Intravenous Immunoglobulin Therapy in Patients With Painful Idiopathic Small Fiber Neuropathy.
Journal
Neurology
ISSN: 1526-632X
Titre abrégé: Neurology
Pays: United States
ID NLM: 0401060
Informations de publication
Date de publication:
18 05 2021
18 05 2021
Historique:
received:
12
08
2020
accepted:
24
02
2021
pubmed:
27
3
2021
medline:
1
6
2021
entrez:
26
3
2021
Statut:
ppublish
Résumé
This is the first double-blind randomized controlled trial evaluating the efficacy and safety of IV immunoglobulin (IVIG) vs placebo in patients with idiopathic small fiber neuropathy (I-SFN). Between July 2016 and November 2018, 60 Dutch patients with skin biopsy-proven I-SFN randomly received a starting dose of IVIG (2 g/kg body weight) or matching placebo (0.9% saline). Subsequently, 3 additional infusions of IVIG (1 g/kg) or placebo were administered at 3-week intervals. The primary outcome was a 1-point change in Pain Intensity Numerical Rating Scale score at 12 weeks compared to baseline. Thirty patients received IVIG, and 30 received placebo. In both groups, 29 patients completed the trial. In 40% of patients receiving IVIG, the mean average pain was decreased by at least 1 point compared to 30% of the patients receiving placebo ( This randomized controlled trial showed that IVIG treatment had no significant effect on pain in patients with painful I-SFN. ClinicalTrials.gov Identifier: NCT02637700, EudraCT 2015-002624-31. This study provides Class I evidence that for patients with painful I-SFN, IVIG did not significantly reduce pain compared to placebo.
Identifiants
pubmed: 33766992
pii: WNL.0000000000011919
doi: 10.1212/WNL.0000000000011919
pmc: PMC8205474
doi:
Substances chimiques
Immunoglobulins, Intravenous
0
Immunologic Factors
0
Banques de données
ClinicalTrials.gov
['NCT02637700']
EudraCT
['2015-002624-31']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e2534-e2545Commentaires et corrections
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Informations de copyright
Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
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