Intravenous Immunoglobulin Therapy in Patients With Painful Idiopathic Small Fiber Neuropathy.

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.

• Authors: Margot Geerts, Bianca T A de Greef, Maurice Sopacua, Sander M J van Kuijk, Janneke G J Hoeijmakers, Catharina G Faber, Ingemar S J Merkies
• Journal: Neurology (Neurology) Vol. 96 Issue 20 Pg. e2534-e2545 (05 18 2021) ISSN: 1526-632X [Electronic] United States
• PMID: 33766992 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Chemical References

• Immunoglobulins, Intravenous
• Immunologic Factors

Topics

• Adult
• Double-Blind Method
• Female
• Humans
• Immunoglobulins, Intravenous (therapeutic use)
• Immunologic Factors (therapeutic use)
• Male
• Middle Aged
• Neuralgia (drug therapy, physiopathology)
• Pain Measurement
• Small Fiber Neuropathy (drug therapy, physiopathology)
• Treatment Outcome