ArticleFrontiers in immunology2026
Expert consensus recommendations for the prevention and management of immunoglobulin therapy-related adverse reactions in primary and secondary immunodeficiencies: a national Delphi study from the Immunodeficiency Group of the Spanish Society of Immunology.
Article in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Introduction: Human immunoglobulin (IG) therapy, administered intravenously (IVIG) or subcutaneously (SCIG), is a cornerstone treatment for primary and secondary immunodeficiencies (PID and SID) and is increasingly used in autoimmune and inflammatory diseases. Although generally safe, adverse drug reactions (ADR) may affect treatment adherence, patient safety, and quality of care. Practical recommendations for the prevention and management of IG-associated ADR remain limited. Objective: To develop expert-based recommendations for the prevention, monitoring, classification, and management of ADR associated with IVIG and SCIG therapy in patients with PID and SID. Methods: A modified Delphi consensus was conducted by the Immunodeficiency Group of the Spanish Society of Immunology (GISEI). An expert coordinating committee developed 44 preliminary statements based on scientific evidence and clinical experience. Statements covered eight domains, including administration practices, ADR classification, premedication, acute management, complementary studies, anti-IgA antibodies, and SCIG-related issues. A national panel of specialists evaluated each statement using a 6-point Likert scale. Consensus was defined as ≥75% agreement. Results: Forty-two recommendations achieved consensus and were included in the final document. High agreement was reached regarding individualized risk assessment, infusion rate adjustment, patient monitoring, and early ADR management. Most IVIG-related ADR were considered mild, occurring during or shortly after infusion, and generally not requiring treatment discontinuation. Premedication was recommended only for selected high-risk patients. SCIG was recognized as a safe and effective alternative associated with fewer systemic reactions and predominantly mild local ADR. The panel also highlighted the limited utility of serial anti-IgA antibody testing and emphasized patient education and periodic retraining for home-based SCIG administration. Discussion: This Delphi-based consensus provides practical and clinically applicable recommendations for the prevention and management of ADR associated with IVIG and SCIG therapy. These recommendations may contribute to standardizing clinical practice, improving patient safety, optimizing treatment tolerability, and reducing variability in IG administration across healthcare settings. Further prospective studies are needed to better define risk factors and preventive strategies for severe ADR associated with IG therapy.
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