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Clinical Trial
. 2019 Mar;24(1):56-63.
doi: 10.1111/jns.12291. Epub 2018 Dec 11.

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

Jean-Marc Léger  1 , Ousmane Alfa Cissé  2 , Dario Cocito  3 , Jean-Marie Grouin  4 , Haider Katifi  5 , Eduardo Nobile-Orazio  6 , Rabye Ouaja  2 , Jean Pouget  7 , Yusuf A Rajabally  8 , Teresa Sevilla  9 , Ingemar S J Merkies  10   11
Affiliations
Clinical Trial

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

Jean-Marc Léger et al. J Peripher Nerv Syst. 2019 Mar.

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® 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 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 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% 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® vs 32 ARs in 11 patients with Kiovig®. 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.

Keywords: IVIg; clinical trial; immunoglobulin; multifocal motor neuropathy.

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Figures

Figure 1
Figure 1
Participants disposition. GFR, glomerular filtration rate; IVIg, intravenous immunoglobulin; mITT, modified intent‐to‐treat; PPS, per protocol set
Figure 2
Figure 2
Geometric boxplots of modified Medical Research Council (MMRC) 10‐sum scores at baseline and 6 months after each treatment sequence. Modified intent‐to‐treat, mITT population. The lower limit of a box represents the first quartile, that is, 25% of data lie below this value; the upper limit of the box represents the third quartile, that is, 25% of the data lie above this value; the horizontal line within the box indicates the median, that is, 50% of data lie above this value. The diamond represents the mean value of the distribution, and the dots outside the box represent outliers. This figure shows that the medians after IqYmune® treatment and Kiovig® treatment are similar to the baseline value and that the distributions are not significantly different
See this image and copyright information in PMC

References

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