Infectious outcomes of a standardized subcutaneous immunoglobulin dose reduction strategy in primary immune deficiencies amid global shortage
IntroductionImmunoglobulin replacement therapy (IgRT), either intravenous (IVIg) or subcutaneous (SCIg), is crucial for managing primary immune deficiencies (PIDs) with hypogammaglobulinemia by reducing infection rates and mortality. During the COVID-19 pandemic, a global shortage of SCIg prompted o...
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Frontiers Media S.A.
2025-01-01
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Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2024.1527514/full |
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author | Pedro Moral Moral Pedro Moral Moral Marta Dafne Cabanero-Navalon Marta Dafne Cabanero-Navalon Paula Teresa López-León Paula Teresa López-León Héctor Balastegui-Martín Héctor Balastegui-Martín Sandra Martínez Mercader Sandra Martínez Mercader Amparo Mir Victor Garcia-Bustos Victor Garcia-Bustos Victor Garcia-Bustos |
author_facet | Pedro Moral Moral Pedro Moral Moral Marta Dafne Cabanero-Navalon Marta Dafne Cabanero-Navalon Paula Teresa López-León Paula Teresa López-León Héctor Balastegui-Martín Héctor Balastegui-Martín Sandra Martínez Mercader Sandra Martínez Mercader Amparo Mir Victor Garcia-Bustos Victor Garcia-Bustos Victor Garcia-Bustos |
author_sort | Pedro Moral Moral |
collection | DOAJ |
description | IntroductionImmunoglobulin replacement therapy (IgRT), either intravenous (IVIg) or subcutaneous (SCIg), is crucial for managing primary immune deficiencies (PIDs) with hypogammaglobulinemia by reducing infection rates and mortality. During the COVID-19 pandemic, a global shortage of SCIg prompted our unit to reduce SCIg doses or maintain the same dose intravenously. This study evaluates the impact of a standardized SCIg dose reduction on infection rates and clinical outcomes in patients with humoral PID and with a low burden of infections.MethodsAdult PID patients on SCIg for at least 6 months, with IgG trough levels ≥ 700 mg/dL (or ≥ 900 mg/dL under specific conditions), and no significant infections in the past 6 months were eligible. A dose reduction of 15 mg/kg/week (60 mg/kg/month) for every 150 mg/dL above 700 mg/dL (or 900 mg/dL) was proposed. Clinical and laboratory data, and infectious events at 6- and 12-month follow-ups, were analyzed.ResultsThirty-one patients with PID were included: common variable immunodeficiency (54.83%), IgG subclass deficiency (9.67%), and other PIDs (35.48%). The average SCIg dose was initially reduced from 7.82 g/week to 5.72 g/week and adjusted to 6.94 g/week at 12 months. There was no significant change in severe or mild infections before and at 6- and 12-months post-dose adjustment. The dose reduction saved an average of 5,550 euros per patient annually, totaling 172,050 euros annually for our cohort.DiscussionOptimizing SCIg doses in selected well-controlled humoral PIDs is feasible without increasing infection rates, conserving this plasma-derived product during shortages. Larger prospective studies are needed to confirm this strategy's utility and its application to other Ig formulations. |
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institution | Kabale University |
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language | English |
publishDate | 2025-01-01 |
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spelling | doaj-art-9f792c722cf6453f9cee519dee76cb392025-01-20T05:23:48ZengFrontiers Media S.A.Frontiers in Immunology1664-32242025-01-011510.3389/fimmu.2024.15275141527514Infectious outcomes of a standardized subcutaneous immunoglobulin dose reduction strategy in primary immune deficiencies amid global shortagePedro Moral Moral0Pedro Moral Moral1Marta Dafne Cabanero-Navalon2Marta Dafne Cabanero-Navalon3Paula Teresa López-León4Paula Teresa López-León5Héctor Balastegui-Martín6Héctor Balastegui-Martín7Sandra Martínez Mercader8Sandra Martínez Mercader9Amparo Mir10Victor Garcia-Bustos11Victor Garcia-Bustos12Victor Garcia-Bustos13Primary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, SpainResearch Group of Chronic Diseases and HIV Infection, Health Research Institute La Fe, Valencia, SpainPrimary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, SpainResearch Group of Chronic Diseases and HIV Infection, Health Research Institute La Fe, Valencia, SpainPrimary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, SpainResearch Group of Chronic Diseases and HIV Infection, Health Research Institute La Fe, Valencia, SpainPrimary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, SpainResearch Group of Chronic Diseases and HIV Infection, Health Research Institute La Fe, Valencia, SpainPrimary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, SpainResearch Group of Chronic Diseases and HIV Infection, Health Research Institute La Fe, Valencia, SpainCentral Research Unit, University of Valencia, Valencia, SpainPrimary Immunodeficiencies Unit, Department of Internal Medicine, University and Polytechnic Hospital La Fe, Valencia, SpainSevere Infection Research Group, Health Research Institute La Fe, Valencia, SpainUnit of Infectious Diseases, University and Polytechnic Hospital La Fe, Valencia, SpainIntroductionImmunoglobulin replacement therapy (IgRT), either intravenous (IVIg) or subcutaneous (SCIg), is crucial for managing primary immune deficiencies (PIDs) with hypogammaglobulinemia by reducing infection rates and mortality. During the COVID-19 pandemic, a global shortage of SCIg prompted our unit to reduce SCIg doses or maintain the same dose intravenously. This study evaluates the impact of a standardized SCIg dose reduction on infection rates and clinical outcomes in patients with humoral PID and with a low burden of infections.MethodsAdult PID patients on SCIg for at least 6 months, with IgG trough levels ≥ 700 mg/dL (or ≥ 900 mg/dL under specific conditions), and no significant infections in the past 6 months were eligible. A dose reduction of 15 mg/kg/week (60 mg/kg/month) for every 150 mg/dL above 700 mg/dL (or 900 mg/dL) was proposed. Clinical and laboratory data, and infectious events at 6- and 12-month follow-ups, were analyzed.ResultsThirty-one patients with PID were included: common variable immunodeficiency (54.83%), IgG subclass deficiency (9.67%), and other PIDs (35.48%). The average SCIg dose was initially reduced from 7.82 g/week to 5.72 g/week and adjusted to 6.94 g/week at 12 months. There was no significant change in severe or mild infections before and at 6- and 12-months post-dose adjustment. The dose reduction saved an average of 5,550 euros per patient annually, totaling 172,050 euros annually for our cohort.DiscussionOptimizing SCIg doses in selected well-controlled humoral PIDs is feasible without increasing infection rates, conserving this plasma-derived product during shortages. Larger prospective studies are needed to confirm this strategy's utility and its application to other Ig formulations.https://www.frontiersin.org/articles/10.3389/fimmu.2024.1527514/fullimmunoglobulin replacement therapyhumoral primary immune deficienciessubcutaneous immunoglobulininfectionscost-effectivenessresource shortage |
spellingShingle | Pedro Moral Moral Pedro Moral Moral Marta Dafne Cabanero-Navalon Marta Dafne Cabanero-Navalon Paula Teresa López-León Paula Teresa López-León Héctor Balastegui-Martín Héctor Balastegui-Martín Sandra Martínez Mercader Sandra Martínez Mercader Amparo Mir Victor Garcia-Bustos Victor Garcia-Bustos Victor Garcia-Bustos Infectious outcomes of a standardized subcutaneous immunoglobulin dose reduction strategy in primary immune deficiencies amid global shortage Frontiers in Immunology immunoglobulin replacement therapy humoral primary immune deficiencies subcutaneous immunoglobulin infections cost-effectiveness resource shortage |
title | Infectious outcomes of a standardized subcutaneous immunoglobulin dose reduction strategy in primary immune deficiencies amid global shortage |
title_full | Infectious outcomes of a standardized subcutaneous immunoglobulin dose reduction strategy in primary immune deficiencies amid global shortage |
title_fullStr | Infectious outcomes of a standardized subcutaneous immunoglobulin dose reduction strategy in primary immune deficiencies amid global shortage |
title_full_unstemmed | Infectious outcomes of a standardized subcutaneous immunoglobulin dose reduction strategy in primary immune deficiencies amid global shortage |
title_short | Infectious outcomes of a standardized subcutaneous immunoglobulin dose reduction strategy in primary immune deficiencies amid global shortage |
title_sort | infectious outcomes of a standardized subcutaneous immunoglobulin dose reduction strategy in primary immune deficiencies amid global shortage |
topic | immunoglobulin replacement therapy humoral primary immune deficiencies subcutaneous immunoglobulin infections cost-effectiveness resource shortage |
url | https://www.frontiersin.org/articles/10.3389/fimmu.2024.1527514/full |
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