背景:托法替尼是一种口服Janus激酶抑制剂,最近被批准用于诱导和维持溃疡性结肠炎(UC)的缓解。
目的:考虑到抗TNF无应答者的数量,本研究旨在评估52周时托法替尼在中重度UC多重失败患者队列中的有效性和安全性.
方法:从2021年1月至2023年3月,我们进行了一项前瞻性多中心研究,观察中重度UC成年患者在抗TNF治疗失败后开始服用托法替尼,为期52周。根据结肠切除率评估有效性和安全性,临床缓解和反应,内镜缓解,无类固醇临床缓解,和不良事件发生率。
结果:我们纳入58例UC患者,年龄42±14.4岁,59%的男性,96.6%左侧或泛结肠炎,谁是失败的单一(65.5%)或多个抗TNF(34.5%)。只有6例(10.3%)患者接受了结肠切除术。结肠切除术在临床上与W8(p=0.023)和W24(p=0.004)时托法替尼10mgbid的必要性和额外周期数相关,并且在W8处有较高的部分Mayo评分(p=0.025)。在W52,临床缓解,临床反应,无类固醇临床缓解率为53.4%,43.1%,和48.3%,分别。在W52进行的22例结肠镜检查中,有11例(50%)显示内窥镜缓解。14例(24.1%)患者发生不良事件,但只有2例(3.4%)导致托法替尼停药.
结论:在抗TNF难治性UC患者的现实生活中,托法替尼已被证明在52周时可有效预防结肠切除术并诱导临床和内镜缓解,且安全性良好.
BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor recently approved to induce and maintain remission in ulcerative colitis (UC).
OBJECTIVE: Considering the number of anti-TNF non-responders, this
study aims to assess the effectiveness and safety of tofacitinib in a cohort of multi-failure patients with moderate-to-severe UC at 52 weeks.
METHODS: From January 2021 to March 2023, we performed a prospective multicenter
study observing adult patients with moderate-to-severe UC starting tofacitinib after an anti-TNF failure for a 52-week-long period. Effectiveness and safety were assessed in terms of colectomy rate, clinical remission and response, endoscopic remission, steroid-free clinical remission, and rate of adverse events.
RESULTS: We included 58 patients with UC with an age of 42 ± 14.4 years, 59% males, 96.6% left-sided or pancolitis, who were failure to a single (65.5%) or more than one anti-TNF (34.5%). Only 6 (10.3%) patients underwent colectomy. Colectomy was clinically associated with the necessity and the number of extra cycles of tofacitinib 10 mg bid at W8 (p = 0.023) and W24 (p = 0.004), and with a higher partial Mayo score at W8 (p = 0.025). At W52, clinical remission, clinical response, and steroid-free clinical remission were 53.4%, 43.1%, and 48.3%, respectively. Of 22 performed colonoscopies at W52, 11 (50%) showed endoscopic remission. Adverse events occurred in 14 (24.1%) patients, but only 2 (3.4%) led to tofacitinib discontinuation.
CONCLUSIONS: In a real-life setting of patients with anti-TNF refractory UC, tofacitinib has proved to be effective in preventing colectomy and inducing clinical and endoscopic remission at 52 weeks with a good safety profile.