Bekemv est un m\u00e9dicament biologique biosimilaire autoris\u00e9 dans l\u2019Union europ\u00e9enne pour le traitement de l\u2019h\u00e9moglobinurie paroxystique nocturne (HPN) chez l\u2019adulte et l\u2019enfant. Cette maladie rare se caract\u00e9rise par une destruction excessive des globules rouges, entra\u00eenant notamment une an\u00e9mie, des thromboses, une pancytop\u00e9nie et des urines fonc\u00e9es. Bekemv contient comme substance active l\u2019eculizumab et est biosimilaire du m\u00e9dicament de r\u00e9f\u00e9rence Soliris, d\u00e9j\u00e0 autoris\u00e9 dans l\u2019UE.<\/p>\n
Le m\u00e9dicament ne peut \u00eatre d\u00e9livr\u00e9 que sur prescription m\u00e9dicale et doit \u00eatre administr\u00e9 par un professionnel de sant\u00e9, sous la supervision d\u2019un m\u00e9decin sp\u00e9cialiste des maladies du sang. Bekemv est administr\u00e9 par perfusion intraveineuse : chez l\u2019adulte sur 25 \u00e0 45 minutes, chez l\u2019enfant sur 1 \u00e0 4 heures. Le sch\u00e9ma th\u00e9rapeutique pr\u00e9voit une perfusion hebdomadaire pendant les 2 \u00e0 5 premi\u00e8res semaines, puis une perfusion toutes les deux semaines. Les patients sont surveill\u00e9s pendant la perfusion et au moins une heure apr\u00e8s. En l\u2019absence d\u2019effets ind\u00e9sirables majeurs lors des premi\u00e8res perfusions, l\u2019administration \u00e0 domicile par un professionnel de sant\u00e9 peut \u00eatre envisag\u00e9e. Le traitement est pr\u00e9vu au long cours, en principe \u00e0 vie, sauf survenue d\u2019effets ind\u00e9sirables graves.<\/p>\n
Sur le plan pharmacologique, Bekemv agit sur le syst\u00e8me du compl\u00e9ment, composante de l\u2019immunit\u00e9 qui est anormalement suractiv\u00e9e chez les patients atteints d\u2019HPN et d\u00e9truit leurs propres globules rouges. L\u2019eculizumab est un anticorps ciblant la prot\u00e9ine C5 du compl\u00e9ment, ce qui bloque l\u2019action de ce syst\u00e8me et limite la destruction des cellules sanguines, r\u00e9duisant ainsi les sympt\u00f4mes de la maladie.<\/p>\n
Les \u00e9tudes de laboratoire comparant Bekemv et Soliris montrent une forte similarit\u00e9 en termes de structure, de puret\u00e9 et d\u2019activit\u00e9 biologique de la substance active. Des \u00e9tudes de pharmacocin\u00e9tique indiquent que les concentrations d\u2019eculizumab obtenues dans l\u2019organisme sont comparables avec Bekemv et Soliris. Une \u00e9tude clinique men\u00e9e chez 42 patients atteints d\u2019HPN a montr\u00e9 que Bekemv et Soliris pr\u00e9viennent de mani\u00e8re similaire la destruction des globules rouges. En tant que biosimilaire, Bekemv b\u00e9n\u00e9ficie des donn\u00e9es d\u2019efficacit\u00e9 et de s\u00e9curit\u00e9 d\u00e9j\u00e0 produites avec Soliris, ce qui a permis de ne pas r\u00e9p\u00e9ter l\u2019ensemble des essais cliniques.<\/p>\n
Le profil de s\u00e9curit\u00e9 de Bekemv est consid\u00e9r\u00e9 comme comparable \u00e0 celui de Soliris. L\u2019effet ind\u00e9sirable le plus fr\u00e9quent est la c\u00e9phal\u00e9e (touchant plus d\u2019un patient sur dix). L\u2019effet ind\u00e9sirable le plus grave identifi\u00e9 est la septic\u00e9mie \u00e0 m\u00e9ningocoque, infection bact\u00e9rienne grave du sang pouvant entra\u00eener des h\u00e9morragies cutan\u00e9es et un choc septique. La liste compl\u00e8te des effets ind\u00e9sirables et des contre-indications figure dans la notice du m\u00e9dicament, \u00e0 consulter avec le m\u00e9decin ou le pharmacien. Ces \u00e9l\u00e9ments sont importants pour la surveillance des risques et la mise en place de mesures de s\u00e9curit\u00e9 appropri\u00e9es dans les syst\u00e8mes de sant\u00e9 nationaux. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Bekemv est un m\u00e9dicament biologique biosimilaire autoris\u00e9 dans l\u2019Union europ\u00e9enne pour le traitement de l\u2019h\u00e9moglobinurie paroxystique nocturne (HPN) chez l\u2019adulte et l\u2019enfant. Cette maladie rare se caract\u00e9rise par une destruction […]<\/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-17727","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\/17727","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=17727"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/17727\/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=17727"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17727"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17727"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}