Gastrenterology and Hepatology Unit, Hospital Santa Maria, Centro Hospitalar Universitário de Lisboa Norte, Lisboa, Portugal.
Inflamm Bowel Dis. 2020 Jan 6;26(2):263-270. doi: 10.1093/ibd/izz131.
Increasing evidence supports the use of reactive therapeutic drug monitoring (TDM) in Crohn's disease (CD) and ulcerative colitis (UC) following secondary loss of response. It is still unknown if proactive TDM can improve clinical outcomes.
Consecutive patients completing infliximab (IFX) induction therapy were prospectively allocated into a proactive TDM protocol (pTDM). Before the fourth infusion and every 2 infusions, IFX trough levels and antidrug antibodies were measured using a drug-sensitive assay (Theradiag, Lisa Tracker). Treatment was proactively escalated aiming at an IFX trough level between 3 and 7 ug/mL (CD) and 5 and 10 ug/mL (UC). A retrospective cohort treated with IFX but without TDM served as the reference group. End points included the need for surgery, hospitalization, treatment discontinuation, and mucosal healing at 2 years of follow-up.
Two hundred five patients were included, 56 in the proactive regimen. Treatment escalation was more common in pTDM patients (76.8% vs 25.5%; P < 0.001), who also required less surgery (8.9% vs 20.8%; P = 0.032) and presented higher rates of mucosal healing (73.2% vs 38.9%; P < 0.0001). Proactive TDM significantly decreased the odds of reaching any unfavorable outcome (odds ratio, 0.358; 95% confidence interval, 0.188-0.683; P = 0.002).
Proactive TDM is associated with fewer surgeries and higher rates of mucosal healing than conventional non-TDM-based management.
越来越多的证据支持在克罗恩病（CD）和溃疡性结肠炎（UC）出现应答丧失后进行反应性治疗药物监测（TDM）。目前仍不清楚主动 TDM 是否能改善临床结局。
连续完成英夫利昔单抗（IFX）诱导治疗的患者前瞻性分配到主动 TDM 方案（pTDM）中。在第四次输注前和每两次输注时，使用药物敏感测定法（Theradiag，Lisa Tracker）测量 IFX 谷浓度和抗药物抗体。治疗被主动升级，目标是 IFX 谷浓度在 3 至 7μg/ml（CD）和 5 至 10μg/ml（UC）之间。接受 IFX 治疗但没有 TDM 的回顾性队列作为对照组。终点包括 2 年随访时需要手术、住院、停药和黏膜愈合。
共纳入 205 例患者，其中 56 例接受主动方案治疗。pTDM 患者的治疗升级更为常见（76.8% vs 25.5%；P<0.001），手术需求较少（8.9% vs 20.8%；P=0.032），黏膜愈合率较高（73.2% vs 38.9%；P<0.0001）。主动 TDM 显著降低了出现任何不良结局的几率（比值比，0.358；95%置信区间，0.188-0.683；P=0.002）。
与传统的非 TDM 基于管理相比，主动 TDM 与较少的手术和更高的黏膜愈合率相关。
