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托法替布在溃疡性结肠炎中的应用:日常临床实践专家共识

Tofacitinib use in ulcerative colitis: An expert consensus for day-to-day clinical practice.

作者信息

Banerjee Rupa, Sharma Vishal, Patel Rajendra, Jena Anuraag, Pal Partha, Raghunathan Nalini, Kumar Ajay, Sood Ajit, Puri Amarender S, Goswami Bhabhadev, Desai Devendra, Mekala Dhanush, Ramesh G N, Rao G V, Peddi Kiran, Philip Mathew, Tandon Manu, Bhatia Shobna, Godbole Shubhankar, Bhatia Sumit, Ghoshal Uday C, Dutta Usha, Midha Vandana, Prasad V G Mohan, Reddy D Nageshwar

机构信息

Department of Medical Gastroenterology, Asian Institute of Gastroenterology, Mindspace Road, Gachibowli, Hyderabad, 500 032, India.

Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160 012, India.

出版信息

Indian J Gastroenterol. 2024 Feb;43(1):22-35. doi: 10.1007/s12664-023-01507-9. Epub 2024 Feb 12.

DOI:10.1007/s12664-023-01507-9
PMID:38347433
Abstract

Rising number of inflammatory bowel disease (IBD) cases in developing countries necessitate clear guidance for clinicians for the appropriate use of advanced therapies. An expert consensus document was generated to guide the usage of tofacitinib, a Janus kinase inhibitor, in ulcerative colitis. Tofacitinib is a useful agent for the induction and maintenance of remission in ulcerative colitis. It can be used in the setting of biological failure or even steroid-dependent and thiopurine refractory disease. Typically, the induction dose is 10 mg BD orally. Usually, clinical response is evident within eight weeks of therapy. In those with clinical response, the dose can be reduced from 10 mg BD to 5 mg BD. Tofacitinib should be avoided or used cautiously in the elderly, patients with cardiovascular co-morbidity, uncontrolled cardiac risk factors, previous thrombotic episodes and those at high risk for venous thrombosis or previous malignancy. Baseline evaluation should include testing for and management of hepatitis B infection and latent tuberculosis. Where feasible, it is prudent to ensure complete adult vaccination, including Herpes zoster, before starting tofacitinib. The use of tofacitinib may be associated with an increased risk of infections such as herpes zoster and tuberculosis reactivation. Maternal exposure to tofacitinib should be avoided during pre-conception, pregnancy, and lactation. There is emerging evidence of tofacitinib in acute severe colitis, although the exact positioning (first-line with steroids or second-line) is uncertain.

摘要

发展中国家炎症性肠病(IBD)病例数不断增加,这就需要为临床医生提供有关合理使用先进疗法的明确指导。为此制定了一份专家共识文件,以指导溃疡性结肠炎中Janus激酶抑制剂托法替布的使用。托法替布是诱导和维持溃疡性结肠炎缓解的有效药物。它可用于生物制剂治疗失败的情况,甚至可用于激素依赖和硫嘌呤难治性疾病。通常,诱导剂量为口服10mg,每日两次。通常,治疗八周内临床反应明显。有临床反应者,剂量可从10mg,每日两次减至5mg,每日两次。老年人、患有心血管合并症的患者、未控制的心脏危险因素患者、既往有血栓形成发作的患者以及静脉血栓形成高危或既往有恶性肿瘤的患者应避免使用或谨慎使用托法替布。基线评估应包括检测和管理乙型肝炎感染及潜伏性结核。在可行的情况下,在开始使用托法替布之前,谨慎做法是确保完成包括带状疱疹疫苗在内的成人全程疫苗接种。使用托法替布可能会增加感染风险,如带状疱疹和结核再激活。在受孕前、怀孕期间和哺乳期应避免孕妇接触托法替布。有新证据表明托法替布可用于急性重症结肠炎,但其确切定位(与激素联用作为一线治疗还是二线治疗)尚不确定。

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本文引用的文献

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Outcomes of Tofacitinib Use in an Irish Pediatric Cohort.托法替布在爱尔兰儿科队列中的使用结果。
JPGN Rep. 2023 Jun 26;4(3):e332. doi: 10.1097/PG9.0000000000000332. eCollection 2023 Aug.
2
Refractory pediatric ulcerative colitis responding to high dose tofacitinib.难治性小儿溃疡性结肠炎对高剂量托法替布有反应。
Pediatr Int. 2023 Jan-Dec;65(1):e15551. doi: 10.1111/ped.15551.
3
The current role of Tofacitinib in acute severe ulcerative colitis in adult patients: A systematic review.托法替布在成年患者急性重症溃疡性结肠炎中的当前作用:一项系统评价。
口服结肠靶向响应性壳聚糖/果胶基纳米颗粒推动了托法替布在结肠炎治疗中的应用。
Sci Rep. 2025 Jan 10;15(1):1569. doi: 10.1038/s41598-024-84322-2.
4
Tofacitinib-induced Hepatitis and Tuberculosis: A Case of Two Rare Adverse Events in a Single Patient.托法替布诱发的肝炎和肺结核:1例患者出现两种罕见不良事件
J Clin Exp Hepatol. 2025 Mar-Apr;15(2):102457. doi: 10.1016/j.jceh.2024.102457. Epub 2024 Nov 28.
5
Strategies for Enhancing Inflammatory Bowel Disease Care in Pakistan: Bridging Gaps and Building Capacities.加强巴基斯坦炎症性肠病护理的策略:弥合差距与建设能力
Crohns Colitis 360. 2024 Apr 22;6(2):otae027. doi: 10.1093/crocol/otae027. eCollection 2024 Apr.
Dig Liver Dis. 2023 Oct;55(10):1311-1317. doi: 10.1016/j.dld.2023.05.021. Epub 2023 Jun 12.
4
Tofacitinib in the treatment of moderate to severe ulcerative colitis in Colombia: Real world experience.托法替布治疗哥伦比亚中重度溃疡性结肠炎的真实世界经验。
Gastroenterol Hepatol. 2023 Aug-Sep;46(7):512-521. doi: 10.1016/j.gastrohep.2022.10.020. Epub 2022 Nov 11.
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Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program.评估溃疡性结肠炎临床项目中按年龄分层的托法替布的安全性和疗效。
Inflamm Bowel Dis. 2023 Jan 5;29(1):27-41. doi: 10.1093/ibd/izac084.
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Tofacitinib Salvage Therapy for Children Hospitalized for Corticosteroid- and Biologic-Refractory Ulcerative Colitis.托法替布挽救治疗用于因皮质类固醇和生物制剂难治性溃疡性结肠炎住院的儿童。
J Pediatr Gastroenterol Nutr. 2022 Dec 1;75(6):724-730. doi: 10.1097/MPG.0000000000003616. Epub 2022 Sep 19.
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Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib.接受托法替尼治疗的溃疡性结肠炎患者疱疹感染的长期风险。
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Review article: latent tuberculosis in patients with inflammatory bowel diseases receiving immunosuppression-risks, screening, diagnosis and management.综述文章:接受免疫抑制治疗的炎症性肠病患者中的潜伏性结核——风险、筛查、诊断和管理。
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