2000-2020 年美国使用沙利度胺、来那度胺和泊马度胺的趋势以及遵守风险评估和缓解战略妊娠检测要求的证据。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-09-01 Epub Date: 2024-05-16 DOI:10.1007/s40264-024-01443-3
Mufaddal Mahesri, Ameet Sarpatwari, Krista F Huybrechts, Joyce Lii, Su Been Lee, Gita A Toyserkani, Cynthia LaCivita, Esther H Zhou, Gerald J Dal Pan, Aaron S Kesselheim, Katsiaryna Bykov
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引用次数: 0

摘要

导言来那度胺、泊马度胺和沙利度胺是治疗多发性骨髓瘤的有效药物,但具有致畸性。为了降低这种风险,美国食品药品管理局(FDA)要求对这些药物实施风险评估和缓解策略(REMS)计划,其中包括对有生育能力的妇女进行妊娠检测--在开始治疗前检测两次,治疗后的第一个月每周检测一次,此后每2-4周检测一次:我们评估了来那度胺、泊马度胺和沙利度胺的配药趋势,并评估了服用这些药物的高危患者对 REMS 妊娠检测要求的遵守情况:利用三个美国医疗保险索赔数据库(Optum Clinformatics® [2004-2020]、Merative Marketscan [2003-2019]和Medicaid [2000-2018]),我们评估了这些药物的每月使用情况、患者特征和用药者的持续治疗情况,以及有生育能力的用药者遵守妊娠检测要求的索赔证据:来那度胺是2006年获得批准后至研究期结束期间处方量最大的药物。研究共发现了48311名来那度胺(平均年龄为59岁[标准差(SD)=16])、17550名沙利度胺(平均年龄为65岁[SD=12])和6560名泊马度胺的用药者(平均年龄为65岁[SD=11]);每种药物45%的用药者为女性。在第 90 天接受随访的初始患者中,70% 仍在接受治疗。有生育能力的新用药者占所有新用药者的 3%(N = 1,920);在这批新用药者中,12% 的人在用药前有两次妊娠检查的报销数据证据,9% 的人在治疗的第一个月至少有 33 天的随访,进行了四次妊娠检查。相比之下,52%的补药患者在配药后7天内进行过一次妊娠试验:尽管大多数来那度胺、泊马度胺和沙利度胺患者都不具备生育潜能,但仍需进一步调查是否存在不坚持妊娠检测的情况。
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Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000-2020.

Introduction: Lenalidomide, pomalidomide, and thalidomide are effective treatments for multiple myeloma but are teratogenic. To mitigate this risk, the US Food and Drug Administration (FDA) required risk evaluation and mitigation strategy (REMS) programs for these drugs, which include pregnancy testing among women of childbearing potential-twice before initiation, weekly in the first month on treatment, and every 2-4 weeks thereafter.

Objective: We evaluated dispensing trends of lenalidomide, pomalidomide, and thalidomide and assessed adherence to REMS pregnancy testing requirements among at-risk patients taking these drugs.

Methods: Using three US health insurance claims databases (Optum Clinformatics® [2004-2020], Merative Marketscan [2003-2019], and Medicaid [2000-2018]), we assessed monthly use of the drugs, patient characteristics and treatment persistence among drug initiators, and claims-based evidence for adherence to pregnancy testing requirements among initiators with child-bearing potential.

Results: Lenalidomide was the most prescribed agent following its approval in 2006 and through the end of the study period. A total of 48,311 lenalidomide (mean age = 59 years [standard deviation (SD) = 16]), 17,550 thalidomide (mean age = 65 years [SD = 12]), and 6560 pomalidomide initiators (mean age = 65 years [SD = 11]) were identified; 45% of initiators of each drug were women. Among initiators under follow-up on day 90, 70% were still on therapy. Initiators of childbearing potential comprised 3% (N = 1,920) of all initiators; among this cohort, 12% had evidence in claims data of two pregnancy tests before initiation, and 9% with at least 33 days of follow-up of four tests during the first month of treatment. By contrast, 52% who received a refill had claims-based evidence of a pregnancy test within 7 days of dispensing.

Conclusion: Although most patients who initiated lenalidomide, pomalidomide, and thalidomide were not of child-bearing potential, further investigation into actual non-adherence to pregnancy testing is needed.

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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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