Khan Freeha, Gao Xian-Hua, Singh Amandeep, Philpott Jessica R, Shen Bo
Center for Inflammatory Bowel Disease, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH, USA.
Gastroenterol Rep (Oxf). 2018 Aug;6(3):184-188. doi: 10.1093/gastro/goy014. Epub 2018 Jun 22.
Our recent study showed the efficacy and safety of vedolizumab in the treatment of chronic antibiotic-refractory pouchitis. However, there are no published studies on its efficacy and safety in Crohn's disease (CD) of the pouch. The aim of this study was to assess the efficacy and safety of vedolizumab in those patients.
This case series included all eligible patients with CD of the pouch from our prospectively maintained, IRB-approved Pouchitis Registry from 2015 to 2017. Disease activity in pouch patients can be monitored using the modified Pouchitis Disease Activity Index (mPDAI). mPDAI is the 18-point pouchitis disease activity index consisting of three principal component scores: symptom (range, 0-6 points), endoscopy, (range 0-6 points), and histology (range, 2-6 points). Pre- and post- treatment (minimum 6 months) pouchoscopy and clinical visits were used to calculate mPDAI.
A total of 12 patients were included in this study, who had restorative proctocolectomy with ileal pouch anal anastomosis for medically refractory ulcerative colitis (UC). The mean age at the time of pre-colectomy diagnosis of UC was 25.0 ± 11.5 years. The mean current age was 41.0 ± 12.1 years, nine (75.0%) were female, three (25.0%) had smoked and eight (66.7%) had used anti-tumor necrosis factor agents prior to vedolizumab use. The mean duration of vedolizumab use was 1.0 ± 6.4 years. There was a significant reduction in mPDAI symptom subscores after vedolizumab therapy (3.50 ± 1.93 vs 5.08 ± 0.79, = 0.015). The pre- and post-treatment mean endoscopy subscores were 1.25 ± 1.36 and 0.91 ± 1.50 in the afferent limb ( = 0.583); 2.58 ± 1.68 and 2.27 ± 2.05 ( = 0.701) in the pouch body; and 2.67 ± 1.93 and 2.09 ± 2.12 ( = 0.511) in the cuff, respectively. None of the patients experienced side effects throughout the vedolizumab therapy.
The findings of our study suggests that vedolizumab appears to be effective and safe in reducing the symptoms in patients with CD of the pouch.
我们最近的研究显示了维多珠单抗治疗慢性抗生素难治性袋炎的疗效和安全性。然而，关于其在袋状克罗恩病（CD）中的疗效和安全性尚无发表的研究。本研究的目的是评估维多珠单抗在这些患者中的疗效和安全性。
本病例系列纳入了2015年至2017年我们前瞻性维护、经机构审查委员会批准的袋炎登记处中所有符合条件的袋状CD患者。袋状患者的疾病活动可以使用改良的袋炎疾病活动指数（mPDAI）进行监测。mPDAI是18分的袋炎疾病活动指数，由三个主要成分评分组成：症状（范围0 - 6分）、内镜检查（范围0 - 6分）和组织学（范围2 - 6分）。治疗前和治疗后（至少6个月）的袋状结肠镜检查和临床访视用于计算mPDAI。
本研究共纳入12例患者，这些患者因药物难治性溃疡性结肠炎（UC）接受了全直肠结肠切除加回肠袋肛管吻合术。UC术前诊断时的平均年龄为25.0±11.5岁。当前平均年龄为41.0±12.1岁，9例（75.0%）为女性，3例（25.0%）有吸烟史，8例（66.7%）在使用维多珠单抗之前使用过抗肿瘤坏死因子药物。维多珠单抗的平均使用时间为1.0±6.4年。维多珠单抗治疗后mPDAI症状子评分显著降低（3.50±1.93对5.08±0.79，P = 0.015）。治疗前和治疗后传入肠袢的平均内镜子评分分别为1.25±1.36和0.91±1.50（P = 0.583）；袋体分别为2.58±1.68和2.27±2.05（P = 0.701）；袖口分别为2.67±1.93和2.09±2.12（P = 0.511）。在整个维多珠单抗治疗过程中，没有患者出现副作用。
我们的研究结果表明，维多珠单抗在减轻袋状CD患者的症状方面似乎是有效且安全的。
