维多珠单抗治疗中重度克罗恩病的真实世界有效性和安全性：来自美国VICTORY联盟的结果
The Real-World Effectiveness and Safety of Vedolizumab for Moderate-Severe Crohn's Disease: Results From the US VICTORY Consortium.
作者信息
Dulai Parambir S, Singh Siddharth, Jiang Xiaoqian, Peerani Farhad, Narula Neeraj, Chaudrey Khadija, Whitehead Diana, Hudesman David, Lukin Dana, Swaminath Arun, Shmidt Eugenia, Wang Shuang, Boland Brigid S, Chang John T, Kane Sunanda, Siegel Corey A, Loftus Edward V, Sandborn William J, Sands Bruce E, Colombel Jean-Frederic
机构信息
Division of Gastroenterology, University of California San Diego, La Jolla, California, USA.
Department of Biomedical Informatics, University of California San Diego, La Jolla, California, USA.
出版信息
Am J Gastroenterol. 2016 Aug;111(8):1147-55. doi: 10.1038/ajg.2016.236. Epub 2016 Jun 14.
OBJECTIVES
We assessed the real-world effectiveness and safety of vedolizumab (VDZ) in moderate-severe Crohn's disease (CD).
METHODS
Retrospective cohort study of seven medical centers, from May 2014 to December 2015. Adults with moderate-severe CD treated with VDZ, with follow-up after initiation of therapy, were included. Using the multivariable Cox proportional hazard analyses, we identified independent predictors of clinical remission or mucosal healing with VDZ. Rates of serious infection (requiring antibiotics, resulting in discontinuation of VDZ, hospitalization or death) and serious adverse events (discontinuation of VDZ, hospitalization or death) were described quantitatively.
RESULTS
We included 212 patients with moderate-severe CD (median age 34 years; 40% male; 90% tumor necrosis factor (TNF)-antagonist exposed) with a median follow-up (IQR) of 39 weeks (25-53). Twelve-month cumulative rates of clinical remission, mucosal healing, and deep remission (clinical remission+mucosal healing) were 35%, 63%, and 26%, respectively. Individuals with prior TNF-antagonist exposure (hazard ratio (HR) 0.40; 95% confidence interval (CI): 0.20-0.81), smoking history (HR 0.47; 95% CI: 0.25-0.89), active perianal disease (HR 0.49; 95% CI: 0.27-0.88), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve clinical remission. Those with prior TNF-antagonist exposure (HR 0.29; 95% CI: 0.12-0.73), and severe disease activity (HR 0.54; 95% CI: 0.31-0.95) were less likely to achieve mucosal healing. During 160 patient years of follow-up (PYF) and 1,433 VDZ infusions, 5 patients developed infusion reactions (3.5 per 1,000 infusions), 21 developed serious infections (13 per 100 PYF), and 17 developed serious adverse events (10 per 100 PYF). A minority of adverse events required discontinuation of therapy (6 per 100 PYF).
CONCLUSIONS
VDZ is a safe and effective treatment option for moderate-severe CD in routine practice. Clinical remission and deep remission (clinical remission and mucosal healing) can be achieved in 1/3 of individuals, and a minority of individuals require discontinuation of therapy due to adverse events.
目的
我们评估了维多珠单抗（VDZ）在中重度克罗恩病（CD）中的实际疗效和安全性。
方法
对2014年5月至2015年12月期间七个医学中心进行的回顾性队列研究。纳入接受VDZ治疗的中重度CD成人患者，并在开始治疗后进行随访。使用多变量Cox比例风险分析，我们确定了VDZ实现临床缓解或黏膜愈合的独立预测因素。定量描述了严重感染（需要使用抗生素、导致VDZ停药、住院或死亡）和严重不良事件（VDZ停药、住院或死亡）的发生率。
结果
我们纳入了212例中重度CD患者（中位年龄34岁；40%为男性；90%曾接触肿瘤坏死因子（TNF）拮抗剂），中位随访时间（四分位间距）为39周（25 - 53周）。临床缓解、黏膜愈合和深度缓解（临床缓解 + 黏膜愈合）的12个月累积发生率分别为35%、63%和26%。既往接触TNF拮抗剂的个体（风险比（HR）0.40；95%置信区间（CI）：0.20 - 0.81）、有吸烟史的个体（HR 0.47；95% CI：0.25 - 0.89）、有活动性肛周疾病的个体（HR 0.49；95% CI：0.27 - 0.88）以及疾病活动严重的个体（HR 0.54；95% CI：0.31 - 0.95）实现临床缓解的可能性较小。既往接触TNF拮抗剂的个体（HR 0.29；95% CI：0.12 - 0.73）以及疾病活动严重的个体（HR 0.54；95% CI：0.31 - 0.95）实现黏膜愈合的可能性较小。在160患者年的随访期（PYF）和1433次VDZ输注过程中，5例患者出现输注反应（每1000次输注3.5例），21例发生严重感染（每100 PYF 13例），17例发生严重不良事件（每100 PYF 10例）。少数不良事件需要停药（每100 PYF 6例）。
结论
在常规临床实践中，VDZ是中重度CD的一种安全有效的治疗选择。三分之一的个体可实现临床缓解和深度缓解（临床缓解和黏膜愈合），少数个体因不良事件需要停药。
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