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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.
Afiliación
  • Léger JM; National Referral Center for Neuromuscular Diseases, University Hospital Pitié-Salpétrière, Paris, France.
  • Alfa Cissé O; Global Medical Affairs, LFB, Les Ulis, France.
  • Cocito D; Department of Neurosciences, Molinette Hospital, Università degli Studi di Torino, Torino, Italy.
  • Grouin JM; Department of Statistics, Rouen University, Rouen, France.
  • Katifi H; Wessex Neurological Centre, Southampton General Hospital, Southampton, UK.
  • Nobile-Orazio E; Neuromuscular and Neuroimmunology Service, Humanitas Clinical and Research Center, Milan University, Milan, Italy.
  • Ouaja R; Global Medical Affairs, LFB, Les Ulis, France.
  • Pouget J; National Referral Center for Neuromuscular Diseases, University Hospital La Timone, Marseille, France.
  • Rajabally YA; School of Life and Health Sciences, Aston Brain Centre, Aston University, Birmingham, UK.
  • Sevilla T; Neurology Department, La Fe University Hospital, Centro de investigación Biomédica en red de enfermedades raras (CIBERER), University of Valencia, Valencia, Spain.
  • Merkies ISJ; Maastricht University Medical Center, Maastricht, The Netherlands.
J Peripher Nerv Syst ; 24(1): 56-63, 2019 03.
Article en En | MEDLINE | ID: mdl-30456899
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Evaluación de Resultado en la Atención de Salud / Enfermedad de la Neurona Motora / Inmunoglobulinas Intravenosas / Factores Inmunológicos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Peripher Nerv Syst Asunto de la revista: NEUROLOGIA Año: 2019 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Estados Unidos
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Evaluación de Resultado en la Atención de Salud / Enfermedad de la Neurona Motora / Inmunoglobulinas Intravenosas / Factores Inmunológicos Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: J Peripher Nerv Syst Asunto de la revista: NEUROLOGIA Año: 2019 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Estados Unidos