{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T03:12:46Z","timestamp":1770779566992,"version":"3.50.0"},"reference-count":22,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,12,11]],"date-time":"2018-12-11T00:00:00Z","timestamp":1544486400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Peripheral Nervous Sys"],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:p>Intravenous immunoglobulin (IVIg) is the gold\u2010standard for maintenance treatment of multifocal motor neuropathy (MMN). This phase III, randomised, double\u2010blind, multi\u2010centre, active\u2010control, crossover study, aimed to evaluate the non\u2010inferiority of IqYmune\u00ae relative to Kiovig\u00ae, primarily based on efficacy criteria. Twenty\u2010two adult MMN patients, treated with any brand of IVIg (except Kiovig\u00ae or IqYmune\u00ae) 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\u00ae followed by IqYmune\u00ae, or IqYmune\u00ae followed by Kiovig\u00ae. Each product was administered for 24\u2009weeks. The primary endpoint was the difference between IqYmune\u00ae and Kiovig\u00ae in mean assessments of modified Medical Research Council (MMRC) 10 sum score (strength of 5 upper\u2010limb and 5 lower\u2010limb muscle groups, on both sides, giving a score from 0 to 100) during the evaluation period (non\u2010inferiority margin of \u0394\u2009=\u20092). A linear mixed model analysis demonstrated the non\u2010inferiority of IqYmune\u00ae relative to Kiovig\u00ae, independently of the covariates (value at baseline, treatment period, and treatment sequence). The estimated \u201cIqYmune\u00ae\u2009\u2212\u2009Kiovig\u00ae\u201d difference was \u22120.01, with a 95% confidence interval (CI) \u22120.51 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\u00ae vs 32 ARs in 11 patients with Kiovig\u00ae. 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.<\/jats:p>","DOI":"10.1111\/jns.12291","type":"journal-article","created":{"date-parts":[[2018,11,20]],"date-time":"2018-11-20T05:09:12Z","timestamp":1542690552000},"page":"56-63","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["IqYmune\u00ae is an effective maintenance treatment for multifocal motor neuropathy: A randomised, double\u2010blind, multi\u2010center cross\u2010over non\u2010inferiority study vs Kiovig\u00ae\u2014The LIME Study"],"prefix":"10.1111","volume":"24","author":[{"given":"Jean\u2010Marc","family":"L\u00e9ger","sequence":"first","affiliation":[{"name":"National Referral Center for Neuromuscular Diseases University Hospital Piti\u00e9\u2010Salp\u00e9tri\u00e8re  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ousmane","family":"Alfa Ciss\u00e9","sequence":"additional","affiliation":[{"name":"Global Medical Affairs, LFB  Les Ulis France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dario","family":"Cocito","sequence":"additional","affiliation":[{"name":"Department of Neurosciences, Molinette Hospital Universit\u00e0 degli Studi di Torino  Torino Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean\u2010Marie","family":"Grouin","sequence":"additional","affiliation":[{"name":"Department of Statistics Rouen University  Rouen France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haider","family":"Katifi","sequence":"additional","affiliation":[{"name":"Wessex Neurological Centre Southampton General Hospital  Southampton UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eduardo","family":"Nobile\u2010Orazio","sequence":"additional","affiliation":[{"name":"Neuromuscular and Neuroimmunology Service, Humanitas Clinical and Research Center Milan University  Milan Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rabye","family":"Ouaja","sequence":"additional","affiliation":[{"name":"Global Medical Affairs, LFB  Les Ulis France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean","family":"Pouget","sequence":"additional","affiliation":[{"name":"National Referral Center for Neuromuscular Diseases University Hospital La Timone  Marseille France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yusuf A.","family":"Rajabally","sequence":"additional","affiliation":[{"name":"School of Life and Health Sciences, Aston Brain Centre Aston University  Birmingham UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teresa","family":"Sevilla","sequence":"additional","affiliation":[{"name":"Neurology Department, La Fe University Hospital Centro de investigaci\u00f3n Biom\u00e9dica en red de enfermedades raras (CIBERER), University of Valencia  Valencia Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ingemar S. 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