Lundekvam Jonas Andre, Høivik Marte Lie, Anisdahl Karoline, Småstuen Milada Cvancarova, Warren David J, Bolstad Nils, Medhus Asle Wilhelm
Department of Gastroenterology, Oslo University Hospital.
Institute of Clinical Medicine, University of Oslo.
Ann Med. 2025 Dec;57(1):2424447. doi: 10.1080/07853890.2024.2424447. Epub 2025 Jan 6.
The benefit of therapeutic drug monitoring (TDM) and implementation of recommendations from the Selection of Therapeutic Targets in Inflammatory Bowel Disease (IBD, STRIDE) are discussed in the IBD community. We report real-world data in ulcerative colitis patients receiving first-line tumour necrosis factor inhibitor (TNFi) treatment followed by TDM, and assess how implementation of the STRIDE II recommendations might affect clinical practice.
Adult, biologically naïve UC patients starting TNFi between 2014 and 2021 at Oslo University Hospital were included in a medical chart review study, and data were collected at three and twelve months after the start of treatment. Target serum drug levels were defined as ≥7.5 mg/L for adalimumab and ≥5 mg/L for infliximab.
Of 141 included patients, 36% were in clinical and biochemical (combined) remission after twelve months. Among 102 treatment persistent patients, 54% were in combined remission after twelve months. Target drug level at three months was associated with clinical remission at twelve months (OR = 2.97, 95% CI [1.24-7.12]) and biochemical remission at twelve months (OR = 2.64, 95% CI [1.03-6.77]). In total, 56% of recorded dosage adjustments were related only to serum drug levels.
Combined remission rates at twelve months for treatment persistent patients suggest that 46% should have been considered for a change of treatment according to the STRIDE II recommendations. A majority of dosage adjustments were made proactively. Target drug level at three months was associated with remission at twelve months and supports the use of proactive TDM.
炎症性肠病（IBD）领域正在讨论治疗药物监测（TDM）的益处以及实施炎症性肠病治疗靶点选择（STRIDE）建议的情况。我们报告了接受一线肿瘤坏死因子抑制剂（TNFi）治疗并随后进行TDM的溃疡性结肠炎患者的真实世界数据，并评估STRIDE II建议的实施可能如何影响临床实践。
纳入了2014年至2021年在奥斯陆大学医院开始使用TNFi的成年、未接受过生物制剂治疗的UC患者进行病历回顾研究，并在治疗开始后的3个月和12个月收集数据。阿达木单抗的目标血清药物水平定义为≥7.5mg/L，英夫利昔单抗为≥5mg/L。
在141例纳入患者中，12个月后36%达到临床和生化（联合）缓解。在102例持续治疗的患者中，12个月后54%达到联合缓解。3个月时的目标药物水平与12个月时的临床缓解（OR = 2.97，95%CI[1.24 - 7.12]）和12个月时的生化缓解（OR = 2.64，95%CI[1.03 - 6.77]）相关。总共，56%的记录剂量调整仅与血清药物水平有关。
持续治疗患者12个月时的联合缓解率表明，根据STRIDE II建议，46%的患者应考虑更换治疗方案。大多数剂量调整是主动进行的。3个月时的目标药物水平与12个月时的缓解相关，并支持主动TDM的应用。
