Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021 May 18;96(20):e2534-e2545.
doi: 10.1212/WNL.0000000000011919. Epub 2021 Mar 25.

Intravenous Immunoglobulin Therapy in Patients With Painful Idiopathic Small Fiber Neuropathy

Margot Geerts  1 , Bianca T A de Greef  1 , Maurice Sopacua  1 , Sander M J van Kuijk  1 , Janneke G J Hoeijmakers  1 , Catharina G Faber  2 , Ingemar S J Merkies  1
Affiliations
Randomized Controlled Trial

Intravenous Immunoglobulin Therapy in Patients With Painful Idiopathic Small Fiber Neuropathy

Margot Geerts et al. Neurology. .

Abstract

Objective: 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).

Methods: 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.

Results: 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 (p = 0.588, odds ratio 1.56, 95% confidence interval 0.53-4.53). No significant differences were found on any of the other prespecified outcomes, including general well-being, autonomic symptoms, and overall functioning and disability.

Conclusions: This randomized controlled trial showed that IVIG treatment had no significant effect on pain in patients with painful I-SFN.

Trial registration information: ClinicalTrials.gov Identifier: NCT02637700, EudraCT 2015-002624-31.

Classification of evidence: This study provides Class I evidence that for patients with painful I-SFN, IVIG did not significantly reduce pain compared to placebo.

PubMed Disclaimer

Figures

Figure 1
Figure 1. Schematic Diagram Representing Overall Study Design and Study Visits
Red triangles represent the treatment visits. The first uploading treatment period was spread out over 2 consecutive days. The other treatment visits consisted of 1 day. IVIg = IV immunoglobulin.
Figure 2
Figure 2. Flowchart of the Trial
IVIg = IV immunoglobulin.
See this image and copyright information in PMC

Comment in

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Hoeijmakers JG, Faber CG, Lauria G, Merkies IS, Waxman SG. Small-fibre neuropathies-advances in diagnosis, pathophysiology and management. Nat Rev Neurol 2012;8:369–379. - PubMed
    1. Cazzato D, Lauria G. Small fibre neuropathy. Curr Opin Neurol 2017;30:490–499. - PubMed
    1. Hoitsma E, Marziniak M, Faber CG, et al. . Small fibre neuropathy in sarcoidosis. Lancet 2002;359:2085–2086. - PubMed
    1. Sumner CJ, Sheth S, Griffin JW, Cornblath DR, Polydefkis M. The spectrum of neuropathy in diabetes and impaired glucose tolerance. Neurology 2003;60:108–111. - PubMed
    1. Brannagan TH III, Hays AP, Chin SS, et al. . Small-fiber neuropathy/neuronopathy associated with celiac disease: skin biopsy findings. Arch Neurol 2005;62:1574–1578. - PubMed

Publication types

Substances

Associated data