Allegretti Jessica R, Barnes Edward L, Stevens Betsey, Storm Margaret, Ananthakrishnan Ashwin, Yajnik Vijay, Korzenik Joshua
Division of Gastroenterology, Brigham and Women's Hospital, 75 Francis Street, Boston, MA, 02141, USA.
Harvard Medical School, Boston, MA, USA.
Dig Dis Sci. 2017 Jun;62(6):1590-1596. doi: 10.1007/s10620-017-4549-3. Epub 2017 Mar 29.
Vedolizumab (VDZ) has demonstrated long-term efficacy in Crohn's disease (CD) and ulcerative colitis (UC) in phase III trials.
Our aim was to evaluate the efficacy of VDZ at week 54 in inflammatory bowel disease (IBD) in a multicenter cohort of patients.
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.
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.
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.
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。
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。
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。
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。
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。