{"id":2465,"date":"2025-05-28T07:00:00","date_gmt":"2025-05-28T07:00:00","guid":{"rendered":"https:\/\/healthscience.institute\/?p=2465"},"modified":"2025-12-09T08:49:58","modified_gmt":"2025-12-09T08:49:58","slug":"fda-approval-multiple-sclerosis-therapy","status":"publish","type":"post","link":"https:\/\/staging.scienceinhealth.com\/fr\/fda-approval-multiple-sclerosis-therapy\/","title":{"rendered":"Approbation de la FDA\u00a0: perc\u00e9e th\u00e9rapeutique de TG pour la scl\u00e9rose en plaques"},"content":{"rendered":"<h2 class=\"wp-block-heading\"><strong>Une th\u00e9rapie qui s\u2019adapte \u00e0 une pause d\u00e9jeuner<\/strong><\/h2>\n\n\n\n<p>Imaginez traiter la scl\u00e9rose en plaques avec juste une perfusion IV d\u2019une heure deux fois par an\u2014une th\u00e9rapie si pratique mais puissante qu\u2019elle peut r\u00e9duire consid\u00e9rablement les taux de rechute. Fin 2022, cela est devenu une r\u00e9alit\u00e9 lorsque TG Therapeutics a obtenu l\u2019approbation de la FDA pour le nouveau m\u00e9dicament Briumvi (ubituximab-xiiy)<sup>1<\/sup>. Briumvi est un anticorps con\u00e7u en laboratoire qui cible les cellules immunitaires connues pour favoriser la SEP. Son approbation marque un nouveau chapitre prometteur dans les soins de la SEP, offrant une grande efficacit\u00e9 avec un calendrier de dosage plus court et plus facile que de nombreux traitements existants.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Pourquoi cette approbation pourrait remodeler le traitement de la SEP<\/strong><\/h2>\n\n\n\n<p>La scl\u00e9rose en plaques (SEP) est un sympt\u00f4me chronique \u00e0 m\u00e9diation immunitaire dans lequel le corps attaque le rev\u00eatement protecteur des nerfs, entra\u00eenant des sympt\u00f4mes de fatigue et de limitations de mobilit\u00e9 ainsi que des perturbations cognitives. Cela commence souvent au d\u00e9but de l\u2019\u00e2ge adulte\u2014tout comme beaucoup d\u2019entre eux fondent une carri\u00e8re et une famille. Bien qu\u2019il existe plus de 20 th\u00e9rapies modificatrices de la maladie (DMT) approuv\u00e9es par la FDA, beaucoup comportent des compromis\u00a0: dosage fr\u00e9quent, longue dur\u00e9e de perfusion ou effets secondaires li\u00e9s au syst\u00e8me immunitaire<sup>2<\/sup>.<\/p>\n\n\n\n<p>L\u2019approbation de Briumvi par la FDA le 28\u00a0d\u00e9cembre\u00a02022 a marqu\u00e9 un grand pas en avant<sup>1<\/sup>. Il est devenu le troisi\u00e8me traitement anti-CD20 approuv\u00e9 pour la SEP, apr\u00e8s Ocrevus (ocrelizumab) et Kesimpta (ofatumumab). Cependant, Briumvi est le premier et le seul qui peut \u00eatre perfus\u00e9 en seulement une heure pour des doses d\u2019entretien<sup>3<\/sup>.\u00ab\u00a0L\u2019approbation de Briumvi est une excellente nouvelle\u00a0\u00bb, a d\u00e9clar\u00e9 June Halper, PDG du Consortium of MS Centers, en soulignant son importance pour les personnes diagnostiqu\u00e9es au cours des ann\u00e9es les plus actives de leur vie.<\/p>\n\n\n\n<p><strong><a href=\"http:\/\/scienceinhealth.com\/newsletter\/\">Abonnez-vous gratuitement pour des articles de sant\u00e9 plus \u00e9clairants adapt\u00e9s \u00e0 vos besoins.<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Les compromis auxquels sont encore confront\u00e9s les patients<\/strong><\/h2>\n\n\n\n<p>Malgr\u00e9 les progr\u00e8s scientifiques, les utilisateurs de la SEP sont toujours confront\u00e9s \u00e0 des obstacles majeurs\u00a0:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Commodit\u00e9 vs. efficacit\u00e9\u00a0:<\/strong> Les th\u00e9rapies puissantes comme Ocrevus n\u00e9cessitent des infusions de 3 \u00e0 4 heures deux fois par an<sup>5<\/sup>, tandis que d\u2019autres comme Kesimpta exigent des auto-injections mensuelles.<\/li>\n\n\n\n<li><strong>S\u00e9curit\u00e9 et tol\u00e9rabilit\u00e9\u00a0:<\/strong> La suppression immunitaire augmente le risque d\u2019infections et de r\u00e9actions \u00e0 la perfusion.<\/li>\n\n\n\n<li><strong>Co\u00fbt et complexit\u00e9\u00a0:<\/strong> Les co\u00fbts de traitement peuvent \u00eatre vertigineux\u2014certains d\u00e9passent 70\u00a0000\u00a0$ par an \u2014 exer\u00e7ant une pression \u00e0 la fois sur les utilisateurs et les syst\u00e8mes de sant\u00e9<sup>6<\/sup>.<\/li>\n<\/ul>\n\n\n\n<p>Le format de perfusion d\u2019une heure de Briumvi a \u00e9t\u00e9 con\u00e7u pour r\u00e9duire ce fardeau tout en maintenant une efficacit\u00e9 \u00e9lev\u00e9e<sup>3<\/sup>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Comment fonctionne Briumvi au niveau cellulaire<\/strong><\/h2>\n\n\n\n<p>Des recherches ont montr\u00e9 que certaines cellules B\u2014cellules immunitaires marqu\u00e9es par le <strong>Prot\u00e9ine CD20<\/strong>\u2014jouent un r\u00f4le cl\u00e9 dans l\u2019inflammation de la SEP. Ces cellules interagissent avec les lymphocytes T, les encourageant \u00e0 attaquer la my\u00e9line, la gaine protectrice autour des nerfs<sup>7<\/sup>.<\/p>\n\n\n\n<p>Briumvi est un anticorps monoclonal dirig\u00e9 contre le CD20, ce qui signifie qu\u2019il se lie au CD20 sur ces cellules B nocives et les signale pour leur destruction. Ce qui rend Briumvi unique, c\u2019est qu\u2019il est glycog\u00e9n\u00e9tiquement pour am\u00e9liorer la capacit\u00e9 naturelle du corps \u00e0 \u00e9liminer ces cellules via une cytotoxicit\u00e9 cellulaire d\u00e9pendante des anticorps<sup>8<\/sup>.Compar\u00e9 aux th\u00e9rapies CD20 plus anciennes, Briumvi offre une dose plus petite (450 mg) et un temps d\u2019infusion plus rapide, sans compromettre la modulation immunitaire.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Ce que les donn\u00e9es nous disent sur la performance de Briumvi<\/strong><\/h2>\n\n\n\n<p>L\u2019approbation de la FDA de Briumvi \u00e9tait bas\u00e9e sur deux \u00e9tudes de phase 3\u2014ULTIMATE I et II \u2014 qui ont inclus 1\u00a0094 participants atteints de SEP r\u00e9currente<sup>10<\/sup>. Il s\u2019agissait d\u2019essais en double aveugle, doubles placebo, comparant Briumvi au t\u00e9riflunomide (Aubagio) sur 96 semaines.<\/p>\n\n\n\n<p>Constatations principales :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Taux de rechute annualis\u00e9 (ARR)\u00a0:<\/strong>\n<ul class=\"wp-block-list\">\n<li>ULTIMATE I\u00a0: 0,08 rechutes\/an (Briumvi) vs. 0,19 (teriflunomide)<\/li>\n\n\n\n<li>ULTIMATE II: 0.09 vs. 0.18<strong><br><\/strong> Cela repr\u00e9sente une r\u00e9duction de 50 \u00e0 60\u00a0% de la fr\u00e9quence des rechutes<sup>10<\/sup>.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>L\u00e9sions c\u00e9r\u00e9brales par IRM\u00a0:<br><\/strong> Les utilisateurs de Briumvi n\u2019avaient presque aucune nouvelle l\u00e9sion stimul\u00e9e par le gadolinium \u00e0 l\u2019IRM, contre environ 0,5 dans le groupe trait\u00e9 au t\u00e9riflunomide\u2014une r\u00e9duction d\u2019environ 95\u00a0% des nouvelles inflammations c\u00e9r\u00e9brales<sup>11<\/sup>.<\/li>\n\n\n\n<li><strong>Aucune preuve d\u2019activit\u00e9 de la maladie (NEDA)\u00a0:<\/strong>\n<ul class=\"wp-block-list\">\n<li>ULTIMATE I\u00a0: 44,6\u00a0% ont atteint le NEDA vs. <strong>15%<\/strong><\/li>\n\n\n\n<li>ULTIMATE II: 43% vs. 11.4%<br> Atteindre NEDA est la norme d\u2019or dans les soins de la SEP<sup>12<\/sup>.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Progression du handicap\u00a0:<br><\/strong> Il n\u2019y avait pas de diff\u00e9rence significative dans l\u2019aggravation du handicap entre les groupes (5,2\u00a0% contre 5,9\u00a0%), bien que plus d\u2019utilisateurs de Briumvi aient montr\u00e9 des signes d\u2019am\u00e9lioration du handicap.<sup>13<\/sup>.<\/li>\n\n\n\n<li><strong>S\u00e9curit\u00e9<\/strong>: <br>Les effets secondaires les plus courants \u00e9taient des r\u00e9actions li\u00e9es \u00e0 la perfusion (47,7\u00a0%), g\u00e9n\u00e9ralement l\u00e9g\u00e8res \u00e0 mod\u00e9r\u00e9es. Le pr\u00e9traitement avec des st\u00e9ro\u00efdes et des antihistaminiques a aid\u00e9 \u00e0 g\u00e9rer ces \u00e9v\u00e9nements<sup>13<\/sup>.<br>Des infections graves sont survenues chez 5,0\u00a0% des utilisateurs de Briumvi contre 2,9\u00a0% sous t\u00e9riflunomide<sup>13<\/sup>.<br>Il est important de noter qu\u2019aucun cas de LEMP (une infection c\u00e9r\u00e9brale rare) n\u2019a eu lieu dans l\u2019un ou l\u2019autre groupe<sup>14<\/sup>.<\/li>\n<\/ul>\n\n\n\n<p><strong><a href=\"http:\/\/scienceinhealth.com\/newsletter\/\">Abonnez-vous gratuitement pour des articles de sant\u00e9 plus \u00e9clairants adapt\u00e9s \u00e0 vos besoins.<\/a><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Ce que cela signifie dans le monde r\u00e9el<\/strong><\/h2>\n\n\n\n<p>Pour beaucoup, le temps de perfusion plus court de Briumvi pourrait changer leur vie. Un rendez-vous semestriel d\u2019une heure, plut\u00f4t qu\u2019une perfusion de plusieurs heures ou une injection mensuelle, pourrait lib\u00e9rer des dizaines d\u2019heures par an. C\u2019est un changement significatif pour les parents, les professionnels et les soignants qui essaient d\u2019\u00e9quilibrer le traitement avec les exigences de la vie<sup>5<\/sup>.<\/p>\n\n\n\n<p>Les cliniques en b\u00e9n\u00e9ficient \u00e9galement\u00a0: des infusions plus courtes augmentent le d\u00e9bit de patients et r\u00e9duisent les co\u00fbts. Le prix catalogue de Briumvi\u201459\u00a0000\u00a0$\/an \u2014 est notablement inf\u00e9rieur \u00e0 celui de concurrents comme Ocrevus, qui se situe autour de 71\u00a0000\u00a0$ \/an<sup>6<\/sup>.<\/p>\n\n\n\n<p><em>\u00ab\u00a0Pour ceux qui n\u2019aiment pas les injections ou ont peu de temps pour les infusions, ce nouveau DMT vaut la peine d\u2019\u00eatre discut\u00e9 avec votre neurologue\u00a0\u00bb,<\/em> a \u00e9crit le chroniqueur MS Ed Tobias<sup>15<\/sup>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Que demander \u00e0 votre professionnel de sant\u00e9<\/strong><\/h2>\n\n\n\n<p>Si vous ou quelqu\u2019un que vous connaissez vivez avec une scl\u00e9rose en plaques r\u00e9currente, demandez \u00e0 votre professionnel de la sant\u00e9 si Briumvi pourrait \u00eatre une option. Pour en savoir plus, consultez le r\u00e9sum\u00e9 des approbations de la FDA ou explorez les ressources d\u2019assistance du<a href=\"https:\/\/www.nationalmssociety.org\/\"> National MS Society<\/a>.<\/p>\n\n\n\n<p><em>L\u2019article ne constitue en aucun cas un avis m\u00e9dical. Veuillez consulter un professionnel de la sant\u00e9 agr\u00e9\u00e9 avant de commencer tout traitement. Ce site peut recevoir des commissions \u00e0 partir des liens ou produits mentionn\u00e9s dans cet article.<\/em><\/p>\n\n\n\n<p><strong><a href=\"http:\/\/scienceinhealth.com\/newsletter\/\">Abonnez-vous gratuitement pour des articles de sant\u00e9 plus \u00e9clairants adapt\u00e9s \u00e0 vos besoins.<\/a><\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Notes de bas de page<\/strong><\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li>U.S. Food &amp; Drug Administration. \u00ab\u00a0La FDA approuve Briumvi pour les formes r\u00e9currentes de scl\u00e9rose en plaques.\u00a0\u00bb 28\u00a0d\u00e9cembre\u00a02022.<a href=\"https:\/\/www.fda.gov\"> FDA.gov<\/a>.&nbsp;<\/li>\n\n\n\n<li>National MS Society. \u00ab\u00a0Traitements modificateurs de la maladie pour la SEP\u00a0\u00bb<a href=\"https:\/\/www.nationalmssociety.org\"> NationalMSSociety.org<\/a>.<\/li>\n\n\n\n<li>TG Therapeutics. \u201cBriumvi: A New Anti-CD20 Therapy with 1-Hour Infusion.\u201d<a href=\"https:\/\/www.tgtherapeutics.com\"> TGtherapeutics.com<\/a>.<\/li>\n\n\n\n<li>Consortium of MS Centers. Press Statement, Jan 2023.<\/li>\n\n\n\n<li>Rocky Mountain MS Center. \u201cMS Drug Comparison Chart,\u201d 2023.<\/li>\n\n\n\n<li>ICER. \u201cPricing Assessment of Disease-Modifying Therapies for MS.\u201d 2023.<\/li>\n\n\n\n<li>Hauser SL et al. \u201cB-Cell Depletion in the Treatment of Multiple Sclerosis.\u201d <em>NEJM<\/em>, 2008.<\/li>\n\n\n\n<li>Fox EJ et al. \u201cMechanism of Action of Ublituximab in MS.\u201d <em>neurologie<\/em>, 2022.<\/li>\n\n\n\n<li>TG Therapeutics Product Label for Briumvi.<a href=\"https:\/\/www.tgtherapeutics.com\"> TGtherapeutics.com<\/a>.<\/li>\n\n\n\n<li>Steinman L, et al. \u201cUblituximab versus Teriflunomide in Relapsing MS.\u201d <em>New England Journal of Medicine<\/em>, 2022; 387:704\u2013714. <\/li>\n\n\n\n<li>Ibid., Supplemental Appendix, MRI Outcomes.<\/li>\n\n\n\n<li>Steinman L et al. NEDA Outcomes in ULTIMATE Trials. NEJM, 2022.<\/li>\n\n\n\n<li>FDA Advisory Committee Briefing Document. December 2022.<\/li>\n\n\n\n<li>ClinicalTrials.gov. \u201cULTIMATE I and II Long-Term Safety Extension.\u201d<a href=\"https:\/\/clinicaltrials.gov\"> ClinicalTrials.gov<\/a>.<\/li>\n\n\n\n<li>Tobias E. \u201cBriumvi&#8217;s Approval is a Big Deal for MS.\u201d <em>Multiple Sclerosis News Today<\/em>, Jan 2023.\\Hauser, S.\u202fL., Waubant, E., Arnold, D.\u202fL., Vollmer, T., Antel, J., Fox, R.\u202fJ., \u2026 et al. (2008). B-cell depletion with rituximab in relapsing\u2013remitting multiple sclerosis. New England Journal of Medicine, 358, 676\u2013688. <a href=\"https:\/\/doi.org\/10.1056\/NEJMoa0706383\">https:\/\/doi.org\/10.1056\/NEJMoa0706383<\/a><\/li>\n\n\n\n<li>Steinman, L., Fox, E.\u202fJ., Hartung, H.-P., Alexander, J.\u202fS., Ortiz, G., Chambers, C., \u2026 Cree, B.\u202fA. (2022). Ublituximab versus teriflunomide in relapsing multiple sclerosis. New England Journal of Medicine, 387, 704\u2013714. <a href=\"https:\/\/doi.org\/10.1056\/NEJMoa2201904\">https:\/\/doi.org\/10.1056\/NEJMoa2201904<\/a><\/li>\n\n\n\n<li>Alvarez, E., Steinman, L., Fox, E.\u202fJ., Hartung, H.-P., Qian, P., Wray, S., \u2026 Cree, B.\u202fA. C. (2024). Improvements in no evidence of disease activity with ublituximab vs. teriflunomide in the ULTIMATE phase 3 studies in relapsing multiple sclerosis. Frontiers in Neurology, 15, Article 1473284. <a href=\"https:\/\/doi.org\/10.3389\/fneur.2024.1473284\">https:\/\/doi.org\/10.3389\/fneur.2024.1473284<\/a><\/li>\n\n\n\n<li>van Langelaar, J., Rijvers, L., Smolders, J., van Luijn, M.\u202fM., Kramer, M., Bending, D., \u2026 van Horssen, J. (2020). B and T cells driving multiple sclerosis: identity, mechanisms and potential triggers. Frontiers in Immunology, 11, Article 760. <a href=\"https:\/\/doi.org\/10.3389\/fimmu.2020.00760\">https:\/\/doi.org\/10.3389\/fimmu.2020.00760<\/a><\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>A Therapy That Fits Into a Lunch Break Imagine treating multiple sclerosis with just a one-hour IV infusion twice&hellip;<\/p>","protected":false},"author":13,"featured_media":1694,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22,18],"tags":[131,132,130],"class_list":["post-2465","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-digital-therapeutics","category-health-tech","tag-briumvi","tag-new-ms-treatment","tag-tg-therapeutics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Approves Briumvi: A Game-Changing MS Therapy - Health Science Institute<\/title>\n<meta name=\"description\" content=\"TG Therapeutics\u2019 Briumvi earns FDA approval for relapsing MS\u2014offering a one-hour infusion with powerful relapse reduction.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Approves Briumvi: A Game-Changing MS Therapy - Health Science Institute\" \/>\n<meta property=\"og:description\" content=\"TG Therapeutics\u2019 Briumvi earns FDA approval for relapsing MS\u2014offering a one-hour infusion with powerful relapse reduction.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/staging.scienceinhealth.com\/fr\/fda-approval-multiple-sclerosis-therapy\/\" \/>\n<meta property=\"og:site_name\" content=\"Health Science Institute\" \/>\n<meta property=\"article:published_time\" content=\"2025-05-28T07:00:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-12-09T08:49:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/staging.scienceinhealth.com\/wp-content\/uploads\/2025\/04\/TG-Therapeutics.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"768\" \/>\n\t<meta property=\"og:image:height\" content=\"512\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"Dr Anne Therese Bernadette Laudato, MD\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Dr Anne Therese Bernadette Laudato, MD\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/staging.scienceinhealth.com\\\/fr\\\/fda-approval-multiple-sclerosis-therapy\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/staging.scienceinhealth.com\\\/fr\\\/fda-approval-multiple-sclerosis-therapy\\\/\"},\"author\":{\"name\":\"Dr Anne Therese Bernadette Laudato, MD\",\"@id\":\"https:\\\/\\\/staging.scienceinhealth.com\\\/de\\\/#\\\/schema\\\/person\\\/7ce8dda369f9cddd401a3b4c4778153b\"},\"headline\":\"FDA Approval: TG Therapeutics&#8217; 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