Kojima Kentaro, Watanabe Kenji, Kawai Mikio, Yagi Soichi, Kaku Koji, Ikenouchi Maiko, Sato Toshiyuki, Kamikozuru Koji, Yokoyama Yoko, Takagawa Tetsuya, Shimizu Masahito, Shinzaki Shinichiro
Department of Gastroenterology, Hyogo Medical University, Nishinomiya 663-8501, Japan.
Department of Gastroenterology, Gifu University Graduate School of Medicine, Gifu 501-1194, Japan.
World J Gastroenterol. 2024 Apr 7;30(13):1871-1886. doi: 10.3748/wjg.v30.i13.1871.
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.
To investigate the long-term efficacy and safety of TOF treatment for UC, including clinical issues.
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.
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 ( = 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% 88.1%; < 0.001). Baseline partial Mayo Score was significantly lower in responders non-responders at week 8 (odds ratio: 0.61, 95% confidence interval: 0.45-0.82, = 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.
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.
关于托法替布（TOF）在足够数量的亚洲溃疡性结肠炎（UC）患者中超过1年的真实世界数据稀缺。
研究TOF治疗UC的长期疗效和安全性，包括临床问题。
我们对作为三级炎症性肠病中心的兵库医科大学111例接受TOF治疗的UC患者进行了回顾性单中心观察分析。纳入2018年5月至2020年2月期间所有连续接受TOF治疗的UC患者。对患者随访至2020年8月。主要结局是第8周时的临床缓解率。次要结局包括第8周时的临床缓解、TOF给药的累积持续率、无结肠切除术生存率、TOF减量后的复发以及第8周和第48周时临床缓解的预测因素。
第8周时临床缓解率和缓解率分别为66.3%和50.5%，第48周时分别为47.1%和43.5%。第48周时总体累积临床缓解率为61.7%，既往使用抗肿瘤坏死因子-α（TNF-α）药物史无影响（P = 0.25）。第48周时未达到临床缓解的患者中TOF累积持续率显著低于第8周时达到缓解的患者（30.9%对88.1%；P < 0.001）。第8周时缓解者的基线部分梅奥评分显著低于未缓解者（优势比：0.61，95%置信区间：0.45 - 0.82，P = 0.001）。45.7%的患者在TOF减量后复发，85.7%的患者在重新增加剂量后4周内有反应。所有6例带状疱疹（HZ）患者在通过TOF达到缓解后发生感染。
TOF对基线活动度较轻的UC患者更有效，其疗效不受既往抗TNF-α药物治疗的影响。大多数复发患者在TOF重新增加剂量后再次有反应，近一半患者在TOF减量后复发。在减量和HZ方面需要特别关注。
