who were biologic-naive, current smokers, had low endoscopic inflammatory burden and who were female.

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In which patients with ulcerative colitis would filgotinib be effective?
Jihye Park
Intestinal Research.2025; 23(1): 1. CrossRef

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IBD

Association between oral corticosteroid starting dose and the incidence of pneumonia in Japanese patients with ulcerative colitis: a nation-wide claims database study: Katsuyoshi Matsuoka, Tomoyuki Inoue, Hiroaki Tsuchiya, Katsumasa Nagano, Toshiyuki Iwahori; Intest Res 2024;22(3):319-335. Published online February 6, 2024; DOI: https://doi.org/10.5217/ir.2023.00071

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
A previous study demonstrated that half of patients started oral corticosteroids (OCS) for ulcerative colitis (UC) exacerbations at lower doses than recommended by Japanese treatment guidelines (initial OCS prednisolone equivalent dose, 30–40 mg). This may relate to physician’s concern about infection, especially pneumonia including Pneumocystis jirovecii pneumonia (PJP), from high OCS doses. We assessed whether pneumonia incidence is increased with guideline-recommended OCS initial doses.
Methods
This retrospective cohort study used the Japan Medical Data Center claims database (2012–2021). The whole cohort consisted of all UC patients who started OCS during the study period meeting the inclusion and exclusion criteria. The matched cohort was created by propensity score matching; the lower (initial OCS dose < 30 mg), guideline-recommended (30–40 mg), and higher groups ( > 40 mg) in a 2:2:1 ratio. Pneumonia incidence in the primary analysis was evaluated in the matched cohort. A Poisson regression model determined pneumonia-related risk factors in the whole cohort.
Results
After screening, 3,349 patients comprised the whole cohort; 1,775 patients comprised the matched cohort (lower dose, n = 710; guideline-recommended dose, n = 710; higher dose, n = 355). The incidence of any pneumonia was low; no differences were observed in incidence rates across these dose subgroups. In total, 3 PJP cases were found in the whole cohort, but not detected in the matched cohort. Several risk factors for any pneumonia were identified, including age, higher comorbidities index, treatment in large facility and hospitalization.
Conclusions
The incidence of pneumonia, including PJP, in UC patients was low across initial OCS dose treatment subgroups.

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IBD

Physician education can minimize inappropriate steroid use in patients with inflammatory bowel disease: the ACTION study: Yehyun Park, Chang Hwan Choi, Hyun Soo Kim, Hee Seok Moon, Do Hyun Kim, Jin Ju Kim, Dennis Teng, Dong Il Park; Intest Res 2022;20(4):452-463. Published online March 11, 2022; DOI: https://doi.org/10.5217/ir.2021.00125

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Background/Aims
Epidemiological data on steroid use in South Korean patients with inflammatory bowel disease (IBD) are limited. We documented the steroid use patterns in these patients, and whether physician education on appropriate steroid use affected these patterns.
Methods
ACTION was an observational cohort study conducted in adults (≥19 years) with IBD. A retrospective chart review was performed at baseline (cohort 1) and 1 year after physician training (cohort 2). Eligible cases with excessive or inappropriate steroid use were identified, along with any associated risk factors.
Results
Data were collected during May 2018-July 2019 from patients with Crohn’s disease (CD) and ulcerative colitis (UC) in cohort 1 (n=1,685) and cohort 2 (n=1,649). At baseline, 155 patients (9.2%) had received steroids within the previous 12 months, 46 (29.7%) of whom had used steroids excessively, 16 (34.8%) of these having inappropriately used excessive steroids. Although steroid exposure was similar in cohort 1 (9.2%) and cohort 2 (9.7%), the latter comprised fewer excessive steroid users (20.0% vs. 29.7%). Severe disease was associated with excessive steroid use in cases with UC, but not with CD.
Conclusions
Although, overall steroid use was relatively low in South Korean patients with IBD, one-third of steroid users used them excessively, and one-third among these used excessive steroids inappropriately. High disease activity was the main risk factor for excessive steroid use which may potentially be reduced by physician education, especially in cases with UC. Active screening to minimize excessive and inappropriate steroid use through physician education should be considered.

Citations

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Corticosteroid Use in Randomized Clinical Trials of Biologics and Small Molecules in Inflammatory Bowel Disease: A Systematic Review
Bruno César da Silva, Sam Papasotiriou, Stephen B Hanauer
Inflammatory Bowel Diseases.2024;[Epub] CrossRef
The Reliability and Quality of Short Videos as a Source of Dietary Guidance for Inflammatory Bowel Disease: Cross-sectional Study
Zixuan He, Zhijie Wang, Yihang Song, Yilong Liu, Le Kang, Xue Fang, Tongchang Wang, Xuanming Fan, Zhaoshen Li, Shuling Wang, Yu Bai
Journal of Medical Internet Research.2023; 25: e41518. CrossRef
Corticosteroid, a double-edged sword in inflammatory bowel disease management: possibility of reducing corticosteroid use through physician education
Seulji Kim, Seong-Joon Koh
Intestinal Research.2022; 20(4): 389. CrossRef

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Review

IBD

Management of Clostridioides difficile infection in patients with inflammatory bowel disease: Sahil Khanna; Intest Res 2021;19(3):265-274. Published online August 18, 2020; DOI: https://doi.org/10.5217/ir.2020.00045

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Inflammatory bowel disease (IBD) is a common diarrheal illness with gastrointestinal and extraintestinal manifestations and complications. The most common infectious complication associated with IBD is Clostridioides difficile infection (CDI). Active IBD predisposes to CDI due to alterations in the gut microbiome. C. difficile is a toxin producing bacterium leading to worsening of underlying IBD, increasing the risk of IBD treatment failure and an increased risk of hospitalization and surgery. Since the symptoms of CDI overlap with those of an IBD flare; it is prudent to recognize that the diagnosis of CDI is challenging and diagnostic tests (nucleic-acid and toxin-based assays) should be interpreted in context of symptoms and test performance. First line treatments for management of CDI in IBD include vancomycin or fidaxomicin. Recurrence prevention strategies should be implemented to mitigate recurrent CDI risk. One needs to monitor IBD disease progression and manage immunosuppression. The risk of recurrent CDI after a primary infection is higher in IBD compared to non-IBD patients. Microbiota restoration therapies are effective to prevent recurrent CDI in IBD patients. This review summarizes the epidemiology, pathophysiology, diagnostic testing, outcomes and management of both CDI and IBD, in CDI complicating IBD.

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Clostridioides difficile Toxin B Induced Senescence: A New Pathologic Player for Colorectal Cancer?
Katia Fettucciari, Alessandro Fruganti, Fabrizio Stracci, Andrea Spaterna, Pierfrancesco Marconi, Gabrio Bassotti
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Risk of all-cause and cause-specific mortality associated with immune-mediated inflammatory diseases in Korea
Oh Chan Kwon, See Young Lee, Jaeyoung Chun, Kyungdo Han, Yuna Kim, Ryul Kim, Min-Chan Park, Jie-Hyun Kim, Young Hoon Youn, Hyojin Park
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Fidaxomicin treatment for Clostridioides difficile infection in patients with inflammatory bowel disease
Andree H Koop, Paul M Travers, Sahil Khanna, Darrell S Pardi, Francis A Farraye, Jana G Hashash
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Leslie Sangurima, Maujid Masood Malik, Nency Ganatra, Rosemary Siby, Sanjay Kumar, Sara Khan, Doju Cheriachan, Lubna Mohammed
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Comparison of 1-Year Colectomy Risk Between the US and Korean Patients with Acute Severe Ulcerative Colitis: A Propensity Score Matching Analysis
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Jongwook Yu, Jae Hee Cheon
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Ann Smith
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Decreased secondary faecal bile acids in children with ulcerative colitis and Clostridioides difficile infection
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Journal of Inflammation Research.2021; Volume 14: 7443. CrossRef

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Original Article

IBD

The impact of corticosteroid use on inpatients with inflammatory bowel disease and positive polymerase chain reaction for Clostridium difficile: Huei-Wen Lim, Isaiah P. Schuster, Ramona Rajapakse, Farah Monzur, Sundas Khan, Keith Sultan; Intest Res 2019;17(2):244-252. Published online February 12, 2019; DOI: https://doi.org/10.5217/ir.2018.00101

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Background/Aims
Optimal management of inflammatory bowel disease (IBD) with concomitant Clostridium difficile infection (CDI) is controversial, especially when CDI diagnosis is made by polymerase chain reaction (PCR) testing, which may reflect colonization without infection.
Methods
We performed a multicenter review of all inpatients with IBD and PCR diagnosed CDI. Outcomes included length of stay, 30- and 90-day readmission, colectomy during admission and within 3 months, intensive care unit (ICU) admission, CDI relapse and death for patients who received corticosteroid (CS) after CDI diagnosis versus those that did not. Propensity-adjusted regression analysis of outcomes based on CS usage was performed.
Results
We identified 177 IBD patients with CDI, 112 ulcerative colitis and 65 Crohn’s disease. For IBD overall, CS after CDI diagnosis was associated with prolonged hospitalization (5.5 days: 95% confidence interval [CI], 1.5–9.6 days; P=0.008), higher colectomy rate within 3 months (odds ratio [OR], 5.5; 95% CI, 1.1–28.2; P=0.042) and more frequent ICU admissions (OR, 7.8; 95% CI, 1.5–41.6; P=0.017) versus no CS. CS use post-CDI diagnosis in UC patients was associated with prolonged hospitalization (6.2 days: 95% CI, 0.4– 12.0 days; P=0.036) and more frequent ICU admissions (OR, 7.4; 95% CI, 1.1–48.7; P=0.036).
Conclusions
CS use among IBD inpatients with CDI diagnosed by PCR is associated with poorer outcomes and would seem to reinforce the importance of C. difficile toxin assay to help distinguish colonization from infection. This adverse effect appears more prominent among those with UC.

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Clostridioides difficile infection in inflammatory bowel disease: a clinical review
Mengjun Tang, Chunhua Wang, Ying Xia, Jian Tang, Jiao Wang, Liang Shen
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The Current Knowledge on Clostridioides difficile Infection in Patients with Inflammatory Bowel Diseases
Alina Boeriu, Adina Roman, Crina Fofiu, Daniela Dobru
Pathogens.2022; 11(7): 819. CrossRef
Korean Association for the Study of Intestinal Diseases guidance for clinical practice of adult inflammatory bowel disease during the coronavirus disease 2019 pandemic: expert consensus statements
Yong Eun Park, Yoo Jin Lee, Ji Young Chang, Hyun Joo Song, Duk Hwan Kim, Young Joo Yang, Byung Chang Kim, Jae Gon Lee, Hee Chan Yang, Miyoung Choi, Seong-Eun Kim, Seung-Jae Myung
Intestinal Research.2022; 20(4): 431. CrossRef
KASID Guidance for Clinical Practice Management of Adult Inflammatory Bowel Disease during the COVID-19 Pandemic: Expert Consensus Statement
Yong Eun Park, Yoo Jin Lee, Ji Young Chang, Hyun Joo Song, Duk Hwan Kim, Young Joo Yang, Byung Chang Kim, Jae Gon Lee, Hee Chan Yang, Miyoung Choi, Seong-Eun Kim, Seung-Jae Myung
The Korean Journal of Gastroenterology.2021; 78(2): 105. CrossRef

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Statement

IBD

Consensus recommendations for patient-centered therapy in mild-to-moderate ulcerative colitis: the i Support Therapy–Access to Rapid Treatment (iSTART) approach: Silvio Danese, Rupa Banerjee, JR Fraser Cummings, Iris Dotan, Paulo G Kotze, Rupert Wing Loong Leong, Kristine Paridaens, Laurent Peyrin-Biroulet, Glyn Scott, Gert Van Assche, Jan Wehkamp, Jesús K Yamamoto-Furusho; Intest Res 2018;16(4):522-528. Published online October 16, 2018; DOI: https://doi.org/10.5217/ir.2018.00073

Abstract PDF Supplementary Material PubReader ePub

Symptomatic ulcerative colitis (UC) can be a chronic, disabling condition. Flares in disease activity are associated with many of the negative impacts of mild-to-moderate UC. Rapid resolution of flares can provide benefits to patients and healthcare systems. i Support Therapy–Access to Rapid Treatment (iSTART) introduces patient-centered care for mild-to-moderate UC. iSTART provides patients with the ability to self-assess symptomology and self-start a short course of second-line treatment when necessary. An international panel of experts produced consensus statements and recommendations. These were informed by evidence from systematic reviews on the epidemiology, mesalazine (5-ASA) treatment, and patient use criteria for second-line therapy in UC. Optimized 5-ASA is the first-line treatment in all clinical guidelines, but may not be sufficient to induce remission in all patients. Corticosteroids should be prescribed as second-line therapy when needed, with budesonide MMX® being a preferred steroid option. Active involvement of suitable patients in management of UC flares has the potential to improve therapy, with patients able to show good accuracy for flare self-assessment using validated tools. There is a place in the UC treatment pathway for an approach such as iSTART, which has the potential to provide patient, clinical and economic benefits.

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Sodium orthovanadate protects against ulcerative colitis and associated liver damage in mice: insights into modulations of Nrf2/Keap1 and NF-κB pathways
Gurpreet Kaur, Ajay Singh Kushwah
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Management and treatment optimization of patients with mild to moderate ulcerative colitis
Ferdinando D’Amico, Ernesto Fasulo, Vipul Jairath, Kristine Paridaens, Laurent Peyrin-Biroulet, Silvio Danese
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Practical management of mild-to-moderate ulcerative colitis: an international expert consensus
Ferdinando D’Amico, Fernando Magro, Axel Dignass, Sameer Al Awadhi, Ana Gutierrez Casbas, Natália Sousa Freitas Queiroz, Grażyna Rydzewska, Byong Duk Ye, Zhihua Ran, Ailsa Hart, Vipul Jairath, Gionata Fiorino, Laurent Peyrin-Biroulet, Silvio Danese
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Original Article

Usefulness of the Cytomegalovirus Antigenemia Assay in Patients With Ulcerative Colitis: Jaeyoung Chun, Changhyun Lee, Ji-eun Kwon, Sung Wook Hwang, Sang Gyun Kim, Joo Sung Kim, Hyun Chae Jung, Jong Pil Im; Intest Res 2015;13(1):50-59. Published online January 29, 2015; DOI: https://doi.org/10.5217/ir.2015.13.1.50

Abstract PDF PubReader

<b>Background/Aims</b><br/>

Patients with ulcerative colitis (UC) are at high risk for cytomegalovirus (CMV) reactivation. The usefulness of the CMV antigenemia assay in active UC patients has rarely been studied. We assessed whether the assay detects CMV colitis and predicts clinical outcomes in patients with UC.

Methods

We retrospectively reviewed the medical records of patients hospitalized for moderate-to-severe UC from 2003 to 2012. Positive CMV antigenemia was defined as ≥1 pp65-positive cell per 2×10⁵ polymorphonuclear neutrophils. CMV colitis was defined as the presence of inclusion bodies and/or positive immunohistochemistry in the colonic mucosa. The primary outcome was steroid refractoriness, defined as the absence of clinical improvement after intravenous high-dose steroid administration.

Results

A total of 43 patients were enrolled. CMV antigenemia was detected in 12 (27.9%) patients. Positive CMV antigenemia was significantly associated with CMV colitis (P =0.001). The sensitivity and specificity of positive CMV antigenemia for diagnosing CMV colitis were 66.7% and 87.1%, respectively. Steroid refractoriness was found in 11 of 12 (91.7%) and 12 of 31 (38.7%) patients with positive and negative CMV antigenemia, respectively (P =0.002). The independent predictors for steroid refractoriness were positive CMV antigenemia (adjusted odds ratio [OR], 7.73; 95% confidence interval [CI], 1.22-49.19; P =0.030) and a shorter duration from the diagnosis of UC (adjusted OR, 0.99; 95% CI, 0.98-0.99; P =0.025).

Conclusions

The CMV antigenemia assay shows low sensitivity but high specificity for detecting CMV colitis and may predict steroid-refractory UC. Early rescue therapy might be considered in UC patients positive for CMV antigenemia.

Citations

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The association between antigenemia, histology with immunohistochemistry, and mucosal PCR in the diagnosis of ulcerative colitis with concomitant human cytomegalovirus infection
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