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

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.

Citations

Citations to this article as recorded by

Clostridioides difficile infection in inflammatory bowel disease: a clinical review
Mengjun Tang, Chunhua Wang, Ying Xia, Jian Tang, Jiao Wang, Liang Shen
Expert Review of Anti-infective Therapy.2024; 22(5): 297. CrossRef
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

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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.

Citations

Citations to this article as recorded by

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
Naunyn-Schmiedeberg's Archives of Pharmacology.2025; 398(2): 1557. CrossRef
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
Expert Review of Clinical Immunology.2024; 20(3): 277. CrossRef
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
Expert Review of Gastroenterology & Hepatology.2024; 18(8): 421. CrossRef
Framework of IBD Care Delivery Across Ages
Stefan Delen, Susanna Jaghult, Irina Blumenstein, Lieven Pouillon, Peter Bossuyt
Journal of Crohn's and Colitis.2024; 18(Supplement): ii55. CrossRef
Effectiveness of Mesalamine in Patients With Ulcerative Colitis: A Systematic Review
Yurianna Santos, Arturo P Jaramillo
Cureus.2023;[Epub] CrossRef
Encoding bacterial colonization and therapeutic modality by wrapping with an adhesive drug-loadable nanocoating
Huilong Luo, Feng Wu, Xinyue Wang, Sisi Lin, Mengmeng Zhang, Zhenping Cao, Jinyao Liu
Materials Today.2023; 62: 98. CrossRef
iSTART-II: An Update on the i Support Therapy–Access to Rapid Treatment (iSTART) Approach for Patient-Centered Therapy in Mild-to-Moderate Ulcerative Colitis
Ferdinando D’Amico, Fernando Magro, Benedicte Caron, Axel Dignass, Vipul Jairath, Ailsa Hart, Paulo Gustavo Kotze, Kristine Paridaens, Sameer Al Awadhi, Taku Kobayashi, Britta Siegmund, Laurent Peyrin-Biroulet, Silvio Danese
Journal of Clinical Medicine.2023; 12(3): 1142. CrossRef
A review article of inflammatory bowel disease treatment and pharmacogenomics
Nashwa Eltantawy, Islam Abd El-Hamid El-Zayyadi, Ahmed A. Elberry, Layla M. Salah, Mohamed E. A. Abdelrahim, Amira B. Kassem
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Archives of Dermatological Research.2022; 315(1): 75. CrossRef
Mesalazine in the induction of clinical and endoscopic remission of mild and moderate ulcerative colitis
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Budesonide MMX in the Treatment of Ulcerative Colitis: Current Perspectives on Efficacy and Safety
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High Serum Osmolality May Predict the Disease Severity in Patients with Acute Ulcerative Colitis
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