Department of Medicine, Shiga University of Medical Science, Seta-Tukinowa, Otsu, 520-2192, Japan.
Center for Gastroenterology and Inflammatory Bowel Disease, Ofuna Chuo Hospital, Kamakura, Japan.
BMC Gastroenterol. 2022 Apr 21;22(1):195. doi: 10.1186/s12876-022-02271-4.
Optimal concentration of ustekinumab (UST) predicting endoscopic remission has not been fully investigated in Crohn's disease (CD). We aimed to identify the optimal UST trough levels predicting clinical, laboratory and endoscopic remission in CD patients.
Twenty-eight patients with CD were enrolled and investigated (27 patients by enteroscopy and 1 by colonoscopy). The endoscopic activity was assessed using the scoring system that applied the Rutgeerts score to observed intestine. Serum UST trough levels and anti-UST antibodies (AUAs) levels were determined by in-house immunoassays.
Endoscopic activity was negatively correlated with serum UST trough levels (Spearman's rank correlation coefficient (ρ) = - 0.66, P = 0.0001) and serum albumin levels (ρ = - 0.60, P = 0.0007). The endoscopic activity was positively and significantly correlated with CRP (ρ = 0.59, P = 0.0009) and ESR (ρ = 0.44, P = 0.033). There was no significant association between the endoscopic score and AUA levels and/or Crohn's disease activity index (CDAI). Serum UST trough levels and albumin levels were significantly higher in the endoscopic remission group (scores of 0 and 1) than in the non-endoscopic remission group (UST trough, mean 3.3 vs. 1.8 μg/mL). No significant difference was observed in AUAs between the endoscopic remission and non-remission groups. Receiver operation curve (ROC) analysis revealed that the optimal cutoff value of UST trough levels predicting normal CRP and serum albumin levels was 1.7 μg/mL for each, and the optimal cutoff value predicting endoscopic remission was 2.0 μg/mL (AUC: 0.80, 95% CI 0.64-0.96).
Achievement of endoscopic remission requires higher UST trough levels than required for normalization of CRP and serum albumin levels.
乌司奴单抗（UST）的最佳浓度预测克罗恩病（CD）的内镜缓解尚未得到充分研究。我们旨在确定预测 CD 患者临床、实验室和内镜缓解的最佳 UST 谷浓度。
共纳入 28 例 CD 患者（27 例经内镜检查，1 例经结肠镜检查）。内镜活动采用 Rutgeerts 评分评估观察到的肠道。通过内部免疫测定法测定血清 UST 谷浓度和抗 UST 抗体（AUAs）水平。
内镜活动与血清 UST 谷浓度（Spearman 秩相关系数（ρ）=-0.66，P=0.0001）和血清白蛋白水平（ρ=-0.60，P=0.0007）呈负相关。内镜活动与 CRP（ρ=0.59，P=0.0009）和 ESR（ρ=0.44，P=0.033）呈正显著相关。内镜评分与 AUA 水平和/或克罗恩病活动指数（CDAI）之间无显著相关性。内镜缓解组（评分 0 和 1）的血清 UST 谷浓度和白蛋白水平显著高于非内镜缓解组（UST 谷浓度，均值 3.3 比 1.8μg/mL）。内镜缓解组和非缓解组之间的 AUA 无显著差异。受试者工作特征曲线（ROC）分析显示，预测 CRP 和血清白蛋白正常的 UST 谷浓度最佳截断值分别为 1.7μg/mL，预测内镜缓解的最佳截断值为 2.0μg/mL（AUC：0.80，95%CI 0.64-0.96）。
实现内镜缓解需要比 CRP 和血清白蛋白正常化更高的 UST 谷浓度。
