额外静脉注射优特克单抗再诱导治疗是难治性克罗恩病患者的一种有效优化策略。
Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn's disease.
作者信息
Yao Jiayin, Peng Xiang, Zhong Yingkui, Su Tao, Bihi Adam, Zhao Junzhang, Liu Tao, Wang Wei, Hu Pinjin, Zhang Min, Zhi Min
机构信息
Department of Gastroenterology, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, China.
Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, China.
出版信息
Front Med (Lausanne). 2023 Jul 24;10:1105981. doi: 10.3389/fmed.2023.1105981. eCollection 2023.
OBJECTIVES
Ustekinumab (UST) optimization strategies, including shortening intervals and intravenous reinduction, should be administered to patients with partial or loss of respond. Evidence comparing these types of optimization treatments is limited. We evaluated the efficacy and safety of weight-based UST intravenous reinduction in patients with refractory Crohn's disease (CD).
METHODS
This was a single-center retrospective observational study. Optimization strategies were designed for patients showing partial or loss of response to standardized UST therapy. Clinical, biochemical, and endoscopic response and remission rate were determined by Crohn's disease activity index (CDAI), C-reactive protein (CRP) levels, and SES-CD evaluation. UST trough concentrations were detected and adverse events were recorded.
RESULTS
A total of 128 patients receiving UST optimization therapies were included, with 105 patients administered shortening intervals of q8w or q4w, and 23 receiving intravenous reinduction followed by subcutaneous q8w or q4w. The follow-up duration for the shortening interval and reinduction cohorts were 15.0 (10.0, 31.0) and 23.0 (13.0, 70.0) weeks, respectively. A significant CDAI delta variation pre-and post-treatment could be found between groups [17.0 (-4.4, 65.9) vs. 69.0(10.7, 151.0), = 0.013]. the trough concentration of UST increased [2.5 (1.3, 5.3) vs. 1.1 (0.5, 2.3), = 0.001] after intravenous reinduction. Clinical and endoscopic remission were achieved in 69.6 and 31.8% of patients in the intravenous reinduction cohort, and 62.9 and 22.2% of patients in the shortening interval cohort, respectively. No significant difference was found between groups regarding safety.
CONCLUSION
Intravenous reinduction brought about favorable recapture of clinical and endoscopic remission, and should have significant priority over the strategy of merely shortening drug intervals, which should be launched before switching to other biologics targeting different inflammatory pathways. identifier NCT04923100. https://classic.clinicaltrials.gov/ct2/show/NCT04923100?id=04923100&draw=2&rank=1.
目的
对于部分缓解或缓解丧失的患者，应采用优特克单抗（UST）优化策略，包括缩短给药间隔和静脉再诱导。比较这些类型优化治疗的证据有限。我们评估了基于体重的UST静脉再诱导治疗难治性克罗恩病（CD）患者的疗效和安全性。
方法
这是一项单中心回顾性观察研究。为对标准化UST治疗显示部分缓解或缓解丧失的患者设计优化策略。通过克罗恩病活动指数（CDAI）、C反应蛋白（CRP）水平和SES-CD评估确定临床、生化和内镜反应及缓解率。检测UST谷浓度并记录不良事件。
结果
共纳入128例接受UST优化治疗的患者，其中105例患者给药间隔缩短至每8周或每4周一次，23例接受静脉再诱导，随后皮下每8周或每4周一次。缩短间隔组和再诱导组的随访时间分别为15.0（10.0，31.0）周和23.0（13.0，70.0）周。两组治疗前后CDAI变化有显著差异[17.0（-4.4，65.9）对69.0（10.7，151.0），P = 0.013]。静脉再诱导后UST谷浓度升高[2.5（1.3，5.3）对1.1（0.5，2.3），P = 0.001]。静脉再诱导组分别有69.6%和31.8%的患者实现临床和内镜缓解，缩短间隔组分别为62.9%和22.2%。两组在安全性方面无显著差异。
结论
静脉再诱导带来了临床和内镜缓解的良好恢复，应比单纯缩短药物间隔的策略具有显著优先级，该策略应在换用针对不同炎症途径的其他生物制剂之前启动。标识符NCT04923100。https://classic.clinicaltrials.gov/ct2/show/NCT04923100?id=04923100&draw=2&rank=1 。
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