Department of Gastroenterology, Sheba Medical Center Tel Hashomer Affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Hashomer, Israel.
Institute of Clinical Pharmacology and Toxicology, Sheba Medical Center Tel Hashomer Affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Hashomer, Israel.
United European Gastroenterol J. 2024 Jun;12(5):627-637. doi: 10.1002/ueg2.12559. Epub 2024 Mar 26.
Small molecule drugs are becoming increasingly used in the treatment of inflammatory bowel diseases (IBD). However, unlike monoclonal antibody drugs, which have few interactions with other medications, the pharmacokinetics of small molecule drugs are complex and may be influenced by a myriad of drug-drug interactions (DDI) as well as by patient characteristics and food intake. This review aims to provide a concise practical guide to small molecule drug interactions for the use of IBD physicians. It starts with a brief overview of the main metabolizing enzymes and transporters involved in drug interactions and the Food and Drug Administration's (FDA) approach to determining drug-interaction hazard thresholds. It is then followed by a more detailed review of the pharmacokinetics of five novel small molecules approved in IBD: Tofacitinib, Upadacitinib, Filgotinib, Ozanimod, and Etrasimod, including their known interactions and specific warnings. This review will also inform readers on challenges in determining the actual magnitude of interactions and their clinical relevance, including the arbitrary nature of some hazard thresholds, the inference of the impact on metabolizing enzymes and transporters from single-drug assays which may not reflect poly-pharmaceutical regimens, and other challenges in this field which the IBD physician needs to be cognizant of. In practice, before administering a small molecule drug, it is advisable to evaluate any potential interactions with other medications the patient is receiving. An increased awareness by health care professionals and patients, may reduce the possible risks associated with DDI of small molecule IBD drugs.
小分子药物在炎症性肠病(IBD)的治疗中越来越多地被使用。然而,与单克隆抗体药物不同,单克隆抗体药物与其他药物的相互作用很少,小分子药物的药代动力学复杂,可能受到无数药物相互作用(DDI)以及患者特征和食物摄入的影响。本综述旨在为 IBD 医生提供小分子药物相互作用的简明实用指南。它首先简要概述了参与药物相互作用的主要代谢酶和转运体,以及食品和药物管理局(FDA)确定药物相互作用危害阈值的方法。然后,更详细地回顾了五种在 IBD 中批准的新型小分子药物的药代动力学:托法替尼、乌帕替尼、非戈替尼、奥扎尼莫德和依特司莫德,包括它们已知的相互作用和特定的警告。本综述还将告知读者在确定相互作用的实际程度及其临床相关性方面所面临的挑战,包括一些危害阈值的任意性、从可能无法反映多药物方案的单一药物测定推断对代谢酶和转运体的影响,以及 IBD 医生需要注意的该领域的其他挑战。在实践中,在给予小分子药物之前,建议评估患者正在接受的任何其他药物的潜在相互作用。医护人员和患者的意识提高,可能会降低与 IBD 小分子药物相互作用相关的潜在风险。