IqYmune® is an effective maintenance treatment for multifocal motor neuropathy: A randomised, double‐blind, multi‐center cross‐over non‐inferiority study vs Kiovig®—The LIME Study: A randomised, double-blind, multi-center cross-over non-inferiority study vs Kiovig (R)-The LIME Study

Jean-Marc Leger*, Ousmane Alfa Cisse, Dario Cocito, Jean-Marie Grouin, Haider Katifi, Eduardo Nobile-Orazio, Rabye Ouaja, Jean Pouget, Yusuf A. Rajabally, Teresa Sevilla, Ingemar S. J. Merkies

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

3 Citations (Web of Science)

Abstract

Intravenous immunoglobulin (IVIg) is the gold-standard for maintenance treatment of multifocal motor neuropathy (MMN). This phase III, randomised, double-blind, multi-centre, active-control, crossover study, aimed to evaluate the non-inferiority of IqYmune (R) relative to Kiovig (R), primarily based on efficacy criteria. Twenty-two adult MMN patients, treated with any brand of IVIg (except Kiovig (R) or IqYmune (R)) 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 (R) followed by IqYmune (R), or IqYmune (R) followed by Kiovig (R). Each product was administered for 24 weeks. The primary endpoint was the difference between IqYmune (R) and Kiovig (R) in mean assessments of modified Medical Research Council (MMRC) 10 sum score (strength of 5 upper-limb and 5 lower-limb muscle groups, on both sides, giving a score from 0 to 100) during the evaluation period (non-inferiority margin of Delta = 2). A linear mixed model analysis demonstrated the non-inferiority of IqYmune (R) relative to Kiovig (R), independently of the covariates (value at baseline, treatment period, and treatment sequence). The estimated "IqYmune (R) - Kiovig (R)" difference was -0.01, with a 95% confidence interval (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 (R) vs 32 ARs in 11 patients with Kiovig (R). No thromboembolic events nor haemolysis 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.

Original languageEnglish
Pages (from-to)56-63
Number of pages8
JournalJournal of the Peripheral Nervous System
Volume24
Issue number1
DOIs
Publication statusPublished - Mar 2019

Keywords

  • clinical trial
  • immunoglobulin
  • IVIg
  • multifocal motor neuropathy
  • SUBCUTANEOUS IMMUNOGLOBULIN THERAPY
  • LIQUID INTRAVENOUS IMMUNOGLOBULIN
  • LONG-TERM THERAPY
  • DISABILITY SCALE
  • CONTROLLED-TRIAL
  • IVIG
  • MANAGEMENT

Cite this