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

Research output: Contribution to journalArticle

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.

Original languageEnglish
JournalJournal of the Peripheral Nervous System
Early online date11 Dec 2018
DOIs
Publication statusE-pub ahead of print - 11 Dec 2018

Fingerprint

Intravenous Immunoglobulins
Therapeutics
Hemolysis
Upper Extremity
Gold
Cross-Over Studies
Biomedical Research
Lower Extremity
Linear Models
Clinical Trials
Confidence Intervals
Kidney
Muscles

Keywords

  • clinical trial
  • immunoglobulin
  • IVIg
  • multifocal motor neuropathy

Cite this

Léger, J. M., Alfa Cissé, O., Cocito, D., Grouin, J. M., Katifi, H., Nobile-Orazio, E., ... Merkies, I. S. J. (2018). 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. Journal of the Peripheral Nervous System. https://doi.org/10.1111/jns.12291
Léger, Jean Marc ; Alfa Cissé, Ousmane ; Cocito, Dario ; Grouin, Jean Marie ; Katifi, Haider ; Nobile-Orazio, Eduardo ; Ouaja, Rabye ; Pouget, Jean ; Rajabally, Yusuf A. ; Sevilla, Teresa ; Merkies, Ingemar S.J. / 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. In: Journal of the Peripheral Nervous System. 2018.
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Léger, JM, Alfa Cissé, O, Cocito, D, Grouin, JM, Katifi, H, Nobile-Orazio, E, Ouaja, R, Pouget, J, Rajabally, YA, Sevilla, T & Merkies, ISJ 2018, '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', Journal of the Peripheral Nervous System. https://doi.org/10.1111/jns.12291

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

In: Journal of the Peripheral Nervous System, 11.12.2018.

Research output: Contribution to journalArticle

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T1 - IqYmune® is an effective maintenance treatment for multifocal motor neuropathy

T2 - A randomised, double-blind, multi-center cross-over non-inferiority study vs Kiovig®—The LIME Study

AU - Léger, Jean Marc

AU - Alfa Cissé, Ousmane

AU - Cocito, Dario

AU - Grouin, Jean Marie

AU - Katifi, Haider

AU - Nobile-Orazio, Eduardo

AU - Ouaja, Rabye

AU - Pouget, Jean

AU - Rajabally, Yusuf A.

AU - Sevilla, Teresa

AU - Merkies, Ingemar S.J.

PY - 2018/12/11

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N2 - 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.

AB - 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.

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