Shelton Edward, Allegretti Jessica R, Stevens Betsy, Lucci Matthew, Khalili Hamed, Nguyen Deanna D, Sauk Jenny, Giallourakis Cosmas, Garber John, Hamilton Matthew J, Tomczak Michal, Makrauer Fredrick, Burakoff Robert B, Levine Jonathan, de Silva Punyaganie, Friedman Sonia, Ananthakrishnan Ashwin, Korzenik Joshua R, Yajnik Vijay
*Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts; †Harvard Medical School, Boston, Massachusetts; and ‡Division of Gastroenterology, Brigham and Women's Hospital, Boston, Massachusetts.
Inflamm Bowel Dis. 2015 Dec;21(12):2879-85. doi: 10.1097/MIB.0000000000000561.
Vedolizumab (VDZ) demonstrated efficacy in Crohn's disease (CD) and ulcerative colitis (UC) in the GEMINI trials. Our aim was to evaluate the efficacy of VDZ at week 14 in inflammatory bowel disease in a multicenter cohort of patients.
Patients at Massachusetts General Hospital and Brigham and Women's Hospital were considered for inclusion. VDZ (300 mg) was administered at weeks 0, 2, 6, and 14. Efficacy was assessed using the Harvey-Bradshaw index for CD, the simple clinical colitis activity index for UC and physician assessment, along with C-reactive protein and decrease of corticosteroid therapy. Clinical response was defined as decrease in Harvey-Bradshaw index ≥3 and simple clinical colitis activity index ≥3 and remission as Harvey-Bradshaw index ≤4, simple clinical colitis activity index ≤2 and physician assessment of response and remission.
Our study included 172 patients (107 CD, 59 UC, 6 inflammatory bowel disease-unclassified, men 48.3%, mean age 40 years and disease duration 14 years). Fourteen patients had ostomy and 9 ileoanal pouch, and only 35.5% fulfilled eligibility for the GEMINI trials. Previous treatment failures with ≥ 2 anti-TNFs occurred in 70.9%, one-third were on an immunomodulator and 46% systemic steroids at baseline. In CD, 48.9% and 23.9% and in UC, 53.9% and 29.3% had clinical response and clinical remission at week 14, respectively. Adverse events occurred in 10.5%.
VDZ is safe and well tolerated in refractory inflammatory bowel disease patients in a clinical practice with efficacy in UC and CD with responses similar to what was seen in clinical trials.
在GEMINI试验中，维多珠单抗（VDZ）在克罗恩病（CD）和溃疡性结肠炎（UC）中显示出疗效。我们的目的是在一个多中心患者队列中评估VDZ在第14周时对炎症性肠病的疗效。
考虑纳入马萨诸塞州总医院和布莱根妇女医院的患者。在第0、2、6和14周给予VDZ（300毫克）。使用CD的哈维-布拉德肖指数、UC的简单临床结肠炎活动指数和医生评估，以及C反应蛋白和皮质类固醇治疗的减少来评估疗效。临床反应定义为哈维-布拉德肖指数降低≥3且简单临床结肠炎活动指数降低≥3，缓解定义为哈维-布拉德肖指数≤4、简单临床结肠炎活动指数≤2以及医生对反应和缓解的评估。
我们的研究纳入了172例患者（107例CD、59例UC、6例未分类的炎症性肠病，男性占48.3%，平均年龄40岁，病程14年）。14例患者有造口术，9例有回肠肛管袋，只有35.5%符合GEMINI试验的入选标准。70.9%的患者既往有≥2种抗TNF治疗失败，三分之一的患者在基线时使用免疫调节剂，46%使用全身类固醇。在CD中，第14周时分别有48.9%和23.9%的患者有临床反应和临床缓解，在UC中分别为53.9%和29.3%。不良事件发生率为10.5%。
在临床实践中，VDZ在难治性炎症性肠病患者中安全且耐受性良好，在UC和CD中均有疗效，反应与临床试验中所见相似。
