Intravenous immunoglobulin for chronic residual peripheral neuropathy in microscopic polyangiitis: A multicentre randomised double-blind trial.

Abstract

OBJECTIVES:

We conducted a Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of intravenous immunoglobulin (IVIg) in patients with glucocorticoid-refractory neuropathy associated with microscopic polyangiitis.

METHODS:

Patients received immunoglobulin or placebo intravenously for 5 consecutive days at baseline and after 4 weeks. The IVIg and placebo groups received IVIg and placebo, respectively, after 8 weeks. The primary and major secondary end-points were the least squares mean of the change in the manual muscle test (MMT) sum score after 8 and 4 weeks, respectively.

RESULTS:

A total of 37 patients were randomised into two groups (IVIg [19] and placebo [18]). The least squares mean for the change in the MMT sum score was 9.02 for IVIg and 6.71 for placebo (difference 2.32, 95% confidence interval -2.60 to 7.23, p = .345) after 8 weeks and 6.81 and 2.83 (difference 3.99, 95% confidence interval -1.22 to 9.19, p = .129), respectively, after 4 weeks. There were no new safety concerns for IVIg.

CONCLUSIONS:

MMT sum scores improved with IVIg compared with placebo after 8 weeks of dosing and two courses of treatment, but the differences were not statistically significant, and the results showed no clear efficacy of IVIg in this patient population. No new safety concerns were raised.

• Authors: Yoshihiro Arimura, Gen Sobue, Naoki Hattori, Hiroshi Takashima, Masayoshi Harigai, Koichi Nagata, Hirofumi Makino
• Journal: Modern rheumatology (Mod Rheumatol) Vol. 33 Issue 6 Pg. 1125-1136 (Nov 01 2023) ISSN: 1439-7609 [Electronic] England
• PMID: 36346309 (Publication Type: Randomized Controlled Trial, Multicenter Study, Clinical Trial, Phase III, Journal Article)
• Copyright: © Japan College of Rheumatology 2022. Published by Oxford University Press.

Chemical References

• Immunoglobulins, Intravenous

Topics

• Humans
• Immunoglobulins, Intravenous (therapeutic use)
• Microscopic Polyangiitis (drug therapy)
• Peripheral Nervous System Diseases
• Double-Blind Method
• Treatment Outcome