{"id":18098,"date":"2026-09-21T14:42:19","date_gmt":"2026-09-21T14:42:19","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=18098"},"modified":"2026-09-21T14:42:19","modified_gmt":"2026-09-21T14:42:19","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-litfulo-ritlecitinib-date-dautorisation-15-09-2023-revision-5-statut-autorise-titre-t","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=18098","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Litfulo, ritlecitinib, date d\u2019autorisation : 15\/09\/2023, r\u00e9vision : 5, statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Litfulo est un m\u00e9dicament contenant du ritlecitinib, indiqu\u00e9 chez les adultes et les adolescents de plus de 12 ans pr\u00e9sentant une alop\u00e9cie areata s\u00e9v\u00e8re, maladie auto-immune responsable d\u2019une perte importante de cheveux au niveau du cuir chevelu ou d\u2019autres parties du corps. Il s\u2019agit d\u2019un traitement immunosuppresseur qui agit en bloquant certaines enzymes (JAK3 et tyrosine kinases de la famille TEC) impliqu\u00e9es dans l\u2019inflammation, afin de r\u00e9duire l\u2019attaque auto-immune des follicules pileux et de permettre une repousse des cheveux.<\/p>\n<p>Le traitement est disponible sous forme de g\u00e9lules administr\u00e9es par voie orale une fois par jour. Litfulo est soumis \u00e0 prescription m\u00e9dicale et doit \u00eatre initi\u00e9 et suivi par un m\u00e9decin exp\u00e9riment\u00e9 dans le diagnostic et la prise en charge de l\u2019alop\u00e9cie areata. Le traitement doit \u00eatre interrompu ou arr\u00eat\u00e9 en cas d\u2019infections graves ou de diminution des cellules sanguines, et arr\u00eat\u00e9 en l\u2019absence d\u2019am\u00e9lioration apr\u00e8s 36 semaines. Le m\u00e9dicament ne doit pas \u00eatre utilis\u00e9 chez les patients pr\u00e9sentant une infection grave active, y compris la tuberculose, ni en cas d\u2019atteinte h\u00e9patique s\u00e9v\u00e8re. Il est contre-indiqu\u00e9 pendant la grossesse et l\u2019allaitement.<\/p>\n<p>L\u2019efficacit\u00e9 de Litfulo a \u00e9t\u00e9 \u00e9valu\u00e9e dans une \u00e9tude principale portant sur 718 adultes et adolescents de plus de 12 ans atteints d\u2019alop\u00e9cie areata s\u00e9v\u00e8re avec plus de 50 % de perte de cheveux sur le cuir chevelu avant traitement. Parmi eux, 261 ont re\u00e7u soit 50 mg de Litfulo, soit un placebo. Apr\u00e8s 24 semaines, 13 % des patients trait\u00e9s par Litfulo \u00e9taient en quasi-r\u00e9mission (plus de 90 % de couverture capillaire du cuir chevelu) et 23 % pr\u00e9sentaient plus de 80 % de couverture capillaire, contre 1,5 % avec le placebo. Apr\u00e8s 48 semaines, 31 % des patients sous Litfulo \u00e9taient en quasi-r\u00e9mission. Sur le plan ressenti, 49 % des patients trait\u00e9s par Litfulo d\u00e9claraient une am\u00e9lioration mod\u00e9r\u00e9e ou importante de leur alop\u00e9cie, contre 9 % sous placebo. Les b\u00e9n\u00e9fices du m\u00e9dicament semblent se maintenir dans le temps sur la dur\u00e9e observ\u00e9e.<\/p>\n<p>Les effets ind\u00e9sirables les plus fr\u00e9quents (jusqu\u2019\u00e0 1 patient sur 10) incluent diarrh\u00e9es, acn\u00e9, infections des voies respiratoires sup\u00e9rieures, urticaire, \u00e9ruptions cutan\u00e9es, folliculite et vertiges. Les autorit\u00e9s de sant\u00e9 recommandent de se r\u00e9f\u00e9rer \u00e0 la notice pour la liste compl\u00e8te des effets ind\u00e9sirables et des restrictions d\u2019utilisation et de consulter un professionnel de sant\u00e9 pour toute question. Les donn\u00e9es disponibles indiquent une efficacit\u00e9 sur l\u2019alop\u00e9cie areata s\u00e9v\u00e8re, mais des incertitudes demeurent concernant la s\u00e9curit\u00e9 d\u2019emploi \u00e0 long terme. Ces \u00e9l\u00e9ments sont pertinents pour le suivi des politiques de prise en charge des maladies auto-immunes et des traitements immunosuppresseurs, en particulier chez les adolescents et les jeunes adultes. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/litfulo\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Litfulo est un m\u00e9dicament contenant du ritlecitinib, indiqu\u00e9 chez les adultes et les adolescents de plus de 12 ans pr\u00e9sentant une alop\u00e9cie areata s\u00e9v\u00e8re, maladie auto-immune responsable d\u2019une perte importante [&hellip;]<\/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 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