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Primerjava učinkovitosti in varnosti tofacitiniba in adalimumaba pri zdravljenju revmatoidnega artritisa
ID Kokalj, Saša (Author), ID Štrukelj, Borut (Mentor) More about this mentor... This link opens in a new window

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Abstract
Kronične vnetne bolezni so neozdravljiva bolezenska stanja, ki lahko bistveno vplivajo na kakovost življenja bolnikov in zahtevajo vseživljenjsko terapijo, ki je namenjena zmanjšanju aktivnosti imunskega sistema ter nadzorovanju bolezni. Revmatoidni artritis je ena najpogostejših kroničnih vnetnih bolezni razširjena po celem svetu, za katero natančen vzrok nastanka še ni znan. Predvidevajo, da se bolezen razvije pri genetsko nagnjenih posameznikih zaradi kombinacije genetske dovzetnosti, epigenetskih modifikacij in okoljskih dejavnikov, ki jih sproži naključen dogodek. Končni terapevtski cilj je bodisi doseči popolno remisijo ali vsaj bistveno zmanjšati aktivnost bolezni, da se prepreči ali bistveno upočasni napredovanje poškodb sklepov, prepreči invalidnost in sistemske manifestacije bolezni ter izboljša kakovost življenja bolnikov. Boljše razumevanje patofiziologije bolezni je omogočilo razvoj novih terapij, pri čemer vedno pogosteje za zdravljenje te bolezni uporabljamo sodobna tarčna zdravila. V magistrski nalogi smo naredili pregled kliničnih študij, ki so proučevale učinkovitost in varnost dveh najpogosteje uporabljenih zdravilnih učinkovin adalimumab (monoklonsko protitelo) in tofacitinib (tarčni sintezni selektivni zaviralec). Literaturo smo poiskali v prosto dostopnih bazah podatkov ter se na osnovni ponavljajočih se zadetkov odločili, da bo glavna baza za črpanje podatkov za naš pregled baza MEDLINE. Glede na vključitvene in izključitvene kriterije smo v nadaljevanju obravnavali sedem študij za tofacitinib in pet študij za adalimumab, ki so preučevale učinkovitost in varnost pri odraslih bolnikih z aktivnim revmatoidnim artritisom. Predstavili smo osnovne lastnosti študij ter izpisali podatke o učinkovitosti in varnosti. V kliničnih študijah je bila dokazana učinkovitost obeh učinkovin, saj sta zmanjšali simptome bolezni, upočasnili oziroma preprečili poškodbe sklepov ter izboljšali telesne funkcije in kakovost življenja bolnikov. Obe učinkovini imata ugoden varnostni profil, vendar pa so študije pokazale nekatere varnostne signale, ki jih je potrebno spremljati (večja možnost oportunističnih okužb, nastanek malignosti, nenormalne vrednosti laboratorijskih preiskav). V študijah z monokonskim protitelesom adalimumab so se protitelesa proti učinkovini pojavila pri majhnem deležu preiskovancev, ob sočasni uporabi metotreksata, pa se je ta odstotek znatno zmanjšal.

Language:Slovenian
Keywords:revmatoidni artritis, tofacitinib, adalimumab, učinkovitost, varnost
Work type:Master's thesis/paper
Organization:FFA - Faculty of Pharmacy
Year:2023
PID:20.500.12556/RUL-150558 This link opens in a new window
Publication date in RUL:20.09.2023
Views:368
Downloads:37
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Secondary language

Language:English
Title:Comparison of tofacitinib and adalimumab efficacy and safety in rheumatoid arthritis treatment
Abstract:
Chronic inflammatory diseases are incurable diseases that can significantly affect patients’ quality of life, requiring lifelong therapy which aims to reduce the activity of the immune system and control of the disease. Rheumatoid arthritis is one of the most common chronic inflammatory diseases spread throughout the world for which the exact cause is still unknown. It is assumed that the disease develops in genetically predisposed individuals due to a combination of genetic susceptibility, epigenetic modification, and environmental factors triggered by a random event. The ultimate therapeutic goal is either to achieve a complete remission or at least significantly reduce the activity of the disease in order to prevent or slow down the progress of joint damage, prevent the disability and systemic manifestation of the disease, and improve patients’ quality of life. A better understanding of the disease pathophysiology has enabled the development of new therapies, and use of modern targeted therapy drugs are increasingly used in the treatment of the disease. In the master's thesis, we reviewed clinical studies that investigated the efficacy and safety of the two most commonly used active substances, adalimumab (a monoclonal antibody) and tofacitinib (a selective target synthesis inhibitor). We have searched the literature in public accessible databases and, on the basis of repeated hits, decided that the main database would be the MEDLINE database. According to the inclusion and exclusion criteria, we considered seven studies for tofacitinib and five studies for adalimumab, which investigated the efficacy and safety in adult patients with active rheumatoid arthritis. We presented the basic characteristics of the studies and listed data on efficacy and safety. In clinical studies, the effectiveness of both active substances was proven, as they reduced the symptoms of the disease, slowed down or prevented joint damage and improved the physical functions and quality of life of patients. Both active substances have a favorable safety profile, but studies have shown some safety signals that need to be monitored (increased possibility of opportunistic infections, occurrence of malignancy, abnormal laboratory values). In studies with the monoclonal antibody adalimumab, antibodies against the active substance appeared in a small proportion of patients, which was significantly reduced when methotrexate was used concomitantly.

Keywords:rheumatoid arthritis, tofacitinib, adalimumab, efficacy, safety

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