Pan Yushan, Ahmed Waseem, Mahtani Prerna, Wong Rochelle, Longman Randy, Jeremy Lukin Dana, Scherl Ellen J, Battat Robert
Joan & Sanford I. Weill Medical College of Cornell University, New York, NY, USA.
Crohn's and Colitis Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Inflamm Bowel Dis. 2022 Dec 1;28(12):1865-1871. doi: 10.1093/ibd/izac030.
In postoperative Crohn's disease (POCD), data are lacking on relationships between serum biologic concentrations and treatment outcomes. We assessed if established threshold concentrations of infliximab (IFX), adalimumab (ADA), and ustekinumab (UST) impact outcomes in POCD.
Data were extracted from POCD patients with serum biologic concentration measurements using Weill Cornell Medicine biobanks. The primary outcome compared rates of deep remission (achieving both objective [endoscopic or biomarker] and clinical [Harvey-Bradshaw index or Crohn's Disease Patient Reported Outcome-2] remission), using established serum drug level cutoffs of IFX ≥3 µg/mL, ADA ≥7.5 µg/mL, and UST ≥4.5 µg/mL.
In 130 patients, median IFX, ADA, and UST concentrations were 10 (interquartile range [IQR], 2.9-26.9) µg/mL, 10.5 (IQR, 4.9-14.9) µg/mL, and 6.9 (IQR, 5.1-10.2) µg/mL, respectively. In patients with IFX ≥3 µg/mL, higher rates of deep remission (39% vs 0%; P = .02) existed compared with those with IFX <3 µg/mL. Similar differences existed for clinical (44% vs 9%; P = .04) and objective (83% vs 62%; P = .1) remission. In patients with ADA ≥7.5 µg/mL, rates of deep (42% vs 0%; P = .02), clinical (42% vs 0%; P = .02), and objective (88% vs 40%; P = .007) remission were higher than patients with lower concentrations. For UST, rates of deep (28% vs 17%; P = 1.0), clinical (33% vs 33%; P = 1.0), and objective (70% vs 67%; P = 1.0) remission were similar between patients regardless of drug concentration.
In POCD, established anti-tumor necrosis factor concentrations were associated with improved outcomes. No relationship between UST concentrations and postoperative outcomes existed.
在克罗恩病术后（POCD）中，血清生物制剂浓度与治疗结果之间的关系尚缺乏数据。我们评估了英夫利昔单抗（IFX）、阿达木单抗（ADA）和乌司奴单抗（UST）的既定阈值浓度是否会影响POCD的治疗结果。
从使用威尔康奈尔医学院生物样本库进行血清生物制剂浓度测量的POCD患者中提取数据。主要结局比较深度缓解率（实现客观[内镜或生物标志物]和临床[哈维-布拉德肖指数或克罗恩病患者报告结局-2]缓解），使用既定的血清药物水平临界值，即IFX≥3µg/mL、ADA≥7.5µg/mL和UST≥4.5µg/mL。
在130例患者中，IFX、ADA和UST的中位浓度分别为10（四分位间距[IQR]，2.9-26.9）µg/mL、10.5（IQR，4.9-14.9）µg/mL和6.9（IQR，5.1-10.2）µg/mL。在IFX≥3µg/mL的患者中，与IFX<3µg/mL的患者相比，深度缓解率更高（39%对0%；P=.02）。临床缓解（44%对9%；P=.04）和客观缓解（83%对62%；P=.1）也存在类似差异。在ADA≥7.5µg/mL的患者中，深度缓解（42%对0%；P=.02）、临床缓解（42%对0%；P=.02）和客观缓解（88%对40%；P=.007）率均高于浓度较低的患者。对于UST，无论药物浓度如何，患者之间的深度缓解（28%对17%；P=1.0）、临床缓解（33%对33%；P=1.0）和客观缓解（70%对67%；P=1.0）率相似。
在POCD中，既定的抗肿瘤坏死因子浓度与改善的治疗结果相关。UST浓度与术后结果之间不存在关系。
