Samaan Mark A, Birdi Siddharth, Morales Maria Sierra, Honap Sailish, Tamilarasan Aravind Gokul, Cunningham Georgina, Koumoutsos Ioannis, Ray Shuvra, Mawdsley Joel, Anderson Simon H C, Sanderson Jeremy, Irving Peter M
IBD Centre, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Gastroenterologia y Hepatologia, Hospital Universitario Ramon y Cajal, Madrid, Spain.
Frontline Gastroenterol. 2019 Jul 11;11(3):188-193. doi: 10.1136/flgastro-2019-101259. eCollection 2020.
Despite the proven efficacy of vedolizumab (VDZ) for ulcerative colitis (UC) and Crohn's disease (CD), suboptimal response is commonly encountered. However, data regarding the effectiveness of dose intensification (by interval shortening) to achieve response are limited.
We evaluated the effectiveness of dose intensification at achieving response in patients with a previously suboptimal response to VDZ. Additionally, we aimed to identify predictors of response to this strategy.
We performed a retrospective cohort study of patients who underwent VDZ dose intensification for suboptimal response. Clinical disease activity was evaluated at the point of dose intensification (baseline) and at weeks 12 and 24. Response was defined as Harvey-Bradshaw Index (HBI) or Simple Clinical Colitis Activity Index (SCCAI) reduction of ≥3, and remission as HBI <5 or SCCAI <3.
A total of 36 patients received dose intensification to 4-weekly infusions: 18 CD, 14 UC and 4 inflammatory bowel disease-unclassified (analysed in the UC group). Median SCCAI scores fell from 6 (range 0-11) at baseline to 4 (0-6, p=0.008) at week 24, while HBI scores did not change significantly (4 (0-27) and 3 (0-8), p=0.092). Overall median C reactive protein (CRP) fell from 6 mg/L (1-23) to 2 mg/L (1-17, p=0.011). Of 20 patients with clinically active disease at baseline, 10 (50%) responded, of whom 4 (20%) achieved remission at week 24. Univariate analysis demonstrated low baseline CRP (p=0.045) and response at week 12 (0.020) were associated with week 24 response.
Our findings demonstrate VDZ dose intensification to be effective at achieving clinical response in half of patients. Low baseline CRP and response at week 12 are potential predictors of week 24 response.
尽管维多珠单抗（VDZ）已被证实对溃疡性结肠炎（UC）和克罗恩病（CD）有效，但仍常见疗效欠佳的情况。然而，关于通过缩短给药间隔进行剂量强化以实现疗效的数据有限。
我们评估了对VDZ先前反应欠佳的患者进行剂量强化以实现疗效的有效性。此外，我们旨在确定对该策略有反应的预测因素。
我们对因反应欠佳而接受VDZ剂量强化的患者进行了一项回顾性队列研究。在剂量强化时（基线）以及第12周和第24周评估临床疾病活动度。反应定义为哈维-布拉德肖指数（HBI）或简单临床结肠炎活动指数（SCCAI）降低≥3，缓解定义为HBI<5或SCCAI<3。
共有36例患者接受了每4周一次的剂量强化输注：18例CD患者，14例UC患者和4例未分类的炎症性肠病患者（在UC组中分析）。SCCAI中位数评分从基线时的6分（范围0-11）降至第24周时的4分（0-6，p=0.008），而HBI评分无显著变化（4分（0-27）和3分（0-8），p=0.092）。总体C反应蛋白（CRP）中位数从6mg/L（1-23）降至2mg/L（1-17，p=0.011）。在基线时临床疾病活动的20例患者中，10例（50%）有反应，其中4例（20%）在第24周实现缓解。单因素分析表明，低基线CRP（p=0.045）和第12周的反应（p=0.020）与第24周的反应相关。
我们的研究结果表明，VDZ剂量强化对半数患者实现临床反应有效。低基线CRP和第12周的反应是第24周反应的潜在预测因素。
