{"id":4999,"date":"2012-11-05T16:37:17","date_gmt":"2012-11-05T21:37:17","guid":{"rendered":"https:\/\/themedicalxchange.com\/2012\/11\/05\/reunion-scientifique-annuelle-et-cours-de-perfecti\/"},"modified":"2021-09-13T17:40:16","modified_gmt":"2021-09-13T21:40:16","slug":"reunion-scientifique-annuelle-et-cours-de-perfecti","status":"publish","type":"post","link":"https:\/\/themedicalxchange.com\/fr\/2012\/11\/05\/reunion-scientifique-annuelle-et-cours-de-perfecti\/","title":{"rendered":"Une \u00e9tude de Phase III vient valider un nouvel agent biologique exer\u00e7ant s\u00e9lectivement son activit\u00e9 dans l\u2019intestin"},"content":{"rendered":"

\u00ab\u00a0Nous avan\u00e7ons l\u2019hypoth\u00e8se que cette observation [l\u2019absence de complications infectieuses] pourrait \u00eatre attribuable \u00e0 l\u2019effet anti-inflammatoire exerc\u00e9 s\u00e9lectivement dans l\u2019intestin par cet anticorps monoclonal\u00a0\u00bb, a affirm\u00e9 le Dr<\/sup>\u00a0Brian\u00a0Feagan, Directeur du Service des essais cliniques de l\u2019Institut de recherche Robarts, \u00e0 London, en Ontario. Pr\u00e9sentant les donn\u00e9es issues de la phase d\u2019entretien de l\u2019essai GEMINI\u00a0I sur la colite ulc\u00e9reuse, le Dr<\/sup>\u00a0Feagan a mentionn\u00e9 que l\u2019activit\u00e9 de ce m\u00e9dicament semblait similaire \u00e0 celle des inhibiteurs du TNF lorsqu\u2019on comparait ces deux types d\u2019agents \u00e0 un placebo. Au cours de la phase d\u2019entretien de l\u2019essai GEMINI\u00a0I, les chercheurs ont tent\u00e9 de d\u00e9terminer si le v\u00e9dolizumab permettait aux patients qui y avaient r\u00e9agi favorablement durant la phase d\u2019induction de conserver cette r\u00e9ponse clinique ou de rester en r\u00e9mission pendant 52\u00a0semaines. Avant d\u2019entreprendre la phase d\u2019induction de l\u2019essai, tous les patients avaient essay\u00e9 au moins un traitement, mais en vain. Les 373\u00a0participants ont \u00e9t\u00e9 r\u00e9partis al\u00e9atoirement de mani\u00e8re \u00e0 recevoir soit du v\u00e9dolizumab toutes les 4\u00a0semaines, soit du v\u00e9dolizumab toutes les 8\u00a0semaines, soit un placebo. Le principal crit\u00e8re d\u2019\u00e9valuation t\u00e9moignant de la r\u00e9mission clinique \u00e9tait l\u2019obtention d\u2019un score de Mayo de 2 ou moins, aucun des scores secondaires n\u2019\u00e9tant sup\u00e9rieur \u00e0 1. Cette \u00e9tude comportait \u00e9galement plusieurs crit\u00e8res d\u2019\u00e9valuation secondaires, tels que la gu\u00e9rison de la muqueuse. La sup\u00e9riorit\u00e9 du v\u00e9dolizumab administr\u00e9 selon un cycle posologique de 4\u00a0semaines s\u2019est r\u00e9v\u00e9l\u00e9e extr\u00eamement significative sur le plan statistique par rapport au placebo pour ce qui est du crit\u00e8re principal, c\u2019est-\u00e0-dire la r\u00e9mission clinique (44,8\u00a0% vs 15,9\u00a0%; p\u00a0<\/em><\u00a00,001), de m\u00eame que pour la majorit\u00e9 des crit\u00e8res d\u2019\u00e9valuation secondaires, y compris la gu\u00e9rison de la muqueuse (56,0\u00a0% vs 19,8\u00a0%; p\u00a0<\/em><\u00a00,001) et la r\u00e9mission sans recours aux corticost\u00e9ro\u00efdes (45,2\u00a0% vs 13,9\u00a0%; p\u00a0<\/em><\u00a00,001). Des avantages similaires sont \u00e9galement ressortis de la comparaison du v\u00e9dolizumab administr\u00e9 selon un cycle posologique de 8\u00a0semaines et du placebo pour la plupart des crit\u00e8res d\u2019\u00e9valuation. Selon une autre pr\u00e9sentation donn\u00e9e devant l\u2019ACG, les r\u00e9sultats obtenus au cours de la phase d\u2019entretien de l\u2019essai GEMINI\u00a0II sur la maladie de Crohn ont \u00e9galement permis de relier le v\u00e9dolizumab a une activit\u00e9 d\u2019une grande ampleur. Dans le cadre de cet essai, dont la m\u00e9thodologie \u00e9tait similaire \u00e0 celle de l\u2019essai sur la colite ulc\u00e9reuse, les sujets ont eux aussi \u00e9t\u00e9 r\u00e9partis al\u00e9atoirement de mani\u00e8re \u00e0 recevoir du v\u00e9dolizumab ou un placebo toutes les 4 ou 8\u00a0semaines. Encore l\u00e0, tous les patients avaient d\u00e9j\u00e0 essay\u00e9 au moins un traitement qui avait \u00e9chou\u00e9 avant d\u2019entreprendre la phase d\u2019induction de cet essai et avaient tous r\u00e9agi favorablement au v\u00e9dolizumab avant d\u2019\u00eatre admis \u00e0 la phase d\u2019entretien. Selon le Dr\u00a0<\/sup>William Sandborn, de la Clinique Scripps, de l\u2019Universit\u00e9 de Californie, \u00e0 San Diego, le taux de r\u00e9mission clinique enregistr\u00e9 au terme des 52\u00a0semaines de la phase d\u2019entretien de l\u2019essai GEMINI\u00a0II se chiffrait \u00e0 39,0\u00a0%, \u00e0 36,4\u00a0% et \u00e0 21,6\u00a0% dans les groupes ayant suivi les cycles de 4 et de 8\u00a0semaines, et dans le groupe t\u00e9moin, respectivement (p\u00a0<\/em><\u00a00,01 pour l\u2019un ou l\u2019autre cycle versus le placebo). La proportion de sujets dont l\u2019indice d\u2019activit\u00e9 de la maladie de Crohn (CDAI) s\u2019\u00e9tait am\u00e9lior\u00e9 d\u2019au moins 100\u00a0points au terme des 52\u00a0semaines s\u2019\u00e9levait \u00e0 43,5\u00a0%, \u00e0 45,5\u00a0% et \u00e0 30,1\u00a0%, respectivement (p\u00a0<\/em><\u00a00,01 pour le cycle de 4\u00a0semaines et p\u00a0<\/em><\u00a00,05 pour celui de 8\u00a0semaines versus le placebo). Les effets ind\u00e9sirables ont \u00e9t\u00e9 plus fr\u00e9quents dans les groupes trait\u00e9s par le v\u00e9dolizumab que chez les t\u00e9moins, mais pas les abandons motiv\u00e9s par de telles manifestations d\u00e9favorables (Fig. 1)<\/a>. Faisant \u00e9cho aux conclusions tir\u00e9es de l\u2019essai GEMINI\u00a0I sur la colite ulc\u00e9reuse, le Dr<\/sup>\u00a0Sanborn a ajout\u00e9\u00a0: \u00ab\u00a0Le v\u00e9dolizumab s\u2019est r\u00e9v\u00e9l\u00e9 un traitement d\u2019entretien plus efficace que le placebo dans les cas rebelles d\u2019une forme mod\u00e9r\u00e9ment ou fortement \u00e9volutive de la maladie de Crohn\u00a0\u00bb. Le Dr<\/sup>\u00a0Sanborn pr\u00e9sentait ces r\u00e9sultats au nom de l\u2019auteur principal de l\u2019\u00e9tude, le Dr<\/sup>\u00a0Stephen Hanauer, de l\u2019Universit\u00e9 de Chicago, en Illinois. Un fait est venu corroborer l\u2019utilit\u00e9 que le v\u00e9dolizumab pourrait avoir dans le traitement de la maladie de Crohn\u00a0: pr\u00e8s de la moiti\u00e9 des patients ayant particip\u00e9 \u00e0 l\u2019essai GEMINI\u00a0II avaient d\u00e9j\u00e0 \u00e9t\u00e9 trait\u00e9s par des inhibiteurs du TNF, mais sans succ\u00e8s. Il faudra r\u00e9aliser des essais pour comparer l\u2019efficacit\u00e9 et l\u2019innocuit\u00e9 des agents biologiques.<\/p>\n","protected":false},"excerpt":{"rendered":"

Las Vegas <\/b> \u2013 \u00c0 la lumi\u00e8re des donn\u00e9es issues d\u2019une \u00e9tude de Phase III, un nouvel agent biologique dot\u00e9 d\u2019une activit\u00e9 s\u00e9lective unique en son genre serait sur le point d\u2019\u00eatre homologu\u00e9 pour le traitement des maladies intestinales inflammatoires (MII). Ce m\u00e9dicament, le v\u00e9dolizumab, cible l\u2019int\u00e9grine \u03b14\u03b27, qui dirige les lymphocytes T vers l\u2019intestin. L\u2019incidence des complications infectieuses enregistr\u00e9e au cours de deux essais de Phase III, l\u2019un ayant port\u00e9 sur la colite ulc\u00e9reuse (GEMINI I) et l\u2019autre, sur la maladie de Crohn (GEMINI II), \u00e9tait si faible comparativement \u00e0 celle qui est g\u00e9n\u00e9ralement observ\u00e9e avec les inhibiteurs du facteur de n\u00e9crose tumorale (TNF) qu\u2019elle porte \u00e0 croire que le mode d\u2019action particulier de cet agent pourrait pr\u00e9senter un grand int\u00e9r\u00eat sur le plan clinique pour le traitement des MII. <\/p>\n","protected":false},"author":1,"featured_media":5000,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"tags":[408,437,523,291],"class_list":["post-4999","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","tag-2012-fr","tag-acg-fr","tag-extract-fr","tag-gastroenterologie","area_tag-gastroenterologie"],"acf":[],"yoast_head":"\nUne \u00e9tude de Phase III vient valider un nouvel agent biologique exer\u00e7ant s\u00e9lectivement son activit\u00e9 dans l\u2019intestin - The Medical Xchange<\/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:\/\/themedicalxchange.com\/fr\/2012\/11\/05\/reunion-scientifique-annuelle-et-cours-de-perfecti\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Une \u00e9tude de Phase III vient valider un nouvel agent biologique exer\u00e7ant s\u00e9lectivement son activit\u00e9 dans l\u2019intestin - The Medical Xchange\" \/>\n<meta property=\"og:description\" content=\"Las Vegas \u2013 \u00c0 la lumi\u00e8re des donn\u00e9es issues d\u2019une \u00e9tude de Phase III, un nouvel agent biologique dot\u00e9 d\u2019une activit\u00e9 s\u00e9lective unique en son genre serait sur le point d\u2019\u00eatre homologu\u00e9 pour le traitement des maladies intestinales inflammatoires (MII). Ce m\u00e9dicament, le v\u00e9dolizumab, cible l\u2019int\u00e9grine \u03b14\u03b27, qui dirige les lymphocytes T vers l\u2019intestin. L\u2019incidence des complications infectieuses enregistr\u00e9e au cours de deux essais de Phase III, l\u2019un ayant port\u00e9 sur la colite ulc\u00e9reuse (GEMINI I) et l\u2019autre, sur la maladie de Crohn (GEMINI II), \u00e9tait si faible comparativement \u00e0 celle qui est g\u00e9n\u00e9ralement observ\u00e9e avec les inhibiteurs du facteur de n\u00e9crose tumorale (TNF) qu\u2019elle porte \u00e0 croire que le mode d\u2019action particulier de cet agent pourrait pr\u00e9senter un grand int\u00e9r\u00eat sur le plan clinique pour le traitement des MII.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/themedicalxchange.com\/fr\/2012\/11\/05\/reunion-scientifique-annuelle-et-cours-de-perfecti\/\" \/>\n<meta property=\"og:site_name\" content=\"The Medical Xchange\" \/>\n<meta property=\"article:published_time\" content=\"2012-11-05T21:37:17+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-09-13T21:40:16+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/themedicalxchange.com\/wp-content\/uploads\/2012\/11\/ACG_7005_Figure_1_FR.PNG\" \/>\n\t<meta property=\"og:image:width\" content=\"960\" \/>\n\t<meta property=\"og:image:height\" content=\"720\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"nuagelab\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"nuagelab\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/themedicalxchange.com\\\/fr\\\/2012\\\/11\\\/05\\\/reunion-scientifique-annuelle-et-cours-de-perfecti\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/themedicalxchange.com\\\/fr\\\/2012\\\/11\\\/05\\\/reunion-scientifique-annuelle-et-cours-de-perfecti\\\/\"},\"author\":{\"name\":\"nuagelab\",\"@id\":\"https:\\\/\\\/themedicalxchange.com\\\/en\\\/#\\\/schema\\\/person\\\/c4e17cbf7de41a40b9366989481cfc4b\"},\"headline\":\"Une \u00e9tude de Phase III vient valider un nouvel agent biologique exer\u00e7ant s\u00e9lectivement son activit\u00e9 dans l\u2019intestin\",\"datePublished\":\"2012-11-05T21:37:17+00:00\",\"dateModified\":\"2021-09-13T21:40:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/themedicalxchange.com\\\/fr\\\/2012\\\/11\\\/05\\\/reunion-scientifique-annuelle-et-cours-de-perfecti\\\/\"},\"wordCount\":828,\"image\":{\"@id\":\"https:\\\/\\\/themedicalxchange.com\\\/fr\\\/2012\\\/11\\\/05\\\/reunion-scientifique-annuelle-et-cours-de-perfecti\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/themedicalxchange.com\\\/wp-content\\\/uploads\\\/2012\\\/11\\\/ACG_7005_Figure_1_FR.PNG\",\"keywords\":[\"2012\",\"ACG\",\"extract\",\"Gastroent\u00e9rologie\"],\"articleSection\":[\"Non classifi\u00e9(e)\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/themedicalxchange.com\\\/fr\\\/2012\\\/11\\\/05\\\/reunion-scientifique-annuelle-et-cours-de-perfecti\\\/\",\"url\":\"https:\\\/\\\/themedicalxchange.com\\\/fr\\\/2012\\\/11\\\/05\\\/reunion-scientifique-annuelle-et-cours-de-perfecti\\\/\",\"name\":\"Une \u00e9tude de Phase III vient valider un nouvel agent biologique exer\u00e7ant s\u00e9lectivement son activit\u00e9 dans l\u2019intestin - 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Ce m\u00e9dicament, le v\u00e9dolizumab, cible l\u2019int\u00e9grine \u03b14\u03b27, qui dirige les lymphocytes T vers l\u2019intestin. 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