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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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Berlin Heidelberg
2019
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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. |
format | Online Article Text |
id | pubmed-6803588 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Springer Berlin Heidelberg |
record_format | MEDLINE/PubMed |
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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