{"id":12738,"date":"2021-02-22T09:00:00","date_gmt":"2021-02-22T14:00:00","guid":{"rendered":"https:\/\/wfh.org\/mise-a-jour-sur-le-fitusiran-a-la-suite-du-congres-2021-de-leahad\/"},"modified":"2024-04-22T09:22:58","modified_gmt":"2024-04-22T13:22:58","slug":"mise-a-jour-sur-le-fitusiran-a-la-suite-du-congres-2021-de-leahad","status":"publish","type":"post","link":"https:\/\/wfh.org\/fr\/article\/mise-a-jour-sur-le-fitusiran-a-la-suite-du-congres-2021-de-leahad\/","title":{"rendered":"Mise \u00e0 jour sur le fitusiran \u00e0 la suite du congr\u00e8s 2021 de l\u2019EAHAD"},"content":{"rendered":"\t\t
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Le fitusiran est un agent th\u00e9rapeutique exp\u00e9rimental fond\u00e9 sur l\u2019interf\u00e9rence ARN pouvant emp\u00eacher la production de la prot\u00e9ine antithrombine dans le foie. L\u2019antithrombine est un frein important pour le syst\u00e8me de coagulation. Chez l\u2019adulte, des quantit\u00e9s insuffisantes d\u2019antithrombine circulante conduisent \u00e0 une thrombose. Il a \u00e9t\u00e9 montr\u00e9 que la baisse de l\u2019antithrombine par le fitusiran augmentait la coagulation et prot\u00e9geait des saignements les personnes atteintes d\u2019h\u00e9mophilie\u00a0A ou B, dont la coagulation est insuffisante. Les essais cliniques sur le fitusiran sont actuellement en phase\u00a0III.<\/p>\r\n\r\n

Le 30\u00a0octobre 2020, en r\u00e9ponse \u00e0 des signalements d\u2019\u00e9v\u00e9nements thrombotiques vasculaires non mortels au sein du programme clinique sur le fitusiran chez des patients adultes et adolescents atteints d\u2019h\u00e9mophilie\u00a0A\/B avec et sans inhibiteurs, le promoteur a volontairement interrompu l\u2019administration dans les \u00e9tudes cliniques en cours. Consultez \u00e0 ce sujet la d\u00e9claration conjointe de la\u00a0FMH<\/a>, de l\u2019EHC<\/a>\u00a0et de la\u00a0NHF<\/a>.<\/p.\r\n\r\n

Il y a eu au total cinq \u00e9v\u00e9nements\u00a0; les deux premiers avaient d\u00e9j\u00e0 \u00e9t\u00e9 signal\u00e9s. Le premier, dont l\u2019issue a \u00e9t\u00e9 fatale, \u00e9tait une thrombose du sinus veineux c\u00e9r\u00e9bral initialement diagnostiqu\u00e9e comme une h\u00e9morragie c\u00e9r\u00e9brale, r\u00e9sultant en l\u2019utilisation concomitante d\u2019une grande quantit\u00e9 de concentr\u00e9 de facteur. Le deuxi\u00e8me \u00e9tait une thrombose atriale apr\u00e8s recours concomitant \u00e0 un agent de contournement (rFVIIa). Ces \u00e9v\u00e9nements \u00e9taient associ\u00e9s \u00e0 l\u2019utilisation de doses de concentr\u00e9s de facteur de coagulation ou d\u2019agent de contournement au-del\u00e0 de celles recommand\u00e9es dans les lignes directrices de la prise en charge des saignements perth\u00e9rapeutiques.<\/p>\r\n\r\n

Les trois \u00e9v\u00e9nements les plus r\u00e9cents, qui ont entra\u00een\u00e9 l\u2019arr\u00eat volontaire de l\u2019administration en octobre 2020, \u00e9taient un infarctus c\u00e9r\u00e9bral, un accident vasculaire c\u00e9r\u00e9bral et un trouble vasculaire rachidien (suspicion de thrombose impliquant une l\u00e9sion rachidienne) en d\u00e9pit du respect des lignes directrices de prise en charge des saignements perth\u00e9rapeutiques. L\u2019\u00e9valuation de ces cinq \u00e9v\u00e9nements a laiss\u00e9 entendre que le risque d\u2019\u00e9v\u00e9nements thrombotiques vasculaires pouvait \u00eatre plus important dans le cas de taux d\u2019antithrombine (AT) en dessous de 10\u00a0% des taux normaux. En cons\u00e9quence, l\u2019\u00e9tude ciblera d\u00e9sormais des taux d\u2019AT compris entre 15\u00a0% et 35\u00a0% aux fins de maintenir un rapport b\u00e9n\u00e9fice-risque favorable pour les patients.<\/p>\r\n\r\n

En janvier 2021, un plan d\u2019administration r\u00e9vis\u00e9 a \u00e9t\u00e9 soumis \u00e0 l\u2019examen des autorit\u00e9s de sant\u00e9 mondiales et approuv\u00e9 par la\u00a0Food and Drug Administration\u00a0<\/em>(FDA) am\u00e9ricaine et la\u00a0Pharmaceuticals and Medical Devices Agency<\/em>\u00a0(PMDA) japonaise. \u00c0 la suite de l\u2019examen par les autorit\u00e9s de sant\u00e9 et les comit\u00e9s d\u2019\u00e9thique de la recherche (IRB) et \u00e0 la signature d\u2019un nouveau consentement par les patients, l\u2019administration de fitusiran reprendra pays par pays. Durant le congr\u00e8s de l\u2019European Association for Haemophilia and Allied Disorders\u00a0<\/em>(EAHAD) d\u00e9but f\u00e9vrier 2021, Sanofi a pr\u00e9sent\u00e9 le sch\u00e9ma d\u2019administration de fitusiran r\u00e9vis\u00e9 qu\u2019il proposait pour att\u00e9nuer le risque de thrombose vasculaire.<\/p>\r\n\r\n

Les lignes directrices de prise en charge des h\u00e9morragies restent inchang\u00e9es durant le traitement prophylactique par fitusiran.<\/p>\r\n\r\n

Nous communiquons cette information, \u00e0 disposition du public, et continuerons \u00e0 tenir nos communaut\u00e9s de patients inform\u00e9es des d\u00e9veloppements \u00e0 venir.<\/p>\r\n\r\n

Le fitusiran est l\u2019un des agents de r\u00e9\u00e9quilibrage en cours de d\u00e9veloppement clinique. Ces agents, qui comprennent les anticorps anti-TFPI et un inhibiteur de la prot\u00e9ine\u00a0C activ\u00e9e, visent \u00e0 renforcer l\u2019activit\u00e9 procoagulante du syst\u00e8me de coagulation, afin de compenser la coagulation d\u00e9faillante dans l\u2019h\u00e9mophilie\u00a0A\/B. Dans certains essais cliniques portant sur les anti-TFPI, des \u00e9v\u00e9nements thrombotiques se sont aussi produits chez un petit nombre de participants. Par cons\u00e9quent, une s\u00e9lection rigoureuse de la dose et une utilisation m\u00e9ticuleuse des concentr\u00e9s de facteur de coagulation durant les saignements perth\u00e9rapeutiques sont extr\u00eamement importantes.<\/p>\r\n\r\n

Pour lire le communiqu\u00e9 de presse int\u00e9gral (en anglais),\u00a0cliquez ici<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Le fitusiran est un agent th\u00e9rapeutique exp\u00e9rimental fond\u00e9 sur l\u2019interf\u00e9rence ARN pouvant emp\u00eacher la production de la prot\u00e9ine antithrombine dans le foie. L\u2019antithrombine est un frein important pour le syst\u00e8me de coagulation. Chez l\u2019adulte, des quantit\u00e9s insuffisantes d\u2019antithrombine circulante conduisent \u00e0 une thrombose. <\/p>\n","protected":false},"author":3,"featured_media":19564,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[177],"tags":[],"search-category":[85],"class_list":["post-12738","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualite-medicale","search-category-article"],"yoast_head":"\nMise \u00e0 jour sur le fitusiran \u00e0 la suite du congr\u00e8s 2021 de l\u2019EAHAD | FMH - F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/wfh.org\/fr\/article\/mise-a-jour-sur-le-fitusiran-a-la-suite-du-congres-2021-de-leahad\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Mise \u00e0 jour sur le fitusiran \u00e0 la suite du congr\u00e8s 2021 de l\u2019EAHAD\" \/>\n<meta property=\"og:description\" content=\"Le fitusiran est un agent th\u00e9rapeutique exp\u00e9rimental fond\u00e9 sur l\u2019interf\u00e9rence ARN pouvant emp\u00eacher la production de la prot\u00e9ine antithrombine dans le foie. 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