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托法替布治疗溃疡性结肠炎的有效性和安全性:一项巴西多中心观察性研究

Effectiveness and Safety of Tofacitinib in the Management of Ulcerative Colitis: A Brazilian Observational Multicentric Study.

作者信息

Perin Ramir Luan, Magro Daniela Oliveira, Andrade Adriana Ribas, Argollo Marjorie, Carvalho Nayara Salgado, Damião Adérson Omar Moura Cintra, Dotti Adriana Zanoni, Ferreira Sandro da Costa, Flores Cristina, Ludvig Juliano Coelho, Nones Rodrigo Bremer, Queiroz Natalia Sousa Freitas, Parra Rogério Serafim, Steinwurz Flavio, Teixeira Fabio Vieira, Kotze Paulo Gustavo

机构信息

Universidade de Passo Fundo (UPF), Passo Fundo, Brazil.

Universidade Estadual de Campinas (UNICAMP), Campinas, Brazil.

出版信息

Crohns Colitis 360. 2022 Dec 19;5(1):otac050. doi: 10.1093/crocol/otac050. eCollection 2023 Jan.

Abstract

BACKGROUND

Ulcerative colitis (UC) is a chronic inflammatory bowel disease which affects the colorectal mucosa with a relapsing-remitting pattern. The therapeutic options currently available for the medical management of UC include many options. Tofacitinib is an oral small molecule, Janus kinase (JAK) inhibitor, more selective for JAK1 and JAK3, which reduces the inflammatory process involved in the pathogenesis of UC.

METHODS

Retrospective observational multicentric study of patients with UC who used tofacitinib in any phase of their treatment. Clinical remission and response (according to Mayo score), mucosal healing, primary and secondary loss of response, discontinuation of the drug with possible causes, and the need for dose optimization or switching to biologicals, need for surgery and adverse events were evaluated.

RESULTS

From a total of 56 included patients, clinical remission was observed in 43.6% at week 12, 54.5% at week 26, 57.9% at week 52, and 40% at the last follow-up visit. Clinical response was observed in 71.4%, 81.8%, 89.5%, and 61.8% at the same time periods, respectively. Mucosal healing rates were 50% and 17.8% needed colectomy.

CONCLUSIONS

Tofacitinib was effective in induction and maintenance of clinical response and remission rates, compatible to other international real-word studies and meta-analyses.

摘要

背景

溃疡性结肠炎(UC)是一种慢性炎症性肠病,以复发-缓解模式影响结直肠黏膜。目前可用于UC药物治疗的选择有很多。托法替布是一种口服小分子Janus激酶(JAK)抑制剂,对JAK1和JAK3具有更高的选择性,可减轻UC发病机制中涉及的炎症过程。

方法

对在治疗任何阶段使用托法替布的UC患者进行回顾性观察多中心研究。评估临床缓解和反应(根据梅奥评分)、黏膜愈合、原发和继发反应丧失、因可能原因停药、剂量优化或改用生物制剂的必要性、手术需求及不良事件。

结果

在总共纳入的56例患者中,第12周时临床缓解率为43.6%,第26周时为54.5%,第52周时为57.9%,最后一次随访时为40%。同期临床反应率分别为71.4%、81.8%、89.5%和61.8%。黏膜愈合率为50%,17.8%的患者需要进行结肠切除术。

结论

托法替布在诱导和维持临床反应及缓解率方面有效,与其他国际真实世界研究和荟萃分析结果一致。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6a55/9855307/346b3352734d/otac050_fig1.jpg

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