{"id":22414,"date":"2026-10-27T16:39:55","date_gmt":"2026-10-27T16:39:55","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=22414"},"modified":"2026-10-27T16:39:55","modified_gmt":"2026-10-27T16:39:55","slug":"medicaments-a-usage-humain-rapport-europeen-public-devaluation-epar-idacio-adalimumab-date-dautorisation-02-04-2019-revision-17-statut-autorise-titre-traduit-en-f","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=22414","title":{"rendered":"M\u00e9dicaments \u00e0 usage humain Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) : Idacio, adalimumab, Date d\u2019autorisation : 02\/04\/2019, R\u00e9vision : 17, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Le document pr\u00e9sente Idacio, un m\u00e9dicament \u00e0 base d\u2019adalimumab, class\u00e9 dans le groupe pharmacoth\u00e9rapeutique des immunosuppresseurs (code L04AB04). Il d\u00e9crit les principales indications th\u00e9rapeutiques du produit, essentiellement dans le champ des maladies inflammatoires chroniques articulaires, cutan\u00e9es et intestinales, chez l\u2019adulte et l\u2019enfant.<\/p>\n<p>Chez l\u2019adulte, Idacio est indiqu\u00e9, le plus souvent en association au m\u00e9thotrexate, dans le traitement de la polyarthrite rhumato\u00efde mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re active lorsque la r\u00e9ponse aux traitements de fond (DMARDs), y compris le m\u00e9thotrexate, est insuffisante, ainsi que dans les formes s\u00e9v\u00e8res, actives et progressives chez des patients jamais trait\u00e9s par m\u00e9thotrexate. Il peut \u00eatre utilis\u00e9 en monoth\u00e9rapie en cas d\u2019intol\u00e9rance ou d\u2019inad\u00e9quation du maintien du m\u00e9thotrexate. L\u2019adalimumab a montr\u00e9, en association au m\u00e9thotrexate, une r\u00e9duction de la progression des l\u00e9sions articulaires radiologiques et une am\u00e9lioration de la fonction physique. Idacio est \u00e9galement indiqu\u00e9 dans la spondylarthrite ankylosante s\u00e9v\u00e8re active apr\u00e8s \u00e9chec des traitements conventionnels, dans les formes s\u00e9v\u00e8res de spondyloarthrite axiale sans signe radiographique de spondylarthrite ankylosante mais avec signes objectifs d\u2019inflammation (CRP \u00e9lev\u00e9e et\/ou IRM) apr\u00e8s \u00e9chec ou intol\u00e9rance aux anti-inflammatoires non st\u00e9ro\u00efdiens, ainsi que dans le rhumatisme psoriasique actif et progressif chez les patients insuffisamment r\u00e9pondants aux DMARDs, avec, dans les formes polyarticulaires sym\u00e9triques, une r\u00e9duction d\u00e9montr\u00e9e de la progression des dommages articulaires p\u00e9riph\u00e9riques et une am\u00e9lioration de la fonction physique. Idacio est en outre indiqu\u00e9 dans le psoriasis en plaques chronique mod\u00e9r\u00e9 \u00e0 s\u00e9v\u00e8re chez l\u2019adulte candidat \u00e0 un traitement syst\u00e9mique.<\/p>\n<p>Chez l\u2019enfant et l\u2019adolescent, Idacio est indiqu\u00e9 dans l\u2019arthrite juv\u00e9nile idiopathique polyarticulaire active, \u00e0 partir de 2 ans, en association au m\u00e9thotrexate apr\u00e8s \u00e9chec d\u2019au moins un DMARD ; la monoth\u00e9rapie est possible en cas d\u2019intol\u00e9rance ou de contre-indication au m\u00e9thotrexate, bien que l\u2019efficacit\u00e9 en monoth\u00e9rapie soit pr\u00e9sent\u00e9e comme sp\u00e9cifique (r\u00e9f\u00e9rence \u00e0 des donn\u00e9es de l\u2019annexe). L\u2019adalimumab n\u2019a pas \u00e9t\u00e9 \u00e9tudi\u00e9 chez les enfants de moins de 2 ans. Idacio est \u00e9galement indiqu\u00e9 dans l\u2019arthrite li\u00e9e \u00e0 l\u2019enth\u00e9site chez les patients de 6 ans et plus apr\u00e8s \u00e9chec ou intol\u00e9rance aux traitements conventionnels.<\/p>\n<p>Les informations fournies portent sur les indications cliniques, les associations th\u00e9rapeutiques recommand\u00e9es, les \u00e2ges d\u2019initiation possibles et certaines preuves d\u2019efficacit\u00e9 (frein \u00e0 la progression radiologique, am\u00e9lioration de la fonction). Aucun \u00e9l\u00e9ment du document ne pr\u00e9cise des autorit\u00e9s sanitaires, pays, d\u00e9cisions r\u00e9glementaires, dates d\u2019autorisation ou donn\u00e9es chiffr\u00e9es de sant\u00e9 publique. Les enjeux de politique publique concernent principalement la place d\u2019un immunosuppresseur biologique dans la prise en charge de pathologies inflammatoires chroniques s\u00e9v\u00e8res, y compris p\u00e9diatriques, et les conditions de recours apr\u00e8s \u00e9chec des traitements conventionnels. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/idacio\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Le document pr\u00e9sente Idacio, un m\u00e9dicament \u00e0 base d\u2019adalimumab, class\u00e9 dans le groupe pharmacoth\u00e9rapeutique des immunosuppresseurs (code L04AB04). Il d\u00e9crit les principales indications th\u00e9rapeutiques du produit, essentiellement dans le champ [&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 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-22414","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\/22414","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=22414"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/22414\/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=22414"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22414"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22414"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}