Real-world patterns of immunoglobulin replacement therapy for infection prevention in common variable immunodeficiency: a multicenter nationwide study

Background and aims: Immunoglobulin replacement therapy (IgRT), administered intravenously (IVIg) or subcutaneously (SCIg), is the cornerstone treatment for patients with Common Variable Immunodeficiency (CVID). Although both modalities demonstrate similar efficacy, SCIg is associated with fewer sys...

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Autores: Moral, PM, Garcia-Bustos, V, Balastegui-Martin, H, Mercader, SM, Bracke, C, Mateu, L, Solanich, X, Antolí, A, Carrillo-Linares, JL, Robles-Marhuenda, A, Puchades, F, Ballesta, AP, López-Osle, N, Torralba-Cabeza, MA, Masdeu, AMB, Niño, JG, Gaya, NT, Castellanos, GP, Sánchez-Martínez, R, Barragán-Casas, JM, González-García, A, de la Peña, JLP, López-Wolf, D, Rufete, AM, Mora, AC, Cabañero-Navalon, MD
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
Repositorio:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
OAI Identifier:oai:isabial.fundanetsuite.com:p11340
Acceso en línea:https://isabial.portalinvestigacion.com/publicaciones11340
https://doi.org/10.3389/fimmu.2025.1640290
Access Level:acceso abierto
Palabra clave:common variable immunodeficiency (CVID)
immunoglobulin replacement therapy (IGRT)
subcutaneous immunoglobulin (SCIg)
intravenous immunoglobulin (IVIg)
real-world evidence
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spelling Real-world patterns of immunoglobulin replacement therapy for infection prevention in common variable immunodeficiency: a multicenter nationwide studyMoral, PMGarcia-Bustos, VBalastegui-Martin, HMercader, SMBracke, CMateu, LSolanich, XAntolí, ACarrillo-Linares, JLRobles-Marhuenda, APuchades, FBallesta, APLópez-Osle, NTorralba-Cabeza, MAMasdeu, AMBNiño, JGGaya, NTCastellanos, GPSánchez-Martínez, RBarragán-Casas, JMGonzález-García, Ade la Peña, JLPLópez-Wolf, DRufete, AMMora, ACCabañero-Navalon, MDcommon variable immunodeficiency (CVID)immunoglobulin replacement therapy (IGRT)subcutaneous immunoglobulin (SCIg)intravenous immunoglobulin (IVIg)real-world evidenceBackground and aims: Immunoglobulin replacement therapy (IgRT), administered intravenously (IVIg) or subcutaneously (SCIg), is the cornerstone treatment for patients with Common Variable Immunodeficiency (CVID). Although both modalities demonstrate similar efficacy, SCIg is associated with fewer systemic adverse events and increased patient autonomy. Despite these advantages, its utilization remains limited in certain regions, particularly in the Mediterranean region. This study aimed to evaluate real-world patterns of IgRT use in Spanish CVID patients and provide a comprehensive analysis of the factors associated with IVIg and SCIg administration in routine clinical practice. Methods: A cross-sectional, multicenter study was conducted using data from the GTEM-SEMI-CVID Registry, encompassing 212 adult CVID patients receiving IgRT across Spain. Patients were grouped based on the administration route: IVIg and SCIg. Demographic, clinical, and immunological data, including IgRT modality, dosage, administration setting, and comorbidities, were collected. Comparative statistical analyses were performed to identify differences between both treatment groups. Results: Of the 212 patients, 58.5% received IVIg and 41.5% received SCIg. SCIg recipients were younger (47.5 vs. 54.8 years, p = 0.003) and predominantly treated at home (80.6% vs. 1.6%, p < 0.001), compared to those receiving IVIg. SCIg use was significantly higher in tertiary hospitals compared to secondary ones (44.4% vs. 17.4%, p = 0.0136). Infection rates, autoimmune comorbidities, weekly doses (7.2 g for IVIg vs. 7.7 g for SCIg, p = 0.142), and IgG trough levels were comparable across groups. Conclusion: This study provides real-world evidence on IgRT patterns in Spanish patients with CVID, revealing a marked increase in SCIg use over the past decade, although IVIg remains predominant, especially in secondary hospitals. Age significantly influenced the choice of modality, with IVIg preferred for older patients and SCIg for younger ones, while disease severity did not impact this decision. These findings underscore the need to optimize access to SCIg, particularly in secondary centers, to enhance patient autonomy and improve therapeutic outcomes.FRONTIERS MEDIA SA2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://isabial.portalinvestigacion.com/publicaciones11340https://doi.org/10.3389/fimmu.2025.1640290Frontiers in ImmunologyISSN: 16643224reponame:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicanteinstname:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)Inglésinfo:eu-repo/semantics/openAccessoai:isabial.fundanetsuite.com:p113402026-06-12T10:20:37Z
dc.title.none.fl_str_mv Real-world patterns of immunoglobulin replacement therapy for infection prevention in common variable immunodeficiency: a multicenter nationwide study
title Real-world patterns of immunoglobulin replacement therapy for infection prevention in common variable immunodeficiency: a multicenter nationwide study
spellingShingle Real-world patterns of immunoglobulin replacement therapy for infection prevention in common variable immunodeficiency: a multicenter nationwide study
Moral, PM
common variable immunodeficiency (CVID)
immunoglobulin replacement therapy (IGRT)
subcutaneous immunoglobulin (SCIg)
intravenous immunoglobulin (IVIg)
real-world evidence
title_short Real-world patterns of immunoglobulin replacement therapy for infection prevention in common variable immunodeficiency: a multicenter nationwide study
title_full Real-world patterns of immunoglobulin replacement therapy for infection prevention in common variable immunodeficiency: a multicenter nationwide study
title_fullStr Real-world patterns of immunoglobulin replacement therapy for infection prevention in common variable immunodeficiency: a multicenter nationwide study
title_full_unstemmed Real-world patterns of immunoglobulin replacement therapy for infection prevention in common variable immunodeficiency: a multicenter nationwide study
title_sort Real-world patterns of immunoglobulin replacement therapy for infection prevention in common variable immunodeficiency: a multicenter nationwide study
dc.creator.none.fl_str_mv Moral, PM
Garcia-Bustos, V
Balastegui-Martin, H
Mercader, SM
Bracke, C
Mateu, L
Solanich, X
Antolí, A
Carrillo-Linares, JL
Robles-Marhuenda, A
Puchades, F
Ballesta, AP
López-Osle, N
Torralba-Cabeza, MA
Masdeu, AMB
Niño, JG
Gaya, NT
Castellanos, GP
Sánchez-Martínez, R
Barragán-Casas, JM
González-García, A
de la Peña, JLP
López-Wolf, D
Rufete, AM
Mora, AC
Cabañero-Navalon, MD
author Moral, PM
author_facet Moral, PM
Garcia-Bustos, V
Balastegui-Martin, H
Mercader, SM
Bracke, C
Mateu, L
Solanich, X
Antolí, A
Carrillo-Linares, JL
Robles-Marhuenda, A
Puchades, F
Ballesta, AP
López-Osle, N
Torralba-Cabeza, MA
Masdeu, AMB
Niño, JG
Gaya, NT
Castellanos, GP
Sánchez-Martínez, R
Barragán-Casas, JM
González-García, A
de la Peña, JLP
López-Wolf, D
Rufete, AM
Mora, AC
Cabañero-Navalon, MD
author_role author
author2 Garcia-Bustos, V
Balastegui-Martin, H
Mercader, SM
Bracke, C
Mateu, L
Solanich, X
Antolí, A
Carrillo-Linares, JL
Robles-Marhuenda, A
Puchades, F
Ballesta, AP
López-Osle, N
Torralba-Cabeza, MA
Masdeu, AMB
Niño, JG
Gaya, NT
Castellanos, GP
Sánchez-Martínez, R
Barragán-Casas, JM
González-García, A
de la Peña, JLP
López-Wolf, D
Rufete, AM
Mora, AC
Cabañero-Navalon, MD
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv common variable immunodeficiency (CVID)
immunoglobulin replacement therapy (IGRT)
subcutaneous immunoglobulin (SCIg)
intravenous immunoglobulin (IVIg)
real-world evidence
topic common variable immunodeficiency (CVID)
immunoglobulin replacement therapy (IGRT)
subcutaneous immunoglobulin (SCIg)
intravenous immunoglobulin (IVIg)
real-world evidence
description Background and aims: Immunoglobulin replacement therapy (IgRT), administered intravenously (IVIg) or subcutaneously (SCIg), is the cornerstone treatment for patients with Common Variable Immunodeficiency (CVID). Although both modalities demonstrate similar efficacy, SCIg is associated with fewer systemic adverse events and increased patient autonomy. Despite these advantages, its utilization remains limited in certain regions, particularly in the Mediterranean region. This study aimed to evaluate real-world patterns of IgRT use in Spanish CVID patients and provide a comprehensive analysis of the factors associated with IVIg and SCIg administration in routine clinical practice. Methods: A cross-sectional, multicenter study was conducted using data from the GTEM-SEMI-CVID Registry, encompassing 212 adult CVID patients receiving IgRT across Spain. Patients were grouped based on the administration route: IVIg and SCIg. Demographic, clinical, and immunological data, including IgRT modality, dosage, administration setting, and comorbidities, were collected. Comparative statistical analyses were performed to identify differences between both treatment groups. Results: Of the 212 patients, 58.5% received IVIg and 41.5% received SCIg. SCIg recipients were younger (47.5 vs. 54.8 years, p = 0.003) and predominantly treated at home (80.6% vs. 1.6%, p < 0.001), compared to those receiving IVIg. SCIg use was significantly higher in tertiary hospitals compared to secondary ones (44.4% vs. 17.4%, p = 0.0136). Infection rates, autoimmune comorbidities, weekly doses (7.2 g for IVIg vs. 7.7 g for SCIg, p = 0.142), and IgG trough levels were comparable across groups. Conclusion: This study provides real-world evidence on IgRT patterns in Spanish patients with CVID, revealing a marked increase in SCIg use over the past decade, although IVIg remains predominant, especially in secondary hospitals. Age significantly influenced the choice of modality, with IVIg preferred for older patients and SCIg for younger ones, while disease severity did not impact this decision. These findings underscore the need to optimize access to SCIg, particularly in secondary centers, to enhance patient autonomy and improve therapeutic outcomes.
publishDate 2025
dc.date.none.fl_str_mv 2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://isabial.portalinvestigacion.com/publicaciones11340
https://doi.org/10.3389/fimmu.2025.1640290
url https://isabial.portalinvestigacion.com/publicaciones11340
https://doi.org/10.3389/fimmu.2025.1640290
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv FRONTIERS MEDIA SA
publisher.none.fl_str_mv FRONTIERS MEDIA SA
dc.source.none.fl_str_mv Frontiers in Immunology
ISSN: 16643224
reponame:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
instname:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
instname_str Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
reponame_str r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
collection r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
repository.name.fl_str_mv
repository.mail.fl_str_mv
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