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Original Articles
- Comparative short-term efficacy of upadacitinib versus tofacitinib for ulcerative colitis: a 24-week real-world study in Japan
- Akiko Tamura, Hiromichi Shimizu, Toshimitsu Fujii, Ami Kawamoto, Ryo Morikawa, Shuji Hibiya, Kento Takenaka, Masakazu Nagahori, Kazuo Ohtsuka, Ryuichi Okamoto
- Received November 14, 2024 Accepted February 10, 2025 Published online March 20, 2025
- DOI: https://doi.org/10.5217/ir.2024.00187 [Epub ahead of print]
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Abstract
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Supplementary Material
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ePub - Background/Aims
Tofacitinib and upadacitinib are small-molecule compounds that inhibit the Janus kinase pathway for the treatment of refractory ulcerative colitis. Only a few reports have compared the efficacy and safety of these 2 drugs in real-world practice. We aimed to show our real-world evidence of these drugs and compare the efficacy and safety profiles in the treatment of ulcerative colitis.
Methods
This study is a single-center retrospective analysis. Patients treated with tofacitinib or upadacitinib at our hospital between June 2018 and January 2024 who were monitored for 24 weeks were included. The primary outcome was steroid-free clinical remission at 24 weeks. Secondary outcomes were response and remission rates at each time point, time series changes in partial Mayo scores and laboratory results, treatment survival at 24 weeks, and the incidence of adverse events.
Results
A total of 68 patients treated with tofacitinib and 34 patients treated with upadacitinib were included. Steroid-free clinical remission rate at 24 weeks was significantly higher in upadacitinib-treated patients than in tofacitinibtreated patients (64.7% vs. 38.2%). The response rates in upadacitinib-treated patients exceeded 60% after 8 weeks of treatment through to 24 weeks, and the rates were higher than those in tofacitinib-treated patients. The incidences of adverse events were 79.4% in upadacitinib-treated patients and 38.2% in tofacitinib-treated patients. The most common adverse event was acne for upadacitinib.
Conclusions
Upadacitinib was more effective than tofacitinib in inducing remission in ulcerative colitis patients. The incidence of adverse events was significantly higher with upadacitinib than tofacitinib.
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- IBD
- Long-term efficacy and safety of tofacitinib in patients with ulcerative colitis: 3-year results from a real-world study
- Hiromichi Shimizu, Yuko Aonuma, Shuji Hibiya, Ami Kawamoto, Kento Takenaka, Toshimitsu Fujii, Eiko Saito, Masakazu Nagahori, Kazuo Ohtsuka, Ryuichi Okamoto
- Intest Res 2024;22(3):369-377. Published online July 16, 2024
- DOI: https://doi.org/10.5217/ir.2023.00194
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Abstract
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- Background/Aims
The efficacy and safety of tofacitinib for the treatment of refractory ulcerative colitis (UC) has been demonstrated in clinical trials. Although, a series of reports with real-world evidence of its short-term efficacy and safety profiles have already been published, reports of long-term real-world data have been limited. We aimed to show our 3-year evidence on the clinical use of tofacitinib for the treatment of UC, focusing on its efficacy and safety profiles.
Methods
A retrospective observational study was conducted on patients who started tofacitinib for active refractory UC at our hospital. The primary outcome was the retention rate until 156 weeks after initiating tofacitinib. The secondary outcomes were short-term efficacy at 4, 8, and 12 weeks; long-term efficacy at 52, 104, and 156 weeks; prognostic factors related to the cumulative retention rate; loss of response; and safety profile, including adverse events.
Results
Forty-six patients who were able to be monitored for up to 156 weeks after tofacitinib initiation, were enrolled in this study. Continuation of tofacitinib was possible until 156 weeks in 54.3%, with > 50% response rates and > 40% remission rates. Among patients in whom response or remission was achieved and tofacitinib was deescalated after 8 weeks of induction treatment, 54.3% experienced relapse but were successfully rescued by and retained on reinduction treatment, except for 1 patient. No serious AEs were observed in the study.
Conclusions
Tofacitinib is effective and safe as long-term treatment in a refractory cohort of UC patients in real-world clinical practice. -
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 - Tofacitinib for ulcerative colitis in Brazil: a multicenter observational study on effectiveness and safety
Rogério Serafim Parra, Renata de Sá Brito Fróes, Daniela Oliveira Magro, Sandro da Costa Ferreira, Munique Kurtz de Mello, Matheus Freitas Cardoso de Azevedo, Aderson Omar Mourão Cintra Damião, Alexandre de Sousa Carlos, Luísa Leite Barros, Maria Luiza Qu
BMC Gastroenterology.2025;[Epub] CrossRef
- In which patients with ulcerative colitis would filgotinib be effective?
- 2,859 View
- 176 Download
- 3 Web of Science
- 2 Crossref
- Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study
- Taku Kobayashi, Kei Moriya, Toshimitsu Fujii, Shigeki Bamba, Shinichiro Shinzaki, Akihiro Yamada, Takashi Hisabe, Shintaro Sagami, Shuji Hibiya, Takahiro Amano, Noritaka Takatsu, Katsutoshi Inagaki, Ken-ichi Iwayama, Toshifumi Hibi
- Received January 11, 2024 Accepted April 29, 2024 Published online July 15, 2024
- DOI: https://doi.org/10.5217/ir.2024.00005 [Epub ahead of print]
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Abstract
PDFSupplementary MaterialPubReaderePub
- Background/Aims
Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
Methods
This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Results
Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.
Conclusions
The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.
- 2,363 View
- 265 Download
- IBD
- Combination of leucine-rich alpha-2 glycoprotein and fecal markers detect Crohn’s disease activity confirmed by balloon-assisted enteroscopy
- Ami Kawamoto, Kento Takenaka, Shuji Hibiya, Yoshio Kitazume, Hiromichi Shimizu, Toshimitsu Fujii, Eiko Saito, Kazuo Ohtsuka, Ryuichi Okamoto
- Intest Res 2024;22(1):65-74. Published online November 9, 2023
- DOI: https://doi.org/10.5217/ir.2023.00092
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Abstract
PDFSupplementary MaterialPubReaderePub
- Background/Aims
Endoscopic activity confirmed by enteroscopy is associated with poor clinical outcome in Crohn’s disease (CD). We investigated which of the existing biomarkers best reflects endoscopic activity in CD patients including the small bowel, and whether their combined use can improve accuracy.
Methods
One hundred and four consecutive patients with ileal and ileocolonic type CD who underwent balloon-assisted enteroscopy (BAE) from October 2021 to August 2022 were enrolled, with clinical and laboratory data prospectively collected and analyzed.
Results
Hemoglobin, platelet count, C-reactive protein, leucine-rich alpha-2 glycoprotein (LRG), fecal calprotectin, and fecal hemoglobin all showed significant difference in those with ulcers found on BAE. LRG and fecal calprotectin showed the highest areas under the curve (0.841 and 0.853) for detecting ulcers. LRG showed a sensitivity of 78% and specificity of 80% at a cutoff value of 13 μg/mL, whereas fecal calprotectin showed a sensitivity of 91% and specificity of 67% at a cutoff value of 151 μg/g. Dual positivity for LRG and fecal calprotectin, as well as LRG and fecal hemoglobin, both predicted ulcers with an improved specificity of 92% and 100%. A positive LRG or fecal calprotectin/hemoglobin showed an improved sensitivity of 96% and 91%. Positivity for LRG and either of the fecal biomarkers was associated with increased risk of hospitalization, surgery, and relapse.
Conclusions
The biomarkers LRG, fecal calprotectin, and fecal hemoglobin can serve as noninvasive and accurate tools for assessing activity in CD patients confirmed by BAE, especially when used in combination. -
Citations
Citations to this article as recorded by- Leucine-rich alpha-2 glycoprotein in combination with C-reactive protein for predicting endoscopic activity in Crohn’s disease: a single-centre, cross-sectional study
Yoshiaki Takada, Hiroki Kiyohara, Yohei Mikami, Masataka Taguri, Ryoya Sakakibara, Yasuhiro Aoki, Kosaku Nanki, Takaaki Kawaguchi, Yusuke Yoshimatsu, Shinya Sugimoto, Tomohisa Sujino, Kaoru Takabayashi, Naoki Hosoe, Haruhiko Ogata, Motohiko Kato, Yasushi
Annals of Medicine.2025;[Epub] CrossRef - Leucine-rich alpha-2 glycoprotein as a superior biomarker to C-reactive protein for detecting small bowel lesions in Crohn’s disease
Masashi Ohno, Atsushi Nishida, Akinori Otsuki, Yoshihiro Yokota, Takayuki Imai, Shigeki Bamba, Osamu Inatomi
World Journal of Gastrointestinal Endoscopy.2025;[Epub] CrossRef - The usefulness of serum leucine-rich alpha-2 glycoprotein as a novel biomarker in monitoring inflammatory bowel disease: a systematic review and meta-analysis
Fatemeh Ojaghi Shirmard, Seyed Morteza Pourfaraji, Behrad Saeedian, Tannaz Bagheri, Abdulrahman Ismaiel, Satohiro Matsumoto, Nastaran Babajani
European Journal of Gastroenterology & Hepatology.2025;[Epub] CrossRef - Diagnostic accuracy and cut-off values of serum leucine-rich alpha-2 glycoprotein for Crohn’s disease activity in the small bowel
Muneyori Okita, Kento Takenaka, Fumihito Hirai, Shinya Ashizuka, Hideki Iijima, Shigeki Bamba, Toshimitsu Fujii, Kenji Watanabe, Yosuke Shimodaira, Hisashi Shiga, Sakiko Hiraoka, Toshihiro Inokuchi, Takeshi Yamamura, Ryo Emoto, Shigeyuki Matsui
Journal of Gastroenterology.2025; 60(5): 573. CrossRef - Which biomarkers best reflect the degree of inflammation in Crohn’s disease?
Jihye Park
Intestinal Research.2024; 22(1): 1. CrossRef - Efficacy of serum leucine-rich alpha-2 glycoprotein in predicting findings of Crohn’s disease small bowel lesion in capsule endoscopy
Teppei Omori, Miki Koroku, Shun Murasugi, Ayumi Ito, Maria Yonezawa, Shinichi Nakamura, Katsutoshi Tokushige
Intestinal Research.2024; 22(4): 464. CrossRef - Selection of anti-cytokine biologics by pretreatment levels of serum leucine-rich alpha-2 glycoprotein in patients with inflammatory bowel disease
Takahiro Amano, Takeo Yoshihara, Shinichiro Shinzaki, Yuko Sakakibara, Takuya Yamada, Naoto Osugi, Satoshi Hiyama, Yoko Murayama, Koji Nagaike, Hideharu Ogiyama, Toshio Yamaguchi, Yuki Arimoto, Ichizo Kobayashi, Shoichiro Kawai, Satoshi Egawa, Takashi Kiz
Scientific Reports.2024;[Epub] CrossRef
- Leucine-rich alpha-2 glycoprotein in combination with C-reactive protein for predicting endoscopic activity in Crohn’s disease: a single-centre, cross-sectional study
- 4,261 View
- 311 Download
- 7 Web of Science
- 7 Crossref
Brief Communication
- IBD
- Rapid prediction of 1-year efficacy of tofacitinib for treating refractory ulcerative colitis
- Hiromichi Shimizu, Toshimitsu Fujii, Shuji Hibiya, Maiko Motobayashi, Kohei Suzuki, Kento Takenaka, Eiko Saito, Masakazu Nagahori, Kazuo Ohtsuka, Mamoru Watanabe
- Intest Res 2021;19(1):115-118. Published online June 11, 2020
- DOI: https://doi.org/10.5217/ir.2020.00030
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Citations
Citations to this article as recorded by- Inflammatory bowel disease therapeutics: a bibliometric analysis of tofacitinib research in ulcerative colitis
Jianping Zhou, Yuting Xi, Yaping Zhang, Rui Zhang, Hao Fu, Ce Zhou
Frontiers in Pharmacology.2025;[Epub] CrossRef - Histological healing induced by tofacitinib in ulcerative colitis: A multicentre study
Sophie Vieujean, David Laharie, Anthony Buisson, Xavier Roblin, Mathurin Fumery, Stephane Nancey, Pauline Wils, Romain Altwegg, Laurence Seidel, Bénédicte Caron, Laurent Peyrin-Biroulet
Digestive and Liver Disease.2024; 56(4): 613. CrossRef - Continued JAK inhibitor treatment on the risk of recurrent herpes zoster reactivation in patients with immune-mediated inflammatory diseases: A nationwide population-based study in South Korea
Young-Eun Kim, Ye-Jee Kim, Dae Hyun Jeong, Seonok Kim, Min Jee Kim, Hyeon Hwa Kim, Kyung-Wook Jo, Sang Hyoung Park, Seokchan Hong
Seminars in Arthritis and Rheumatism.2024; 65: 152362. CrossRef - Preventing and managing cardiovascular events in patients with inflammatory bowel diseases treated with small-molecule drugs, an international Delphi consensus
Pablo A. Olivera, Axel Dignass, Marla C. Dubinsky, Giovanni Peretto, Paulo G. Kotze, Iris Dotan, Taku Kobayashi, Subrata Ghosh, Fernando Magro, Jose Rocha Faria-Neto, Britta Siegmund, Silvio Danese, Laurent Peyrin-Biroulet
Digestive and Liver Disease.2024; 56(8): 1270. CrossRef - Long-term efficacy and safety of tofacitinib in patients with ulcerative colitis: 3-year results from a real-world study
Hiromichi Shimizu, Yuko Aonuma, Shuji Hibiya, Ami Kawamoto, Kento Takenaka, Toshimitsu Fujii, Eiko Saito, Masakazu Nagahori, Kazuo Ohtsuka, Ryuichi Okamoto
Intestinal Research.2024; 22(3): 369. CrossRef - Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis: post-marketing surveillance study
Hyuk Yoon, Byong Duk Ye, Sang-Bum Kang, Kang-Moon Lee, Chang Hwan Choi, Joo-young Jo, Juwon Woo, Jae Hee Cheon
BMC Gastroenterology.2024;[Epub] CrossRef - Effectiveness of tofacitinib in patients with ulcerative colitis: an updated systematic review and meta-analysis of real-world studies
Chien-Hung Lin, Wen-Sheng Liu, Chuan Wan, Hsin-Hui Wang
BMJ Open Gastroenterology.2024; 11(1): e001347. CrossRef - Real-World Evidence of Tofacinitib in Ulcerative Colitis: Short-Term and Long-Term Effectiveness and Safety
María Chaparro, Diana Acosta, Cristina Rodríguez, Francisco Mesonero, Miren Vicuña, Manuel Barreiro-de Acosta, Agnès Fernández-Clotet, Álvaro Hernández Martínez, Maite Arroyo, Isabel Vera, Alexandra Ruiz-Cerulla, Beatriz Sicilia, M. José Cabello Tapia, Ca
American Journal of Gastroenterology.2023; 118(7): 1237. CrossRef - Real-life effectiveness and safety of tofacitinib treatment in patients with ulcerative colitis: a KASID multicenter cohort study
Seung Hwan Shin, Kyunghwan Oh, Sung Noh Hong, Jungbok Lee, Shin Ju Oh, Eun Soo Kim, Soo-Young Na, Sang-Bum Kang, Seong-Joon Koh, Ki Bae Bang, Sung-Ae Jung, Sung Hoon Jung, Kyeong Ok Kim, Sang Hyoung Park, Suk-Kyun Yang, Chang Hwan Choi, Byong Duk Ye
Therapeutic Advances in Gastroenterology.2023;[Epub] CrossRef - Review article: Risk of cardiovascular events in patients with inflammatory bowel disease receiving small molecule drugs
Pablo A. Olivera, Juan S. Lasa, Giovanni Peretto, Stephane Zuily, Silvio Danese, Laurent Peyrin‐Biroulet
Alimentary Pharmacology & Therapeutics.2023; 57(11): 1231. CrossRef - Positioning of tofacitinib in treatment of ulcerative colitis: a global perspective
Shubhra Mishra, Anuraag Jena, Rinkalben Kakadiya, Vishal Sharma, Vineet Ahuja
Expert Review of Gastroenterology & Hepatology.2022; 16(8): 737. CrossRef - Oral beclomethasone dipropionate as an add-on therapy and response prediction in Korean patients with ulcerative colitis
Kyuwon Kim, Hee Seung Hong, Kyunghwan Oh, Jae Yong Lee, Seung Wook Hong, Jin Hwa Park, Sung Wook Hwang, Dong-Hoon Yang, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Byong Duk Ye, Sang Hyoung Park
The Korean Journal of Internal Medicine.2022; 37(6): 1140. CrossRef - Review article: guide to tofacitinib dosing in patients with ulcerative colitis
Peter M. Irving, Yvette Leung, Marla C. Dubinsky
Alimentary Pharmacology & Therapeutics.2022; 56(7): 1131. CrossRef - Management of inflammatory bowel disease beyond tumor necrosis factor inhibitors: novel biologics and small-molecule drugs
Soo-Young Na, You Sun Kim
The Korean Journal of Internal Medicine.2022; 37(5): 906. CrossRef - Effectiveness and Safety of Tofacitinib for Ulcerative Colitis
Vikas Taneja, Mohammed El-Dallal, Zadid Haq, Kartikeya Tripathi, Hannah K. Systrom, Linda F. Wang, Hyder Said, Paul A. Bain, Youlian Zhou, Joseph D. Feuerstein
Journal of Clinical Gastroenterology.2022; 56(10): e323. CrossRef - Real-world experience with tofacitinib in ulcerative colitis: a systematic review and meta-analysis
Laura A. Lucaciu, Nathan Constantine-Cooke, Nikolas Plevris, Spyros Siakavellas, Lauranne A.A.P. Derikx, Gareth-Rhys Jones, Charles W. Lees
Therapeutic Advances in Gastroenterology.2021;[Epub] CrossRef
- Inflammatory bowel disease therapeutics: a bibliometric analysis of tofacitinib research in ulcerative colitis
- 6,970 View
- 253 Download
- 19 Web of Science
- 16 Crossref
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