{"id":1955,"date":"2024-01-26T17:14:00","date_gmt":"2024-01-26T16:14:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1955"},"modified":"2024-04-10T17:55:51","modified_gmt":"2024-04-10T15:55:51","slug":"54a-liecivo-upadacitinib-rinvoq-na-liecbu-dospelych-pacientov-so-stredne-tazkou-az-tazkou-aktivnou-ulceroznou-kolitidou-po-predoslej-konvencnej-a-biologickej-liecbe","status":"publish","type":"post","link":"https:\/\/niho.sk\/en\/54a-liecivo-upadacitinib-rinvoq-na-liecbu-dospelych-pacientov-so-stredne-tazkou-az-tazkou-aktivnou-ulceroznou-kolitidou-po-predoslej-konvencnej-a-biologickej-liecbe\/","title":{"rendered":"54A: Lie\u010divo upadacitinib (Rinvoq) na lie\u010dbu dospel\u00fdch pacientov so stredne \u0165a\u017ekou a\u017e \u0165a\u017ekou akt\u00edvnou ulcer\u00f3znou kolit\u00eddou 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

    Ulcer\u00f3zna kolit\u00edda (UC) je chronick\u00e9 z\u00e1palov\u00e9 ochorenie \u010driev, charakterizovan\u00e9 dif\u00faznym slizni\u010dn\u00fdm z\u00e1palom ohrani\u010den\u00fdm na muk\u00f3zu rekta a hrub\u00e9ho \u010dreva. Presn\u00e1 pr\u00ed\u010dina ochorenia je doteraz nezn\u00e1ma, predpoklad\u00e1 sa v\u0161ak, \u017ee je v\u00fdsledkom naru\u0161enia zdravej rovnov\u00e1hy muk\u00f3znej imunity a enterickej mikrofl\u00f3ry. UC m\u00f4\u017ee vznikn\u00fa\u0165 v akomko\u013evek veku, m\u00e1 v\u0161ak dva vekov\u00e9 vrcholy vzniku medzi 15 a\u017e 30 rokmi a n\u00e1sledne men\u0161\u00ed vrchol je aj vo veku 50 a\u017e 70 rokov. Priebeh ochorenia je charakterizovan\u00fd n\u00e1razovou periodicitou s \u0165a\u017eko predv\u00eddate\u013en\u00fdm vznikom relapsu a remisie. UC je chronick\u00e9 ochorenie, jeho priebeh sa m\u00f4\u017ee pohybova\u0165 od neakt\u00edvneho ochorenia (remisia) po chronick\u00e9 refrakt\u00e9rne ochorenie s potenci\u00e1lom progresie ochorenia v priebehu \u010dasu. Medzi naj\u010dastej\u0161ie klinick\u00e9 pr\u00edznaky patr\u00ed krvav\u00e1 hna\u010dka, bolesti brucha, nutkanie na stolicu alebo tenezmy. Pribli\u017ene u 20 \u2013 30 % pacientov s UC bude potrebn\u00fd chirurgick\u00fd z\u00e1krok v priebehu \u017eivota. Akt\u00edvne ochorenie UC vytv\u00e1ra ve\u013ek\u00fa z\u00e1\u0165a\u017e na pacientov po fyzickej aj psychickej str\u00e1nke m\u00e1 tie\u017e \u010dasto v\u00fdrazn\u00fd dopad na osobn\u00fd, spolo\u010densk\u00fd a pracovn\u00fd \u017eivot pacienta. <\/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

        Odborn\u00edk sa vo vstupe vyjadril, \u017ee schv\u00e1lenie roz\u0161\u00edrenia indik\u00e1cie UPA by viedlo k roz\u0161\u00edreniu obmedzen\u00fdch mo\u017enost\u00ed lie\u010dby pacientov s UC, najm\u00e4 pacientov po zlyhan\u00ed predo\u0161l\u00fdch terapeutick\u00fdch l\u00edni\u00ed.<\/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 ulcer\u00f3znou kolit\u00eddou 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 so strednou 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],"class_list":["post-1955","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-rinvoq"],"_links":{"self":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1955","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/comments?post=1955"}],"version-history":[{"count":0,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/posts\/1955\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media\/1953"}],"wp:attachment":[{"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1955"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1955"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1955"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}