Moral Moral Pedro, Garcia-Bustos Victor, Balastegui-Martin Héctor, Martínez Mercader Sandra, Bracke Carmen, Mateu Lourdes, Solanich Xavier, Antolí Arnau, Carrillo-Linares Juan Luis, Robles-Marhuenda Ángel, Puchades Francesc, Pelaez Ballesta Ana, López-Osle Nuria, Torralba-Cabeza Miguel Ángel, Bielsa Masdeu Ana María, Gil Niño Jorge, Tornador Gaya Nuria, Pascual Castellanos Guillem, Sánchez-Martínez Rosario, Barragán-Casas José Manuel, González-García Andrés, Patier de la Peña José Luís, López-Wolf Daniel, Mora Rufete Antonia, Canovas Mora Alba, Cabañero-Navalon Marta Dafne
Primary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, Spain.
Research Group of Chronic Diseases and HIV Infection, Health Research Institute La Fe, Valencia, Spain.
Front Immunol. 2025 Jul 23;16:1640290. doi: 10.3389/fimmu.2025.1640290. eCollection 2025.
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.
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.
Of the 212 patients, 58.5% received IVIg and 41.5% received SCIg. SCIg recipients were younger (47.5 vs. 54.8 years, = 0.003) and predominantly treated at home (80.6% . 1.6%, < 0.001), compared to those receiving IVIg. SCIg use was significantly higher in tertiary hospitals compared to secondary ones (44.4% . 17.4%, = 0.0136). Infection rates, autoimmune comorbidities, weekly doses (7.2 g for IVIg . 7.7 g for SCIg, = 0.142), and IgG trough levels were comparable across groups.
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.
免疫球蛋白替代疗法（IgRT），通过静脉注射（IVIg）或皮下注射（SCIg）给药，是普通可变免疫缺陷（CVID）患者的基础治疗方法。尽管两种给药方式疗效相似，但SCIg的全身不良事件较少，且患者自主性增强。尽管有这些优势，但其在某些地区的应用仍然有限，尤其是在地中海地区。本研究旨在评估西班牙CVID患者使用IgRT的实际情况，并全面分析常规临床实践中与IVIg和SCIg给药相关的因素。
利用GTEM-SEMI-CVID注册中心的数据进行了一项横断面多中心研究，纳入了西班牙212例接受IgRT的成年CVID患者。根据给药途径将患者分组：IVIg组和SCIg组。收集了人口统计学、临床和免疫学数据，包括IgRT方式、剂量、给药地点和合并症。进行了比较统计分析以确定两个治疗组之间的差异。
在212例患者中，58.5%接受IVIg治疗，41.5%接受SCIg治疗。与接受IVIg的患者相比，接受SCIg的患者更年轻（47.5岁对54.8岁，P = 0.003），且主要在家中接受治疗（80.6%对1.6%，P < 0.001）。与二级医院相比，三级医院中SCIg的使用显著更高（44.4%对17.4%，P = 0.0136）。各组的感染率、自身免疫合并症、每周剂量（IVIg为7.2 g对SCIg为7.7 g，P = 0.142）和IgG谷值水平相当。
本研究提供了西班牙CVID患者IgRT使用情况的实际证据，表明在过去十年中SCIg的使用显著增加，尽管IVIg仍然占主导地位，尤其是在二级医院。年龄对给药方式的选择有显著影响，老年患者更倾向于IVIg，年轻患者更倾向于SCIg，而疾病严重程度并未影响这一决定。这些发现强调了优化SCIg的可及性的必要性，特别是在二级中心，以增强患者自主性并改善治疗效果。
