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Primerjava nastanka protiteles proti zdravilom pri bolnikih, zdravljenih z inovativnimi biološkimi zdravili in podobnimi biološkimi zdravili
ID Levanič, Davorin (Avtor), ID Štrukelj, Borut (Mentor) Več o mentorju... Povezava se odpre v novem oknu, ID Locatelli, Igor (Komentor)

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Izvleček
Prva biološka zdravila v obliki zdravilnih rastlinskih in živalskih delov pozna človeštvo že tisočletja. Danes biološka zdravila pojmujemo kot sodobna biološka zdravila, ki predstavljajo prihodnost in so vedno večja, pomembnejša in hitro razvijajoča tematika. Zdravje ljudi kot najpomembnejša komponenta kakovosti življenja ter za to potreben razvoj zdravil, nista samoumevna, vendar dolga in zahtevna. Pri bioloških zdravilih, zaradi izvora in načina proizvodnje, najpogosteje govorimo o imunogenosti, katere dokazljivost temelji na zaznavanju protiteles proti zdravilu (ADA). Biološka zdravila, podobno kot klasična, delimo na originatorje in biološko primerljiva zdravila, vendar pa razlika med njimi pomembneje vpliva na izbor in potek zdravljenja. Pri zdravljenju z biološkimi zdravili pogosto uporabljamo sočasno tudi imunomodulatorna zdravila, ki vplivajo na imunogenost. Namen je bil pregledati literaturo, izdelati sistematični, kritični pregled in meta-analizo na podlagi do sedaj objavljenih raziskav, ki so v čim večji meri pokrivale področje imunogenosti bioloških zdravil. Natančneje, nastanek protiteles proti zdravilu pri podobnih in inovativnih bioloških zdravilih, njihovo primerjavo in morebiten vpliv uporabe sočasne terapije z imunomodulatorji. Raziskave smo poiskali z vmesnikom PubMed v podatkovni bazi MEDLINE, kjer smo s predhodno določenim iskalnim profilom našli vseeno širok nabor 6684 člankov. Z ustrezno metodologijo in prikazom v obliki PRISMA diagrama smo nabor zožili na 51 člankov, ki so bili vključeni v meta-analizo, 83 člankov pa je bilo analiziranih v obliki sistematičnega in kritičnega pregleda. Meta-analizo smo izvedli s programom Review Manager 5.4. na podlagi dihotomne razdelitve najvišje incidence pozitivnih ADA meritev in upoštevanjem vrednosti razmerij tveganj s prikazom v obliki drevesnega diagrama. Rezultati meta-analize z osnovno delitvijo na učinkovine, glede na oceno imunogenosti preko prisotnosti ADA, pri treh učinkovinah kažejo večjo korist podobnih bioloških zdravil, vendar ne z enako gotovostjo. Ostale skupine, z izjemo dveh, ki nakazujeta korist inovativnih bioloških zdravil, prikazujejo enakovrednost podobnih in inovativnih bioloških zdravil. Rezultati v primerih sočasne uporabe imunomodulatornih zdravil nakazujejo nezmožnost statistično značilnega sklepa. Predstavljenih je tudi nekaj zanimivih nasprotij z že znanimi tujimi ugotovitvami. V številnih strokovnih člankih zaznani redki poudarki ocene in vpliva imunogenosti na podlagi ADA, pa nakazujejo potrebo po bolj ustreznem dokazovanju imunogenosti.

Jezik:Slovenski jezik
Ključne besede:biološka zdravila, imunogenost, ADA, imunomodulatorji, meta-analiza
Vrsta gradiva:Magistrsko delo/naloga (mb22)
Organizacija:FFA - Fakulteta za farmacijo
Leto izida:2021
Datum objave v RUL:18.06.2021
Število ogledov:294
Število prenosov:111
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Sekundarni jezik

Jezik:Angleški jezik
Naslov:Comparison of anti-drug antibody occurence in patients treated with innovative biologics and similar biological medicinal products
Izvleček:
The first biological drugs in the form of medicinal plant and animal parts have known mankind for millennia. Today, biological medicines are primarily seen as modern biological medicines, which represent the future and are an increasing, important and rapidly evolving topic. Human health, as the most important component of quality of life and the development of medicines required, is not self-evident, but long and complicated. In the case of biological medicinal products, due to the origin and method of production, the most reported is immunogenicity, the detection of which is based on antibodies against the medicinal product (ADA). Biological medicines, like classical medicines, are divided into originators and similars, but the difference between them has a significant impact on the selection and course of treatment. Treatment with immunomodulatory medicinal products is also commonly used with biological medicinal products. The purpose was to review the literature, to produce a systematic, critical review and meta-analysis on the basis of research published so far which covered as much as possible the immunogenicity of biological medicinal products. Specifically, the formation of antibodies against the drug in similar and innovative biological medicinal drugs, their comparison and the possible effect of the use of concomitant therapy with immunomodulators. The research was found with PubMed interface in the MEDLINE database, where we found a wide range of 6684 articles with a predefined search profile. Using the appropriate methodology and PRISMA diagram, we narrowed the set to 51 articles that were included in the meta-analysis and 83 that were analyzed as systematic and critical review. Meta-analysis was performed with Review Manager 5.4. based on the dichotomy split of the highest incidence of positive ADA measurements and taking into account the value of risk ratios with tree chart display. The results of the meta-analysis in three active substances indicate a greater benefit of biosimilars but with different certainties. Other groups, with the exception of two that suggest the benefit of innovative biological medicines, demonstrate the equivalence of biosimilar and originator in the field of immunogenicity. The results in cases of concomitant use of immunmodulators indicate the inability of a statistically significant conclusion. There are also some interesting contradictions with already known foreign findings. Rare emphasis on the assessment and impact of ADA-based immunogenicity in a number of expert articles suggests the need for more adequate demonstration of immunogenicity.

Ključne besede:biologics, immunogenicity, ADA, immunomodulators, meta-analysis

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