Authors
Andrea Duminuco, Laura Anastasia Caruso, Rossella Garro, Chiara Finocchiaro, Annalisa Santisi, Arianna Sbriglione, Alessandro Petronaci, Francesco Di Raimondo, Giuseppe Alberto Palumbo
Published in
Expert review of hematology. Pages 1-13. Oct 05, 2026. Epub Oct 05, 2026.
Abstract
Secondary immunodeficiency (SID) with hypogammaglobulinemia is a frequent complication of B-cell hematological malignancies, arising from the disease and from an expanding range of B-cell-depleting and T-cell-engaging therapies. Immunoglobulin replacement therapy (IgRT) is widely used to prevent infection, yet the evidence underpinning this practice is surprisingly weak.
The randomized trials, almost all conducted before 2000 and confined to chronic lymphocytic leukemia (CLL) and multiple myeloma (MM), show a reduction in clinically documented infection (pooled relative risk [RR] 0.72) but no effect on mortality and an increased risk of adverse events. When high-risk-of-bias trials are excluded, even the infection benefit loses statistical significance (RR 0.80; 95% CI, 0.62-1.04). Contemporary real-world CLL data found no association between regular IgRT and fewer infection-related hospitalizations.
Against this backdrop, IgRT use continues to rise, driven partly by the profound hypogammaglobulinemia that follows CAR-T cells and bispecific antibodies, settings supported only by observational data. This narrative review synthesizes the mechanisms, setting-specific evidence, and practical management of IgRT, argues for a critical, stewardship-minded stance in which IgRT is reserved (severe hypogammaglobulinemia with recurrent or severe bacterial infection failing simpler measures), and outlines the adequately powered, modern-era trials needed to resolve the uncertainty.
PMID:
42831600
Bibliographic data and abstract were imported from PubMed on 05 Oct 2026.
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