{"id":4264,"date":"2025-08-02T11:30:03","date_gmt":"2025-08-02T08:30:03","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=4264"},"modified":"2025-08-02T12:04:33","modified_gmt":"2025-08-02T09:04:33","slug":"high-anti-aav-antibodies-may-not-prevent-elevidys-administration","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/tr\/high-anti-aav-antibodies-may-not-prevent-elevidys-administration\/","title":{"rendered":"Y\u00fcksek Anti-AAV Antikorlar\u0131 Art\u0131k Elevidys Uygulamas\u0131na Engel Olmayabilir"},"content":{"rendered":"<p class=\"wp-block-paragraph\">Duchenne kas distrofisi hastal\u0131\u011f\u0131 i\u00e7in geli\u015ftirilen Elevidys gen terapisinin uygulanmas\u0131n\u0131n \u00f6n\u00fcndeki en \u00f6nemli engellerden biri, y\u00fcksek anti-AAV antikorlar\u0131d\u0131r. Hansa Biopharma, Duchenne kas distrofisi i\u00e7in gen terapisi uygulanmadan \u00f6nce imlifidaz tedavisinden elde edilen destekleyici verileri ortaya koymaktad\u0131r. \u00dc\u00e7 hastada imlifidaz tedavisinin ard\u0131ndan, mevcut anti-AAV antikorlar\u0131 1:400 titrenin alt\u0131na d\u00fc\u015ferek ELEVIDYS tedavisine olanak sa\u011flam\u0131\u015ft\u0131r.<\/p>\n\n\n\n<div class=\"wp-block-rank-math-toc-block\" id=\"rank-math-toc\"><h2>\u0130\u00e7indekiler<\/h2><nav><ul><li><a href=\"#hansa-biopharma-reports-encouraging-results-from-imlifidase-treatment\">Hansa Biopharma, imlifidase&#039;dan cesaret verici sonu\u00e7lar bildiriyor<\/a><\/li><li><a href=\"#what-does-imlifidase-do-in-gene-therapies\">\u0130mlifidaz Gen Terapilerinde Ne Yapar?<\/a><\/li><li><a href=\"#what-is-the-srp-9001-104-clinical-trial\">SRP-9001-104 Klinik Ara\u015ft\u0131rmas\u0131 Nedir?<\/a><\/li><\/ul><\/nav><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">Hansa Biopharma, SRP-9001-104 denemesinde Sarepta&#039;n\u0131n ELEVIDYS&#039;ini (delandistrogene moxeparvovec-rokl) almadan \u00f6nce Hansa&#039;n\u0131n imlifidaz\u0131yla tedavi edilen Duchenne kas distrofisi (DMD) olan \u00fc\u00e7 hastadan elde edilen \u00f6nemli sonu\u00e7lar\u0131 duyurdu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hansa-biopharma-reports-encouraging-results-from-imlifidase-treatment\">Hansa Biopharma, imlifidase&#039;dan cesaret verici sonu\u00e7lar bildiriyor<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Tek doz imlifidaz uygulamas\u0131ndan sonra, \u00fc\u00e7 hastada IgG antikorlar\u0131nda h\u0131zl\u0131 bir d\u00fc\u015f\u00fc\u015f g\u00f6zlemlendi ve ba\u015flang\u0131\u00e7 seviyesinden \u226595% seviyelerine indi. Ayr\u0131ca, bu \u00fc\u00e7 hastada \u00f6nceden var olan anti-AAV antikorlar\u0131 1:400 titresinin alt\u0131na d\u00fc\u015ft\u00fc ve bu da ELEVIDYS tedavisine olanak sa\u011flad\u0131.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u0130mlifidaz\u0131n g\u00fcvenlik profili \u00f6nceki deneyimlerle uyumluydu ve \u00e7al\u0131\u015fma herhangi bir yeni g\u00fcvenlik sinyali \u00fcretmedi. Gen tedavisinin uygulanmas\u0131ndan on iki hafta sonra, \u00e7al\u0131\u015fmadaki hastalarda AAV arac\u0131l\u0131 transd\u00fcksiyon ve mikro-distrofin ekspresyonuna dair kan\u0131tlar g\u00f6r\u00fcld\u00fc, ancak bu seviyeler ELEVIDYS ile yap\u0131lan di\u011fer \u00e7al\u0131\u015fmalarda g\u00f6r\u00fclenlerden daha d\u00fc\u015f\u00fckt\u00fc. Bu sonu\u00e7lara dayanarak, Hansa ve Sarepta program i\u00e7in uygun sonraki ad\u0131mlar\u0131 tart\u0131\u015facakt\u0131r.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-does-imlifidase-do-in-gene-therapies\">\u0130mlifidaz Gen Terapilerinde Ne Yapar?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u0130mlifidase \u015fu anda kar\u015f\u0131lanmam\u0131\u015f ihtiyac\u0131n y\u00fcksek oldu\u011fu b\u00f6lgelerde gen tedavisine \u00f6n tedavi olarak de\u011ferlendiriliyor.<\/strong> Bir\u00e7ok gen terapisi, Adeno \u0130li\u015fkili Vir\u00fcs (AAV) vekt\u00f6rlerinin kullan\u0131m\u0131na dayanmaktad\u0131r. Baz\u0131 hastalarda ba\u011f\u0131\u015f\u0131kl\u0131k sistemi, gen terapisi tedavisinin ba\u015far\u0131s\u0131n\u0131 engelleyen antikorlar ta\u015f\u0131r. AAV bazl\u0131 gen terapisinden \u00f6nce imlifidaz ile \u00f6n tedavi, antikorlar\u0131 inaktive etme ve b\u00f6ylece AAV bazl\u0131 gen terapilerine kar\u015f\u0131 \u00f6nceden antikorlar\u0131 olan hastalarda gen terapisini m\u00fcmk\u00fcn k\u0131lma potansiyeline sahiptir. G\u00fcn\u00fcm\u00fczde, NAb&#039;lerin ortalama olarak her 3 ki\u015fiden 1&#039;inin gen terapisi tedavilerinden faydalanmas\u0131n\u0131 engelledi\u011fi tahmin edilmektedir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"what-is-the-srp-9001-104-clinical-trial\">SRP-9001-104 Klinik Ara\u015ft\u0131rmas\u0131 Nedir?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>SRP-9001-104, ELEVIDYS&#039;e kar\u015f\u0131 \u00f6nceden antikorlar\u0131 olan, d\u00f6rt ila dokuz ya\u015f aras\u0131ndaki ayaktan DMD&#039;li erkek hastalar \u00fczerinde yap\u0131lan a\u00e7\u0131k etiketli bir \u00e7al\u0131\u015fmad\u0131r.<\/strong> Alt\u0131 hastaya kadar imlifidaz ve ard\u0131ndan ELEVIDYS tedavisi uygulanacakt\u0131r. \u00c7al\u0131\u015fmaya dahil edilen t\u00fcm hastalar, Sarepta&#039;n\u0131n gen tedavisini uygulamak i\u00e7in kullan\u0131lan vekt\u00f6r olan AAVrh74&#039;\u00fc hedef alan antikorlar\u0131n varl\u0131\u011f\u0131 nedeniyle \u015fu anda ELEVIDYS tedavisi almaya uygun de\u011fildir.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Daha fazla bilgi edin: <a href=\"https:\/\/dmdwarrior.com\/tr\/frequently-asked-questions-about-elevidys-used-for-duchenne-muscular-dystrophy\/\">Elevidys Hakk\u0131nda S\u0131k\u00e7a Sorulan Sorular<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>One of the most significant obstacles to the application of Elevidys gene therapy developed for Duchenne muscular dystrophy disease is the high anti-AAV antibodies. Hansa Biopharma announces supportive data from treatment with imlifidase prior to the administration of gene therapy for Duchenne muscular dystrophy. Following imlifidase therapy in three patients, pre-existing anti-AAV antibodies decreased to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4270,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[33,61,401,400,65],"class_list":["post-4264","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-elevidys","tag-gene-therapy","tag-hansa-biopharma","tag-imlifidase","tag-sarepta"],"subtitle":"Hansa Biopharma'nin IgG inaktive edici tedavisi olan \u0130mlifidaz, gen tedavilerinin uygulanmas\u0131n\u0131 engelleyen y\u00fcksek anti-AAV antikorlar\u0131n\u0131 d\u00fc\u015f\u00fcrebilir. Bu, imlifidaz\u0131n hem IgG hem de mevcut anti-AAV antikorlar\u0131n\u0131 \u00f6nemli \u00f6l\u00e7\u00fcde d\u00fc\u015f\u00fcrerek hastalar\u0131n Elevidys gen tedavisi almas\u0131na olanak sa\u011flayabilece\u011fi anlam\u0131na gelir.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/4264","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/comments?post=4264"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/posts\/4264\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media\/4270"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/media?parent=4264"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/categories?post=4264"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/tr\/wp-json\/wp\/v2\/tags?post=4264"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}