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The Real-World Effectiveness and Safety of Vedolizumab for Moderate-Severe Crohn's Disease: Results From the US VICTORY Consortium.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
Am J Gastroenterol. 2016 Aug;111(8):1147-55. doi: 10.1038/ajg.2016.236. Epub 2016 Jun 14.
2
The safety of vedolizumab for ulcerative colitis and Crohn's disease.维多珠单抗用于溃疡性结肠炎和克罗恩病的安全性。
Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18.
3
Integrin antagonists as potential therapeutic options for the treatment of Crohn's disease.整合素拮抗剂作为治疗克罗恩病的潜在治疗选择。
Expert Opin Investig Drugs. 2016;25(3):263-73. doi: 10.1517/13543784.2016.1148137.
4
Efficacy of Vedolizumab as Induction Therapy in Refractory IBD Patients: A Multicenter Cohort.维多珠单抗作为难治性炎症性肠病患者诱导治疗的疗效:一项多中心队列研究
Inflamm Bowel Dis. 2015 Dec;21(12):2879-85. doi: 10.1097/MIB.0000000000000561.
5
Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease.维多珠单抗在溃疡性结肠炎和克罗恩病患者中的群体药代动力学-药效学
Aliment Pharmacol Ther. 2015 Jul;42(2):188-202. doi: 10.1111/apt.13243. Epub 2015 May 20.
6
Vedolizumab for the treatment of moderately to severely active ulcerative colitis.维得利珠单抗用于治疗中度至重度活动性溃疡性结肠炎。
Pharmacotherapy. 2015 Apr;35(4):412-23. doi: 10.1002/phar.1561.
7
Concentrations of 6-thioguanine nucleotide correlate with trough levels of infliximab in patients with inflammatory bowel disease on combination therapy.在接受联合治疗的炎症性肠病患者中,6-硫代鸟嘌呤核苷酸的浓度与英夫利昔单抗的谷浓度相关。
Clin Gastroenterol Hepatol. 2015 Jun;13(6):1118-24.e3. doi: 10.1016/j.cgh.2014.12.026. Epub 2015 Jan 3.
8
Comparative effectiveness of immunosuppressants and biologics for inducing and maintaining remission in Crohn's disease: a network meta-analysis.比较免疫抑制剂和生物制剂在诱导和维持克罗恩病缓解方面的疗效:一项网络荟萃分析。
Gastroenterology. 2015 Feb;148(2):344-54.e5; quiz e14-5. doi: 10.1053/j.gastro.2014.10.011. Epub 2014 Oct 16.
9
Effects of vedolizumab induction therapy for patients with Crohn's disease in whom tumor necrosis factor antagonist treatment failed.英夫利昔单抗诱导治疗对肿瘤坏死因子拮抗剂治疗失败的克罗恩病患者的影响。
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10
Vedolizumab as induction and maintenance therapy for Crohn's disease.维得利珠单抗作为克罗恩病的诱导缓解和维持治疗药物。
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维多珠单抗治疗的炎症性肠病多中心队列患者1年临床反应和缓解的预测因素

Predictors of Clinical Response and Remission at 1 Year Among a Multicenter Cohort of Patients with Inflammatory Bowel Disease Treated with Vedolizumab.

作者信息

Allegretti Jessica R, Barnes Edward L, Stevens Betsey, Storm Margaret, Ananthakrishnan Ashwin, Yajnik Vijay, Korzenik Joshua

机构信息

Division of Gastroenterology, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02141, USA.

Harvard Medical School, Boston, MA, USA.

出版信息

Dig Dis Sci. 2017 Jun;62(6):1590-1596. doi: 10.1007/s10620-017-4549-3. Epub 2017 Mar 29.

DOI:10.1007/s10620-017-4549-3
PMID:28357697
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5661939/
Abstract

BACKGROUND

Vedolizumab (VDZ) has demonstrated long-term efficacy in Crohn's disease (CD) and ulcerative colitis (UC) in phase III trials.

AIMS

Our aim was to evaluate the efficacy of VDZ at week 54 in inflammatory bowel disease (IBD) in a multicenter cohort of patients.

METHODS

Adult patients completing induction therapy with VDZ were eligible for this study. Clinical response and remission was assessed using the Harvey-Bradshaw Index (HBI) for CD, the Simple Clinical Colitis Activity Index for UC and physician assessment.

RESULTS

Among 136 total patients (96 CD and 40 UC), 76 (56%) demonstrated clinical response or remission at week 54. In univariate analysis, for patients with CD concomitant initiation of immunomodulator therapy (2.71, 95% CI 1.11-6.57), the addition of an immunomodulator (OR 11.49, 3.16-41.75) and CRP < 3 (4.92, 95% CI 1.99-12.15) was associated with increased odds of clinical response or remission at week 54. For UC patients, hospitalization after VDZ induction was associated with decreased odds of response or remission at week 54 (OR 0.22, 95% CI 0.05-0.88). On multivariate analysis in CD, addition of an immunomodulator (OR 8.33, 95% CI 2.15-32.26) remained significant predictors of clinical response or remission at week 54.

CONCLUSIONS

Among a multicenter cohort of patients with IBD demonstrating primary response to VDZ, the addition of combination therapy with an immunomodulator is a significant predictor of clinical response or remission at week 54 in patients with CD.

摘要

背景

在III期试验中,维得利珠单抗(VDZ)已在克罗恩病(CD)和溃疡性结肠炎(UC)中显示出长期疗效。

目的

我们的目的是在一个多中心患者队列中评估VDZ在第54周时对炎症性肠病(IBD)的疗效。

方法

完成VDZ诱导治疗的成年患者有资格参加本研究。使用CD的哈维-布拉德肖指数(HBI)、UC的简单临床结肠炎活动指数和医生评估来评估临床反应和缓解情况。

结果

在总共136例患者(96例CD和40例UC)中,76例(56%)在第54周时表现出临床反应或缓解。在单因素分析中,对于CD患者,同时开始免疫调节剂治疗(2.71,95%CI 1.11 - 6.57)、加用免疫调节剂(OR 11.49,3.16 - 41.75)和C反应蛋白<3(4.92,95%CI 1.99 - 12.15)与第54周时临床反应或缓解的几率增加相关。对于UC患者,VDZ诱导后住院与第54周时反应或缓解的几率降低相关(OR 0.22,95%CI 0.05 - 0.88)。在CD的多因素分析中,加用免疫调节剂(OR 8.33,95%CI 2.15 - 32.26)仍然是第54周时临床反应或缓解的显著预测因素。

结论

在一个对VDZ有初始反应的IBD多中心患者队列中,加用免疫调节剂联合治疗是CD患者第54周时临床反应或缓解的显著预测因素。