Division of Gastroenterology and Hepatology, Department of Medicine, McGill University, Montreal, QC, Canada.
Medical Affairs, Janssen Inc, Toronto, ON, Canada.
Dig Dis Sci. 2022 Jul;67(7):3148-3157. doi: 10.1007/s10620-021-07173-1. Epub 2021 Aug 17.
The value of ustekinumab (UST) therapeutic drug monitoring (TDM) in clinical practice remains unclear. This study examined the impact of UST TDM on clinical decision making in patients with Crohn's disease (CD).
A total of 110 consecutive UST-treated CD patients were enrolled in this multicenter, single-arm cross-sectional study. During a single study visit, clinical decisions, disease characteristics, and serum and fecal samples were obtained. The primary outcome was congruency of the actual and two hypothetical clinical decisions based on provision of UST TDM (with and without fecal calprotectin [FCP]) to participating clinicians. Decisions were compared against those of a review panel. A sub-study retrospectively measured the associations of clinical outcomes at the next follow-up visit with serum UST concentration [UST].
No differences in the pattern of decisions by clinicians were observed before and after provision of UST TDM (P = 1.0) or UST TDM + FCP (P = 0.86). However, 39% (TDM) and 50% (TDM + FCP) of hypothetical decisions differed from the initial decisions. The review panel's decisions differed with the addition of TDM + FCP (P = 0.0006), but not TDM alone (P = 0.16). The sub-study (n = 53) failed to detect an association between therapeutic serum [UST] at the initial study visit and clinical outcomes at the next visit.
In consecutive CD patients treated with UST, the addition of TDM into routine clinical practice did not significantly impact clinical decisions and there was no association between short-term clinical outcomes and serum [UST]. Further studies are warranted before clinicians routinely implement UST TDM into clinical practice.
乌司奴单抗（UST）治疗药物监测（TDM）在临床实践中的价值尚不清楚。本研究旨在评估 UST TDM 对克罗恩病（CD）患者临床决策的影响。
本多中心、单臂、横断面研究纳入了 110 例连续接受 UST 治疗的 CD 患者。在单次研究访视中，收集了临床决策、疾病特征、血清和粪便样本。主要结局是根据提供 UST TDM（联合或不联合粪便钙卫蛋白[FCP]）给参与临床医生，实际和两种假设临床决策的一致性。决策与审查小组的决策进行了比较。一项亚研究回顾性测量了下一次随访时的临床结局与血清 UST 浓度[UST]的相关性。
在提供 UST TDM（P=1.0）或 UST TDM+FCP（P=0.86）前后，临床医生的决策模式没有差异。然而，39%（TDM）和 50%（TDM+FCP）的假设决策与初始决策不同。审查小组的决策随着 TDM+FCP 的加入而有所不同（P=0.0006），但 TDM 单独加入则不然（P=0.16）。亚研究（n=53）未能检测到初始研究访视时治疗性血清[UST]与下一次访视时临床结局之间的相关性。
在连续接受 UST 治疗的 CD 患者中，将 TDM 纳入常规临床实践并未显著影响临床决策，并且短期临床结局与血清[UST]之间没有相关性。在临床医生常规将 UST TDM 纳入临床实践之前，还需要进一步的研究。
