Exploring Multidimensional Risk Factors Associated with Local Adverse Reactions to Subcutaneous Immunoglobulin Therapy: Insights from a Nationwide Multicenter Study
Por:
Mercader, SM, Garcia-Bustos, V, Moral, PM, Buenaventura, CM, Vergara, EE, Bosch, MCM, Balastegui-Martín, H, Maycas, SG, Amores, MG, Sanz, NG, Palazón, ME, Mulet, MM, Carrasco, IC, López, A, Ruiz, CDH, Ruiz-López, L, Guzmán, RG and Cabañero-Navalon, MD
Publicada:
15 ago 2025
Resumen:
Background/Objectives: 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. Methods: 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. Results: Among 223 included patients, 73.1% reported LARs, primarily swelling, pruritus, and rash. Independent predictors included smaller abdominal perimeter (OR 0.955, p < 0.001), history of skin disease (OR 2.75, p = 0.044), greater distance to hospital (OR 1.01, p = 0.050), and absence of anxiety (OR 0.089, p = 0.001). Model discrimination was good (AUC 0.801), with minimal optimism after internal validation (validated AUC 0.788). Conclusions: 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.
Filiaciones:
Mercader, SM:
Univ & Polytech Hosp La Fe, Dept Internal Med, Primary Immunodeficiencies Unit, Valencia 46026, Spain
Garcia-Bustos, V:
Univ & Polytech Hosp La Fe, Dept Internal Med, Primary Immunodeficiencies Unit, Valencia 46026, Spain
Hlth Res Inst La Fe, Severe Infect Res Grp, Valencia 46026, Spain
Moral, PM:
Univ & Polytech Hosp La Fe, Dept Internal Med, Primary Immunodeficiencies Unit, Valencia 46026, Spain
Hlth Res Inst La Fe, Res Grp Chron Dis & HIV Infect, Valencia 46026, Spain
Buenaventura, CM:
Univ & Polytech Hosp La Fe, Dept Internal Med, Primary Immunodeficiencies Unit, Valencia 46026, Spain
Vergara, EE:
Univ & Polytech Hosp La Fe, Dept Internal Med, Primary Immunodeficiencies Unit, Valencia 46026, Spain
Bosch, MCM:
Univ & Polytech Hosp La Fe, Dept Internal Med, Primary Immunodeficiencies Unit, Valencia 46026, Spain
Balastegui-Martín, H:
Univ & Polytech Hosp La Fe, Dept Internal Med, Primary Immunodeficiencies Unit, Valencia 46026, Spain
Hlth Res Inst La Fe, Res Grp Chron Dis & HIV Infect, Valencia 46026, Spain
Maycas, SG:
Vall dHebron Univ Hosp, Pediat Infect Dis & Immunodeficiencies Unit, Barcelona 08035, Spain
Vall dHebron Inst Recerca, Infect & Immun Pediat Patients Res Grp, Barcelona 08035, Spain
Amores, MG:
Vall dHebron Inst Recerca, Infect & Immun Pediat Patients Res Grp, Barcelona 08035, Spain
Sanz, NG:
Vall dHebron Inst Recerca, Infect & Immun Pediat Patients Res Grp, Barcelona 08035, Spain
Palazón, ME:
Gregorio Maranon Gen Univ Hosp, Area Immunol, Multidisciplinary Day Hosp, Madrid 28007, Spain
Mulet, MM:
Gregorio Maranon Gen Univ Hosp, Area Immunol, Multidisciplinary Day Hosp, Madrid 28007, Spain
Carrasco, IC:
Reina Sofia Univ Hosp, Immunol Day Hosp Unit, Cordoba 14004, Spain
López, A:
La Paz Univ Hosp, Oncohematol Day Hosp, Madrid 28046, Spain
Ruiz, CDH:
Doctor Negrin Univ Hosp Gran Canaria, Internal Med Day Hosp, Gran Canaria 35010, Spain
:
St Joan de Deu Hosp, Pediat Allergy & Clin Immunol Dept, Clin Immunol & Primary Immunodeficiencies Unit, Barcelona 08950, Spain
Guzmán, RG:
Son Espases Univ Hosp, Day Hosp, Palma De Mallorca 07120, Spain
Cabañero-Navalon, MD:
Univ & Polytech Hosp La Fe, Dept Internal Med, Primary Immunodeficiencies Unit, Valencia 46026, Spain
Hlth Res Inst La Fe, Res Grp Chron Dis & HIV Infect, Valencia 46026, Spain
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