随着生物药物的引入,炎症性肠病的治疗发生了重大变化。多亏了这些药物,治疗目标已经从临床反应和缓解发展到更雄心勃勃的目标,如内窥镜或放射学缓解。然而,尽管生物制剂非常有效,相当比例的患者不会达到初始反应或可能随着时间的推移而失去反应。我们知道,生物制剂的谷浓度与其治疗效果之间存在直接关系,更苛刻的治疗目标需要更高的药物水平,暴露不足是很常见的。生物药物的治疗药物监测,以及药代动力学模型,为IBD患者提供个性化治疗方法的可能性。在过去的几年里,在诱导期间或之后积累了有关其效用的相关信息,以及在维持生物治疗方面,在被动或主动策略中,在戒断或治疗降级之前。本文件的目的是建立有关炎症性肠病患者治疗药物监测生物制剂的实用性的建议。在不同的临床实践场景中,并确定其效用明显的领域,有希望的,或有争议。
The treatment of inflammatory bowel disease has undergone a significant transformation following the introduction of biologic drugs. Thanks to these drugs, treatment goals have evolved from clinical response and remission to more ambitious objectives, such as endoscopic or radiologic remission. However, even though biologics are highly effective, a significant percentage of patients will not achieve an initial response or may lose it over time. We know that there is a direct relationship between the trough concentrations of the biologic and its therapeutic efficacy, with more demanding therapeutic goals requiring higher drug levels, and inadequate exposure being common. Therapeutic drug monitoring of biologic medications, along with pharmacokinetic models, provides us with the possibility of offering a personalized approach to treatment for patients with IBD. Over the past few years, relevant information has accumulated regarding its utility during or after induction, as well as in the maintenance of biologic treatment, in reactive or proactive strategies, and prior to withdrawal or treatment de-escalation. The aim of this document is to establish recommendations regarding the utility of therapeutic drug monitoring of biologics in patients with inflammatory bowel disease, in different clinical practice scenarios, and to identify areas where its utility is evident, promising, or controversial.