{"id":1721,"date":"2022-09-16T18:42:00","date_gmt":"2022-09-16T16:42:00","guid":{"rendered":"https:\/\/niho.sk\/?p=1721"},"modified":"2024-03-23T13:07:06","modified_gmt":"2024-03-23T12:07:06","slug":"liecivo-daratumumab-darzalex-2","status":"publish","type":"post","link":"https:\/\/www.niho.sk\/en\/liecivo-daratumumab-darzalex-2\/","title":{"rendered":"2B: Lie\u010divo daratumumab (Darzalex)\u00a0v kombin\u00e1cii s bortezomibom, melfalanom a predniz\u00f3nom na lie\u010dbu dospel\u00fdch pacientov s novodiagnostikovan\u00fdm mnohopo\u010detn\u00fdm myel\u00f3mom, ktor\u00ed nie s\u00fa vhodn\u00ed na autol\u00f3gnu transplant\u00e1ciu kme\u0148ov\u00fdch buniek"},"content":{"rendered":"
    \n
  1. O ak\u00fd liek sa jedn\u00e1?<\/strong><\/li>\n<\/ol>\n\n\n\n

    Darzalex (\u00fa\u010dinn\u00e1 l\u00e1tka daratumumab) je monoklon\u00e1lna protil\u00e1tka via\u017euca sa na typ prote\u00ednu, ktor\u00fd sa nach\u00e1dza vo ve\u013ek\u00fdch mno\u017estv\u00e1ch na n\u00e1dorov\u00fdch bunk\u00e1ch mnohopo\u010detn\u00e9ho myel\u00f3mu. Daratumumab br\u00e1ni rastu n\u00e1dorov\u00fdch buniek pomocou aktiv\u00e1cie imunitn\u00e9ho syst\u00e9mu. Darzalex 1800 mg s.c. je pod\u00e1van\u00fd lek\u00e1rom alebo zdravotnou sestrou formou injekcie po\u010das 3 – 5 min\u00fat.<\/p>\n\n\n\n

    Liek bol registrovan\u00fd v Eur\u00f3pskej liekovej agent\u00fare (European Medicines Agency, EMA) v roku 2016 pre pacientov s recidivuj\u00facim alebo refrakt\u00e9rnym mnohopo\u010detn\u00fdm myel\u00f3mom. V roku 2018 bola roz\u0161\u00edren\u00e1 indik\u00e1cia pre pou\u017eitie v kombin\u00e1ci\u00ed s bortezomibom, melfalanom a predniz\u00f3nom na lie\u010dbu dospel\u00fdch pacientov s novodiagnostikovan\u00fdm mnohopo\u010detn\u00fdm myel\u00f3mom, ktor\u00ed nie s\u00fa vhodn\u00ed na autol\u00f3gnu transplant\u00e1ciu kme\u0148ov\u00fdch buniek. V roku 2020 bola registr\u00e1cia vo v\u0161etk\u00fdch indik\u00e1ciach roz\u0161\u00edren\u00e1 aj na 1 800 mg balenie ur\u010den\u00e9 na podko\u017en\u00e9 injek\u010dn\u00e9 podanie. <\/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

      Mnopo\u010detn\u00fd myel\u00f3m je n\u00e1dorov\u00e9 ochorenie plazmatick\u00fdch buniek. <\/strong>N\u00e1sledkom ochorenia m\u00f4\u017ee doch\u00e1dza\u0165 k \u00fatlaku fyziologickej krvotvorby a po\u0161kodeniam kostry osteolytick\u00fdmi l\u00e9ziami, n\u00edzkou kostnou hmotou a patologick\u00fdmi zlomeninami.<\/p>\n\n\n\n

      Na Slovensku pribudne pribli\u017ene 330 novodiagnostikovan\u00fdch pacientov ro\u010dne. Mnohopo\u010detn\u00fd myel\u00f3m je vo v\u00fdraznej v\u00e4\u010d\u0161ine pr\u00edpadov diagnostikovan\u00fd u pacientov vo vy\u0161\u0161om veku, medi\u00e1nov\u00fd vek v \u010dase diagnostiky je okolo 65 \u2013 70 rokov. V\u0161etci pacienti s potvrdenou diagn\u00f3zou si vy\u017eaduj\u00fa lie\u010dbu, bez lie\u010dby je medi\u00e1n pre\u017e\u00edvania u symptomatick\u00fdch pacientov 6 mesiacov.<\/p>\n\n\n\n

      OZ LyL na z\u00e1klade rozhovorov s pacientmi uv\u00e1dza, \u017ee pacienti pri prvom kontakte nav\u0161t\u00edvili najm\u00e4 neurologick\u00fa, p\u013e\u00facnu, kardiologick\u00fa a gastroenterologick\u00fa ambulanciu. Proces diagnostiky trval do 6 mesiacov. Pacienti poci\u0165ovali pr\u00edznaky ochorenia u\u017e 1-3 roky pred diagnostikovan\u00edm.<\/p>\n\n\n\n

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

        Pod\u013ea vstupu klinick\u00e9ho odborn\u00edka, v klinickej praxi re\u017eim Daratumumab v kombin\u00e1cii s bortezomibom, melfalanom a predniz\u00f3nom (DaraVMP) nahrad\u00ed najm\u00e4 re\u017eim Bortezomib + melfalan + predniz\u00f3n (VMP) ke\u010f\u017ee re\u017eimy bortezomib + cyklofosfamid + dexametaz\u00f3n (VCd) a bortezomib + dexametaz\u00f3n (Vd) u\u017e\u00edvaj\u00fa najm\u00e4 krehk\u00ed pacienti s komorbiditami, u ktor\u00fdch by re\u017eim VMP (alebo DaraVMP) mohol ma\u0165 pr\u00edli\u0161n\u00e9 ne\u017eiad\u00face \u00fa\u010dinky.<\/p>\n\n\n\n

        Odborn\u00edci sa vyjadrili, \u017ee na Slovensku s\u00fa\u010dasn\u00e1 lie\u010dba mnohopo\u010detn\u00e9ho myel\u00f3mu nie je v s\u00falade s najnov\u0161\u00edmi medzin\u00e1rodn\u00fdmi odpor\u00fa\u010daniami, ke\u010f\u017ee ch\u00fdbaj\u00fa nov\u00e9 lie\u010diva ako daratumumab. U lek\u00e1rov pracuj\u00facich s pacientmi s mnohopo\u010detn\u00fdm myel\u00f3mom m\u00f4\u017ee nekategorizovanie Darzalexu podpori\u0165 frustr\u00e1ciu zo zaost\u00e1vania za najlep\u0161\u00edm \u0161tandardom.<\/p>\n\n\n\n

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

          Na z\u00e1klade svojej anal\u00fdzy NIHO odpor\u00fa\u010da nevyhovie\u0165<\/strong> \u017eiadosti o kategorizovanie lieku Darzalex v indik\u00e1cii pacientov s novodiagnostikovan\u00fdm mnohopo\u010detn\u00fdm myel\u00f3mom, ktor\u00ed nie s\u00fa vhodn\u00ed na autol\u00f3gnu transplant\u00e1ciu kme\u0148ov\u00fdch buniek, pokia\u013e dr\u017eite\u013e registr\u00e1cie neuprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady<\/strong> tak, aby s\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti pod\u013ea \u00a77 z\u00e1kona 363\/2011 Z.z.. <\/p>\n\n\n\n

          DaraVMP preuk\u00e1zal v klinickom sk\u00fa\u0161an\u00ed klinicky relevantn\u00e9 pr\u00ednosy oproti VMP. EMA kon\u0161tatovala dobr\u00fa tolerovate\u013enos\u0165 pridania daratumumabu. Pacienti u\u017e\u00edvaj\u00faci DaraVMP dosiahli lep\u0161ie v\u00fdsledky mortality aj morbidity.<\/p>\n\n\n\n

          \u200b\u200bV predlo\u017eenom modeli NIHO identifikovalo viacero z\u00e1va\u017en\u00fdch nedostatkov, ktor\u00e9 neadekv\u00e1tne<\/p>\n\n\n\n

          zv\u00fdhod\u0148ovali v\u00fdsledok DaraVMP vo\u010di porovn\u00e1van\u00fdm re\u017eimom. Tieto nedostatky sme upravili, aby model bli\u017e\u0161ie zodpovedal klinickej praxi.<\/p>","protected":false},"excerpt":{"rendered":"

          Na z\u00e1klade svojej anal\u00fdzy NIHO odpor\u00fa\u010da nevyhovie\u0165 \u017eiadosti o kategorizovanie lieku Darzalex v indik\u00e1cii pacientov s novodiagnostikovan\u00fdm mnohopo\u010detn\u00fdm myel\u00f3mom, ktor\u00ed nie s\u00fa vhodn\u00ed na autol\u00f3gnu transplant\u00e1ciu kme\u0148ov\u00fdch buniek, pokia\u013e dr\u017eite\u013e registr\u00e1cie neuprav\u00ed po\u017eadovan\u00fa v\u00fd\u0161ku \u00fahrady tak, aby s\u013a\u0148ala krit\u00e9ri\u00e1 n\u00e1kladovej efekt\u00edvnosti <\/p>","protected":false},"author":3,"featured_media":1720,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[11],"tags":[15,14],"class_list":["post-1721","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sumar-hodnotenia","tag-daratumumab","tag-darzalex"],"_links":{"self":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1721","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=1721"}],"version-history":[{"count":0,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/posts\/1721\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media\/1720"}],"wp:attachment":[{"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/media?parent=1721"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/categories?post=1721"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.niho.sk\/en\/wp-json\/wp\/v2\/tags?post=1721"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}