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Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients

PURPOSE: Subcutaneous immunoglobulin replacement therapy (IgRT) may be administered once a week with a pump or every other day with a syringe (rapid push). The objective of the study was to compare the impact of pump and rapid push infusions on patient’s life quality index (LQI). METHODS: This study...

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Autores principales: Bienvenu, Boris, Cozon, Grégoire, Mataix, Yves, Lachaud, Dominique, Alix, Antoine, Hoarau, Cyrille, Antier, Daniel, Hachulla, Eric, Brice, Sylvie, Viallard, Jean-François, Tamisier, Stéphanie, Fauchais, Anne-Laure, Renon-Carron, Françoise, Clerson, Pierre, Fardini, Yann, Crave, Jean-Charles, Miossec, Pierre
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6028863/
https://www.ncbi.nlm.nih.gov/pubmed/29855752
http://dx.doi.org/10.1007/s10875-018-0507-x
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author Bienvenu, Boris
Cozon, Grégoire
Mataix, Yves
Lachaud, Dominique
Alix, Antoine
Hoarau, Cyrille
Antier, Daniel
Hachulla, Eric
Brice, Sylvie
Viallard, Jean-François
Tamisier, Stéphanie
Fauchais, Anne-Laure
Renon-Carron, Françoise
Clerson, Pierre
Fardini, Yann
Crave, Jean-Charles
Miossec, Pierre
author_facet Bienvenu, Boris
Cozon, Grégoire
Mataix, Yves
Lachaud, Dominique
Alix, Antoine
Hoarau, Cyrille
Antier, Daniel
Hachulla, Eric
Brice, Sylvie
Viallard, Jean-François
Tamisier, Stéphanie
Fauchais, Anne-Laure
Renon-Carron, Françoise
Clerson, Pierre
Fardini, Yann
Crave, Jean-Charles
Miossec, Pierre
author_sort Bienvenu, Boris
collection PubMed
description PURPOSE: Subcutaneous immunoglobulin replacement therapy (IgRT) may be administered once a week with a pump or every other day with a syringe (rapid push). The objective of the study was to compare the impact of pump and rapid push infusions on patient’s life quality index (LQI). METHODS: This study was a randomized, crossover, multicenter, non-inferiority trial conducted in adults with primary immunodeficiency (PID) accustomed to weekly infusions at home by pump. Patients used pump or rapid push for 3 months each according to the randomized sequence. Main criterion was PID-LQI factor I (treatment interference). Non-inferiority ratio was set at 90%. RESULTS: Thirty patients entered the study; 28 completed the two periods. IgRT exposure was similar during each period. At the end of each period, mean LQI factor 1 was 87.0 (IC95% [80.3; 94.3]) and 77.80 (IC95% [71.5; 84.7]) for pump and rapid push, respectively. There was a slightly larger effect of rapid push on treatment interference than with pump so that the primary endpoint could not be met. No difference was found on other LQI components, satisfaction (TSQM), or quality of life (SF36v2). Eight patients declared to prefer rapid push while 19 others preferred pump. Of rapid push infusions, 67.2% led to local reactions vs 71.8% of pump infusions (p = 0.11) illustrating its good tolerance. Rapid push and pump infusions achieved similar trough IgG levels with similar incidence of infections. Rapid push saved 70% of administration cost when compared to pump. CONCLUSIONS: Since IgRT is a lifelong treatment in PID patients, individualization of treatment is of paramount importance. Rapid push is a new administration method in the physician’s armamentarium which is preferred by some patients and is cost-effective. CLINICALTRIALS.GOV IDENTIFIER: NCT02180763 CLINICAL IMPLICATIONS: Self-administration of small volumes of immunoglobulins at home, every other day, using a syringe (rapid push) is a cost-effective alternative to administration of larger volumes by pump once a week. CAPSULE SUMMARY: This study compared subcutaneous infusions of immunoglobulins either weekly via a pump or every other day via a syringe (rapid push). Rapid push is preferred by some patients and is cost-effective, therefore completing a physician’s armamentarium.
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spelling pubmed-60288632018-07-23 Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients Bienvenu, Boris Cozon, Grégoire Mataix, Yves Lachaud, Dominique Alix, Antoine Hoarau, Cyrille Antier, Daniel Hachulla, Eric Brice, Sylvie Viallard, Jean-François Tamisier, Stéphanie Fauchais, Anne-Laure Renon-Carron, Françoise Clerson, Pierre Fardini, Yann Crave, Jean-Charles Miossec, Pierre J Clin Immunol Original Article PURPOSE: Subcutaneous immunoglobulin replacement therapy (IgRT) may be administered once a week with a pump or every other day with a syringe (rapid push). The objective of the study was to compare the impact of pump and rapid push infusions on patient’s life quality index (LQI). METHODS: This study was a randomized, crossover, multicenter, non-inferiority trial conducted in adults with primary immunodeficiency (PID) accustomed to weekly infusions at home by pump. Patients used pump or rapid push for 3 months each according to the randomized sequence. Main criterion was PID-LQI factor I (treatment interference). Non-inferiority ratio was set at 90%. RESULTS: Thirty patients entered the study; 28 completed the two periods. IgRT exposure was similar during each period. At the end of each period, mean LQI factor 1 was 87.0 (IC95% [80.3; 94.3]) and 77.80 (IC95% [71.5; 84.7]) for pump and rapid push, respectively. There was a slightly larger effect of rapid push on treatment interference than with pump so that the primary endpoint could not be met. No difference was found on other LQI components, satisfaction (TSQM), or quality of life (SF36v2). Eight patients declared to prefer rapid push while 19 others preferred pump. Of rapid push infusions, 67.2% led to local reactions vs 71.8% of pump infusions (p = 0.11) illustrating its good tolerance. Rapid push and pump infusions achieved similar trough IgG levels with similar incidence of infections. Rapid push saved 70% of administration cost when compared to pump. CONCLUSIONS: Since IgRT is a lifelong treatment in PID patients, individualization of treatment is of paramount importance. Rapid push is a new administration method in the physician’s armamentarium which is preferred by some patients and is cost-effective. CLINICALTRIALS.GOV IDENTIFIER: NCT02180763 CLINICAL IMPLICATIONS: Self-administration of small volumes of immunoglobulins at home, every other day, using a syringe (rapid push) is a cost-effective alternative to administration of larger volumes by pump once a week. CAPSULE SUMMARY: This study compared subcutaneous infusions of immunoglobulins either weekly via a pump or every other day via a syringe (rapid push). Rapid push is preferred by some patients and is cost-effective, therefore completing a physician’s armamentarium. Springer US 2018-05-31 2018 /pmc/articles/PMC6028863/ /pubmed/29855752 http://dx.doi.org/10.1007/s10875-018-0507-x Text en © The Author(s) 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Article
Bienvenu, Boris
Cozon, Grégoire
Mataix, Yves
Lachaud, Dominique
Alix, Antoine
Hoarau, Cyrille
Antier, Daniel
Hachulla, Eric
Brice, Sylvie
Viallard, Jean-François
Tamisier, Stéphanie
Fauchais, Anne-Laure
Renon-Carron, Françoise
Clerson, Pierre
Fardini, Yann
Crave, Jean-Charles
Miossec, Pierre
Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients
title Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients
title_full Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients
title_fullStr Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients
title_full_unstemmed Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients
title_short Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients
title_sort rapid push vs pump-infused subcutaneous immunoglobulin treatment: a randomized crossover study of quality of life in primary immunodeficiency patients
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6028863/
https://www.ncbi.nlm.nih.gov/pubmed/29855752
http://dx.doi.org/10.1007/s10875-018-0507-x
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