Sagar Rebecca, Lenti Marco V, Clark Tanya, Rafferty Helen J, Gracie David J, Ford Alexander C, O'Connor Anthony, Ahmad Tariq, Hamlin P John, Selinger Christian P
Leeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.
Leeds Institute of Medical Research at St. James's, University of Leeds, Leeds, United Kingdom.
Inflamm Intest Dis. 2021 Apr 13;6(3):132-139. doi: 10.1159/000515593. eCollection 2021 Sep.
Therapeutic drug monitoring (TDM) of infliximab (IFX) trough levels and anti-drug antibodies in conjunction with symptoms, disease history, and investigations can aid decision-making. This study evaluated 1-year outcomes of patients with decisions that were altered on the basis of TDM results, in order to investigate whether outcomes from TDM-based decisions to adjust or stop IFX treatment are durable.
We retrospectively collected clinical outcomes 12 months post treatment decisions based on proactive TDM. Patients whose initial treatment decisions were altered on the basis of TDM results were compared with those where the decision remained unchanged. Events of interest were inpatient admissions with active inflammatory bowel disease (IBD), further changes to biologic therapy, and IBD-related health-care costs.
Of 189 patients, 54 (28%) had initial treatment decisions altered in the light of TDM results. The 135 patients whose initial decision was not altered in light of TDM results served as the comparator. There were no differences in hospitalization rates or subsequent biologic switches between the altered decision groups and the comparator group. IBD-related health-care costs were higher in those whose initial decision was altered (median GBP 7,912 vs. GBP 6,521; < 0.0001) due to higher drug costs (median GBP 7,062 vs. GBP 6,012; < 0.0001).
Our study demonstrates good outcomes from changes to IFX treatment based on TDM. Patients with a decision to stop, switch, or continue with an adjusted IFX dose experienced comparable clinical outcomes but had higher drug-related expenditure than those whose treatment decision was not altered in light of TDM.
英夫利昔单抗(IFX)谷浓度和抗药物抗体的治疗药物监测(TDM)结合症状、病史及检查有助于决策制定。本研究评估了根据TDM结果改变治疗决策的患者的1年结局,以调查基于TDM的调整或停用IFX治疗决策的结局是否持久。
我们回顾性收集了基于主动TDM的治疗决策后12个月的临床结局。将初始治疗决策根据TDM结果改变了的患者与决策未改变的患者进行比较。关注的事件包括因活动性炎症性肠病(IBD)住院、生物治疗的进一步改变以及IBD相关的医疗费用。
189例患者中,54例(28%)的初始治疗决策根据TDM结果进行了改变。135例初始决策未根据TDM结果改变了的患者作为对照。改变决策组与对照组在住院率或随后的生物制剂转换方面没有差异。初始决策改变的患者的IBD相关医疗费用更高(中位数7912英镑对6521英镑;<0.0001),原因是药物成本更高(中位数7062英镑对6012英镑;<0.0001)。
我们的研究表明基于TDM改变IFX治疗可获得良好结局。决定停用、转换或继续调整IFX剂量的患者临床结局相当,但与治疗决策未根据TDM改变的患者相比,药物相关支出更高。