Department of Gastroenterology and Liver Diseases, IBD Center, Tel Aviv Medical Center, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
J Clin Gastroenterol. 2021 Oct 1;55(9):810-814. doi: 10.1097/MCG.0000000000001435.
Biomarker normalization and endoscopic remission are superior to clinical remission in achieving improved long-term clinical outcomes in patients with inflammatory bowel diseases.
To study whether higher maintenance adalimumab levels are associated with clinical remission, biomarker normalization, and endoscopic remission.
Data were collected retrospectively from the patients' medical records. We defined clinical remission as a Harvey Bradshaw Index ≤5 or a partial Mayo score ≤2 for Crohn's disease (CD) and ulcerative colitis (UC), respectively, biomarker normalization as a C-reactive protein <0.5 mg/dL and/or calprotectin <250 (mg/kg), endoscopic remission as a (simple endoscopic score-CD) ≤3/4 for ileal/extensive CD, respectively, or an endoscopic Mayo score ≤1 for UC, and deep remission as the combination of clinical and endoscopic remission with normal biomarkers.
Ninety-seven patients were included (82 CD and 15 UC). Patients who achieved clinical remission, biomarker normalization, or endoscopic remission had higher serum trough adalimumab levels compared with patients not in remission [mean (M)±standard error (SE)=8.98±0.78 vs. 5.92±0.96 μg/mL; P=0.016, 9.38±0.85 vs. 5.48±0.87 μg/mL; P=0.002; 9.13±0.88 vs. 6.02±0.77 μg/mL; P=0.019, respectively]. Receiver-operating curve analysis showed that an adalimumab level of ≥8.25 μg/mL was associated with deep remission (sensitivity 84%, specificity 70%, area under the curve 0.775; P<0.001).
Clinical remission, biomarker normalization, and endoscopic remission are positively associated with adalimumab trough levels. Adalimumab level of ≥8.25 μg/mL is associated with deep remission. This study provides additional data to guide therapeutic drug monitoring with adalimumab.
生物标志物正常化和内镜缓解优于临床缓解，可改善炎症性肠病患者的长期临床结局。
研究更高的阿达木单抗维持水平是否与临床缓解、生物标志物正常化和内镜缓解相关。
数据从患者的病历中回顾性收集。我们将临床缓解定义为克罗恩病（CD）的 Harvey Bradshaw 指数≤5 或部分 Mayo 评分≤2，溃疡性结肠炎（UC）分别为 C-反应蛋白<0.5mg/dL 和/或钙卫蛋白<250(mg/kg)，内镜缓解定义为回肠/广泛 CD 的简单内镜评分-CD≤3/4，或 UC 的内镜 Mayo 评分≤1，深度缓解定义为生物标志物正常的临床和内镜缓解的组合。
共纳入 97 例患者（82 例 CD 和 15 例 UC）。与未缓解的患者相比，达到临床缓解、生物标志物正常化或内镜缓解的患者血清阿达木单抗谷水平更高[平均（M）±标准误差（SE）=8.98±0.78 比 5.92±0.96μg/mL；P=0.016，9.38±0.85 比 5.48±0.87μg/mL；P=0.002；9.13±0.88 比 6.02±0.77μg/mL；P=0.019]。受试者工作特征曲线分析显示，阿达木单抗水平≥8.25μg/mL 与深度缓解相关（敏感性 84%，特异性 70%，曲线下面积 0.775；P<0.001）。
临床缓解、生物标志物正常化和内镜缓解与阿达木单抗谷水平呈正相关。阿达木单抗水平≥8.25μg/mL 与深度缓解相关。本研究提供了额外的数据来指导阿达木单抗的治疗药物监测。
