Kajikawa Go, Sawada Tsunaki, Nakamura Masanao, Yamamura Takeshi, Maeda Keiko, Ishikawa Eri, Uetsuki Kota, Hirose Takashi, Iida Tadashi, Mizutani Yasuyuki, Yamao Kentaro, Ishikawa Takuya, Furukawa Kazuhiro, Kawashima Hiroki
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Department of Endoscopy, Nagoya University Hospital, Nagoya, Japan.
Nagoya J Med Sci. 2024 Aug;86(3):407-421. doi: 10.18999/nagjms.86.3.407.
Vedolizumab is a treatment option for ulcerative colitis but data on predictors of treatment response remain insufficient to establish personalized treatment strategies. We aimed to investigate the real-world effectiveness of vedolizumab in adult patients with ulcerative colitis and explore factors involved in predicting treatment response. This single-center, single-arm, prospective observational study included 26 patients with clinically active ulcerative colitis patients' characteristics at baseline, epidemiological information, existing treatment, clinical activity index score, endoscopic score, and blood test data were collected. Serum levels of tumor necrosis factors alpha, interferon gamma, interleukin-4, interleukin-6, interleukin-10, interleukin-17, soluble mucosal addressin cell adhesion molecule 1, and soluble vascular cell adhesion molecule 1 were measured. Patient characteristics in the remission and non-remission groups were compared based on these parameters. Clinical remission at 6 weeks of treatment occurred in 9 (35%) of the 26 patients. At 14 weeks, clinical remission was observed in 11 patients (42%). There were no significant differences pertaining to age, sex, duration of disease, extent of disease, steroid resistance, or prior treatment with biological agents among the two groups after 14 weeks of treatment. Hemoglobin ≥ 11.5 g/dL (odds ratio, 15.0; 95% confidence interval, 1.50-149; P=0.014) and soluble mucosal addressin cell adhesion molecule 1 ≥ 765 pg/mL (odds ratio, 17.3; 95% confidence interval, 2.36-127; P=0.004) were significant factors. In conclusion, hemoglobin and serum soluble mucosal addressin cell adhesion molecule 1 levels are factors correlated with the therapeutic efficacy of vedolizumab.
维多珠单抗是溃疡性结肠炎的一种治疗选择,但关于治疗反应预测指标的数据仍不足以制定个性化治疗策略。我们旨在研究维多珠单抗在成年溃疡性结肠炎患者中的实际疗效,并探索预测治疗反应的相关因素。这项单中心、单臂、前瞻性观察性研究纳入了26例临床活动期溃疡性结肠炎患者,收集了他们的基线特征、流行病学信息、现有治疗情况、临床活动指数评分、内镜评分和血液检查数据。检测了血清肿瘤坏死因子α、干扰素γ、白细胞介素-4、白细胞介素-6、白细胞介素-10、白细胞介素-17、可溶性黏膜地址素细胞黏附分子1和可溶性血管细胞黏附分子1的水平。根据这些参数比较了缓解组和未缓解组的患者特征。26例患者中有9例(35%)在治疗6周时实现临床缓解。在14周时,观察到11例患者(42%)实现临床缓解。治疗14周后,两组在年龄、性别、病程、疾病范围、类固醇抵抗或既往生物制剂治疗方面无显著差异。血红蛋白≥11.5 g/dL(比值比,15.0;95%置信区间,1.50 - 149;P = 0.014)和可溶性黏膜地址素细胞黏附分子1≥765 pg/mL(比值比,17.3;95%置信区间,2.36 - 127;P = 0.004)是显著因素。总之,血红蛋白和血清可溶性黏膜地址素细胞黏附分子1水平是与维多珠单抗治疗疗效相关的因素。