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, Palací Mur Berta, 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
Primary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, Spain.
Severe Infection Research Group, Health Research Institute La Fe, Valencia, Spain.
Front Immunol. 2025 Feb 14;16:1532367. doi: 10.3389/fimmu.2025.1532367. eCollection 2025.
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.
A multicenter, cross-sectional 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.
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.
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.
皮下注射免疫球蛋白（SCIg）已成为原发性免疫缺陷病（PID）和继发性免疫缺陷病（SID）患者静脉注射的替代给药方式，具有全身不良反应较少和患者自主性更高等优点。然而，关于SCIg使用的全面真实世界数据，包括临床和以患者为中心的结局，仍然匮乏。这项由免疫缺陷病专家护理团队开展的研究，评估了西班牙PID和SID患者使用不同制剂的SCIg治疗的临床特征、报告的不良反应以及生活质量结局。
在西班牙的8个免疫缺陷病护理单元开展了一项多中心横断面研究，纳入了2004年至2024年期间接受SCIg治疗的223例成年患者。收集并分析了人口统计学、合并症、SCIg治疗特征、报告的不良事件以及生活质量指标（欧洲五维健康量表-3水平、希洪量表）的数据。
该队列中女性占61.4%，平均年龄为47.1岁，其中65%为PID患者，常见变异型免疫缺陷是最常见的诊断类型（39.8%）。总体而言，SCIg耐受性良好，简易10%（fSCIg）制剂和20%制剂的总体不良事件发生率无显著差异。然而，10% fSCIg报告的轻度局部皮疹（58.7%对36.9%，p=0.002）和发热（10.6%对1.7%，p=0.01）频率较高。生活质量评分表明，患者在活动能力和自我护理方面的受限程度最小，主观健康评分为72.7/100。与10%组相比，使用20% SCIg的患者自我给药所需的培训课程更少。
在这个大型多中心队列中，不同的SCIg制剂有效且总体耐受性良好，支持其用于维持PID和SID患者的足够IgG水平并促进患者独立。该研究结果提倡采用优化患者满意度并满足个体需求的定制方法，强调专业免疫缺陷病护理团队在确保安全、有效和以患者为中心的SCIg给药方面的关键作用。
