{"id":6792,"date":"2025-05-26T14:55:57","date_gmt":"2025-05-26T12:55:57","guid":{"rendered":"https:\/\/rvh-synergie.org\/actualites\/la-fda-approuve-nucala-pour-une-maladie-pulmonaire-obstructive-chronique\/"},"modified":"2025-05-26T14:55:58","modified_gmt":"2025-05-26T12:55:58","slug":"la-fda-approuve-nucala-pour-une-maladie-pulmonaire-obstructive-chronique","status":"publish","type":"post","link":"https:\/\/rvh-synergie.org\/actualites\/la-fda-approuve-nucala-pour-une-maladie-pulmonaire-obstructive-chronique\/","title":{"rendered":"La FDA approuve Nucala pour une maladie pulmonaire obstructive chronique"},"content":{"rendered":"<div>\n<div class=\"article-gallery lightGallery\">\n<div data-thumb=\"https:\/\/scx1.b-cdn.net\/csz\/news\/tmb\/2025\/fda-approves-nucala-fo.jpg\" data-src=\"https:\/\/scx2.b-cdn.net\/gfx\/news\/2025\/fda-approves-nucala-fo.jpg\" data-sub-html=\"\">\n<figure class=\"article-img\">\n<\/figure><\/div>\n<\/div>\n<p>La Food and Drug Administration des \u00c9tats-Unis a approuv\u00e9 le NUCALA de GSK (m\u00e9polizumab) en tant que traitement d&rsquo;entretien compl\u00e9mentaire pour les patients adultes atteints d&rsquo;une maladie pulmonaire obstructive chronique insuffisamment contr\u00f4l\u00e9e (MPOC).<\/p>\n<p>Nucala se distingue comme le seul biologique approuv\u00e9 qui a \u00e9t\u00e9 sp\u00e9cifiquement \u00e9valu\u00e9 chez les patients dont le ph\u00e9notype \u00e9osinophile est d\u00e9fini par un seuil de nombre sanguin d&rsquo;\u00e9osinophile (BEC) aussi faible que \u2265150 cellules \/ \u00b5l. Jusqu&rsquo;\u00e0 70% des patients atteints de MPOC aux \u00c9tats-Unis dont la maladie n&rsquo;est pas correctement contr\u00f4l\u00e9e avec une th\u00e9rapie triple inhal\u00e9e et qui continuent de ressentir des exacerbations ont un BEC \u2265 150 cellules \/ \u00b5l.<\/p>\n<p>L&rsquo;approbation de Nuccala \u00e9tait bas\u00e9e sur les r\u00e9sultats de deux essais de groupes de groupes de phase III, randomis\u00e9s (1: 1), en double aveugle, en matin\u00e9e et Metrex, qui ont tous deux examin\u00e9 Nucala 100 mg administr\u00e9 par voie sous-cutan\u00e9e toutes les quatre semaines en plus d&rsquo;une th\u00e9rapie triple inhal\u00e9e optimale.<\/p>\n<p>Dans l&rsquo;essai Matinee, qui a \u00e9t\u00e9 pr\u00e9sent\u00e9 \u00e0 l&rsquo;American Thoracic Society 2025 International Congress, 804 patients atteints de MPOC avec un BEC de \u2265300 cellules \/ \u00b5l ont vu une r\u00e9duction statistiquement significative des exacerbations mod\u00e9r\u00e9es ou s\u00e9v\u00e8res lorsque NUCALA (versus placebo) a \u00e9t\u00e9 ajout\u00e9 \u00e0 une th\u00e9rapie triple inhal\u00e9e (0,80 versus 1,01 par ann\u00e9e; Ratio, 0,79).<\/p>\n<p>Dans un crit\u00e8re d&rsquo;\u00e9valuation secondaire pr\u00e9d\u00e9fini, le taux d&rsquo;exacerbations de la MPOC n\u00e9cessitant des visites aux services d&rsquo;urgence ou l&rsquo;hospitalisation a diminu\u00e9 (rapport de taux, 0,65).<\/p>\n<p>Dans l&rsquo;essai Metrex, les r\u00e9sultats \u00e9taient similaires, les patients prenant Nucala (contre placebo) constatant une diminution significative des exacerbations mod\u00e9r\u00e9es ou s\u00e9v\u00e8res (1,40 contre 1,71 \u00e9v\u00e9nements par an; ratio de taux, 0,82).<\/p>\n<p>Les \u00e9v\u00e9nements ind\u00e9sirables rapport\u00e9s \u00e9taient similaires pour les groupes Nucala et placebo.<\/p>\n<p>\u00ab\u00a0La MPOC n&rsquo;est pas seulement une maladie, c&rsquo;est un cycle implacable\u00a0\u00bb, a d\u00e9clar\u00e9 Jean Wright, MD, chef de la direction de la Fondation de la MPOC, dans un communiqu\u00e9.<\/p>\n<p>\u00ab\u00a0Pour les personnes vivant avec la MPOC, la gestion des exacerbations est un d\u00e9fi continu, m\u00eame avec une th\u00e9rapie d&rsquo;entretien inhal\u00e9e. Des biologiques comme le m\u00e9polizumab offrent un renouvellement d&rsquo;optimisme pour les personnes touch\u00e9es par la MPOC.\u00a0\u00bb<\/p>\n<p>                                        <!-- print only --><\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>La Food and Drug Administration des \u00c9tats-Unis a approuv\u00e9 le NUCALA de GSK (m\u00e9polizumab) en<\/p>\n","protected":false},"author":1,"featured_media":6793,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[86],"tags":[321,250,447,248,5447,2634,8,2276,47],"class_list":["post-6792","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-les-maladies","tag-approuve","tag-chronique","tag-fda","tag-maladie","tag-nucala","tag-obstructive","tag-pour","tag-pulmonaire","tag-une","generate-columns","tablet-grid-50","mobile-grid-100","grid-parent","grid-50","resize-featured-image"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - 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