Hospital Pharmacy, Hospital General Universitario Reina Sofía, España.
Public Health, Universidad de Murcia.
Rev Esp Enferm Dig. 2020 May;112(5):360-366. doi: 10.17235/reed.2020.6618/2019.
previous studies have shown that higher infliximab trough levels are associated with favorable short-term and long-term therapeutic outcomes in inflammatory bowel disease. There is a need to determine which patients could benefit from proactive therapeutic drug monitoring in the induction phase. The aim of this study was to evaluate the pharmacokinetic variability of infliximab, determine the factors associated with achieving target infliximab trough levels in the induction phase and analyze the clinical and biochemical response at week 26 of treatment.
a retrospective observational study was performed of patients with inflammatory bowel disease and data available on serum levels of infliximab during the induction period. The percentage of patients that achieved target infliximab trough levels at week 6 was determined. Clinical remission and response and biochemical remission were evaluated at week 26.
thirty patients were included and only 13 (43.3 %) had infliximab trough levels > 15 µg/mL at week 6. A clinical response was observed during the maintenance period in 71.4 % of patients, their infliximab levels were significantly higher than in non-responders (6.3 µg/mL [IQR: 6.7] vs 1.0 µg/mL [IQR: 5.0], respectively; p = 0.016). Likewise, 53.6 % of patients achieved biochemical remission (responders 6.2 µg/mL [IQR: 5.2] vs non-responders 3.2 µg/mL [IQR: 5.0]; p = 0.031).
less than half of patients had target infliximab levels during the induction period. Therapeutic drug monitoring during this period is related to the achievement of therapeutic levels of infliximab and may lead to a better clinical response in these patients.
先前的研究表明，英夫利昔单抗的谷浓度较高与炎症性肠病的短期和长期治疗效果良好相关。需要确定哪些患者在诱导期可以从积极的治疗药物监测中受益。本研究旨在评估英夫利昔单抗的药代动力学变异性，确定诱导期达到目标英夫利昔单抗谷浓度的相关因素，并分析治疗 26 周时的临床和生化反应。
对炎症性肠病患者进行了回顾性观察性研究，并对诱导期英夫利昔单抗的血清水平数据进行了评估。确定了第 6 周达到目标英夫利昔单抗谷浓度的患者比例。第 26 周评估临床缓解和反应以及生化缓解。
共纳入 30 例患者，仅 13 例（43.3%）在第 6 周时英夫利昔单抗谷浓度>15μg/mL。在维持期观察到 71.4%的患者出现临床反应，他们的英夫利昔单抗水平明显高于无反应者（6.3μg/mL[IQR：6.7]与 1.0μg/mL[IQR：5.0]；p=0.016）。同样，53.6%的患者达到生化缓解（有反应者 6.2μg/mL[IQR：5.2]与无反应者 3.2μg/mL[IQR：5.0]；p=0.031）。
不到一半的患者在诱导期达到目标英夫利昔单抗水平。在此期间进行治疗药物监测与达到英夫利昔单抗的治疗水平相关，并可能导致这些患者获得更好的临床反应。
