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.
本项多中心研究的主要目的是探讨预防性静脉注射免疫球蛋白（IVIG）替代治疗对接受靶向BCMA双特异性抗体（bsAb）治疗患者临床结局的影响，其中感染仍是导致发病和死亡的重要原因。本研究回顾性分析了2017年11月至2023年12月期间接受标准治疗药物teclistamab或研究性靶向BCMA双特异性抗体治疗的患者。预防性IVIG定义为在首次记录感染前开始IVIG治疗。所有分析均针对该分组固有的永生时间偏倚进行了校正。本研究共纳入225例患者。预防性IVIG组与非预防性IVIG组的中位随访时间分别为9个月和11个月。12个月时，预防性IVIG组与非预防性IVIG组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）。≥3级感染的12个月累积发生率在预防性IVIG组为35%（95%CI 21%，57%），非预防性IVIG组为45%（95%CI 34%，60%）（p=0.37）。所有级别感染的中位无感染生存期（IFS）在预防性IVIG组为7.7个月（95%CI 3.3，14），非预防性IVIG组为3个月（95%CI 2.6，4.5）（p=0.021）。≥3级感染的中位IFS在预防性IVIG组为14个月（95%CI 8.8，未达到），非预防性IVIG组为7.5个月（95%CI 6.1，14）（p=0.022）。接受预防性IVIG治疗的患者具有更优的无进展生存期（中位PFS：15个月 vs 8个月；p=0.026）和总生存期（中位OS：16个月 vs 44个月；p=0.007）。多变量分析显示，预防性IVIG与改善的总生存期独立相关（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）则提示不良预后。在靶向BCMA双特异性抗体治疗的患者中，补充IVIG与改善的临床结局相关，包括更优的无感染生存期和总生存期。
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