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美国医院中多发性骨髓瘤患者使用替西妥单抗早期启动者的真实世界患者概况及逐步给药过程:一项使用Premier医疗数据库的分析

Real-world patient profile and step-up dosing process of early initiators of teclistamab for multiple myeloma in US hospitals: An analysis using the Premier Healthcare Database.

作者信息

Rose Tan Carlyn, Chinaeke Eric, Kim Nina, Lin Dee, Hester Laura, Fowler Jessica, Gifkins Dina, Walker Sian, Fu Alex Z, Wu Bingcao

机构信息

Memorial Sloan Kettering Cancer Center, New York, NY.

Janssen Scientific Affairs, LLC, Titusville, NJ.

出版信息

J Manag Care Spec Pharm. 2025 Aug;31(8):772-781. doi: 10.18553/jmcp.2025.31.8.772.

Abstract

BACKGROUND

Teclistamab is the first-in-class B cell maturation × cluster of differentiation 3 T cell bispecific antibody approved in the United States for relapsed or refractory multiple myeloma (MM). During the first year following US Food and Drug Administration approval, many institutions initiated teclistamab step-up dosing (SUD) in hospital settings.

OBJECTIVE

To describe patient characteristics, length of hospital stay (LOS) during SUD, and real-world incidence and management of cytokine release syndrome (CRS) among patients with MM who initiated teclistamab in US hospital settings.

METHODS

This retrospective observational study used the Premier Healthcare Database and included patients (≥18 years) with confirmed MM who received at least 1 teclistamab administration in a hospital setting between November 1, 2022, and September 21, 2023. We descriptively analyzed characteristics across all patients included as well as SUD patterns, LOS (defined as the time between admission to discharge), and CRS in those who completed SUD. CRS was identified using (ICD-10-CM) codes and a symptom- and treatment-based algorithm (the Keating algorithm).

RESULTS

A total of 413 patients were included. The median age (range) of the patients was 69 (32-89) years, 47.5% of patients were aged at least 70 years, and 69.7% had Medicare insurance. Most patients were male (56.4%), White (63.4%), and non-Hispanic (86.0%); 24.2% were Black. Most patients were treated in urban hospitals (96.4%), with 86.7% in teaching hospitals and 90.8% in hospitals with at least 300 beds. At the index hospital encounter, 47.9% of patients presented with anemia, 40.0% with peripheral neuropathy, and 35.8% with renal impairment/failure. Among 302 patients who completed SUD as of the data cutoff, 91.4% completed SUD in a single inpatient admission with a mean LOS of 8.7 days, after omitting extreme outliers; most patients had a 2-day (36.1%) or 3-day (31.1%) interval between SUD doses. CRS, per ICD-10-CM codes, was observed in 31.8% of patients (24.2% grade 1, 4.6% grade 2, and 1.0% grade 3). Per the Keating algorithm, 28.5% of patients experienced CRS-related symptoms, including fever (15.2%) and hypotension (10.3%); most of the events were classified as mild. Most patients with a complete SUD period had documented dexamethasone (97.0%) and acetaminophen (93.7%), 78.5% received diphenhydramine, and 29.8% received tocilizumab at any time during the SUD period.

CONCLUSIONS

This large, national, real-world study of patients with MM treated with teclistamab confirmed that early initiators of teclistamab were older adults from diverse racial groups with substantial comorbidities. Despite these factors, most patients were able to safely complete SUD following label-described schedules with manageable CRS events.

摘要

背景

替雷利珠单抗是美国批准用于复发或难治性多发性骨髓瘤(MM)的首个B细胞成熟抗原×分化簇3 T细胞双特异性抗体。在美国食品药品监督管理局批准后的第一年,许多机构在医院环境中启动了替雷利珠单抗逐步给药(SUD)。

目的

描述在美国医院环境中开始使用替雷利珠单抗的MM患者的特征、SUD期间的住院时间(LOS)以及细胞因子释放综合征(CRS)的真实世界发病率和管理情况。

方法

这项回顾性观察性研究使用了Premier医疗数据库,纳入了2022年11月1日至2023年9月21日期间在医院环境中接受至少1次替雷利珠单抗给药的确诊MM患者(≥18岁)。我们对所有纳入患者的特征以及SUD模式、LOS(定义为入院至出院的时间)和完成SUD的患者中的CRS进行了描述性分析。使用国际疾病分类第十版临床修订本(ICD-10-CM)编码和基于症状及治疗的算法(基廷算法)识别CRS。

结果

共纳入413例患者。患者的中位年龄(范围)为69(32 - 89)岁,47.5%的患者年龄至少为70岁,69.7%有医疗保险。大多数患者为男性(56.4%)、白人(63.4%)和非西班牙裔(86.0%);24.2%为黑人。大多数患者在城市医院接受治疗(96.4%),其中86.7%在教学医院,90.8%在床位至少300张的医院。在索引医院就诊时,47.9%的患者有贫血,40.0%有周围神经病变,35.8%有肾功能损害/衰竭。截至数据截止时,在302例完成SUD的患者中,91.4%在单次住院期间完成SUD,排除极端异常值后平均LOS为8.7天;大多数患者在SUD剂量之间间隔2天(36.1%)或3天(31.1%)。根据ICD-10-CM编码,31.8%的患者观察到CRS(24.2%为1级,4.6%为2级,1.0%为3级)。根据基廷算法,28.5%的患者出现CRS相关症状,包括发热(15.2%)和低血压(10.3%);大多数事件被分类为轻度。大多数完成完整SUD疗程的患者在SUD期间的任何时间都有记录使用地塞米松(97.0%)和对乙酰氨基酚(93.7%),78.5%接受苯海拉明治疗,29.8%接受托珠单抗治疗。

结论

这项对接受替雷利珠单抗治疗的MM患者进行的大规模、全国性、真实世界研究证实,替雷利珠单抗的早期使用者是来自不同种族且有大量合并症的确老年患者。尽管存在这些因素,但大多数患者能够按照标签描述程序安全完成SUD,CRS事件可控。

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Immunotherapy for the treatment of multiple myeloma.免疫疗法治疗多发性骨髓瘤。
Front Immunol. 2022 Oct 28;13:1027385. doi: 10.3389/fimmu.2022.1027385. eCollection 2022.

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