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Original Articles
- Real-world efficacy and safety of upadacitinib in difficult-to-treat Crohn’s disease: a 24-week multicenter study from China
- Zile Zhang, Shuowen Zhang, Wensong Ge, Yue Li, Ruidong Chen, Wen Tang, Qunying Wang, Yihong Fan, Linyan Zhou, Feng Tian, Chunxiao Chen, Yubei Gu, Duowu Zou
- Received March 31, 2026 Accepted July 2, 2026 Published online September 4, 2026
- DOI: https://doi.org/10.5217/ir.2026.00114 [Epub ahead of print]
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Abstract
PDF - Background/Aims
Real-world evidence for upadacitinib use in strictly defined difficult-to-treat Crohn’s disease (DTT-CD), particularly in Asian populations, remains limited. Herein, we aimed to evaluate the efficacy and safety of upadacitinib in Chinese patients with DTT-CD.
Methods
This multicenter, bidirectional cohort study was conducted at 8 Chinese inflammatory bowel disease centers. Patients received upadacitinib 45 mg once daily for 12 weeks induction, followed by 15 mg daily for maintenance. The coprimary endpoints were clinical remission at week 12 and week 24.
Results
Among the 151 DTT-CD patients enrolled, the clinical remission rates were 47.0% at week 12 and 62.9% at week 24, with endoscopic remission achieved in 28.1% of patients at week 24. Adverse events occurred in 42 (27.8%) during induction and in 33 (21.9%) during maintenance, with 3 serious events (venous thrombosis, perforation, and hemorrhage) reported during the maintenance phase. Notably, 2 male reproductive system-related adverse events were observed, including blue semen in 2 patients and a suspected case of paternal teratogenicity with fetal anomalies and pregnancy loss. The drug persistence at week 24 was 93.4%.
Conclusions
Upadacitinib demonstrated robust efficacy in Chinese patients with DTT-CD, with a manageable safety profile and high treatment persistence.
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- 30 Download
- Efficacy and safety of mirikizumab in maintenance therapy for ulcerative colitis in difficult-to-treat inflammatory bowel disease: a single-center retrospective study in Japan
- Ichiro Mizushima, Yusuke Yoshimatsu, Hiroki Kiyohara, Shinya Sugimoto, Tomohisa Sujino, Kaoru Takabayashi, Yohei Mikami, Takanori Kanai
- Received August 13, 2025 Accepted November 19, 2025 Published online February 11, 2026
- DOI: https://doi.org/10.5217/ir.2025.00176 [Epub ahead of print]
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Abstract
PDF
Supplementary Material
PubReader
ePub - Background/Aims
Randomized controlled trials have confirmed the efficacy and safety of mirikizumab, an anti-interleukin-23p19 monoclonal antibody, for moderate-to-severe active ulcerative colitis (UC). However, there are no real-world data on the efficacy and safety of mirikizumab for UC as maintenance therapy, especially in difficult-to-treat inflammatory bowel disease (DTT-IBD). This study aimed to evaluate the long-term efficacy and safety of mirikizumab in patients with UC of DTT-IBD.
Methods
This was a single-center retrospective observational study involving adult patients with UC who received mirikizumab between January 2023 and April 2025 and met the criteria for DTT-IBD (e.g., failure of biologics and advanced small molecule drugs with at least 2 different mechanisms of action). The primary outcome was the clinical response at week 52. Secondary outcomes included steroid-free clinical remission within 52 weeks and the persistency of mirikizumab use. Adverse events were also recorded.
Results
Thirty-two patients were included in this study. The median 2-item patient-reported outcome score at baseline was 3 (interquartile range, 2–4). The proportion of patients with a clinical response at week 52 was 33.3% (95% confidence interval, 14.6%–57.0%). Steroid-free clinical remission was achieved in 26.7% (95% confidence interval, 12.3%–45.9%) of the patients. The cumulative continuous rate of mirikizumab use at week 52 was approximately 60%. Only 1 patient developed a serious adverse event requiring hospitalization (pneumonia), and mirikizumab was successfully resumed after recovery.
Conclusions
The present study demonstrated real-world data regarding maintenance therapy with mirikizumab for UC among patients with DTT-IBD. -
Citations
Citations to this article as recorded by
- Comments on “Efficacy and safety of mirikizumab in maintenance therapy for ulcerative colitis in difficultto- treat inflammatory bowel disease: a single-center retrospective study in Japan”
Chenchen Xu, Hailing Li
Intestinal Research.2026;[Epub] CrossRef - Real-world effectiveness and predictors of need for extended induction of mirikizumab therapy in ulcerative colitis
Cathy McShane, Itay Kalisky, Jonah S Moore, Raquel Milgrom, Joanne Stempak, Pablo A Olivera, Geoffrey Nguyen, Kenneth Croitoru, Vivian W Huang, Laura E Targownik, Adam V Weizman, A Hillary Steinhart, Zane Gallinger, Sun-Ho Lee, Greg Rosenfeld, Mark S Silv
Journal of the Canadian Association of Gastroenterology.2026;[Epub] CrossRef
- Comments on “Efficacy and safety of mirikizumab in maintenance therapy for ulcerative colitis in difficultto- treat inflammatory bowel disease: a single-center retrospective study in Japan”
- 3,199 View
- 425 Download
- 2 Web of Science
- 2 Crossref
- 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
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Abstract
PDFPubReader
<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.
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Citations
Citations to this article as recorded by- Cytomegalovirus Colitis during Budesonide Therapy for Ulcerative Colitis
Kana Tamazawa, Masato Aizawa, Jun Wada, Natsuki Ishizaki, Kohei Suzuki, Kakeru Otomo, Tadayuki Takagi, Kazutomo Togashi, Hiromasa Ohira
Internal Medicine.2026; 65(16): 2205. CrossRef - Sensitivity and specificity of diagnostic modalities to diagnose CMV in coexisting IBD in patients hospitalized with acute colitis: a systematic review and meta-analysis
Simon Mark Seddon, David Godfrey, Sheng Wei Lo, George Azzi, Faris Gondal, William Beattie, Jonathan Segal
Inflammatory Bowel Diseases.2026;[Epub] CrossRef - Identifying new strategies to combat cytomegalovirus by integrating existing and innovative approaches in diagnosis and treatment
Nargiz Imamova, Ayten Feteliyeva, Adil M. Allahverdiyev
Future Virology.2025; 20(10): 379. CrossRef - The association between antigenemia, histology with immunohistochemistry, and mucosal PCR in the diagnosis of ulcerative colitis with concomitant human cytomegalovirus infection
Tsukasa Yamawaka, Hiroki Kitamoto, Masanori Nojima, Tomoe Kazama, Kohei Wagatsuma, Keisuke Ishigami, Shuji Yamamoto, Yusuke Honzawa, Minoru Matsuura, Hiroshi Seno, Hiroshi Nakase
Journal of Gastroenterology.2023; 58(1): 44. CrossRef - Predictive Factors of Cytomegalovirus Viremia during the Clinical Course of Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis: A Single Center Observational Study
Makoto Harada, Ryohei Iwabuchi, Akinori Yamaguchi, Daiki Aomura, Yosuke Yamada, Kosuke Sonoda, Yutaka Kamimura, Koji Hashimoto, Yuji Kamijo
Journal of Clinical Medicine.2023; 12(1): 351. CrossRef - A quick guide to diagnosis and treatment of cytomegalovirus infection in the gut: current dilemmas
Iļja Drjagunovs, Sniedze Laivacuma, Indra Zeltiņa, Aleksejs Derovs
Proceedings of the Latvian Academy of Sciences. Section B. Natural, Exact, and Applied Sciences..2022; 76(5-6): 585. CrossRef - Iranian kidney transplant recipients with COVID‐19 infection: Clinical outcomes and cytomegalovirus coinfection
Hamideh Molaei, Leila Khedmat, Eghlim Nemati, Zohreh Rostami, Seyed Hassan Saadat
Transplant Infectious Disease.2021;[Epub] CrossRef - Granulocyte and Monocyte Adsorptive Apheresis for Ulcerative Colitis in a Patient with Low Bone Mineral Density Due to Fanconi-Bickel Syndrome
Makoto Tanaka, Mayuko Nakanishi, Hajime Miyazaki, Ryuichi Morita, Hiroki Eguchi, Yoshiya Takeda, Masanobu Katayama, Motoo Tanaka, Masamichi Bamba, Tadashi Shigematsu
Internal Medicine.2021; 60(15): 2413. CrossRef - Fulminant amebic colitis in a patient with concomitant cytomegalovirus infection after systemic steroid therapy: A case report
Naoki Shijubou, Toshiyuki Sumi, Koki Kamada, Takeyuki Sawai, Yuichi Yamada, Tatsuru Ikeda, Hisashi Nakata, Yuji Mori, Hirofumi Chiba
World Journal of Clinical Cases.2021; 9(15): 3726. CrossRef - Risk Factors of Cytomegalovirus Reactivation in Ulcerative Colitis Patients: A Meta-Analysis
Yafei Qin, Grace Wang, Dejun Kong, Guangming Li, Hongda Wang, Hong Qin, Hao Wang
Diagnostics.2021; 11(11): 1952. CrossRef - High mucosal cytomegalovirus DNA helps predict adverse short-term outcome in acute severe ulcerative colitis
Saransh Jain, Divya Namdeo, Pabitra Sahu, Saurabh Kedia, Peush Sahni, Prasenjit Das, Raju Sharma, Vipin Gupta, Govind Makharia, Lalit Dar, Simon PL Travis, Vineet Ahuja
Intestinal Research.2021; 19(4): 438. CrossRef - Current Diagnostic and Therapeutic Approaches to Cytomegalovirus Infections in Ulcerative Colitis Patients Based on Clinical and Basic Research Data
Yoshihiro Yokoyama, Tsukasa Yamakawa, Takehiro Hirano, Tomoe Kazama, Daisuke Hirayama, Kohei Wagatsuma, Hiroshi Nakase
International Journal of Molecular Sciences.2020; 21(7): 2438. CrossRef - Ulcerative Colitis and Cytomegalovirus Infection: From A to Z
Fadi H Mourad, Jana G Hashash, Viraj C Kariyawasam, Rupert W Leong
Journal of Crohn's and Colitis.2020; 14(8): 1162. CrossRef - Cytomegalovirus and Inflammatory Bowel Diseases (IBD) with a Special Focus on the Link with Ulcerative Colitis (UC)
Alexandre Jentzer, Pauline Veyrard, Xavier Roblin, Pierre Saint-Sardos, Nicolas Rochereau, Stéphane Paul, Thomas Bourlet, Bruno Pozzetto, Sylvie Pillet
Microorganisms.2020; 8(7): 1078. CrossRef - A Practical Review of Cytomegalovirus in Gastroenterology and Hepatology
Ali Y. Fakhreddine, Catherine T. Frenette, Gauree G. Konijeti
Gastroenterology Research and Practice.2019; 2019: 1. CrossRef - Antiviral Treatment for Colonic Cytomegalovirus Infection in Ulcerative Colitis Patients Significantly Improved Their Surgery Free Survival
Yinghong Wang, Pankaj Aggarwal, Xiuli Liu, Haiyan Lu, Lei Lian, Xianrui Wu, Shibin Guo, Nitin Aggarwal, Bret Lashner, Bo Shen
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Kiyotaka Okawa, Tetsuya Aoki, Wataru Ueda, Koji Sano, Hiroshi Ono, Syusuke Nakauchi
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Sung Chul Park, Yoon Mi Jeen, Yoon Tae Jeen
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Hiroshi Nakase, Kei Onodera
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Ho-Su Lee, Sang Hyoung Park, Sung-Han Kim, Jihun Kim, Jene Choi, Hyo Jeong Lee, Wan Soo Kim, Jeong-Mi Lee, Min Seob Kwak, Sung Wook Hwang, Dong-Hoon Yang, Kyung-Jo Kim, Byong Duk Ye, Jeong-Sik Byeon, Seung-Jae Myung, Yong Sik Yoon, Chang Sik Yu, Jin-Ho Ki
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Kyeong Ok Kim
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Sooyun Chang, Jae Hee Cheon
Intestinal Research.2015; 13(1): 2. CrossRef - Author's Reply
Jaeyoung Chun, Jong Pil Im
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Saifun Nahar
World Journal of Gastroenterology.2015; 21(44): 12667. CrossRef
- Cytomegalovirus Colitis during Budesonide Therapy for Ulcerative Colitis
- 8,540 View
- 74 Download
- 25 Web of Science
- 25 Crossref
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