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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
PubReader
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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- Propensity score-matched real-world comparative treatment outcomes of Janus kinase inhibitors for ulcerative colitis in patients with and without prior exposure to anti-tumor necrosis factor α antibody
- Maiko Ikenouchi, Hirokazu Fukui, Soichi Yagi, Akira Nogami, Koji Kaku, Toshiyuki Sato, Mikio Kawai, Koji Kamikozuru, Yoko Yokoyama, Tetsuya Takagawa, Toshihiko Tomita, Taku Kobayashi, Shinichiro Shinzaki
- Received September 22, 2024 Accepted November 20, 2024 Published online February 3, 2025
- DOI: https://doi.org/10.5217/ir.2024.00148 [Epub ahead of print]
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Abstract
PDFSupplementary MaterialPubReaderePub
- Background/Aims
Tofacitinib (TFB), filgotinib (FIL), and upadacitinib (UPA) are Janus kinase (JAK) inhibitors approved for moderate-to-severe ulcerative colitis (UC). The appropriate positioning of each JAK inhibitor in the treatment algorithm, however, is unclear. Furthermore, real-world efficacy of JAK inhibitors for patients with UC and prior anti-tumor necrosis factor α antibody (aTNF) treatment are not fully investigated. We compared the efficacy and safety of 3 JAK inhibitors in patients with UC, considering their prior aTNF exposure.
Methods
A retrospective study was conducted in patients with UC who started TFB, FIL, or UPA at 2 academic centers. This propensity score-matched cohort study assessed the effectiveness of the 3 JAK inhibitors for UC in patients with and without prior aTNF exposure, comparing steroid-free clinical remission and response rates after 8 weeks.
Results
Among 274 patients who met the inclusion criteria, 145 experienced aTNF exposure (TFB: 59.2%, 100/169; FIL: 34.5%, 20/58; UPA: 53.2%, 25/47). Based on propensity score-matching, UPA led to a higher steroid-free clinical remission rates than TFB (adjusted odds ratio [aOR], 5.57; 95% confidence interval [CI], 1.42–21.90) or FIL (aOR, 9.00; 95% CI, 1.42–57.10) in patients exposed to aTNF. Steroid-free clinical remission and clinical response rates did not differ significantly between each group in patients non-exposed to aTNF. The incidence of adverse events was slightly higher with UPA than TFB or FIL.
Conclusions
UPA may be more effective for UC than TFB or FIL, especially in patients with previous aTNF exposure, although consideration should be given to adverse events.
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- Upadacitinib induction is effective and safe in ulcerative colitis patients including those with prior exposure to tofacitinib: a multicenter real-world cohort study
- Robert Gilmore, Richard Fernandes, Imogen Hartley, Arteen Arzivian, Rupert Leong, Bridgette Andrew, Abhinav Vasudevan, Tessa Greeve, Gregory Thomas Moore, Steven Kim, Daniel Lightowler, Abhey Singh, Gillian Mahy, Aditya Mithanthaya, Kannan Venugopaul, Sangwoo Han, Robert Bryant, Jack West, Jonathan Segal, Britt Christensen, Crispin Corte, Nik Ding, Yoon-Kyo An, Jakob Begun
- Received August 12, 2024 Accepted October 7, 2024 Published online December 20, 2024
- DOI: https://doi.org/10.5217/ir.2024.00127 [Epub ahead of print]
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Abstract
PDFPubReaderePub
- Background/Aims
Upadacitinib is a novel selective Janus kinase inhibitor approved for use in ulcerative colitis. Clinical trials had rigorous criteria and excluded many patient subgroups. Given limited real-world effectiveness data, we examined outcomes of patients treated with upadacitinib for ulcerative colitis in a real-world population.
Methods
Patients that commenced upadacitinib for moderate-to-severe ulcerative colitis from September 2022 until March 2023 were identified at 13 inflammatory bowel disease centers across Australia. Clinical, biochemical, endoscopic, and intestinal ultrasound outcomes were recorded retrospectively at baseline, week 8, and week 16.
Results
One hundred and fifty-two patients (61 female [40%], median age 38 years [interquartile range, 28–50]) were included. The primary endpoint of clinical remission was met in 79% at week 8, and 84% at week 16. A total of 42 patients (28%) with prior tofacitinib exposure were included. No significant difference in clinical remission was observed by week 16 between tofacitinib experienced compared to tofacitinib naïve patients (86% vs. 84%, P= 0.67). Complete intestinal ultrasound data was available for 36 patients, showing transmural remission in 64% at week 8 and 81% at week 16, with a decrease in median bowel wall thickness of 2.3 mm and 2.4 mm, respectively.
Conclusions
Upadacitinib resulted in high rates of clinical remission at 8 and 16 weeks in this large real-world cohort of ulcerative colitis patients. Upadacitinib is effective in patients with prior tofacitinib exposure. Intestinal ultrasound shows significant rates of transmural remission at week 8, sustained through week 16. -
Citations
Citations to this article as recorded by
- Letter: Toward Intra‐Class Switching With JAK Inhibitors?
Mathieu Uzzan, David Laharie
Alimentary Pharmacology & Therapeutics.2025; 61(5): 919. CrossRef
- Letter: Toward Intra‐Class Switching With JAK Inhibitors?
- 1,639 View
- 226 Download
- 1 Web of Science
- 1 Crossref
- 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
PDFSupplementary MaterialPubReaderePub
- 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?
- 2,837 View
- 176 Download
- 3 Web of Science
- 2 Crossref
Review
- IBD
- Current new challenges in the management of ulcerative colitis
- Tomohiro Fukuda, Makoto Naganuma, Takanori Kanai
- Intest Res 2019;17(1):36-44. Published online January 25, 2019
- DOI: https://doi.org/10.5217/ir.2018.00126
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Abstract
PDFPubReaderePub
- Ulcerative colitis (UC) is a chronic inflammatory condition of the gastrointestinal tract. Although the cause of UC is postulated to be multifactorial in nature, including genetic predisposition, epithelial barrier defects, dysregulation of immune responses, and environmental factors, the specific pathogenesis of UC is still incompletely understood. In the treatment of UC so far, a method of suppressing immunity and treating it has been mainstream. Immunosuppressant drugs, including thiopurines (azathioprine or 6-mercaptopurine), anti-tumor necrosis factor-α (anti-TNF-α) antibody (infliximab and adalimumab), and calcineurin inhibitor, can be used in treat patients with corticosteroid-dependent and/or corticosteroid-refractory moderateto- severe UC. Recently, in addition to such a conventional therapeutic agent, golimumab, which is the first transgenic human monoclonal anti-TNF-α antibody to be fabricated, anti α-4/β-7 integrin antibody, and Janus kinase inhibitor have been reported to novel immunosuppressant therapy. Furthermore, other treatments with unique mechanisms different from immunosuppression, have also been suggested, including fecal microbiota transplantation and Indigo naturalis, which is a Chinese herbal medicine. We compared the features and efficacy of these new treatments. In this issue, the features and treatment options for these new treatments is reviewed.
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Citations
Citations to this article as recorded by- Systemic investigation of the mechanism underlying the therapeutic effect of Astragalus membranaceus in ulcerative colitis
Jingxin Mao, Lihong Tan, Cheng Tian, Wenxiang Wang, YanLin Zou, Zhaojing Zhu, Yan Li
The American Journal of the Medical Sciences.2025; 369(2): 238. CrossRef - Histologic features and predicting prognosis in ulcerative colitis patients with mild endoscopic activity
Seung Yong Shin, Hee Sung Kim, Kisung Kim, Chang Won Choi, Jung Min Moon, Jeong Wook Kim, Hyun Jin Joo, Jeongkuk Seo, Muhyeon Sung, Chang Hwan Choi
The Korean Journal of Internal Medicine.2024; 39(1): 68. CrossRef - Recent Updates on the Therapeutics Benefits, Clinical Trials, and Novel
Delivery Systems of Chlorogenic Acid for the Management of Diseases with a
Special Emphasis on Ulcerative Colitis
Ranjit K. Harwansh, Hemant Bhati, Rohitas Deshmukh
Current Pharmaceutical Design.2024; 30(6): 420. CrossRef - Dose-dependent effects of cobalt chloride supplementation in a rat model of acetic acid-induced ulcerative colitis
Akinleye Stephen Akinrinde, Ekundayo Stephen Samuel, Bisi Olajumoke Adeoye
Comparative Clinical Pathology.2024; 33(5): 705. CrossRef - Pharmacogenetics in personalized treatment in pediatric patients with inflammatory bowel disease (IBD)
Daniela Kosorínová, Pavlína Suchá, Zuzana Havlíčeková, Marek Pršo, Pavol Dvoran, Peter Bánovčin
Česko-slovenská pediatrie.2024; 79(4): 213. CrossRef - Long‐term safety and efficacy of filgotinib for the treatment of moderately to severely active ulcerative colitis: Interim analysis from up to 4 years of follow‐up in the SELECTION open‐label long‐term extension study
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Alimentary Pharmacology & Therapeutics.2024; 60(5): 563. CrossRef - Loganin Ameliorates Acute Kidney Injury and Restores Tofacitinib Metabolism in Rats: Implications for Renal Protection and Drug Interaction
Hyeon Gyeom Choi, So Yeon Park, Sung Hun Bae, Sun-Young Chang, So Hee Kim
Biomolecules & Therapeutics.2024; 32(5): 601. CrossRef - Dynamic changes in the gut microbiota composition during adalimumab therapy in patients with ulcerative colitis: implications for treatment response prediction and therapeutic targets
Han Na Oh, Seung Yong Shin, Jong-Hwa Kim, Jihye Baek, Hyo Jong Kim, Kang-Moon Lee, Soo Jung Park, Seok-Young Kim, Hyung-Kyoon Choi, Wonyong Kim, Woo Jun Sul, Chang Hwan Choi
Gut Pathogens.2024;[Epub] CrossRef - Protective effect of (E)-(2,4-dihydroxy)-α-aminocinnamic acid, a hydroxy cinnamic acid derivative, in an ulcerative colitis model induced by TNBS
Astrid Mayleth Rivera Antonio, Itzia Irene Padilla Martínez, Yazmín Karina Márquez-Flores, Alan Hipólito Juárez Solano, Mónica A. Torres Ramos, Martha Cecilia Rosales Hernández
Bioscience Reports.2024;[Epub] CrossRef - Lactiplantibacillus plantarum BW2013 protects mucosal integrity and modulates gut microbiota of mice with colitis
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Canadian Journal of Microbiology.2023; 69(4): 158. CrossRef - Reviewing not Homer’s Iliad, but “Kai Bao Ben Cao”: indigo dye—the past, present, and future
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Intestinal Research.2023; 21(2): 174. CrossRef - Effect and mechanism of total ginsenosides repairing SDS‑induced Drosophila enteritis model based on MAPK pathway
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Experimental and Therapeutic Medicine.2023;[Epub] CrossRef - Effects of Hyperlipidemia on the Pharmacokinetics of Tofacitinib, a JAK 1/3 Inhibitor, in Rats
Jong Mun Won, Hyeon Gyeom Choi, So Yeon Park, Jang-Hee Kim, So Hee Kim
Pharmaceutics.2023; 15(9): 2195. CrossRef - Knowledge, attitude, and practice of patients living with inflammatory bowel disease: A cross-sectional study
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World Journal of Gastroenterology.2023; 29(43): 5818. CrossRef - Biomarker dynamics during infliximab salvage for acute severe ulcerative colitis: C-reactive protein (CRP)-lymphocyte ratio and CRP-albumin ratio are useful in predicting colectomy
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- Systemic investigation of the mechanism underlying the therapeutic effect of Astragalus membranaceus in ulcerative colitis
- 9,899 View
- 440 Download
- 46 Web of Science
- 45 Crossref
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