{"id":2587,"date":"2019-12-21T13:26:00","date_gmt":"2019-12-21T12:26:00","guid":{"rendered":"http:\/\/www.atopika.org\/2019\/12\/21\/atopijski-dermatitis-i-bioloski-lijek\/"},"modified":"2020-09-11T05:28:59","modified_gmt":"2020-09-11T03:28:59","slug":"atopijski-dermatitis-i-bioloski-lijek","status":"publish","type":"post","link":"https:\/\/www.atopika.org\/hr\/2019\/12\/21\/atopijski-dermatitis-i-bioloski-lijek\/","title":{"rendered":"Atopijski dermatitis i biolo\u0161ki lijek"},"content":{"rendered":"&#13;\n<p>Zavod za zdravstveno osiguranje Slovenije (ZZZS)  je 3. prosinca 2019. objavio klasifikaciju prvog biolo\u0161kog lijeka za pacijente s atopijskim dermatitisom na popisu lijekova koji vrijede od srijede, 18. prosinca 2019. Dostup lijeku omogu\u0107en je odraslima i adolescentima s umjerenim do te\u0161kim atopijskim dermatitisom koji su kandidati za sustavno lije\u010denje. <\/p>&#13;\n&#13;\n<h2 class=\"wp-block-heading\">\u0160to je biolo\u0161ki lijek za atopijski dermatitis?<\/h2>&#13;\n&#13;\n<p> Biolo\u0161ki lijek za odrasle koji boluju od umjerenog do te\u0161kog atopijskog dermatitisa je odobrila FDA po\u010detkom 2017. godine. Krajem 2017. godine lijek je odobrila i EMA za lije\u010denje umjerenog do te\u0161kog atopijskog dermatitisa u odraslih bolesnika koji su kandidati za sistemsku terapiju, a potom 2019. i za adolescente starije od 12 godina.&#13;\n&#13;\nLijek predstavlja iskorak u lije\u010denju atopijskog dermatitisa i djeluje na potpuno druga\u010diji na\u010din od ostalih do danas dostupnih lijekova.<\/p>&#13;\n&#13;\n<h2 class=\"wp-block-heading\">\u0160to je biolo\u0161ki lijek?<\/h2>&#13;\n&#13;\n<p>Biolo\u0161ki proizvodi su genetski proizvedeni iz proteina dobivenih iz \u017eivih stanica ili tkiva. Osmi\u0161ljeni su tako da ciljaju odre\u0111ene dijelove imunolo\u0161kog sustava koji doprinose kroni\u010dnim upalnim bolestima, poput atopijskog dermatitisa. Njihovo djelovanje je mnogo specifi\u010dnije i selektivnije u odnosu na druge sustavne lijekove koji se koriste za lije\u010denje atopijskog dermatitisa. Zbog metode proizvodnje pomo\u0107u \u017eivih stanica, lijek je puno skuplji u usporedbi s nebiolo\u0161kim lijekovima. Biolo\u0161ki lijekovi se godinama koriste za lije\u010denje psorijaze, astme i artritisa. Trenutno se razvijaju mnogi drugi biolo\u0161ki lijekovi za atopijski dermatitis.<\/p>&#13;\n&#13;\n<ul class=\"wp-block-list\"><li><strong>Zakon o lijekovima definira biolo\u0161ki lijek<\/strong> kao lijek koji uklju\u010duje biolo\u0161ku tvar ili tvar dobivenu postupkom koji uklju\u010duje biolo\u0161ke sustave. Biolo\u0161ka tvar je ona koja se dobiva iz biolo\u0161kog izvora ili njegovom upotrebom i koja zahtijeva kombinaciju fizikalno-kemijskih i biolo\u0161kih ispitivanja kako bi se utvrdila njezina kvaliteta, zajedno s proizvodnim postupkom i njegovom kontrolom. To su, primjerice, lijekovi proizvedeni biolo\u0161kim ili biotehnolo\u0161kim postupcima, uklju\u010duju\u0107i stani\u010dne kulture i rekombinantnu DNK tehnologiju, lijekovi dobiveni iz krvi i plazme, imunolo\u0161ki lijekovi i sli\u010dno.<\/li>&#13;\n<\/ul>&#13;\n<h2 class=\"wp-block-heading\">Kako djeluje lijek?<\/h2>&#13;\n&#13;\n<p>Imunolo\u0161ki sustav na\u0161eg tijela koristi me\u0111ustani\u010dne posrednike &#8211; interleukine (IL) za komunikaciju izme\u0111u stanica. Intereukini tako\u0111er poma\u017eu u za\u0161titi tijela od patogenih mikroorganizama. Imunolo\u0161ki sustav bolesnika s atopijskim dermatitisom pretjerano reagira na brojne alergene (antigene koji poti\u010du reakcije preosjetljivosti tipa 1). Rezultat toga je prekomjerna proizvodnja interleukina, koji u primjeru atopijskog dermatitisa pokre\u0107u sustavnu upalu. Biolo\u0161ki lijek djeluje tako da sprje\u010dava vezanje interleukina na stani\u010dne receptore.<\/p>&#13;\n&#13;\n<p>Djelatna tvar je ljudsko ljudsko monoklonsko protutijelo koje se ve\u017ee na alfa podjedinicu receptora IL-4, \u010dime se sprje\u010dava vezanje interleukina IL-4 i IL-13 na stani\u010dne receptore koji poma\u017eu u odr\u017eavanju imunolo\u0161kog odgovora Th2 stanica.<\/p>&#13;\n&#13;\n<p>Sprje\u010davaju\u0107i vezanje na stani\u010dne receptore, lijek ima sna\u017ean u\u010dinak protiv pruritusa (intenzivnog svrbe\u017ea) i posljedi\u010dno smanjenu stopu pruritusa kod velikog broja pacijenata. To je revolucionarni skok naprijed u razumijevanju ove bolesti i razumijevanju svrbe\u017ea. Ujedno je to i prvi lijek za atopijski dermatitis koji je razvijen uz razumijevanje da osip sam po sebi nije uzrok svrbe\u017ea. Uzrok svrbe\u017ea nastaje radi upale koja je posljedica prekomjernog odgovora imunolo\u0161kog sustava, \u0161to se ne mo\u017ee ubla\u017eiti lokalnim lijekovima u slu\u010dajevima umjerenog do te\u0161kog atopijskog dermatitisa.<\/p>&#13;\n&#13;\n<h2 class=\"wp-block-heading\">Koja je u\u010dinkovitost lijeka?<\/h2>&#13;\n&#13;\n<p>U jednom klini\u010dkom istra\u017eivanju, vi\u0161e od polovica pacijenata izjavila je da su njihovi simptomi smanjeni za 75%. Djelatna tvar zna\u010dajno smanjuje svrbe\u017e i pobolj\u0161ava kvalitetu sna kod mnogih pacijenata.<\/p>&#13;\n&#13;\n<h2 class=\"wp-block-heading\">Kako mogu znati da li ispunjavam uvjete za lijek?<\/h2>&#13;\n&#13;\n<p>Biolo\u0161ki lijek za atopijski dermatitis je indiciran za lije\u010denje umjerenog do te\u0161kog atopijskog dermatitisa u odraslih i adolescenata starijih od 12 godina koji su kandidati za sustavno lije\u010denje i ne reagiraju na prethodnu metodu izbora lije\u010denja ove bolesti. Ako mislite da ste pogodan kandidat za lije\u010denje, savjetujte se s dermatologom. Ako dermatolog odlu\u010di da se radi o stanju koje bi se lije\u010dilo biolo\u0161kim lijekom, podnosi se prijedlog za lije\u010denje komisiji za odobrenje lije\u010denja biolo\u0161kim lijekom, koja djeluje na Sveu\u010dili\u0161nom medicinskom centru Maribor i Sveu\u010dili\u0161nom medicinskom centru Ljubljana.<\/p>&#13;\n&#13;\n<h2 class=\"wp-block-heading\">Kako se lijek koristi? Je li lijek u obliku kreme ili tablete?<\/h2>&#13;\n&#13;\n<p>Biolo\u0161ki lijek za atopijski dermatitis je lijek koji se ubrizgava potko\u017enom injekcijom. Pacijenti ili njihovi njegovatelji mogu sami koristiti lijek nakon \u0161to ih zdravstveni stru\u010dnjak pravilno nau\u010di tehnici potko\u017enog ubrizgavanja.<\/p>&#13;\n&#13;\n<p>Preporu\u010dena doza za odrasle i adolescente (preko 60 kg): po\u010detna je doza od 600 mg (dvije injekcije od 300 mg), a zatim 300 mg supkutano svaki drugi tjedan. U adolescenata te\u017eine manje od 60 kg koristi se injekcija od 200 mg.<\/p>&#13;\n&#13;\n<h2 class=\"wp-block-heading\">\u0160to se doga\u0111a ako lijek nema u\u010dinka za nekoliko tjedana?<\/h2>&#13;\n&#13;\n<p>Va\u0161 \u0107e lije\u010dnik razmotriti prekid lije\u010denja ako ne do\u0111e do pobolj\u0161anja nakon 16 tjedana.<\/p>&#13;\n&#13;\n<h2 class=\"wp-block-heading\">Koje su nuspojave lijeka?<\/h2>&#13;\n&#13;\n<p>Lijek, kao i svaki drugi, tako\u0111er ima mogu\u0107e nuspojave. Prije upotrebe lijeka pa\u017eljivo se posavjetujte s lije\u010dnikom, pro\u010ditajte prilo\u017eene upute, izrazite svoje strahove i budite aktivni \u010dlan va\u0161eg lije\u010denja. Pratite svoje rezultate, nove informacije u podru\u010dju lije\u010denja lijekom i sura\u0111ujte s lije\u010dnikom. <\/p>&#13;\n&#13;\n<p>Naj\u010de\u0161\u0107e nuspojave su:<\/p>&#13;\n&#13;\n<ul class=\"wp-block-list\"><li>reakcije na mjestu ubrizgavanja, <\/li>&#13;\n<li>konjuktivitis (konjuktivitis), <\/li>&#13;\n<li>upala o\u010dnih kapaka (blefaritis), <\/li>&#13;\n<li>oralni herpes.<\/li>&#13;\n<\/ul>&#13;\n<p>Sve dok imamo svoje zdravlje, imamo sve. Postanite aktivan \u010dlan u lije\u010denju svog tijela. \u010citajte, pratite i pitajte.<\/p>&#13;\n","protected":false},"excerpt":{"rendered":"<p>&#13; Zavod za zdravstveno osiguranje Slovenije (ZZZS) je 3. prosinca 2019. objavio klasifikaciju prvog biolo\u0161kog lijeka za pacijente s atopijskim dermatitisom na popisu lijekova koji vrijede od srijede, 18. prosinca 2019. Dostup lijeku omogu\u0107en je odraslima i adolescentima s umjerenim do te\u0161kim atopijskim dermatitisom koji su kandidati za sustavno lije\u010denje. &#13; &#13; \u0160to je biolo\u0161ki [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":2588,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[65],"tags":[],"class_list":["post-2587","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-opce"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Atopijski dermatitis i biolo\u0161ki lijek - Atopika<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.atopika.org\/hr\/2019\/12\/21\/atopijski-dermatitis-i-bioloski-lijek\/\" \/>\n<meta property=\"og:locale\" content=\"hr_HR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Atopijski dermatitis i biolo\u0161ki lijek - Atopika\" \/>\n<meta property=\"og:description\" content=\"&#013; Zavod za zdravstveno osiguranje Slovenije (ZZZS) je 3. prosinca 2019. objavio klasifikaciju prvog biolo\u0161kog lijeka za pacijente s atopijskim dermatitisom na popisu lijekova koji vrijede od srijede, 18. prosinca 2019. Dostup lijeku omogu\u0107en je odraslima i adolescentima s umjerenim do te\u0161kim atopijskim dermatitisom koji su kandidati za sustavno lije\u010denje. &#013; &#013; \u0160to je biolo\u0161ki [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.atopika.org\/hr\/2019\/12\/21\/atopijski-dermatitis-i-bioloski-lijek\/\" \/>\n<meta property=\"og:site_name\" content=\"Atopika\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/ZavodAtopika\" \/>\n<meta property=\"article:published_time\" content=\"2019-12-21T12:26:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-09-11T03:28:59+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.atopika.org\/wp-content\/uploads\/2020\/02\/canva-biologist-doing-experiments-in-her-laboratory.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"525\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Tina Mesari\u010d\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Napisao\/la\" \/>\n\t<meta name=\"twitter:data1\" content=\"Tina Mesari\u010d\" \/>\n\t<meta name=\"twitter:label2\" content=\"Procijenjeno vrijeme \u010ditanja\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minuta\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.atopika.org\\\/hr\\\/2019\\\/12\\\/21\\\/atopijski-dermatitis-i-bioloski-lijek\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.atopika.org\\\/hr\\\/2019\\\/12\\\/21\\\/atopijski-dermatitis-i-bioloski-lijek\\\/\"},\"author\":{\"name\":\"Tina Mesari\u010d\",\"@id\":\"https:\\\/\\\/www.atopika.org\\\/hr\\\/#\\\/schema\\\/person\\\/49c1087a289bda3e5fceeba66fa27376\"},\"headline\":\"Atopijski dermatitis i biolo\u0161ki lijek\",\"datePublished\":\"2019-12-21T12:26:00+00:00\",\"dateModified\":\"2020-09-11T03:28:59+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.atopika.org\\\/hr\\\/2019\\\/12\\\/21\\\/atopijski-dermatitis-i-bioloski-lijek\\\/\"},\"wordCount\":913,\"publisher\":{\"@id\":\"https:\\\/\\\/www.atopika.org\\\/hr\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.atopika.org\\\/hr\\\/2019\\\/12\\\/21\\\/atopijski-dermatitis-i-bioloski-lijek\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.atopika.org\\\/wp-content\\\/uploads\\\/2020\\\/02\\\/canva-biologist-doing-experiments-in-her-laboratory.jpg\",\"articleSection\":[\"Op\u0107e\"],\"inLanguage\":\"hr\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.atopika.org\\\/hr\\\/2019\\\/12\\\/21\\\/atopijski-dermatitis-i-bioloski-lijek\\\/\",\"url\":\"https:\\\/\\\/www.atopika.org\\\/hr\\\/2019\\\/12\\\/21\\\/atopijski-dermatitis-i-bioloski-lijek\\\/\",\"name\":\"Atopijski dermatitis i biolo\u0161ki lijek - 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