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Efficacy and Safety of Octagam® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy
INTRODUCTION: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a debilitating autoimmune neuropathy that is treated with intravenous immunoglobulin (IVIG). The aim of this retrospective study was to investigate the efficacy and safety of the sucrose-free IVIG Octagam® (Octapharma...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6534624/ https://www.ncbi.nlm.nih.gov/pubmed/30903535 http://dx.doi.org/10.1007/s40120-019-0132-5 |
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author | Belmokhtar, Chafké Lozeron, Pierre Adams, David Franques, Jérôme Lacour, Arnaud Godet, Etienne Bataille, Mathieu Dubourg, Odile Angibaud, Gilles Delmont, Emilien Bouhour, Françoise Corcia, Philippe Pouget, Jean |
author_facet | Belmokhtar, Chafké Lozeron, Pierre Adams, David Franques, Jérôme Lacour, Arnaud Godet, Etienne Bataille, Mathieu Dubourg, Odile Angibaud, Gilles Delmont, Emilien Bouhour, Françoise Corcia, Philippe Pouget, Jean |
author_sort | Belmokhtar, Chafké |
collection | PubMed |
description | INTRODUCTION: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a debilitating autoimmune neuropathy that is treated with intravenous immunoglobulin (IVIG). The aim of this retrospective study was to investigate the efficacy and safety of the sucrose-free IVIG Octagam® (Octapharma AG, Lachen, Switzerland) in patients with CIDP. METHODS: Data from 47 patients who received at least one dose of Octagam were collected from the records of 11 centres in France. Efficacy was assessed using Overall Neuropathy Limitation Scale (ONLS). Safety was evaluated using adverse event rates. RESULTS: Data from 24 patients who were IVIG naïve (n = 11) or had stopped IVIG ≥ 12 weeks before initiation of Octagam therapy (washout group; n = 13) were included in the efficacy analysis. At 4 months post-initiation of Octagam treatment, 41.7% of patients had improved their functional status (decrease of ≥ 1 ONLS score) with a significant change in the ONLS score from baseline (– 0.42; p = 0.04; signed test). Functional status was reduced in only two patients: one patient in the IVIG-naïve group and one patient in the IVIG-washout group. All 47 patients were included in the safety analysis, which showed that Octagam was well tolerated, with a frequency of 0.04 adverse events per Octagam course. The most common adverse drug reaction was headache. CONCLUSIONS: These real-life results are consistent with the efficacy and safety of IVIG reported in randomised controlled studies. A long-term prospective study of Octagam in patients with CIDP is warranted. FUNDING: Octapharma, France SAS. |
format | Online Article Text |
id | pubmed-6534624 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-65346242019-06-07 Efficacy and Safety of Octagam® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy Belmokhtar, Chafké Lozeron, Pierre Adams, David Franques, Jérôme Lacour, Arnaud Godet, Etienne Bataille, Mathieu Dubourg, Odile Angibaud, Gilles Delmont, Emilien Bouhour, Françoise Corcia, Philippe Pouget, Jean Neurol Ther Original Research INTRODUCTION: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a debilitating autoimmune neuropathy that is treated with intravenous immunoglobulin (IVIG). The aim of this retrospective study was to investigate the efficacy and safety of the sucrose-free IVIG Octagam® (Octapharma AG, Lachen, Switzerland) in patients with CIDP. METHODS: Data from 47 patients who received at least one dose of Octagam were collected from the records of 11 centres in France. Efficacy was assessed using Overall Neuropathy Limitation Scale (ONLS). Safety was evaluated using adverse event rates. RESULTS: Data from 24 patients who were IVIG naïve (n = 11) or had stopped IVIG ≥ 12 weeks before initiation of Octagam therapy (washout group; n = 13) were included in the efficacy analysis. At 4 months post-initiation of Octagam treatment, 41.7% of patients had improved their functional status (decrease of ≥ 1 ONLS score) with a significant change in the ONLS score from baseline (– 0.42; p = 0.04; signed test). Functional status was reduced in only two patients: one patient in the IVIG-naïve group and one patient in the IVIG-washout group. All 47 patients were included in the safety analysis, which showed that Octagam was well tolerated, with a frequency of 0.04 adverse events per Octagam course. The most common adverse drug reaction was headache. CONCLUSIONS: These real-life results are consistent with the efficacy and safety of IVIG reported in randomised controlled studies. A long-term prospective study of Octagam in patients with CIDP is warranted. FUNDING: Octapharma, France SAS. Springer Healthcare 2019-03-22 /pmc/articles/PMC6534624/ /pubmed/30903535 http://dx.doi.org/10.1007/s40120-019-0132-5 Text en © The Author(s) 2019 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial 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 Research Belmokhtar, Chafké Lozeron, Pierre Adams, David Franques, Jérôme Lacour, Arnaud Godet, Etienne Bataille, Mathieu Dubourg, Odile Angibaud, Gilles Delmont, Emilien Bouhour, Françoise Corcia, Philippe Pouget, Jean Efficacy and Safety of Octagam® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy |
title | Efficacy and Safety of Octagam® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy |
title_full | Efficacy and Safety of Octagam® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy |
title_fullStr | Efficacy and Safety of Octagam® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy |
title_full_unstemmed | Efficacy and Safety of Octagam® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy |
title_short | Efficacy and Safety of Octagam® in Patients With Chronic Inflammatory Demyelinating Polyneuropathy |
title_sort | efficacy and safety of octagam® in patients with chronic inflammatory demyelinating polyneuropathy |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6534624/ https://www.ncbi.nlm.nih.gov/pubmed/30903535 http://dx.doi.org/10.1007/s40120-019-0132-5 |
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