{"id":1711,"date":"2022-10-17T18:22:00","date_gmt":"2022-10-17T16:22:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1711"},"modified":"2024-03-23T13:02:33","modified_gmt":"2024-03-23T12:02:33","slug":"liecivo-rizankizumab-skyrizi-na-liecbu-pacientov-s-loziskovou-psoriazou","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/liecivo-rizankizumab-skyrizi-na-liecbu-pacientov-s-loziskovou-psoriazou\/","title":{"rendered":"1: Lie\u010divo rizankizumab (Skyrizi) na lie\u010dbu pacientov s lo\u017eiskovou psori\u00e1zou"},"content":{"rendered":"
    \n
  1. O ak\u00fd liek ide?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Skyrizi (\u00fa\u010dinn\u00e1 l\u00e1tka rizankizumab) je monoklon\u00e1lna protil\u00e1tka, ktor\u00e1 m\u00e1 zmier\u0148ova\u0165 prejavy psori\u00e1zy. Pod\u00e1va sa podko\u017ene injekciou do stehna, alebo brucha v 0. t\u00fd\u017edni, v 4. t\u00fd\u017edni a n\u00e1sledne ka\u017ed\u00fdch 12 t\u00fd\u017ed\u0148ov. <\/p>\n\n\n\n

    Liek bol registrovan\u00fd v Eur\u00f3pskej liekovej agent\u00fare (European Medicines Agency, EMA) v roku 2019 na lie\u010dbu stredne z\u00e1va\u017enej a\u017e z\u00e1va\u017enej lo\u017eiskovej psori\u00e1zy a akt\u00edvnej psoriatickej artrit\u00eddy. Lie\u010dbu m\u00f4\u017ee indikova\u0165 dermatol\u00f3g. Liek Skyrizi je aktu\u00e1lne na Slovensku prepl\u00e1can\u00fd, av\u0161ak farmaceutick\u00e1 firma po\u017eiadala o vy\u0161\u0161iu \u00fahradu za liek. <\/p>\n\n\n\n

      \n
    1. \u010co je z\u00e1\u0165a\u017e ochorenia pre pacienta? Ako je z\u00e1sadn\u00e9?<\/strong><\/li>\n<\/ol>\n\n\n\n

      Psori\u00e1za je chronick\u00e9 z\u00e1palov\u00e9 ko\u017en\u00e9 ochorenie, ktor\u00e9 sa m\u00f4\u017ee prejavi\u0165 lo\u017eiskami na ko\u017ei ve\u013ekosti 1 \u2013 10 cm s prekr\u00fdvaj\u00facimi sa \u0161upinkami. Lo\u017eisk\u00e1 m\u00f4\u017eu by\u0165 asymptomatick\u00e9, ale \u010dasto je pr\u00edtomn\u00e9 svrbenie a pri postihnut\u00ed dlan\u00ed a piat m\u00f4\u017ee d\u00f4js\u0165 k bolestivej praskline ko\u017ee. <\/p>\n\n\n\n

      V s\u00fa\u010dasnosti sa psori\u00e1za pova\u017euje za komplexn\u00e9 multisyst\u00e9mov\u00e9 ochorenie sprostredkovan\u00e9 imunitou. Trp\u00ed n\u00edm 0,5 \u2013 11,4 % dospelej popul\u00e1cie a plat\u00ed, \u017ee \u010d\u00edm \u010falej od rovn\u00edka, t\u00fdm je v\u00fdskyt \u010dastej\u0161\u00ed. <\/p>\n\n\n\n

      Diagn\u00f3za je vo v\u00e4\u010d\u0161ine pr\u00edpadov zalo\u017een\u00e1 na vy\u0161etren\u00ed pacienta doplnenom o rodinn\u00fa anamn\u00e9zu. U \u010dasti pacientov s nejasn\u00fdm n\u00e1lezom je mo\u017en\u00e9 doplni\u0165 vy\u0161etrenie biopsiou ko\u017ee. Pod\u013ea pacientskej organiz\u00e1cie OZ Bodk\u00e1\u010dik trv\u00e1 stanovenie diagn\u00f3zy a nastavenie lie\u010dby na Slovensku dlho. <\/p>\n\n\n\n

        \n
      1. Ako sa na rizankizumab pozeraj\u00fa odborn\u00edci? <\/strong><\/li>\n<\/ol>\n\n\n\n

        Odborn\u00edci o\u010dak\u00e1vaj\u00fa od rizankizumabu vy\u0161\u0161iu \u00fa\u010dinnos\u0165 v zni\u017eovan\u00ed z\u00e1va\u017enost\u00ed sympt\u00f3mov psori\u00e1zy oproti porovnate\u013en\u00fdm liekom. Ako pozit\u00edvum hodnotia ukazovatele ako napr\u00edklad r\u00fdchlos\u0165 n\u00e1stupu \u00fa\u010dinku, kr\u00e1tkodob\u00fa aj dlhodob\u00fa \u00fa\u010dinnos\u0165, bezpe\u010dnos\u0165 alebo efekt na viacer\u00e9 dom\u00e9ny, nielen na ko\u017eu. <\/p>\n\n\n\n

        Pod\u013ea pacientskej organiz\u00e1cie OZ Bodk\u00e1\u010dik prin\u00e1\u0161a rizankizumab zlep\u0161enie stavu, zlep\u0161enie v\u00fdkonu \u010dinnost\u00ed pacienta a odb\u00faranie starostlivosti pri o\u0161etrovan\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

          Pod\u013ea NIHO je rizankizumab v zni\u017eovan\u00ed rozsahu a z\u00e1va\u017enosti psori\u00e1zy v klinicky relevantn\u00fdch ukazovate\u013eoch \u0161tatisticky v\u00fdznamne \u00fa\u010dinnej\u0161\u00ed oproti porovn\u00e1van\u00fdm lie\u010div\u00e1m. D\u00f4kazy o tomto \u00fa\u010dinku v\u0161ak maj\u00fa metodologick\u00e9 nedostatky a \u010diasto\u010dn\u00e9 rozdiely v zahrnutej popul\u00e1cii. Nie s\u00fa dostupn\u00e9 d\u00f4kazy dostato\u010dnej kvality o zv\u00fd\u0161en\u00ed kvality \u017eivota pacienta pri lie\u010dbe rizankizumabom. <\/p>\n\n\n\n

          Klinick\u00fd pr\u00ednos rizankizumabu dr\u017eite\u013e registr\u00e1cie preukazuje nepriamym porovnan\u00edm s dne\u0161nou lie\u010dbou lo\u017eiskovej psori\u00e1zy, ktor\u00e9 m\u00e1 metodologick\u00e9 nedostatky a teda je spojen\u00e1 s ur\u010ditou miernou neistotou.<\/p>\n\n\n\n

          NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti na zv\u00fd\u0161enie ceny<\/strong> za balenie v indik\u00e1cii lie\u010dby pacientov s lo\u017eiskovou psori\u00e1zou. Naopak, v s\u00falade s novelou z\u00e1kona 363\/2011 Z.z. z 01.08.2022 NIHO odpor\u00fa\u010da, aby dr\u017eite\u013e registr\u00e1cie upravil po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak<\/strong>, aby sp\u013a\u0148ala krit\u00e9ria n\u00e1kladovej efekt\u00edvnosti pod\u013ea \u00a77 predmetn\u00e9ho z\u00e1kona. <\/p>","protected":false},"excerpt":{"rendered":"

          Skyrizi (\u00fa\u010dinn\u00e1 l\u00e1tka rizankizumab) je monoklon\u00e1lna protil\u00e1tka, ktor\u00e1 m\u00e1 zmier\u0148ova\u0165 prejavy psori\u00e1zy. Pod\u00e1va sa podko\u017ene injekciou do stehna, alebo brucha v 0. t\u00fd\u017edni, v 4. t\u00fd\u017edni a n\u00e1sledne ka\u017ed\u00fdch 12 t\u00fd\u017ed\u0148ov.  Liek bol registrovan\u00fd v Eur\u00f3pskej liekovej agent\u00fare (European Medicines Agency, EMA) v roku 2019 na lie\u010dbu stredne z\u00e1va\u017enej a\u017e z\u00e1va\u017enej lo\u017eiskovej psori\u00e1zy a akt\u00edvnej psoriatickej artrit\u00eddy. […]<\/p>\n","protected":false},"author":3,"featured_media":1713,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[13,12],"class_list":["post-1711","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-rizankizumab","tag-skyrizi"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1711","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=1711"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1711\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1713"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1711"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1711"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1711"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}