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

Autor:	Kojima K; Department of Gastroenterology, Hyogo Medical University, Nishinomiya 663-8501, Japan.; Department of Gastroenterology, Gifu University Graduate School of Medicine, Gifu 501-1194, Japan., Watanabe K; Department of Gastroenterology, Hyogo Medical University, Nishinomiya 663-8501, Japan.; Department of Internal Medicine for Inflammatory Bowel Disease, The University of Toyama, Toyama 930-0194, Japan. kenjiw@med.u-toyama.ac.jp., Kawai M; Department of Gastroenterology, Hyogo Medical University, Nishinomiya 663-8501, Japan., Yagi S; Department of Gastroenterology, Hyogo Medical University, Nishinomiya 663-8501, Japan., Kaku K; Department of Gastroenterology, Hyogo Medical University, Nishinomiya 663-8501, Japan., Ikenouchi M; Department of Gastroenterology, Hyogo Medical University, Nishinomiya 663-8501, Japan., Sato T; Department of Gastroenterology, Hyogo Medical University, Nishinomiya 663-8501, Japan., Kamikozuru K; Department of Gastroenterology, Hyogo Medical University, Nishinomiya 663-8501, Japan., Yokoyama Y; Department of Gastroenterology, Hyogo Medical University, Nishinomiya 663-8501, Japan., Takagawa T; Center for Clinical Research and Education, Hyogo Medical University, Nishinomiya 663-8501, Japan., Shimizu M; Department of Gastroenterology, Gifu University Graduate School of Medicine, Gifu 501-1194, Japan., Shinzaki S; Department of Gastroenterology, Hyogo Medical University, Nishinomiya 663-8501, Japan.
Jazyk:	angličtina
Zdroj:	World journal of gastroenterology [World J Gastroenterol] 2024 Apr 07; Vol. 30 (13), pp. 1871-1886.
DOI:	10.3748/wjg.v30.i13.1871
Abstrakt:	Background: Real-world data on tofacitinib (TOF) covering a period of more than 1 year for a sufficient number of Asian patients with ulcerative colitis (UC) are scarce. Aim: To investigate the long-term efficacy and safety of TOF treatment for UC, including clinical issues. Methods: We performed a retrospective single-center observational analysis of 111 UC patients administered TOF at Hyogo Medical University as a tertiary inflammatory bowel disease center. All consecutive UC patients who received TOF between May 2018 and February 2020 were enrolled. Patients were followed up until August 2020. The primary outcome was the clinical response rate at week 8. Secondary outcomes included clinical remission at week 8, cumulative persistence rate of TOF administration, colectomy-free survival, relapse after tapering of TOF and predictors of clinical response at week 8 and week 48. Results: The clinical response and remission rates were 66.3% and 50.5% at week 8, and 47.1% and 43.5% at week 48, respectively. 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). The cumulative TOF persistence rate at week 48 was significantly lower in patients without clinical remission than in those with remission at week 8 (30.9% vs 88.1%; P < 0.001). Baseline partial Mayo Score was significantly lower in responders vs 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. All 6 patients with herpes zoster (HZ) developed the infection after achieving remission by TOF. Conclusion: 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. Most relapsed patients responded again after re-increase of TOF and nearly half relapsed after tapering off TOF. Special attention is needed for tapering and HZ. Competing Interests: 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. (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)
Databáze:	MEDLINE
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