Therapeutic drug monitoring (TDM) of biologics is a rapidly evolving field. We aimed to provide a consensus statement regarding the clinical utility of TDM for biologics in inflammatory bowel disease (IBD). A modified Delphi method was applied to develop consensus statements. A comprehensive literature review was performed regarding TDM of biologic therapies in IBD, and 45 statements were subsequently formulated on the potential application of TDM in IBD. The statements, along with literature, were then presented to a panel of 10 gastroenterologists with expertise in IBD and TDM who anonymously rated them on a scale of 1-10 (1 = strongly disagree and 10 = strongly agree). An expert consensus development meeting was held virtually to review, discuss, refine, and reformulate statements that did not meet criteria for agreement or that were ambiguous. During the meeting, additional statements were proposed. Panelists then confidentially revoted, and statements rated ≥7 by 80% or more of the participants were accepted. During the virtual meeting, 8 statements were reworded, 7 new statements were proposed, and 19 statements were rerated. Consensus was finally reached in 48/49 statements. The panel agreed that reactive TDM should be used for all biologics for both primary nonresponse and secondary loss of response. It was recommended that treatment discontinuation should not be considered for infliximab or adalimumab until a drug concentration of at least 10-15 μg/mL was achieved. Consensus was also achieved regarding the utility of proactive TDM for anti-tumor necrosis factor therapy. It was recommended to perform proactive TDM after induction and at least once during maintenance. Consensus was achieved in most cases regarding the utility of TDM of biologics in IBD, specifically for reactive and proactive TDM of anti-tumor necrosis factors.

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关于炎症性肠病生物制剂治疗药物监测的综合文献综述和专家共识声明。

生物制剂的治疗药物监测 (TDM) 是一个快速发展的领域。我们的目的是就 TDM 在炎症性肠病 (IBD) 生物制剂中的临床应用提供共识声明。应用修改后的德尔菲法来制定共识声明。对 IBD 生物疗法 TDM 进行了全面的文献综述，随后就 TDM 在 IBD 中的潜在应用制定了 45 条声明。然后，这些陈述以及文献被提交给由 10 名具有 IBD 和 TDM 专业知识的胃肠病学家组成的小组，他们以 1-10 的评分标准（1 = 强烈不同意，10 = 强烈同意）对这些内容进行匿名评分。以虚拟方式召开了专家共识制定会议，以审查、讨论、完善和重新制定不符合协议标准或含糊不清的声明。会议期间，提出了补充发言。然后小组成员进行秘密投票，80% 或更多参与者评分≥7 的陈述被接受。在虚拟会议期间，8 项声明被改写，7 项新声明被提出，19 项声明被重新评级。最终以 48/49 的发言达成共识。专家组一致认为，反应性 TDM 应用于所有生物制剂，以应对原发性无反应和继发性反应丧失。建议在达到至少 10-15 μg/mL 的药物浓度之前，不应考虑停止英夫利昔单抗或阿达木单抗的治疗。关于主动 TDM 在抗肿瘤坏死因子治疗中的应用也达成了共识。建议在诱导后和维护期间至少执行一次主动 TDM。