静脉注射补充免疫球蛋白(IVIG)对接受bcma定向双特异性抗体治疗多发性骨髓瘤患者无感染生存期的影响

IF 12.9 1区 医学 Q1 HEMATOLOGY
Meera Mohan, Aniko Szabo, Heloise Cheruvalath, Anna Clennon, Vineel Bhatlapenumarthi, Anannya Patwari, Metodi Balev, Divaya Bhutani, Asis Shrestha, Sharmilan Thanendrarajan, Binod Dhakal, Maurizio Zangari, Anup Trikannad, Sruthi Vellanki, Samer Al-Hadidi, Suzanne Lentzsch, Frits van Rhee, Aishee Bag, Anita D’Souza, Nishi Shah, Rajshekhar Chakraborty, Mansi R. Shah, Carolina Schinke
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引用次数: 0

摘要

这项多机构研究的主要目的是了解原发性静脉注射免疫球蛋白(IVIG)替代对bcma定向双特异性抗体(bsAb)受体临床结果的影响,其中感染仍然是发病率和死亡率的重要原因。这是一项回顾性研究,在2017年11月至2023年12月期间接受teclistamab或bcma指导的研究性bsAb治疗的患者。初级IVIG预防被定义为在首次记录感染之前开始IVIG。所有的分析都针对这一组固有的不朽时间偏差进行了调整。该分析共纳入225例患者。初级IVIG预防被定义为在首次记录感染之前开始IVIG。接受和未接受初级免疫球蛋白预防治疗的患者的中位随访时间分别为9个月和11个月。在接受和不接受初级免疫球蛋白预防的12个月内,所有级别感染的累积发生率分别为56% (95%CI 40%,78%)和60% (95%CI 48%, 76%);P = 0.72。接受初级免疫球蛋白预防的12个月累计≥3级感染发生率为35% (95% CI 21%, 57%),未接受初级免疫球蛋白预防的为45% (95% CI 34%, 60%);p = 0.37。所有级别感染的中位无感染生存期(IFS)在初级IVIG预防组为7.7个月(95% CI 3.3, 14),未进行IVIG预防组为3个月(95% CI 2.6, 4.5) (p = 0.021)。≥3级IFS的中位值分别为14个月(95% CI 8.8, NR)和7.5个月(95% CI 6.1, 14),分别为原发性IVIG和非原发性IVIG;p = 0.022。初级IVIG预防的患者具有优越的无进展生存期(PFS)[中位PFS为15个月vs 8个月;p = 0.026]和总生存期(OS)[中位OS 16 vs 44个月;p = 0.007]。在多变量分析中,初级IVIG预防与改善OS独立相关(HR = 0.37;p = 0.021),而髓外病变(HR = 2.71;p = <0.001)和高危疾病(HR = 1.88;P = 0.031)导致预后不良。在bcma导向的bsAb接受者中,补充IVIG与改善的临床结果相关,包括有利的IFS和OS。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Effect of Intravenous Immunoglobulin (IVIG) Supplementation on infection-free survival in recipients of BCMA-directed bispecific antibody therapy for multiple myeloma

Effect of Intravenous Immunoglobulin (IVIG) Supplementation on infection-free survival in recipients of BCMA-directed bispecific antibody therapy for multiple myeloma

The main objective of this multi-institutional study is to understand the effect of primary intravenous immunoglobulin (IVIG) replacement on clinical outcomes in recipients of BCMA-directed bispecific antibody (bsAb), where infection remains an important cause of morbidity and mortality. This is a retrospective study of patients treated with either standard of care teclistamab or BCMA-directed investigational bsAb between Nov 2017 and Dec 2023. Primary IVIG prophylaxis was defined as starting IVIG prior to first documented infection. All analyses were adjusted for immortal-time bias inherent in this grouping. A total of 225 patients were included in this analysis. Primary IVIG prophylaxis was defined as starting IVIG prior to first documented infection. The median follow-up of patients treated with and without primary IVIG prophylaxis was, 9 and 11 months, respectively. The cumulative incidence of all grade infections at 12 months with and without primary IVIG prophylaxis were 56% (95%CI 40%,78%) and 60% (95% CI 48%, 76%); p = 0.72, respectively. The 12-month cumulative incidence of ≥ grade 3 infections was 35% (95% CI 21%, 57%) with primary IVIG prophylaxis and 45% (95% CI 34%, 60%) without; p = 0.37. The median infection free survival (IFS) for all-grade infections was 7.7 (95% CI 3.3, 14) months with primary IVIG prophylaxis and 3 (95% CI 2.6, 4.5) months without (p = 0.021). The median ≥ grade 3 IFS was 14 (95% CI 8.8, NR) and 7.5 (95% CI 6.1, 14) months, with and without primary IVIG respectively; p = 0.022. Patients on primary IVIG prophylaxis had a superior progression-free-survival (PFS) [median PFS 15 vs 8 months; p = 0.026] and overall-survival (OS) [median OS 16 vs 44 months; p = 0.007]. On multivariate analysis, primary IVIG prophylaxis was independently associated with improved OS (HR = 0.37; p = 0.021), while the presence of extra-medullary (HR = 2.71; p = <0.001) and high-risk disease (HR = 1.88; p = 0.031) conferred poor outcomes. In recipients of BCMA-directed bsAb, IVIG supplementation was associated with an improved clinical outcome, including favorable IFS and OS.

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来源期刊
CiteScore
16.70
自引率
2.30%
发文量
153
审稿时长
>12 weeks
期刊介绍: Blood Cancer Journal is dedicated to publishing high-quality articles related to hematologic malignancies and related disorders. The journal welcomes submissions of original research, reviews, guidelines, and letters that are deemed to have a significant impact in the field. While the journal covers a wide range of topics, it particularly focuses on areas such as: Preclinical studies of new compounds, especially those that provide mechanistic insights Clinical trials and observations Reviews related to new drugs and current management of hematologic malignancies Novel observations related to new mutations, molecular pathways, and tumor genomics Blood Cancer Journal offers a forum for expedited publication of novel observations regarding new mutations or altered pathways.
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