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Human immune globulin 10% with recombinant human hyaluronidase in multifocal motor neuropathy

OBJECTIVE: The primary aim was to determine the safety of treatment with human immune globulin 10% with recombinant human hyaluronidase (fSCIg) compared to intravenous immunoglobulin (IVIg) in a prospective open-label study in patients with multifocal motor neuropathy (MMN). METHODS: Our study consi...

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Autores principales: Herraets, Ingrid J. T., Bakers, Jaap N. E., van Eijk, Ruben P. A., Goedee, H. Stephan, van der Pol, W. Ludo, van den Berg, Leonard H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6803588/
https://www.ncbi.nlm.nih.gov/pubmed/31325017
http://dx.doi.org/10.1007/s00415-019-09475-x
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author Herraets, Ingrid J. T.
Bakers, Jaap N. E.
van Eijk, Ruben P. A.
Goedee, H. Stephan
van der Pol, W. Ludo
van den Berg, Leonard H.
author_facet Herraets, Ingrid J. T.
Bakers, Jaap N. E.
van Eijk, Ruben P. A.
Goedee, H. Stephan
van der Pol, W. Ludo
van den Berg, Leonard H.
author_sort Herraets, Ingrid J. T.
collection PubMed
description OBJECTIVE: The primary aim was to determine the safety of treatment with human immune globulin 10% with recombinant human hyaluronidase (fSCIg) compared to intravenous immunoglobulin (IVIg) in a prospective open-label study in patients with multifocal motor neuropathy (MMN). METHODS: Our study consisted of two phases: the IVIg phase (visits 1–3; 12 weeks), in which patients remained on IVIg treatment, and the fSCIg phase (visits 4–7; 36 weeks), in which patients received fSCIg treatment. After visit 3, IVIg was switched to an equivalent dose and frequency of fSCIg. Outcome measures were safety, muscle strength, disability and treatment satisfaction. RESULTS: Eighteen patients were enrolled in this study. Switching to fSCIg reduced the number of systemic adverse events (IVIg 11.6 vs. fSCIg 5.0 adverse events/per person-year, p < 0.02), and increased the number of local reactions at the injection site (IVIg 0 vs. fSCIg 3.3 local reactions/per person-year, p < 0.01). Overall, no significant differences in muscle strength and disability between fSCIg and IVIg were found. Treatment with fSCIg was perceived as optimal treatment option by 8 of the 17 patients (47.1%) and they continued with fSCIg after study closure because of improved independence and flexibility to administer treatment. CONCLUSION: Treatment with fSCIg can be considered a safe alternative for patients with MMN on IVIg treatment. fSCIg could be a favorable option in patients who prefer self-treatment and more independency, and in patients who experience systemic adverse events on IVIg or have difficult intravenous access. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00415-019-09475-x) contains supplementary material, which is available to authorized users.
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spelling pubmed-68035882019-11-05 Human immune globulin 10% with recombinant human hyaluronidase in multifocal motor neuropathy Herraets, Ingrid J. T. Bakers, Jaap N. E. van Eijk, Ruben P. A. Goedee, H. Stephan van der Pol, W. Ludo van den Berg, Leonard H. J Neurol Original Communication OBJECTIVE: The primary aim was to determine the safety of treatment with human immune globulin 10% with recombinant human hyaluronidase (fSCIg) compared to intravenous immunoglobulin (IVIg) in a prospective open-label study in patients with multifocal motor neuropathy (MMN). METHODS: Our study consisted of two phases: the IVIg phase (visits 1–3; 12 weeks), in which patients remained on IVIg treatment, and the fSCIg phase (visits 4–7; 36 weeks), in which patients received fSCIg treatment. After visit 3, IVIg was switched to an equivalent dose and frequency of fSCIg. Outcome measures were safety, muscle strength, disability and treatment satisfaction. RESULTS: Eighteen patients were enrolled in this study. Switching to fSCIg reduced the number of systemic adverse events (IVIg 11.6 vs. fSCIg 5.0 adverse events/per person-year, p < 0.02), and increased the number of local reactions at the injection site (IVIg 0 vs. fSCIg 3.3 local reactions/per person-year, p < 0.01). Overall, no significant differences in muscle strength and disability between fSCIg and IVIg were found. Treatment with fSCIg was perceived as optimal treatment option by 8 of the 17 patients (47.1%) and they continued with fSCIg after study closure because of improved independence and flexibility to administer treatment. CONCLUSION: Treatment with fSCIg can be considered a safe alternative for patients with MMN on IVIg treatment. fSCIg could be a favorable option in patients who prefer self-treatment and more independency, and in patients who experience systemic adverse events on IVIg or have difficult intravenous access. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00415-019-09475-x) contains supplementary material, which is available to authorized users. Springer Berlin Heidelberg 2019-07-19 2019 /pmc/articles/PMC6803588/ /pubmed/31325017 http://dx.doi.org/10.1007/s00415-019-09475-x Text en © The Author(s) 2019 Open AccessThis 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 Communication
Herraets, Ingrid J. T.
Bakers, Jaap N. E.
van Eijk, Ruben P. A.
Goedee, H. Stephan
van der Pol, W. Ludo
van den Berg, Leonard H.
Human immune globulin 10% with recombinant human hyaluronidase in multifocal motor neuropathy
title Human immune globulin 10% with recombinant human hyaluronidase in multifocal motor neuropathy
title_full Human immune globulin 10% with recombinant human hyaluronidase in multifocal motor neuropathy
title_fullStr Human immune globulin 10% with recombinant human hyaluronidase in multifocal motor neuropathy
title_full_unstemmed Human immune globulin 10% with recombinant human hyaluronidase in multifocal motor neuropathy
title_short Human immune globulin 10% with recombinant human hyaluronidase in multifocal motor neuropathy
title_sort human immune globulin 10% with recombinant human hyaluronidase in multifocal motor neuropathy
topic Original Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6803588/
https://www.ncbi.nlm.nih.gov/pubmed/31325017
http://dx.doi.org/10.1007/s00415-019-09475-x
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