{"id":37249,"date":"2022-05-06T15:36:58","date_gmt":"2022-05-06T19:36:58","guid":{"rendered":"https:\/\/wfh.org\/pfizer-sangamo-therapeutics-report-severe-adverse-event-sae-from-phase-3-affine-haemophilia-a-gene-therapy-study\/"},"modified":"2024-04-12T09:56:10","modified_gmt":"2024-04-12T13:56:10","slug":"pfizer-sangamo-therapeutics-signalent-un-evenement-indesirable-grave-dans-letude-affine-de-phase-iii-portant-sur-la-therapie-genique-dans-lhemophilie-a","status":"publish","type":"post","link":"https:\/\/wfh.org\/fr\/article\/pfizer-sangamo-therapeutics-signalent-un-evenement-indesirable-grave-dans-letude-affine-de-phase-iii-portant-sur-la-therapie-genique-dans-lhemophilie-a\/","title":{"rendered":"Pfizer\/Sangamo Therapeutics signalent un \u00e9v\u00e9nement ind\u00e9sirable grave dans l\u2019\u00e9tude AFFINE de phase III portant sur la th\u00e9rapie g\u00e9nique dans l\u2019h\u00e9mophilie A"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"37249\" class=\"elementor elementor-37249 elementor-36613\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-487fc85 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"487fc85\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ea3f908\" data-id=\"ea3f908\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa6c1e1 gallery-spacing-custom elementor-widget elementor-widget-image-gallery\" data-id=\"aa6c1e1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image-gallery.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-image-gallery\">\n\t\t\t<div id='gallery-1' class='gallery galleryid-37249 gallery-columns-3 gallery-size-full'><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon landscape'>\n\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"770\" height=\"350\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/EHC.png\" class=\"attachment-full size-full\" alt=\"Logo European haemophilia consortium\" srcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/EHC.png 770w, https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/EHC-300x136.png 300w, https:\/\/wfh.org\/wp-content\/uploads\/2022\/01\/EHC-768x349.png 768w\" sizes=\"(max-width: 770px) 100vw, 770px\" \/>\n\t\t\t<\/div><\/figure><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon landscape'>\n\t\t\t\t<img decoding=\"async\" width=\"600\" height=\"300\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/12\/NHF-logo.png\" class=\"attachment-full size-full\" alt=\"\" srcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/12\/NHF-logo.png 600w, https:\/\/wfh.org\/wp-content\/uploads\/2021\/12\/NHF-logo-300x150.png 300w\" sizes=\"(max-width: 600px) 100vw, 600px\" \/>\n\t\t\t<\/div><\/figure><figure class='gallery-item'>\n\t\t\t<div class='gallery-icon landscape'>\n\t\t\t\t<img decoding=\"async\" width=\"1277\" height=\"603\" src=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/04\/WFH-trilingual-logo-EN.png\" class=\"attachment-full size-full\" alt=\"\" aria-describedby=\"gallery-1-29974\" srcset=\"https:\/\/wfh.org\/wp-content\/uploads\/2021\/04\/WFH-trilingual-logo-EN.png 1277w, https:\/\/wfh.org\/wp-content\/uploads\/2021\/04\/WFH-trilingual-logo-EN-192x91.png 192w, https:\/\/wfh.org\/wp-content\/uploads\/2021\/04\/WFH-trilingual-logo-EN-768x363.png 768w\" sizes=\"(max-width: 1277px) 100vw, 1277px\" \/>\n\t\t\t<\/div>\n\t\t\t\t<figcaption class='wp-caption-text gallery-caption' id='gallery-1-29974'>\n\t\t\t\tstock\n\t\t\t\t<\/figcaption><\/figure>\n\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e4eb854 elementor-widget elementor-widget-text-editor\" data-id=\"e4eb854\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"\">Le giroctocog\u00e8ne fitelparvovec (SB-525 ou PF-07055480) est un essai de th\u00e9rapie g\u00e9nique pour le traitement de l\u2019h\u00e9mophilie A en cours de d\u00e9veloppement par Pfizer\/Sangamo Therapeutics. L\u2019\u00e9tude de phase III AFFINE (<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04370054\" target=\"_blank\" rel=\"noopener\">NCT04370054<\/a>) est une \u00e9tude multicentrique en ouvert, \u00e0 un seul bras, visant \u00e0 \u00e9valuer l\u2019efficacit\u00e9 et la s\u00e9curit\u00e9 d\u2019une perfusion unique de giroctocog\u00e8ne fitelparvovec chez plus d\u2019une cinquantaine de participants adultes de sexe masculin (\u00e2g\u00e9s de 18 \u00e0 64 ans) atteints d\u2019h\u00e9mophilie A mod\u00e9r\u00e9ment s\u00e9v\u00e8re \u00e0 s\u00e9v\u00e8re. Il s\u2019agit d\u2019un virus ad\u00e9noassoci\u00e9 (AAV) d\u00e9livrant le g\u00e8ne du facteur VIII d\u00e9l\u00e9t\u00e9 du domaine B.<\/p>\n<p class=\"\">Pfizer a indiqu\u00e9 que le participant ayant d\u00e9velopp\u00e9 une TVP pr\u00e9sentait des ant\u00e9c\u00e9dents d\u2019\u00e9v\u00e9nements thrombotiques avant sa participation \u00e0 l\u2019\u00e9tude, facteur de risque connu des \u00e9v\u00e9nements ult\u00e9rieurs et crit\u00e8re d\u2019exclusion pour la participation \u00e0 AFFINE. Ce patient n\u2019aurait pas d\u00fb prendre part \u00e0 l\u2019\u00e9tude, mais ces \u00e9v\u00e9nements peuvent parfois survenir et sont d\u00e9sign\u00e9s par le terme \u00ab \u00e9cart par rapport au protocole \u00bb. Le cas a \u00e9t\u00e9 \u00e9valu\u00e9 afin de comprendre tous les facteurs potentiels y ayant contribu\u00e9, notamment les doses manqu\u00e9es d\u2019anticoagulants oraux directs prescrits par l\u2019investigateur. Le patient va bien. Pfizer a communiqu\u00e9 ces informations aux investigateurs de l\u2019\u00e9tude, aux autorit\u00e9s de sant\u00e9 et au comit\u00e9 de surveillance des donn\u00e9es (DMC) externe ind\u00e9pendant. Pfizer a en outre r\u00e9pondu aux demandes des autorit\u00e9s de sant\u00e9. La F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie (FMH), le Consortium europ\u00e9en de l\u2019h\u00e9mophilie (EHC) et la <em>National Hemophilia Foundation<\/em> (NHF) font part de cette information accessible au public. La discussion pourrait se poursuivre lors du World Congress 2022 de la F\u00e9d\u00e9ration mondiale de l\u2019h\u00e9mophilie au cours de l\u2019atelier intitul\u00e9 <em>Coagulation Product Safety, Supply, and Access: Current treatment landscape: Part 1 of 2: Safety and efficacy<\/em>, qui se d\u00e9roulera le dimanche 8 mai.<\/p>\n<p class=\"\">En novembre 2021, la FDA a prononc\u00e9 la suspension clinique d\u2019AFFINE, suite \u00e0 la suspension volontaire de Pfizer, afin de proc\u00e9der \u00e0 une modification du protocole en cons\u00e9quence de taux de facteur VIII sup\u00e9rieurs \u00e0 150 % chez certains participants. La modification du protocole avait pour but de fournir des lignes directrices pour la prise en charge clinique de taux de facteur VIII \u00e9lev\u00e9s. Peu apr\u00e8s ces \u00e9v\u00e9nements, en novembre 2021, l\u2019EHC, la FMH et la NHF ont <a href=\"https:\/\/www.ehc.eu\/fda-places-the-pfizer-sangamo-therapeutics-phase-3-affine-haemophilia-a-gene-therapy-study-on-clinical-hold\/\" target=\"_blank\" rel=\"noopener\">communiqu\u00e9<\/a> conjointement sur cette suspension.<\/p>\n<p class=\"\">En mars 2022, la FDA a lev\u00e9 la suspension clinique susmentionn\u00e9e sur l\u2019\u00e9tude AFFINE de phase III. Pfizer a alors fait savoir qu\u2019il maintenait sa suspension volontaire tant que toutes les conditions n\u00e9cessaires n\u2019\u00e9taient pas r\u00e9unies, y compris la validation des protocoles d\u2019\u00e9tude mis \u00e0 jour par les autorit\u00e9s r\u00e9glementaires.<\/p>\n<p class=\"\">La surveillance des probl\u00e8mes de s\u00e9curit\u00e9 pour une technologie nouvelle comme la th\u00e9rapie g\u00e9nique est essentielle pour notre communaut\u00e9. \u00c0 cette fin, le Registre de la th\u00e9rapie g\u00e9nique est en cours de d\u00e9veloppement pour enregistrer la plupart ou l\u2019ensemble des patients recevant une th\u00e9rapie g\u00e9nique \u00e0 mesure que ces produits sont autoris\u00e9s.<\/p>\n<p class=\"\">Les trois organisations continueront \u00e0 tenir la communaut\u00e9 des patients inform\u00e9e des d\u00e9veloppements pertinents \u00e0 venir en faveur de la mise en place et du besoin \u00e9vident d\u2019un registre mondial d\u00e9di\u00e9 aux patients sous th\u00e9rapie g\u00e9nique afin de faciliter la distinction entre signal de s\u00e9curit\u00e9 et risque de base.<\/p>\n<p class=\"\">Nous recommandons \u00e0 nos membres de contacter leur m\u00e9decin traitant et le centre de traitement de l\u2019h\u00e9mophilie pour toute autre question qu\u2019ils pourraient avoir.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7469f87 elementor-widget elementor-widget-spacer\" data-id=\"7469f87\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>5 mai 2022 \u2013 Pfizer\/Sangamo Therapeutics indiquent avoir eu connaissance d\u2019un \u00e9v\u00e9nement ind\u00e9sirable grave, \u00e0 savoir une thrombose veineuse profonde (TVP) infrapoplit\u00e9e chez un participant \u00e0 l\u2019essai clinique sur le giroctocog\u00e8ne fitelparvovec dont les taux de facteur VIII \u00e9taient \u00e9lev\u00e9s. \u00ab \u00c9v\u00e9nement ind\u00e9sirable grave \u00bb (EIG) est le terme utilis\u00e9 pour d\u00e9crire la survenue d\u2019un probl\u00e8me de sant\u00e9 grave au cours d\u2019une \u00e9tude, que le traitement exp\u00e9rimental en soit ou non \u00e0 l\u2019origine.<\/p>\n","protected":false},"author":3,"featured_media":30514,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[197],"tags":[],"search-category":[85],"class_list":["post-37249","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-declarations-publiques-et-recommandations-de-la-fmh","search-category-article"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - 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