{"id":1952,"date":"2024-01-26T17:10:00","date_gmt":"2024-01-26T16:10:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1952"},"modified":"2024-04-10T17:14:29","modified_gmt":"2024-04-10T15:14:29","slug":"54b-liecivo-upadacitinib-rinvoq-na-liecbu-dospelych-pacientov-so-stredne-tazkou-az-tazkou-aktivnou-crohnovou-chorobou-po-predoslej-konvencnej-a-biologickej-liecbe","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/54b-liecivo-upadacitinib-rinvoq-na-liecbu-dospelych-pacientov-so-stredne-tazkou-az-tazkou-aktivnou-crohnovou-chorobou-po-predoslej-konvencnej-a-biologickej-liecbe\/","title":{"rendered":"54B: Lie\u010divo upadacitinib (Rinvoq) na lie\u010dbu dospely\u0301ch pacientov so stredne \u0165a\u017ekou a\u017e \u0165a\u017ekou akt\u00edvnou Crohnovou chorobou po predo\u0161lej konven\u010dnej a biologickej lie\u010dbe"},"content":{"rendered":"
    \n
  1. Ak\u00e1 je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako z\u00e1sadn\u00e9 je ochorenie?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Crohnova choroba (z angl. Crohn’s disease, CD) je chronick\u00e9 z\u00e1palov\u00e9 ochorenia, ktor\u00e9 sa m\u00f4\u017ee vyskytn\u00fa\u0165 v akejko\u013evek \u010dasti gastrointestin\u00e1lneho traktu (z angl. inflammatory bowel disease, IBD). Charakteristick\u00fdm znakom CD je vznik fok\u00e1lnych, (peri)transmur\u00e1lnych, \u010di granulomat\u00f3znych z\u00e1palov, ktor\u00e9 sprev\u00e1dzaj\u00fa symptomatick\u00e9 prejavy naj\u010dastej\u0161ie vo forme bolesti \u017eal\u00fadka, krvavej stolice, hna\u010diek \u010di straty telesnej hmotnosti. Ochorenie postihuje najm\u00e4 \u013eud\u00ed v produkt\u00edvnom veku a v\u00fdrazne im zni\u017euje kvalitu \u017eivota.<\/p>\n\n\n\n

      \n
    1. O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n

      Upadacitinib m\u00e1 ma\u0165 imunosupres\u00edvne (potl\u00e1\u010daj\u00face imunitn\u00fa reakciu) \u00fa\u010dinky a m\u00e1 p\u00f4sobi\u0165 na Janusovej kin\u00e1zy (JAK) s preferenciou pre JAK1 alebo JAK1\/JAK3. Proz\u00e1palov\u00e9 cytok\u00edny JAK s\u00fa s\u00fa\u010das\u0165ou patol\u00f3gie z\u00e1palov\u00fdch ochoren\u00ed \u010driev, upadacitinib m\u00e1 blokovan\u00edm JAK zmier\u0148ova\u0165 prejavy z\u00e1palu.<\/p>\n\n\n\n

      Eur\u00f3pska liekov\u00e1 agent\u00fara (z angl. European Medicines Agency, EMA) odporu\u010dila schv\u00e1lenie lieku Rinvoq v okt\u00f3bri 2019.<\/p>\n\n\n\n

        \n
      1. Ako sa na hodnoten\u00e9 lie\u010divo pozeraj\u00fa odborn\u00edci?\u00a0<\/strong><\/li>\n<\/ol>\n\n\n\n

        Osloven\u00fd odborn\u00edk sa vyjadril, \u017ee implement\u00e1cia lie\u010diva bude pr\u00ednosom v lie\u010dbe CD na Slovensku. Upadacitinib predstavuje pod\u013ea odborn\u00edka zatia\u013e jedin\u00fd JAK inhib\u00edtor, ktor\u00fd preuk\u00e1zal v\u00fdznamn\u00fa klinick\u00fa \u00fa\u010dinnos\u0165 v lie\u010dbe CD v randomizovan\u00fdch kontrolovan\u00fdch \u0161t\u00fadiach (U-EXCEED, U-EXCEL a U-ENDURE) a to u biologicky naivn\u00fdch pacientov ako aj u pacientov po zlyhanej predch\u00e1dzaj\u00facej biologickej lie\u010dbe.<\/p>\n\n\n\n

          \n
        1. \u010co hodnotilo NIHO a ak\u00fd je v\u00fdsledok?<\/strong><\/li>\n<\/ol>\n\n\n\n

          Dr\u017eite\u013e registr\u00e1cie (AbbVie Deutschland GmbH & Co. KG (DEU)) podal \u017eiados\u0165 o zaradenie lie\u010diva upadacitinib (Rinvoq) na lie\u010dbu dospel\u00fdch pacientov so stredne \u0165a\u017ekou a\u017e \u0165a\u017ekou akt\u00edvnou Crohnovou chorobou po predo\u0161lej konven\u010dnej a biologickej lie\u010dbe.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Rinvoq v predmetnej indik\u00e1ci\u00ed, pokia\u013e dr\u017eite\u013e registr\u00e1cie uprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby sp\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti.<\/p>\n\n\n\n

          V\u00fdsledok hodnotenia n\u00e1kladovej efekt\u00edvnosti je aj pri uvedenej \u00fahrade spojen\u00fd s vysokou mierou neistoty, \u017ee v klinickej praxi nebud\u00fa splnen\u00e9 krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti. NIHO preto odpor\u00fa\u010da po\u017eadova\u0165 od dr\u017eite\u013ea registr\u00e1cie adekv\u00e1tnu dodato\u010dn\u00fa z\u013eavu, ktor\u00e1 zn\u00ed\u017ei t\u00fato neistotu.<\/p>","protected":false},"excerpt":{"rendered":"

          NIHO odpor\u00fa\u010da vyhovie\u0165 \u017eiadosti o kategorizovanie lieku Rinvoq v predmetnej indik\u00e1ci\u00ed, pokia\u013e…<\/p>","protected":false},"author":3,"featured_media":1953,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[137,136],"class_list":["post-1952","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-rinvoq","tag-upadacitinib"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1952","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1952"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1952\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1953"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1952"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1952"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1952"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}