The Real World Impact of Immunoglobulin Replacement Therapy on Severe Bacterial Infection for Patients With Hypogammaglobulinemia Secondary to Hematologic Malignancies: A Japanese Claims Database Study

EJHaem Pub Date : 2025-07-02 DOI:10.1002/jha2.70091

Keichiro Mihara, Takakazu Kawase, Takahiko Miyama, Katsuhiko Iwasaki, Ayako Shoji, Masayuki Matsumaru

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引用次数: 0

Abstract

Objectives

The understanding of usefulness of immunoglobulin replacement therapy (IgRT) for hypogammaglobulinemia (HGG) in patients with hematologic malignancies (HM) has changed over time. This is mainly caused by the introduction of new treatment, such as B-cell targeted agents. We investigated the real world effectiveness of IgRT on the severe bacterial infection (SBI) incidence in patients with HGG secondary to HMs using a Japanese claims database provided by MDV Inc.

Methods

Patients who were diagnosed with both HM and HGG from May 2010 to March 2021 in this database and prescribed IgRT with the dosage of > 5 g/month were eligible. We compared the SBI incidence, which was defined as a prescription of intravenous antibacterial agents during hospitalization, between during 12-month before IgRT initiation (baseline period) and 12-month after IgRT initiation (follow-up period).

Results

In total 1621 eligible patients, 37.9% and 17.7% of patients were for non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM), respectively. A total of 24.4% of patients were hematopoietic stem cell transplantation (HSCT) recipients. In the follow-up period, SBI incidence significantly decreased than that in the baseline period (2.3 events per person-year vs. 0.9; p < 0.001). Similar results were observed in various subgroups such as patients who were diagnosed with NHL or MM, treated with anti-CD20 monoclonal antibody or anti-CD38 monoclonal antibody, or HSCT recipients. In the small number of patients whose baseline serum IgG levels were available (n = 28), decrease of the SBI incidence in the follow-up period was observed regardless of IgG levels. A reduction of the SBI incidence was seen in patients with < 400 mg/dL (2.6 vs. 0.6).

Conclusion

IgRT may decrease the SBI incidence in patients with HGG secondary to HM.

Trial Registration:

Registered at UMIN Clinical Trials Registry, UMIN000047418

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免疫球蛋白替代疗法对血液病继发低γ球蛋白血症患者严重细菌感染的现实影响：一项日本索赔数据库研究

随着时间的推移，人们对免疫球蛋白替代疗法（IgRT）治疗血液恶性肿瘤（HM）患者低γ球蛋白血症（HGG）的有效性的认识发生了变化。这主要是由于引入了新的治疗方法，如b细胞靶向药物。我们使用MDV公司提供的日本索赔数据库，调查了IgRT对HMs继发HGG患者严重细菌感染（SBI）发生率的实际有效性。方法本数据库2010年5月至2021年3月诊断为HM和HGG的患者，使用IgRT，剂量为>；5 g/月为合格。我们比较了开始IgRT前12个月（基线期）和开始IgRT后12个月（随访期）的SBI发生率，SBI的定义是住院期间静脉使用抗菌药物的情况。结果1621例符合条件的患者中，非霍奇金淋巴瘤（NHL）和多发性骨髓瘤（MM）分别占37.9%和17.7%。共有24.4%的患者接受了造血干细胞移植（HSCT）。在随访期间，SBI发生率显著低于基线期(每人年2.3次vs. 0.9次；p & lt;0.001)。在不同的亚组中也观察到类似的结果，如诊断为NHL或MM的患者，接受抗cd20单克隆抗体或抗cd38单克隆抗体治疗的患者，或接受HSCT的患者。在少数基线血清IgG水平可用的患者中（n = 28），无论IgG水平如何，随访期间SBI发病率均有所下降。SBI的发生率在<；400mg /dL （2.6 vs. 0.6）。结论IgRT可降低HGG继发HM患者SBI的发生率。试验注册：在UMIN临床试验注册中心注册，号码：UMIN000047418

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EJHaem

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