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ORIGINAL RESEARCH article
Front. Immunol.
Sec. Primary Immunodeficiencies
Volume 16 - 2025 |
doi: 10.3389/fimmu.2025.1532367
Patient-centered outcomes with subcutaneous immunoglobulin use for infection control in primary and secondary immunodeficiencies: data of a GEIE Spanish Registry
Provisionally accepted
Sandra Martínez Mercader 1*
Victor Garcia-Bustos 1,2* Pedro Moral Moral 1,3* Carmen Martínez Buenaventura 1* Elisa Escudero Vergara 1* María Carmen Montaner Bosch 1* Héctor Balastegui-Martín 1* Sonia Galindo Maycas 4* Berta Palací Mur 4* Marian Escobar Palazón 5* María Moreno Mulet 5* Ignacio Campanero Carrasco 6* Alicia López 7* Carlos Daniel Hernández Ruiz 8* Laura Ruiz-López 9*
Rocío Guzmán Guzmán 9 Marta Dafne Cabanero- Navalon 1,3*- 1 Primary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, Spain
- 2 Severe Infection Research Group, Health Research Institute La Fe, Valencia, Spain
- 3 Research Group of Chronic Diseases and HIV Infection, Health Research Institute La Fe, Valencia, Spain
- 4 Pediatric Infectious Diseases and Immunodeficiencies Unit, Vall d’Hebron University Hospital, Barcelona, Spain
- 5 Area of Immunology - Multidisciplinary Day Hospital, Gregorio Marañón General University Hospital, Madrid, Spain
- 6 Immunology Day Hospital Unit, Reina Sofía University Hospital, Córdoba, Spain
- 7 Onco-Hematology Day Hospital, La Paz University Hospital, Madrid, Spain
- 8 Internal Medicine Day Hospital, Doctor Negrín University Hospital, Gran Canaria, Spain
- 9 Clincal Immunology and Primary Immunodeficiencies Unit, Pediatric Allergy and Clinical Immunology Department, Sant Joan de Déu Hospital, Barcelona, Spain
Background and aim: Subcutaneous immunoglobulin (SCIg) has emerged as an alternative to intravenous administration for patients with primary (PID) and secondary immunodeficiencies (SID), offering benefits such as fewer systemic adverse reactions and greater patient autonomy. However, comprehensive real-world data on SCIg use, including clinical and patient-centered outcomes, remain scarce. This study, conducted by expert immunodeficiency nursing teams, assesses the clinical characteristics, reported adverse effects, and quality-of-life outcomes associated with SCIg therapy with different formulations in patients with PID and SID across Spain. Methods: A multicenter, crosssectional study was conducted across 8 immunodeficiency nursing units in Spain, involving 223 adult patients treated with SCIg from 2004 to 2024. Data on demographics, comorbidities, SCIg treatment characteristics, reported adverse events, and quality-of-life metrics (EuroQol-5D-3L, Gijón Scale) were collected and analyzed. Results: The cohort (61.4% female, mean age: 47.1 years) included 65% PID patients, with common variable immunodeficiency being the most frequent diagnosis (39.8%). SCIg demonstrated good tolerability overall, with no significant differences in global adverse event rates between facilitated 10% (fSCIg) and 20% formulations. However, 10% fSCIg was associated with higher reported frequencies of mild local rash (58.7% vs. 36.9%, p=0.002) and fever (10.6% vs. 1.7%, p=0.01). Quality-of-life scores indicated minimal limitations in mobility and self-care, with a mean subjective health rating of 72.7/100. Patients using 20% SCIg required fewer educational sessions for self-administration compared to the 10% group. Conclusion: The different SCIg formulations in this large, multicenter cohort was effective and generally well-tolerated, supporting its use for maintaining adequate IgG levels and promoting patient independence in PID and SID. The study's findings advocate for tailored approaches that optimize patient satisfaction and address individual needs, emphasizing the critical role of dedicated immunodeficiency nursing teams in ensuring safe, effective, and patient-centered SCIg administration.
Keywords: subcutaneous immunoglobulin (SCIg), Primary immunodeficiency (PID), Secondary immunodeficiency (SID), Patient-centered outcomes, Quality of Life
Received: 21 Nov 2024; Accepted: 22 Jan 2025.
Copyright: © 2025 Martínez Mercader, Garcia-Bustos, Moral Moral, Martínez Buenaventura, Escudero Vergara, Montaner Bosch, Balastegui-Martín, Galindo Maycas, Palací Mur, Escobar Palazón, Moreno Mulet, Campanero Carrasco, López, Hernández Ruiz, Ruiz-López, Guzmán Guzmán and Cabanero- Navalon. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Sandra Martínez Mercader, Primary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, Spain
Victor Garcia-Bustos, Severe Infection Research Group, Health Research Institute La Fe, Valencia, Spain
Pedro Moral Moral, Primary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, Spain
Carmen Martínez Buenaventura, Primary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, Spain
Elisa Escudero Vergara, Primary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, Spain
María Carmen Montaner Bosch, Primary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, Spain
Héctor Balastegui-Martín, Primary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, Spain
Sonia Galindo Maycas, Pediatric Infectious Diseases and Immunodeficiencies Unit, Vall d’Hebron University Hospital, Barcelona, Spain
Berta Palací Mur, Pediatric Infectious Diseases and Immunodeficiencies Unit, Vall d’Hebron University Hospital, Barcelona, Spain
Marian Escobar Palazón, Area of Immunology - Multidisciplinary Day Hospital, Gregorio Marañón General University Hospital, Madrid, Spain
María Moreno Mulet, Area of Immunology - Multidisciplinary Day Hospital, Gregorio Marañón General University Hospital, Madrid, Spain
Ignacio Campanero Carrasco, Immunology Day Hospital Unit, Reina Sofía University Hospital, Córdoba, Spain
Alicia López, Onco-Hematology Day Hospital, La Paz University Hospital, Madrid, Spain
Carlos Daniel Hernández Ruiz, Internal Medicine Day Hospital, Doctor Negrín University Hospital, Gran Canaria, Spain
Laura Ruiz-López, Clincal Immunology and Primary Immunodeficiencies Unit, Pediatric Allergy and Clinical Immunology Department, Sant Joan de Déu Hospital, Barcelona, Spain
Marta Dafne Cabanero- Navalon, Primary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, Spain
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