Intravenous Immunoglobulin Therapy in Patients With Painful Idiopathic Small Fiber Neuropathy

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Abstract

ObjectiveThis 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).MethodsBetween 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.ResultsThirty 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.ConclusionsThis randomized controlled trial showed that IVIG treatment had no significant effect on pain in patients with painful I-SFN.
Original languageEnglish
Pages (from-to)E2534-E2545
Number of pages12
JournalNeurology
Volume96
Issue number20
DOIs
Publication statusPublished - 18 May 2021

Keywords

  • PERIPHERAL NEUROPATHY
  • LARGE COHORT
  • VALIDATION
  • MUTATIONS
  • DENSITIES
  • EFFICACY
  • SPECTRUM
  • DISEASE
  • TRIALS
  • SKIN

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