Real-world efficacy and safety of tofacitinib treatment in Asian patients with ulcerative colitis

doi:10.3748/wjg.v30.i13.1871

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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World J Gastroenterol. Apr 7, 2024; 30(13): 1871-1886
Published online Apr 7, 2024. doi: 10.3748/wjg.v30.i13.1871

Real-world efficacy and safety of tofacitinib treatment in Asian patients with ulcerative colitis

Kentaro Kojima, Kenji Watanabe, Mikio Kawai, Soichi Yagi, Koji Kaku, Maiko Ikenouchi, Toshiyuki Sato, Koji Kamikozuru, Yoko Yokoyama, Tetsuya Takagawa, Masahito Shimizu, Shinichiro Shinzaki

Kentaro Kojima, Kenji Watanabe, Mikio Kawai, Soichi Yagi, Koji Kaku, Maiko Ikenouchi, Toshiyuki Sato, Koji Kamikozuru, Yoko Yokoyama, Shinichiro Shinzaki, Department of Gastroenterology, Hyogo Medical University, Nishinomiya 663-8501, Japan

Kentaro Kojima, Masahito Shimizu, Department of Gastroenterology, Gifu University Graduate School of Medicine, Gifu 501-1194, Japan

Kenji Watanabe, Department of Internal Medicine for Inflammatory Bowel Disease, The University of Toyama, Toyama 930-0194, Japan

Tetsuya Takagawa, Center for Clinical Research and Education, Hyogo Medical University, Nishinomiya 663-8501, Japan

Author contributions: Kojima K and Watanabe K participated in the conception and design of the study and were involved in the acquisition, analysis, or interpretation of data; Kojima K wrote the manuscript; Watanabe K and Shinzaki S accessed and verified the study data. All authors critically reviewed and provided final approval of the manuscript; all authors were responsible for the decision to submit the manuscript for publication.

Institutional review board statement: This investigation was approved by the Institutional Ethics Committee of Hyogo Medical University Hospital, No. 3030.

Informed consent statement: The need for patient consent was waived due to the retrospective nature of the study.

Conflict-of-interest statement: Watanabe K received honoraria and had expenses paid to attend or give a presentation or advice at a meeting for the following companies: AbbVie GK, EA Pharma Co., Ltd., Pfizer Japan Inc., Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Kyorin Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd.; received research grants from EA Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., EP-CRSU Co., Ltd., received scholarship grants from AbbVie GK, EA Pharma Co., Ltd., Mitsubishi Tanabe Pharma Corporation, JIMRO Co., Ltd., Nippon Kayaku Co., Ltd.; and has been an endowed chair for AbbVie GK, EA Pharma Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Zeria Pharmaceutical Co., Ltd., JIMRO Co., Ltd., Otsuka Pharmaceutical Factory, Inc., Asahi Kasei Medical Co., Ltd., Mochida Pharmaceutical Co., Ltd. SS received honoraria and had expenses paid to attend or give a presentation or advice at meetings for AbbVie GK, EA Pharma Co., Ltd., Pfizer Japan Inc., Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Kyorin Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Nippon Kayaku Co., Ltd., Gilead Sciences, JIMRO Co., Ltd., Nippon Kayaku Co., Zeria Pharmaceutical Co., Ltd., Alfresa Pharma Corporation, Astra Zeneka K.K., Eisai Co., Ltd., Sekisui Medical Co., Ltd. And received research grants from Sekisui Medical Co., Ltd.

Data sharing statement: No additional data are available.

Corresponding author: Kenji Watanabe, FACG, MD, PhD, Professor, Department of Gastroenterology, Hyogo Medical University, 1-1, Mukogawa-cho, Nishinomiya City, Hyogo Prefecture, Nishinomiya 663-8501, Japan. kenjiw@med.u-toyama.ac.jp

Received: January 9, 2024
Peer-review started: January 9, 2024
First decision: January 17, 2024
Revised: January 30, 2024
Accepted: March 13, 2024
Article in press: March 13, 2024
Published online: April 7, 2024
Processing time: 84 Days and 16.6 Hours

ARTICLE HIGHLIGHTS

Research background

Various therapeutic agents are currently available as advanced therapies. Tofacitinib (TOF) was approved to treat the patients with intractable ulcerative colitis (UC) as first Janus kinase inhibitor in Japan.

Research motivation

Real-world data for the efficacy and safety of TOF treatment covering a period of more than 1 year with a sufficient number of Asian patients with UC are scarce. We investigated to optimize TOF treatment by using data of our specialized IBD center.

Research objectives

The aim of this study is to investigate the efficacy and safety of TOF treatment covering a period of more than 1 year in patients with intractable UC.

Research methods

We performed a retrospective single-center observational analysis of 111 UC patients administered TOF between May 2018 and February 2020. The primary outcome was the clinical response rate at week 8.

Research results

The overall cumulative clinical remission rate was 61.7% at week 48 and history of anti- tumor necrosis factor-alpha (TNF-α) agents use had no influence (P = 0.25). Baseline partial Mayo Score was significantly lower in responders compared with non-responders at week 8 (odds ratio: 0.61, 95% confidence interval: 0.45-0.82, P = 0.001). Relapse occurred in 45.7% of patients after TOF tapering, and 85.7% of patients responded within 4 wk after re-increase.

Research conclusions

TOF was more effective in UC patients with mild activity at baseline and its efficacy was not affected by previous treatment with anti-TNF-α agents. Although careful monitoring for herpes zoster is necessary, most patients continue TOF without severe adverse events.

Research perspectives

Future prospective studies with a large number of UC patients and long follow-up periods are needed in clinical practice and we should consider the positioning of TOF in many treatment options for active UC.