IqYmune ® is an effective maintenance treatment for multifocal motor neuropathy: a randomised, double‐blind, multicenter cross‐over non‐inferiority study versus Kiovig® ‐ The LIME Study

Intravenous immunoglobulin (IVIg) is the gold ‐standard for maintenance treatment of multifocal motor neuropathy (MMN). This phase III, randomised, double‐blind, multicentre, active‐control, crossover study, aimed to evaluate the non‐inferiority of IqYmune® relative to Kiovig®, primarily based on efficacy criteria.Twenty ‐two adult MMN patients, treated with any brand of IVIg (except Kiovig® or IqYmune®) at a stable maintenance dose within the range of 1 to 2 g/kg every 4 to 8 weeks, were randomised to receive either Kiovig followed by IqYmune, or IqYmune followed by Kiovig. Each product was administered for 24 weeks. The primary endpoint was the difference between IqYmune® and Kiovig® in mean assessments of modified Medical Research Council (MMRC) 10 sum score (strength of five upper‐limb and five lower‐limb muscle groups, on both sides, giving a score from 0 to 100) during the evaluation period (no n‐inferiority margin of Δ = 2).A linear mixed model analysis demonstrated the non ‐inferiority of IqYmune relative to Kiovig, independently of the covariates (value at baseline, treatment period and treatment sequence). The estimated ‘IqYmune ‐ Kiovig’ difference was ‐0.01, with a 95% CI ‐0.51 to 0.48. The number of adverse reactions (ARs) and the percentage of patien ts affected were similar for the two products: 39 ARs in 10 patients with IqYmune® versus 32 ARs in 11 patients with Kiovig®. No thromboembolic events nor hemolysis nor renal imp...
Source: Journal of the Peripheral Nervous System - Category: Neurology Authors: Tags: RESEARCH REPORT Source Type: research