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...

Full description

Saved in:
Bibliographic Details
Main Authors: Pedro Moral Moral, Marta Dafne Cabanero-Navalon, Paula Teresa López-León, Héctor Balastegui-Martín, Sandra Martínez Mercader, Amparo Mir, Victor Garcia-Bustos
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Immunology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fimmu.2024.1527514/full
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1832594088131559424
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.
format Article
id doaj-art-9f792c722cf6453f9cee519dee76cb39
institution Kabale University
issn 1664-3224
language English
publishDate 2025-01-01
publisher Frontiers Media S.A.
record_format Article
series Frontiers in Immunology
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
work_keys_str_mv AT pedromoralmoral infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage
AT pedromoralmoral infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage
AT martadafnecabaneronavalon infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage
AT martadafnecabaneronavalon infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage
AT paulateresalopezleon infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage
AT paulateresalopezleon infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage
AT hectorbalasteguimartin infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage
AT hectorbalasteguimartin infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage
AT sandramartinezmercader infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage
AT sandramartinezmercader infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage
AT amparomir infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage
AT victorgarciabustos infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage
AT victorgarciabustos infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage
AT victorgarciabustos infectiousoutcomesofastandardizedsubcutaneousimmunoglobulindosereductionstrategyinprimaryimmunedeficienciesamidglobalshortage