Yao Jiayin, Zhang Heng, Su Tao, Peng Xiang, Zhao Junzhang, Liu Tao, Wang Wei, Hu Pinjin, Zhi Min, Zhang Min
Department of Gastroenterology, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510655, China.
Department of Colorectal Surgery, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou 510655, China.
J Clin Med. 2023 Jan 25;12(3):939. doi: 10.3390/jcm12030939.
There is insufficient evidence to confirm the efficacy of ustekinumab (UST) in promoting fistula closure in perianal fistulizing Crohn's disease (CD) patients. We aimed to evaluate the efficacy of UST in a real-world setting. The data were retrospectively analyzed. Intestinal clinical and endoscopic changes were evaluated. Fistula radiological outcomes were determined using the Van Assche score. A total of 108 patients were included, 43.5% of whom had complex perianal fistulas. Intestinal clinical and endoscopic remission was achieved in 65.7% and 31.5% of patients, respectively. The fistula clinical remission and response rates were 40.7% and 63.0%, respectively, with a significant reduction in Perianal Crohn's disease Activity Index [5.0(3.0, 8.0) vs. 7.5(5.0, 10.0), < 0.001] and Crohn's Anal Fistula Quality of Life [23.5(9.3, 38.8) vs. 49.0(32.3, 60.0), < 0.001]. Radiological healing, partial response, no change, and deterioration were observed in 44.8%, 31.4%, 13.4%, and 10.4% of patients, respectively. The cut-off UST trough concentration for predicting fistula clinical remission was 2.11 μg/mL with an area under the curve of 0.795, a sensitivity of 93.3%, and a specificity of 67.6%. UST is efficacious in promoting radiological fistula closure in patients with perianal fistulizing CD. A UST trough concentration over 2.11 μg/mL was correlated with a higher likelihood of perianal fistula clinical remission.
没有足够的证据证实乌司奴单抗（UST）对促进肛周瘘管型克罗恩病（CD）患者的瘘管闭合有效。我们旨在评估UST在实际临床中的疗效。对数据进行回顾性分析。评估肠道临床和内镜变化。使用范阿舍评分确定瘘管的放射学结果。共纳入108例患者，其中43.5%患有复杂性肛周瘘管。分别有65.7%和31.5%的患者实现肠道临床缓解和内镜缓解。瘘管临床缓解率和缓解反应率分别为40.7%和63.0%，肛周克罗恩病活动指数显著降低[5.0（3.0，8.0）对7.5（5.0，10.0），<0.001]，克罗恩肛门瘘管生活质量显著降低[23.5（9.3，38.8）对49.0（32.3，60.0），<0.001]。分别有44.8%、31.4%、13.4%和10.4%的患者出现放射学愈合、部分缓解、无变化和病情恶化。预测瘘管临床缓解的UST谷浓度临界值为2.11μg/mL，曲线下面积为0.795，敏感性为93.3%，特异性为67.6%。UST对促进肛周瘘管型CD患者的放射学瘘管闭合有效。UST谷浓度超过2.11μg/mL与肛周瘘管临床缓解的较高可能性相关。
