Idefirix est un m\u00e9dicament hospitalier destin\u00e9 \u00e0 pr\u00e9venir le rejet aigu du greffon chez des adultes en attente de transplantation r\u00e9nale, pr\u00e9sentant une tr\u00e8s forte sensibilisation immunologique au donneur (test de crossmatch positif). Il est r\u00e9serv\u00e9 aux patients qui, en raison de ce profil immunologique, ont une probabilit\u00e9 faible d\u2019acc\u00e9der \u00e0 une greffe dans le cadre des syst\u00e8mes actuels d\u2019allocation de reins. Le m\u00e9dicament a obtenu le statut de m\u00e9dicament orphelin pour une indication rare le 12 janvier 2017.<\/p>\n
Idefirix contient de l\u2019imlifidase, une enzyme qui d\u00e9grade les anticorps de type immunoglobuline G (IgG) responsables du risque \u00e9lev\u00e9 de rejet du rein donn\u00e9. Il est administr\u00e9 en perfusion intraveineuse unique dans les 24 heures pr\u00e9c\u00e9dant la transplantation, avec possibilit\u00e9 d\u2019une seconde dose dans les 24 heures suivant la premi\u00e8re si n\u00e9cessaire. La prise en charge impose un encadrement par un m\u00e9decin exp\u00e9riment\u00e9 dans l\u2019utilisation d\u2019immunosuppresseurs et la gestion des patients hautement sensibilis\u00e9s, et ne se substitue pas au traitement immunosuppresseur standard post-greffe, qui reste requis.<\/p>\n
Les donn\u00e9es d\u2019efficacit\u00e9 proviennent principalement d\u2019une \u00e9tude incluant 19 patients en insuffisance r\u00e9nale terminale hautement sensibilis\u00e9s, identifi\u00e9s par un crossmatch positif. Dans les 24 heures suivant l\u2019administration d\u2019Idefirix, 17 patients sont devenus crossmatch-n\u00e9gatifs et 1 borderline positif, rendant 18 patients \u00e9ligibles \u00e0 la greffe r\u00e9nale. Seize avaient un rein fonctionnel six mois apr\u00e8s la transplantation. Trois \u00e9tudes compl\u00e9mentaires ont fourni des donn\u00e9es de soutien ; l\u2019analyse de l\u2019ensemble des quatre \u00e9tudes montre que 43 patients sur 46 avaient un rein fonctionnel \u00e0 six mois.<\/p>\n
Les effets ind\u00e9sirables les plus fr\u00e9quents (plus de 1 patient sur 10) sont des infections, notamment pneumonies, infections urinaires et sepsis. Parmi les autres effets ind\u00e9sirables fr\u00e9quents (jusqu\u2019\u00e0 1 patient sur 10) figurent douleurs et r\u00e9actions au point de perfusion, \u00e9l\u00e9vation des enzymes h\u00e9patiques, myalgies, c\u00e9phal\u00e9es et bouff\u00e9es vasomotrices. Des effets ind\u00e9sirables graves sont \u00e9galement rapport\u00e9s, avec une fr\u00e9quence pouvant atteindre 1 patient sur 10. L\u2019utilisation est strictement encadr\u00e9e par prescription hospitali\u00e8re. Le texte ne pr\u00e9cise pas de pays particulier d\u2019utilisation ni de d\u00e9cision r\u00e9glementaire sp\u00e9cifique autre que la d\u00e9signation de m\u00e9dicament orphelin. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Idefirix est un m\u00e9dicament hospitalier destin\u00e9 \u00e0 pr\u00e9venir le rejet aigu du greffon chez des adultes en attente de transplantation r\u00e9nale, pr\u00e9sentant une tr\u00e8s forte sensibilisation immunologique au donneur (test […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[257,227,226],"class_list":["post-17731","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17731","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=17731"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17731\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=17731"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17731"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17731"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}