Department of Gastroenterology, Ankara City Hospital, Ankara, Turkey.
Turk J Gastroenterol. 2022 Oct;33(10):831-837. doi: 10.5152/tjg.2022.21684.
Vedolizumab, which is a monoclonal antibody that selectively binds to α4β7 integrin in the gastrointestinal system, may be an effective and safe treatment alternative in those with anti-tumor necrosis factor-resistant inflammatory bowel disease.
Patients administered vedolizumab due to anti-tumor necrosis factor resistant or anti-tumor necrosis factor side effects between August 2017 and November 2020 were included in the study. Crohn's patients were evaluated using the Harvey-Bradshaw index and Simple Endoscopic Score for Crohn's Disease, whereas ulcerative colitis patients were evaluated with the Partial Mayo Score Index and Rachmilewitz score. All patients were followed up for 3 months and their blood samples were taken every 3 months. Hemoglobin, white blood cell, leukocyte, lymphocyte, and platelet counts of the patients were performed. Albumin, C-reactive protein, and erythrocye sedimentation rate values were recorded. The side effect profile for vedolizumab was evaluated for all patients. Among the side effects, arthralgia and flu-like symptoms were observed.
A total of 48 patients (18 ulcerative colitis and 30 Crohn's disease) were included in the study. Vedolizumab therapy was initi- ated in the patients due to anti-tumor necrosis factor resistance (17 ulcerative colitis and 26 Crohn's disease) or anti-tumor necrosis factor side effects (1 ulcerative colitis and 4 Crohn's disease). A total of 30 (63%) patients, including 15 (83%) ulcerative colitis and 15 (50%) Crohn's disease, responded to treatment (both response and remission). The mean duration of response to treatment was 4.5 ± 1.5 months. A total of 20 (42%) patients in the vedolizumab therapy subgroup (10/10, ulcerative colitis/Crohn's disease) went into remission. The mean Harvey-Bradshaw Index value was 9.8 ± 2.8 in the Crohn's disease patients at the time of initial treatment. The mean Simple Endoscopic Score for Crohn's disease value was 11.2 ± 3.1 at the time of initial treatment. The mean Harvey-Bradshaw Index value was 6.5 ± 3.0 and the mean Simple Endoscopic Score for Crohn's disease value was 4.9 ± 3.6 at 6 months post-treatment. The mean Ulcerative Colitis Endoscopic Index (Rachmilewitz) value was 9.3 ± 1.2 at the time of initial treatment. In addition, the mean Partial Mayo Scoring Index was 6.4 ± 1.5 at the time of initial treatment. The mean Ulcerative Colitis Endoscopic Index (Rachmilewitz) value was 0 (0-6.0), and the mean Partial Mayo Scoring Index was 1.5 (0.3-4.0) at 6 months post-treatment.
Vedolizumab therapy is effective in both induction and maintenance of remission in inflammatory bowel disease patients who are resistant to anti-tumor necrosis factor or who can not receive anti-tumor necrosis factor therapy due to side effects. No signifi- cant side effect was observed in the patients during follow-up.
Vedolizumab 是一种单克隆抗体，可选择性结合胃肠道中的 α4β7 整合素，在抗肿瘤坏死因子耐药的炎症性肠病患者中，可能是一种有效且安全的治疗选择。
纳入 2017 年 8 月至 2020 年 11 月因抗肿瘤坏死因子耐药或抗肿瘤坏死因子副作用而接受 vedolizumab 治疗的患者。克罗恩病患者采用 Harvey-Bradshaw 指数和简单克罗恩病内镜评分进行评估，溃疡性结肠炎患者采用部分 Mayo 评分指数和 Rachmilewitz 评分进行评估。所有患者均随访 3 个月，每 3 个月采集一次血样。检测患者的血红蛋白、白细胞、白细胞、淋巴细胞和血小板计数。记录白蛋白、C 反应蛋白和红细胞沉降率值。评估所有患者 vedolizumab 的副作用情况。在副作用中，观察到关节痛和流感样症状。
共纳入 48 例患者（18 例溃疡性结肠炎和 30 例克罗恩病）。由于抗肿瘤坏死因子耐药（17 例溃疡性结肠炎和 26 例克罗恩病）或抗肿瘤坏死因子副作用（1 例溃疡性结肠炎和 4 例克罗恩病），开始对患者进行 vedolizumab 治疗。共有 30 名（63%）患者，包括 15 名（83%）溃疡性结肠炎和 15 名（50%）克罗恩病患者对治疗有反应（均有缓解和缓解）。治疗反应的平均持续时间为 4.5±1.5 个月。在 vedolizumab 治疗亚组中，共有 20 名（42%）患者（10/10，溃疡性结肠炎/克罗恩病）进入缓解期。克罗恩病患者初诊时的平均 Harvey-Bradshaw 指数为 9.8±2.8。初诊时克罗恩病的简单内镜评分平均为 11.2±3.1。治疗后 6 个月时，平均 Harvey-Bradshaw 指数为 6.5±3.0，平均简单内镜评分克罗恩病为 4.9±3.6。初诊时溃疡性结肠炎内镜指数（Rachmilewitz）平均值为 9.3±1.2。此外，初诊时的平均部分 Mayo 评分指数为 6.4±1.5。初诊时溃疡性结肠炎内镜指数（Rachmilewitz）为 0（0-6.0），部分 Mayo 评分指数为 1.5（0.3-4.0），治疗后 6 个月。
Vedolizumab 治疗在抗肿瘤坏死因子耐药或因副作用不能接受抗肿瘤坏死因子治疗的炎症性肠病患者中，既能诱导缓解，又能维持缓解。在随访期间，患者未出现明显副作用。
