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.

Fecha de publicación: 01/03/2019 Fecha Ahead of Print: 19/11/2018

Autores de IIS La Fe

• 

  Teresa Sevilla Mantecón

  Autor

Participantes ajenos a IIS La Fe

• Léger JM
• Alfa-Cissé O
• Cocito D
• Grouin JM
• Katifi H
• Nobile-Orazio E
• Ouaja R
• Pouget J
• Rajabally YA
• Merkies I

Grupos

• Patología Neuromuscular y Ataxias

  

  Investigador Principal

  Teresa Sevilla Mantecón

Abstract

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 (non-inferiority margin of = 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 patients 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 impairment were observed. In this first clinical trial comparing two IVIg brands for maintenance treatment of MMN, efficacy and tolerability of both brands were similar.

Keywords

• IVIg, Immunoglobulin, clinical trial, multifocal motor neuropathy