Exploring Multidimensional Risk Factors Associated with Local Adverse Reactions to Subcutaneous Immunoglobulin Therapy: Insights from a Nationwide Multicenter Study

: Subcutaneous immunoglobulin (SCIg) is a well-established alternative to intravenous immunoglobulin (IVIg) in patients with primary (PID) and secondary immunodeficiency (SID), with demonstrated benefits in safety and quality of life. However, its implementation remains limited in parts of Southern...

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Autores: Martínez Mercader, Sandra, Garcia-Bustos, Victor, Moral Moral, Pedro, Martínez Buenaventura, Carmen, Escudero Vergara, Elisa, Montaner Bosch, María Carmen, Balastegui-Martín, Héctor, Galindo Maycas, Sonia, González Amores, Miriam, Gimenez Sanz, Noemí, Escobar Palazón, Marian, Moreno Mulet, María, Campanero Carrasco, Ignacio, López, Alicia, Hernández Ruiz, Carlos Daniel, Ruiz-López, Laura, Guzmán Guzmán, Rocío, Cabañero-Navalon, Marta Dafne
Tipo de recurso: artículo
Fecha de publicación:2025
País:España
Institución:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositorio:Docusalut
Idioma:inglés
OAI Identifier:oai:docusalut.com:20.500.13003/25894
Acceso en línea:https://hdl.handle.net/20.500.13003/25894
Access Level:acceso abierto
Palabra clave:Common Variable Immunodeficiency
Immunoglobulins, Intravenous
Inmunodeficiencia Variable Común
Inmunoglobulinas Intravenosas
common variable immunodeficiency (CVID)
immunoglobulin replacement therapy (IgRT)
intravenous immunoglobulin (IVIg)
real-world evidence
subcutaneous immunoglobulin (SCIg)
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spelling Exploring Multidimensional Risk Factors Associated with Local Adverse Reactions to Subcutaneous Immunoglobulin Therapy: Insights from a Nationwide Multicenter StudyMartínez Mercader, SandraGarcia-Bustos, VictorMoral Moral, PedroMartínez Buenaventura, CarmenEscudero Vergara, ElisaMontaner Bosch, María CarmenBalastegui-Martín, HéctorGalindo Maycas, SoniaGonzález Amores, MiriamGimenez Sanz, NoemíEscobar Palazón, MarianMoreno Mulet, MaríaCampanero Carrasco, IgnacioLópez, AliciaHernández Ruiz, Carlos DanielRuiz-López, LauraGuzmán Guzmán, RocíoCabañero-Navalon, Marta DafneCommon Variable ImmunodeficiencyImmunoglobulins, IntravenousInmunodeficiencia Variable ComúnInmunoglobulinas Intravenosascommon variable immunodeficiency (CVID)immunoglobulin replacement therapy (IgRT)intravenous immunoglobulin (IVIg)real-world evidencesubcutaneous immunoglobulin (SCIg): Subcutaneous immunoglobulin (SCIg) is a well-established alternative to intravenous immunoglobulin (IVIg) in patients with primary (PID) and secondary immunodeficiency (SID), with demonstrated benefits in safety and quality of life. However, its implementation remains limited in parts of Southern Europe, partly due to frequent local adverse reactions (LARs), which, despite being mild, can affect adherence and clinician confidence. This study aimed to identify clinical, anatomical, psychosocial, and geographical factors associated with LARs and to develop an exploratory model for individualized risk estimation. : We conducted a retrospective, multicenter observational study in eight Spanish hospitals using data from the GEIE Registry. Patients aged ≥14 years with PID or SID receiving SCIg for ≥1 month were included. Demographic, clinical, anatomical, and psychosocial variables were collected. A multivariable logistic regression model was built to identify independent predictors of LARs and internally validated using bootstrap resampling (500 iterations). A nomogram was constructed for personalized risk prediction. : Among 223 included patients, 73.1% reported LARs, primarily swelling, pruritus, and rash. Independent predictors included smaller abdominal perimeter (OR 0.955, < 0.001), history of skin disease (OR 2.75, = 0.044), greater distance to hospital (OR 1.01, = 0.050), and absence of anxiety (OR 0.089, = 0.001). Model discrimination was good (AUC 0.801), with minimal optimism after internal validation (validated AUC 0.788). : LARs are common among patients receiving SCIg and could be influenced by anatomical, dermatological, psychological, and geographical factors. This exploratory multicenter study underscores the clinical relevance of these factors and may guide more personalized and safer use of SCIg.MDPI20252025-01-0120252025-01-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/20.500.13003/25894reponame:Docusalutinstname:Conselleria de Salut i Consum del Govern de les Illes BalearsInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:docusalut.com:20.500.13003/258942026-06-22T12:44:07Z
dc.title.none.fl_str_mv Exploring Multidimensional Risk Factors Associated with Local Adverse Reactions to Subcutaneous Immunoglobulin Therapy: Insights from a Nationwide Multicenter Study
title Exploring Multidimensional Risk Factors Associated with Local Adverse Reactions to Subcutaneous Immunoglobulin Therapy: Insights from a Nationwide Multicenter Study
spellingShingle Exploring Multidimensional Risk Factors Associated with Local Adverse Reactions to Subcutaneous Immunoglobulin Therapy: Insights from a Nationwide Multicenter Study
Martínez Mercader, Sandra
Common Variable Immunodeficiency
Immunoglobulins, Intravenous
Inmunodeficiencia Variable Común
Inmunoglobulinas Intravenosas
common variable immunodeficiency (CVID)
immunoglobulin replacement therapy (IgRT)
intravenous immunoglobulin (IVIg)
real-world evidence
subcutaneous immunoglobulin (SCIg)
title_short Exploring Multidimensional Risk Factors Associated with Local Adverse Reactions to Subcutaneous Immunoglobulin Therapy: Insights from a Nationwide Multicenter Study
title_full Exploring Multidimensional Risk Factors Associated with Local Adverse Reactions to Subcutaneous Immunoglobulin Therapy: Insights from a Nationwide Multicenter Study
title_fullStr Exploring Multidimensional Risk Factors Associated with Local Adverse Reactions to Subcutaneous Immunoglobulin Therapy: Insights from a Nationwide Multicenter Study
title_full_unstemmed Exploring Multidimensional Risk Factors Associated with Local Adverse Reactions to Subcutaneous Immunoglobulin Therapy: Insights from a Nationwide Multicenter Study
title_sort Exploring Multidimensional Risk Factors Associated with Local Adverse Reactions to Subcutaneous Immunoglobulin Therapy: Insights from a Nationwide Multicenter Study
dc.creator.none.fl_str_mv Martínez Mercader, Sandra
Garcia-Bustos, Victor
Moral Moral, Pedro
Martínez Buenaventura, Carmen
Escudero Vergara, Elisa
Montaner Bosch, María Carmen
Balastegui-Martín, Héctor
Galindo Maycas, Sonia
González Amores, Miriam
Gimenez Sanz, Noemí
Escobar Palazón, Marian
Moreno Mulet, María
Campanero Carrasco, Ignacio
López, Alicia
Hernández Ruiz, Carlos Daniel
Ruiz-López, Laura
Guzmán Guzmán, Rocío
Cabañero-Navalon, Marta Dafne
author Martínez Mercader, Sandra
author_facet Martínez Mercader, Sandra
Garcia-Bustos, Victor
Moral Moral, Pedro
Martínez Buenaventura, Carmen
Escudero Vergara, Elisa
Montaner Bosch, María Carmen
Balastegui-Martín, Héctor
Galindo Maycas, Sonia
González Amores, Miriam
Gimenez Sanz, Noemí
Escobar Palazón, Marian
Moreno Mulet, María
Campanero Carrasco, Ignacio
López, Alicia
Hernández Ruiz, Carlos Daniel
Ruiz-López, Laura
Guzmán Guzmán, Rocío
Cabañero-Navalon, Marta Dafne
author_role author
author2 Garcia-Bustos, Victor
Moral Moral, Pedro
Martínez Buenaventura, Carmen
Escudero Vergara, Elisa
Montaner Bosch, María Carmen
Balastegui-Martín, Héctor
Galindo Maycas, Sonia
González Amores, Miriam
Gimenez Sanz, Noemí
Escobar Palazón, Marian
Moreno Mulet, María
Campanero Carrasco, Ignacio
López, Alicia
Hernández Ruiz, Carlos Daniel
Ruiz-López, Laura
Guzmán Guzmán, Rocío
Cabañero-Navalon, Marta Dafne
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv Common Variable Immunodeficiency
Immunoglobulins, Intravenous
Inmunodeficiencia Variable Común
Inmunoglobulinas Intravenosas
common variable immunodeficiency (CVID)
immunoglobulin replacement therapy (IgRT)
intravenous immunoglobulin (IVIg)
real-world evidence
subcutaneous immunoglobulin (SCIg)
topic Common Variable Immunodeficiency
Immunoglobulins, Intravenous
Inmunodeficiencia Variable Común
Inmunoglobulinas Intravenosas
common variable immunodeficiency (CVID)
immunoglobulin replacement therapy (IgRT)
intravenous immunoglobulin (IVIg)
real-world evidence
subcutaneous immunoglobulin (SCIg)
description : Subcutaneous immunoglobulin (SCIg) is a well-established alternative to intravenous immunoglobulin (IVIg) in patients with primary (PID) and secondary immunodeficiency (SID), with demonstrated benefits in safety and quality of life. However, its implementation remains limited in parts of Southern Europe, partly due to frequent local adverse reactions (LARs), which, despite being mild, can affect adherence and clinician confidence. This study aimed to identify clinical, anatomical, psychosocial, and geographical factors associated with LARs and to develop an exploratory model for individualized risk estimation. : We conducted a retrospective, multicenter observational study in eight Spanish hospitals using data from the GEIE Registry. Patients aged ≥14 years with PID or SID receiving SCIg for ≥1 month were included. Demographic, clinical, anatomical, and psychosocial variables were collected. A multivariable logistic regression model was built to identify independent predictors of LARs and internally validated using bootstrap resampling (500 iterations). A nomogram was constructed for personalized risk prediction. : Among 223 included patients, 73.1% reported LARs, primarily swelling, pruritus, and rash. Independent predictors included smaller abdominal perimeter (OR 0.955, < 0.001), history of skin disease (OR 2.75, = 0.044), greater distance to hospital (OR 1.01, = 0.050), and absence of anxiety (OR 0.089, = 0.001). Model discrimination was good (AUC 0.801), with minimal optimism after internal validation (validated AUC 0.788). : LARs are common among patients receiving SCIg and could be influenced by anatomical, dermatological, psychological, and geographical factors. This exploratory multicenter study underscores the clinical relevance of these factors and may guide more personalized and safer use of SCIg.
publishDate 2025
dc.date.none.fl_str_mv 2025
2025-01-01
2025
2025-01-01
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.13003/25894
url https://hdl.handle.net/20.500.13003/25894
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv MDPI
publisher.none.fl_str_mv MDPI
dc.source.none.fl_str_mv reponame:Docusalut
instname:Conselleria de Salut i Consum del Govern de les Illes Balears
instname_str Conselleria de Salut i Consum del Govern de les Illes Balears
reponame_str Docusalut
collection Docusalut
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.198674

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