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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

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          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.

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          Most cited references19

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          Randomized controlled trial of intravenous immunoglobulin versus oral prednisolone in chronic inflammatory demyelinating polyradiculoneuropathy.

          This multicenter, randomized, double-blind, crossover trial compared a six week course of oral prednisolone tapering from 60 mg to 10 mg daily with intravenous immunoglobulin (IVIg) 2.0 g/kg given over one to two days for treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Twenty-four of the thirty-two randomized patients completed both treatment periods. Both treatments produced significant improvements in the primary outcome measure, change in an 11-point disability scale two weeks after randomization. There was slightly, but not significantly, more improvement after IVIg than with prednisolone, the mean difference between the groups in change in disability grade being 0.16 (95% CI = -0.35 to 0.66). There were also slightly, but not significantly, greater improvements favoring IVIg in the secondary outcome measures: time to walk 10 meters after two weeks and improvement in disability grade after six weeks. Results may have been biased against IVIg by the eight patients who did not complete the second arm of the trial. A serious adverse event (psychosis) attributable to treatment occurred in one patient while on prednisolone and in none with IVIg.
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            Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial

            Approximately two-thirds of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) need long-term intravenous immunoglobulin. Subcutaneous immunoglobulin (SCIg) is an alternative option for immunoglobulin delivery, but has not previously been investigated in a large trial of CIDP. The PATH study compared relapse rates in patients given SCIg versus placebo.
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              EFNS guidelines for the use of intravenous immunoglobulin in treatment of neurological diseases: EFNS task force on the use of intravenous immunoglobulin in treatment of neurological diseases.

              Despite high-dose intravenous immunoglobulin (IVIG) is widely used in treatment of a number of immune-mediated neurological diseases, the consensus on its optimal use is insufficient. To define the evidence-based optimal use of IVIG in neurology, the recent papers of high relevance were reviewed and consensus recommendations are given according to EFNS guidance regulations. The efficacy of IVIG has been proven in Guillain-Barré syndrome (level A), chronic inflammatory demyelinating polyradiculoneuropathy (level A), multifocal mononeuropathy (level A), acute exacerbations of myasthenia gravis (MG) and short-term treatment of severe MG (level A recommendation), and some paraneoplastic neuropathies (level B). IVIG is recommended as a second-line treatment in combination with prednisone in dermatomyositis (level B) and treatment option in polymyositis (level C). IVIG should be considered as a second or third-line therapy in relapsing-remitting multiple sclerosis, if conventional immunomodulatory therapies are not tolerated (level B), and in relapses during pregnancy or post-partum period (good clinical practice point). IVIG seems to have a favourable effect also in paraneoplastic neurological diseases (good practice point) [corrected],stiff-person syndrome (level A), some acute-demyelinating diseases and childhood refractory epilepsy (good practice point).
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                Author and article information

                Contributors
                jean-marc.leger@aphp.fr
                Journal
                J Peripher Nerv Syst
                J. Peripher. Nerv. Syst
                10.1111/(ISSN)1529-8027
                JNS
                Journal of the Peripheral Nervous System
                Wiley Periodicals, Inc. (Malden, USA )
                1085-9489
                1529-8027
                11 December 2018
                March 2019
                : 24
                : 1 ( doiID: 10.1111/jns.2019.24.issue-1 )
                : 56-63
                Affiliations
                [ 1 ] National Referral Center for Neuromuscular Diseases University Hospital Pitié‐Salpétrière Paris France
                [ 2 ] Global Medical Affairs, LFB Les Ulis France
                [ 3 ] Department of Neurosciences, Molinette Hospital Università degli Studi di Torino Torino Italy
                [ 4 ] Department of Statistics Rouen University Rouen France
                [ 5 ] Wessex Neurological Centre Southampton General Hospital Southampton UK
                [ 6 ] Neuromuscular and Neuroimmunology Service, Humanitas Clinical and Research Center Milan University Milan Italy
                [ 7 ] National Referral Center for Neuromuscular Diseases University Hospital La Timone Marseille France
                [ 8 ] School of Life and Health Sciences, Aston Brain Centre Aston University Birmingham UK
                [ 9 ] Neurology Department, La Fe University Hospital Centro de investigación Biomédica en red de enfermedades raras (CIBERER), University of Valencia Valencia Spain
                [ 10 ] Maastricht University Medical Center Maastricht The Netherlands
                [ 11 ] St. Elisabeth Hospital Willemstad Curacao
                Author notes
                [*] [* ] Correspondence

                Jean‐Marc Léger, National Referral Center for Neuromuscular Diseases, University Hospital Pitié‐Salpétrière, Paris, France.

                Email: jean-marc.leger@ 123456aphp.fr

                Article
                JNS12291
                10.1111/jns.12291
                6590491
                30456899
                ddef40b2-5468-4e3c-b6d9-a7644a0e3493
                © 2018 LFB. Journal of the Peripheral Nervous System published by Wiley Periodicals, Inc. on behalf of Peripheral Nerve Society.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 17 October 2018
                : 26 October 2018
                : 26 October 2018
                Page count
                Figures: 2, Tables: 7, Pages: 8, Words: 5552
                Funding
                Funded by: LFB
                Categories
                Research Report
                Research Reports
                Custom metadata
                2.0
                jns12291
                March 2019
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.4 mode:remove_FC converted:24.06.2019

                clinical trial,immunoglobulin,ivig,multifocal motor neuropathy

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