生物制剂和靶向合成改变疾病抗风湿药物的禁忌症和特别警告系统概述:建立 "安全核对表 "框架。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-07-16 DOI:10.1007/s40264-024-01461-1
Lykke Skaarup, Elvina Ingrid, Alexandre Sepriano, Elena Nikiphorou, René Østgård, Kim Lauper, Ilona Grosse-Michaelis, Margreet Kloppenburg, Bente Glintborg, David F L Liew, Tue W Kragstrup
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引用次数: 0

摘要

背景/目的:本综述旨在概述禁忌症、特别警告和盒装警告,目的是建立一个框架,为一类药物或疾病适应症创建一个处方安全核对表。本研究涵盖生物改良抗风湿药(bDMARDs)和靶向合成 DMARDs(tsDMARDs):我们确定了欧洲药品管理局(EMA)和美国食品药品管理局(FDA)提供的禁忌症、盒装警告和特别警告。研究包括抗 CD20、肿瘤坏死因子抑制剂 (TNFi)、白细胞介素-1 抑制剂 (IL-1i) 等药物类别中获准用于治疗类风湿性关节炎 (RA)、银屑病关节炎 (PsA)、轴性脊柱关节炎 (SpA) 和幼年特发性关节炎 (JIA) 的 b/tsDMARDs、细胞毒性 T 淋巴细胞相关蛋白 (CTLA) 4、白细胞介素-12/23 抑制剂 (IL-12/23i)、白细胞介素 6 受体抑制剂 (IL-6Ri)、Janus 激酶抑制剂 (JAKi)、磷酸二酯酶 4 抑制剂 (PDE4i)、白细胞介素-17 抑制剂 (IL-17i) 和白细胞介素-23 抑制剂 (IL-23i)。研究结果除 PDE4i 外,所有药物类别都有与感染(包括结核病)相关的禁忌和/或警告。抗CD20、IL-1i、IL-6Ri和JAKi列出了带状疱疹警告,而抗CD20、TNFi、IL-1i、CTLA4-Ig、IL-6Ri和JAKi则列出了肝炎再激活警告。除PDE4i、IL-17i和IL-23i外,所有药物类别都提到了恶性肿瘤风险。其他警告包括脱髓鞘疾病(TNFi、CTLA4-Ig和IL-6Ri)、心力衰竭(抗CD20和TNFi)、重大心脏不良事件(JAKi和IL-12/23)和静脉血栓栓塞(JAKi)、高脂血症(IL-6Ri和JAKi)、肝功能损害(TNFi、IL-1i、IL-6Ri 和 JAKi)、肾功能损害(IL-1i、JAKi 和 PDE4i)、炎症性肠病(IL-17i)、胃肠道穿孔(IL-6Ri、JAKi)、全血细胞减少(抗 CD20、TNFi、IL-1i、IL-6Ri、JAKi)和抑郁症(PDE4i)。禁忌症和警告似乎随着药物批准时间的推移而增加:本综述概述了如何建立一个框架,以便从医疗监管机构提供的单个医疗产品处方信息中创建一个易于访问和可操作的处方安全核对表。
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A Systematic Overview of Contraindications and Special Warnings for Biologic and Targeted Synthetic Disease Modifying Antirheumatic Drugs: Establishing a Framework to Create a "Safety Checklist".

Background/aim: The purpose of this review is to provide an overview of the contraindications, special warnings, and boxed warnings with the aim to establish a framework to create a prescription safety checklist for a class of drugs or disease indication. This study covers biologic disease modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs).

Methods: We identified contraindications, boxed warnings, and special warnings provided by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The study included b/tsDMARDs approved for treating rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (SpA), and juvenile idiopathic arthritis (JIA) within the drug-classes anti-CD20, tumor necrosis factor inhibitors (TNFi), interleukin-1 inhibitors (IL-1i), cytotoxic T-lymphocyte-associated protein (CTLA) 4, interleukin-12/23 inhibitors (IL-12/23i), interleukin 6 receptor inhibitors (IL-6Ri), Janus kinase inhibitors (JAKi), phosphodiesterase 4 inhibitors (PDE4i), interleukin-17 inhibitors (IL-17i), and interleukin-23 inhibitors (IL-23i).

Results: All drug classes, except PDE4i, had contraindications and/or warnings related to infections, including tuberculosis. A warning about herpes zoster was listed for anti-CD20, IL-1i, IL-6Ri, and JAKi, while a warning about hepatitis reactivation was listed for anti-CD20, TNFi, IL-1i, CTLA4-Ig, IL-6Ri, and JAKi. Malignancy risk was mentioned for all drug classes except PDE4i, IL-17i, and IL-23i. Other warnings included demyelinating disease (TNFi, CTLA4-Ig, and IL-6Ri), heart failure (anti-CD20 and TNFi), major adverse cardiac events (JAKi and IL-12/23) and venous thromboembolism (JAKi), hyperlipidemia (IL-6Ri and JAKi), liver impairment (TNFi, IL-1i, IL-6Ri, and JAKi), kidney impairment (IL-1i, JAKi, and PDE4i), inflammatory bowel disease (IL-17i), gastrointestinal perforation (IL-6Ri, JAKi), cytopenia (anti-CD20, TNFi, IL-1i, IL-6Ri, JAKi), and depression (PDE4i). Contraindications and warnings appeared to increase with the passage of time since the drug's approval.

Conclusion: This review provides an overview to establish the framework to create an easily accessible and actionable prescription safety checklist from individual medical product prescription information provided by regulatory medical authorities.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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