Denosumab Ascend est un m\u00e9dicament biologique indiqu\u00e9 chez l\u2019adulte pour pr\u00e9venir les complications osseuses li\u00e9es aux cancers avanc\u00e9s ayant m\u00e9tastas\u00e9 \u00e0 l\u2019os (fractures, compressions m\u00e9dullaires, recours \u00e0 la radioth\u00e9rapie ou \u00e0 la chirurgie sur l\u2019os). Il est \u00e9galement indiqu\u00e9 dans le traitement des tumeurs \u00e0 cellules g\u00e9antes de l\u2019os chez l\u2019adulte et l\u2019adolescent dont la croissance osseuse est achev\u00e9e, lorsque la chirurgie est impossible ou jug\u00e9e \u00e0 haut risque de complications.<\/p>\n
Ce m\u00e9dicament contient du d\u00e9nosumab et est autoris\u00e9 dans l\u2019Union europ\u00e9enne en tant que m\u00e9dicament biosimilaire du m\u00e9dicament de r\u00e9f\u00e9rence Xgeva. Les \u00e9tudes de laboratoire ont montr\u00e9 une grande similarit\u00e9 avec Xgeva en termes de structure, de puret\u00e9 et d\u2019activit\u00e9 biologique. Des donn\u00e9es pharmacocin\u00e9tiques indiquent que les concentrations de d\u00e9nosumab obtenues dans l\u2019organisme sont comparables \u00e0 celles du m\u00e9dicament de r\u00e9f\u00e9rence. Une \u00e9tude compl\u00e9mentaire men\u00e9e chez 504 femmes m\u00e9nopaus\u00e9es atteintes d\u2019ost\u00e9oporose a montr\u00e9, apr\u00e8s un an de traitement, une efficacit\u00e9 comparable en termes de densit\u00e9 min\u00e9rale osseuse vert\u00e9brale, ce qui soutient la similarit\u00e9 clinique.<\/p>\n
Denosumab Ascend est soumis \u00e0 prescription m\u00e9dicale. Il se pr\u00e9sente sous forme de solution injectable administr\u00e9e par voie sous-cutan\u00e9e (cuisse, abdomen ou bras). Dans les cancers avec atteinte osseuse, l\u2019injection est r\u00e9alis\u00e9e toutes les quatre semaines. Dans les tumeurs \u00e0 cellules g\u00e9antes de l\u2019os, le sch\u00e9ma pr\u00e9voit une injection toutes les quatre semaines, avec deux injections suppl\u00e9mentaires une et deux semaines apr\u00e8s la premi\u00e8re. Les patients doivent recevoir une suppl\u00e9mentation en calcium et en vitamine D pendant le traitement.<\/p>\n
Le d\u00e9nosumab est un anticorps monoclonal ciblant la prot\u00e9ine RANKL, impliqu\u00e9e dans l\u2019activation des ost\u00e9oclastes, cellules responsables de la r\u00e9sorption osseuse. En bloquant RANKL, le m\u00e9dicament r\u00e9duit la formation et l\u2019activit\u00e9 des ost\u00e9oclastes, limite la perte osseuse et diminue la survenue de fractures et autres complications osseuses graves. Dans les tumeurs \u00e0 cellules g\u00e9antes de l\u2019os, il inhibe \u00e9galement les cellules de type ost\u00e9oclastique, ce qui freine la destruction osseuse et permet le remplacement tumoral par de l\u2019os normal.<\/p>\n
Les principaux acteurs mentionn\u00e9s sont les autorit\u00e9s de l\u2019Union europ\u00e9enne charg\u00e9es de l\u2019autorisation des m\u00e9dicaments, qui ont reconnu Denosumab Ascend comme biosimilaire de Xgeva. Les informations pratiques suppl\u00e9mentaires sur l\u2019utilisation, les pr\u00e9cautions et la surveillance sont renvoy\u00e9es \u00e0 la notice du m\u00e9dicament et au m\u00e9decin ou pharmacien. Les enjeux de politique publique concernent principalement l\u2019acc\u00e8s \u00e0 une alternative biosimilaire pour la pr\u00e9vention des complications osseuses li\u00e9es au cancer et le traitement des tumeurs osseuses rares, avec des implications potentielles en termes de co\u00fbts et d\u2019organisation des soins sp\u00e9cialis\u00e9s en oncologie et en maladies osseuses. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Denosumab Ascend est un m\u00e9dicament biologique indiqu\u00e9 chez l\u2019adulte pour pr\u00e9venir les complications osseuses li\u00e9es aux cancers avanc\u00e9s ayant m\u00e9tastas\u00e9 \u00e0 l\u2019os (fractures, compressions m\u00e9dullaires, recours \u00e0 la radioth\u00e9rapie ou […]<\/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-18239","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\/18239","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=18239"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/18239\/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=18239"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=18239"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=18239"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}