Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Inflamm Bowel Dis. 2021 Mar 15;27(4):482-492. doi: 10.1093/ibd/izaa102.
Reports on the feasibility and effectiveness of translating proactive, antitumor necrosis factor (TNF) therapeutic drug monitoring (TDM) for inflammatory bowel disease into practice-wide quality improvement (QI) are lacking. We aimed to determine whether a TDM QI program improved outcomes at a large academic pediatric gastroenterology practice.
We instituted local anti-TNF TDM practice guidelines to proactively monitor and optimize drug levels (goal >5 μg/mL). We conducted a retrospective single-center cohort analysis of patient outcomes before (pre-TDM) and after (post-TDM) guideline institution and assessed the independent effect by multivariable regression. Primary outcome was sustained clinical remission (SCR22-52), defined as physician global assessment (PGA) of inactive from 22 to 52 weeks and off corticosteroids at 52 weeks.
We identified 108 pre-TDM and 206 post-TDM patients. The SCR22-52 was achieved in 42% of pre-TDM and 59% of post-TDM patients (risk difference, 17.6%; 95% CI, 5.4-29%; P = 0.004). The post-TDM group had an increased adjusted odds of achieving SCR22-52 (odds ratio, 2.03; 95% CI, 1.27-3.26; P = 0.003). The adjusted risk of developing high titer antidrug antibodies (ADAs) was lower in the post-TDM group (hazard ratio, 0.18; 95% CI, 0.09-0.35; P < 0.001). Although the risk of anti-TNF cessation for any reason was not significantly different, there was a lower adjusted risk of cessation related to any detectable ADA in the post-TDM group (hazard ratio, 0.45; 95% CI, 0.26-0.77; P = 0.003).
A practice-wide proactive anti-TNF TDM QI program improved key clinical outcomes at our institution, including sustained clinical remission, incidence of high titer ADA, and anti-TNF cessation related to ADA.
缺乏关于将抗肿瘤坏死因子（TNF）主动治疗药物监测（TDM）转化为实践范围质量改进（QI）的可行性和有效性的报告。我们旨在确定大型学术儿科胃肠病学实践中是否可以通过 TDMQI 项目改善结果。
我们制定了局部抗 TNF TDM 实践指南，以主动监测和优化药物水平（目标> 5μg/mL）。我们进行了回顾性单中心队列分析，比较了指南实施前后（TDM 前和 TDM 后）患者的结局，并通过多变量回归评估了独立效果。主要结局是持续的临床缓解（SCR22-52），定义为 22 至 52 周时医生总体评估（PGA）为无活动状态，52 周时停用皮质类固醇。
我们确定了 108 例 TDM 前和 206 例 TDM 后患者。TDM 前患者中 SCR22-52 的达到率为 42%，TDM 后患者为 59%（风险差异，17.6%；95%CI，5.4-29%；P=0.004）。TDM 后组达到 SCR22-52 的调整后优势比更高（比值比，2.03；95%CI，1.27-3.26；P=0.003）。TDM 后组发生高滴度抗药物抗体（ADA）的风险较低（风险比，0.18；95%CI，0.09-0.35；P<0.001）。尽管任何原因停止抗 TNF 治疗的风险无显著差异，但 TDM 后组与任何可检测 ADA 相关的 ADA 停止的调整后风险较低（风险比，0.45；95%CI，0.26-0.77；P=0.003）。
我们机构的一项全实践范围的主动抗 TNF TDMQI 项目改善了关键临床结局，包括持续的临床缓解、高滴度 ADA 的发生率以及与 ADA 相关的抗 TNF 停药。
