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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2019
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.
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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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