Intestinal Research

Original Articles

Escalation to biologics after corticosteroids in patients with newly diagnosed Crohn’s disease in Japan: a claims analysis from 2010 to 2021: Minoru Matsuura, Annabelle Yoon, Jun Miyoshi, Tadakazu Hisamatsu; Received April 17, 2025 Accepted August 18, 2025 Published online November 25, 2025; DOI: https://doi.org/10.5217/ir.2025.00059 [Epub ahead of print]

Abstract PDF PubReader ePub: Background/Aims
A previous health insurance claims study of Japanese patients with newly diagnosed Crohn’s disease (CD) reported an increase in “step-up” approach from 2010 to 2020, with biologic use in the first year remaining stable. This study examined systemic corticosteroid (SCS) use for newly diagnosed CD in Japan and compared patients who were escalated (“step-up”) and were not escalated to biologics.
Methods
This retrospective longitudinal cohort study used health insurance claims data (JMDC database). Patients diagnosed with CD from 2010 to 2020 who had no CD-related claims for ≥ 1 year before index, were traceable for ≥ 1 year after index, and treated with ≥ 1 pre-defined treatment were included. Patients classified by SCS and/or biologic use within 1 year after diagnosis were compared.
Results
Of 823 patients, 379 (46.1%) received SCS in the first year; of these, 43.5% escalated to biologics (step-up group) and 56.5% did not (SCS group). The proportion of patients receiving SCS increased from 25.8% in 2010–2011 to 55.5% in 2020; proportion escalated to biologics increased from 33.8% in 2016–2017 to 51.0% in 2020. The step-up group was significantly younger, more likely to have perianal lesions, and received more intensive treatments than the SCS group. In terms of SCS use, the step-up group was more likely to have shorter time-to-SCS initiation, and a higher initial SCS dose, than the SCS group.
Conclusions
Escalation from SCS to biologics in Japanese patients with newly diagnosed CD increased between 2016 and 2020, particularly in patients with younger onset CD or perianal complications.

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Clinical spectrum of acute severe ulcerative colitis in the biologic era: a prospective cohort study from India: Arshdeep Singh, Mayur Luthra, Arshia Bhardwaj, Ramit Mahajan, Riya Sharma, Dharmatma Singh, Devanshi Jain, Omesh Goyal, Varun Mehta, Kirandeep Kaur, Yogesh Kumar Gupta, Vandana Midha, Ajit Sood; Received November 18, 2024 Accepted March 4, 2025 Published online June 9, 2025; DOI: https://doi.org/10.5217/ir.2024.00189 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
Acute severe ulcerative colitis (ASUC) is a time-critical situation requiring urgent intervention. Limited data exist on the evolving clinical spectrum of ASUC in the era of advanced therapies.
Methods
This prospective real-world observational cohort study included 145 adult patients hospitalized with ASUC between January 2020 and June 2024. ASUC was defined by the modified Truelove and Witts criteria. Demographics and disease characteristics, including disease severity, probable precipitating factors, and corticosteroid failure rates, were recorded.
Results
The median age of patients was 36 years (interquartile range, 26–48.5 years) with 63 females (43.4%). Most patients had left-sided colitis (53.1%). The median disease duration was 1 year (IQR, 0.5–3 years), with 91 patients (62.7%) presenting with ASUC within the first year of diagnosis of ulcerative colitis. One-third of the patients had previous exposure to biologics and small molecules. The most commonly reported probable precipitants of ASUC were poor compliance with treatment (n = 43, 29.6%), antibiotic use (n = 35, 24.1%), high perceived stress (n = 32, 22.1%), and Clostridioides difficile infection (n = 19, 13.1%). Forty patients (27.5%) were non-responders to intravenous corticosteroids (IVCS). Twenty-nine patients (20%) received medical rescue therapy (infliximab, n = 14 [48.27%], cyclosporine A, n = 6 [20.68%], and tofacitinib, n = 9 [31.03%]). Seven patients (4.82%; 4 after non-response to IVCS and 3 after non-response to medical rescue therapy) underwent colectomy.
Conclusions
In this cohort of ASUC patients, poor treatment compliance, antibiotic use, stress, and C. difficile infection were common precipitants of flare-ups. Nearly one-third of patients required medical rescue therapy, and a small proportion ultimately underwent colectomy.

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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

Abstract PDF Supplementary Material PubReader ePub

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.

Citations

Citations to this article as recorded by

In which patients with ulcerative colitis would filgotinib be effective?
Jihye Park
Intestinal Research.2025; 23(1): 1. CrossRef
Three Janus kinase inhibitors in ulcerative colitis: is upadacitinib taking the lead?
Yoon Suk Jung
Intestinal Research.2025; 23(4): 394. 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.

Citations

Citations to this article as recorded by

Metabolic Disorders and Inflammatory Bowel Diseases
Hye Kyung Hyun, Jae Hee Cheon
Gut and Liver.2025; 19(3): 307. CrossRef
Assessment of healthcare resource utilization and direct medical cost in relation to treatment length of oral corticosteroids in biologic-initiated patients with ulcerative colitis: a Japanese claims database study
Celine Miyazaki, Tomoyuki Inoue, Shinya Sugimoto, Shinichi Yoshigoe, Nan Li
Journal of Medical Economics.2025; 28(1): 1526. CrossRef
Severe Pneumocystis jirovecii Pneumonia That Was Difficult to Diagnose due to Complications of Postoperative Candida Sepsis in an Elderly Patient with Ulcerative Colitis: A Case Report
Kenichiro Toritani, Hideaki Kimura, Manabu Maebashi, Kota Imanishi, Minoru Homma, Kazuki Kurimura, Serina Haruyama, Yoshinori Nakamori, Reiko Kunisaki, Itaru Endo
Case Reports in Gastroenterology.2025; 19(1): 675. CrossRef

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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

Abstract PDF PubReader ePub

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

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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Synergic effect of combined melatonin and tofacitinib on ameliorating dextran sulfate sodium-induced colitis in rat---role of JAKs/STAT, cell-stress signaling, and inflammatory-immune reaction
Chia-Lo Chang
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Ferdinando D’Amico, Ernesto Fasulo, Vipul Jairath, Kristine Paridaens, Laurent Peyrin-Biroulet, Silvio Danese
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Stefan Delen, Susanna Jaghult, Irina Blumenstein, Lieven Pouillon, Peter Bossuyt
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