Effectiveness of Additional Risk Minimization Measures Related to Interstitial Lung Disease/Pneumonitis With Trastuzumab Deruxtecan Treatment of Breast Cancer in European Countries: Results and Learnings From a Post-Authorization Safety Survey Among Physicians.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-09-01 DOI:10.1002/pds.70206

Angelika Wientzek-Fleischmann, Ulf Stellmacher, Elisabeth Beyerlein, Annegret Gohlke, Birgit Ehlken

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Abstract

Background: Interstitial lung disease (ILD)/pneumonitis is an important safety risk of trastuzumab deruxtecan (T-DXd) treatment. This study assessed the effectiveness of additional risk minimization measures (aRMMs) outlined in the educational material (EM) for the product regarding physicians' awareness, knowledge, and implementation related to the risk, early detection, and management of ILD/pneumonitis.

Methods: A web-based survey was conducted among prescribers of T-DXd from seven European countries (Austria, Denmark, France, Germany, Sweden, Spain, and the UK) between 03/2021 and 11/2022. The overall effectiveness of the aRMMs was determined as the percentage of physicians correctly responding to questions in the awareness, knowledge, and implementation domains, with cut-off thresholds of ≥ 80%, ≥ 60%, and ≥ 75%, respectively.

Results: Overall, 172 prescribing physicians from seven countries completed the survey questionnaire (response rate: 3.1%). The majority (73.8%) of the physicians acknowledged receiving EMs. In all, 91.6%, 46.7%, and 76.7% of the physicians correctly responded to questions in the awareness, knowledge, and implementation domains, respectively. The low score observed in the knowledge domain was primarily because the respondents did not acknowledge fever as a typical symptom of ILD/pneumonitis. When a post hoc sensitivity analysis was performed where "fever" was not classified as a mandatory answer to the question about typical symptoms for ILD/pneumonitis, the proportion of physicians achieving the threshold increased to 68.6%.

Conclusion: The aRMMs effectively imparted awareness and supported the management of T-DXd-induced ILD/pneumonitis.

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在欧洲国家，曲妥珠单抗德鲁德替康治疗乳腺癌与间质性肺病/肺炎相关的额外风险最小化措施的有效性：一项授权后医生安全性调查的结果和经验

背景：间质性肺病(ILD)/肺炎是曲妥珠单抗德鲁德替康（T-DXd）治疗的重要安全风险。本研究评估了该产品教育材料（EM）中概述的额外风险最小化措施（aRMMs）的有效性，该措施涉及医生对ILD/肺炎风险、早期发现和管理的认识、知识和实施。方法：于2021年3月至2022年11月对欧洲7个国家（奥地利、丹麦、法国、德国、瑞典、西班牙和英国）的T-DXd处方者进行网络调查。aRMMs的总体有效性确定为医生在意识、知识和实施领域正确回答问题的百分比，截止阈值分别为≥80%、≥60%和≥75%。结果：总体而言，来自7个国家的172名处方医生完成了调查问卷（回复率：3.1%）。大多数（73.8%）的医生承认接受过急诊。总体而言，91.6%、46.7%和76.7%的医生正确回答了意识、知识和实施领域的问题。在知识领域观察到的低分主要是因为应答者不承认发烧是ILD/肺炎的典型症状。当进行事后敏感性分析时，“发烧”没有被归类为ILD/肺炎典型症状问题的强制性答案，达到阈值的医生比例增加到68.6%。结论：aRMMs有效地提高了对t - dxd诱导的ILD/肺炎的认识并支持了治疗。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.