Literaturni pregled varnosti in učinkovitosti monoklonskih protiteles za preventivno zdravljenje migrene

Kokol, Jasmina (author), Štrukelj, Borut (mentor)

Migrena je druga najpogostejša nevrološka motnja na svetu in po podatkih Svetovne študije o bremenu bolezni odgovorna za več nezmožnosti (izraženo kot število let, ki jih ljudje preživijo z boleznijo, ki jim onemogoča normalno življenje) kot vse druge nevrološke motnje skupaj. Na področju preventivnega zdravljenja migrene se je v zadnjih letih zgodilo veliko napredka, predvsem zaradi novih monoklonskih protiteles, ki so bila razvita posebej za ta namen. Trenutno so v uporabi štiri monoklonska protitelesa proti migreni, ki so registrirana za preventivno zdravljenje migrene in ki se uporabljajo, ko ima bolnik vsaj štiri dni z migreno na mesec (eptinezumab, erenumab, fremanezumab in galkanezumab). Evropsko združenje za glavobol v smernicah ta zdravila uvršča v prvo linijo preventivnega zdravljenja migrene tako pri bolnikih z epizodno kot s kronično migreno. Namen magistrskega dela je bil narediti medsebojno primerjavo varnosti in učinkovitosti monoklonskih protiteles za preventivno zdravljenje migrene. Zanimalo nas je ali se medsebojno razlikujejo v varnosti in učinkovitosti. Naredili smo pregled ustreznih kliničnih študij, ki so proučevale njihovo varnost in učinkovitost. Glavna baza za pridobivanje člankov je bila baza PubMed. Pregledali smo zadetke na podlagi iskalnega ključa ter na osnovi vnaprej določenih vključitvenih in izključitvenih kriterijev naredili podroben pregled ustreznih kliničnih študij in rezultate medsebojno primerjali. V kliničnih študijah je bila dokazana primerljiva učinkovitost vseh štirih monoklonskih protiteles, saj so zmanjšala mesečno število dni z migreno, zmanjšala se je potreba po akutnem zdravljenju migrene, odziv na zdravljenje je bil visok, prav tako pa so tudi rezultati, o katerih so poročali bolniki, pokazali ugoden vpliv zdravljenja na njihovo življenje in delovanje. Pojavnost neželenih učinkov po uvedbi terapije in resnih neželenih učinkov je bila primerljiva s placebom, večinoma pa ti niso bili povezani s proučevano učinkovino. Zaradi svoje učinkovitosti in ugodnega varnostnega profila monoklonska protitelesa za preventivno zdravljenje migrene tako predstavljajo pomembno možnost preventivnega zdravljenja tako epizodne kot kronične migrene.

• Language: Slovenian
• Keywords: migrena, monoklonsko protitelo, peptid, povezan z genom za kalcitonin (CGRP), preventivno zdravljenje migrene
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2024
• PID: 20.500.12556/RUL-166067
• Publication date in RUL: 19.12.2024

Secondary language

• Language: English
• Title: Literature review of safety and efficacy of monoclonal antibodies used for preventive treatment of migraine

Abstract

Migraine is the second most common neurological disorder in the world and, according to the Global Burden of Disease Study, is responsible for more disability (expressed as the Years Lived with Disability) than all other neurological disorders combined. In recent years, there has been significant progress in the field of preventive migraine treatment due to the development of new monoclonal antibodies. Currently, four monoclonal antibodies are in use for migraine prevention, which are registered for migraine prophylaxis and are in use when a patient experiences at least four migraine days per month (eptinezumab, erenumab, fremanezumab, and galkanezumab). The European Headache Federation includes these drugs in the first line of migraine prevention for both episodic and chronic migraine patients. The aim of this master's thesis was to conduct an analysis of the safety and efficacy of monoclonal antibodies for preventive migraine treatment. We were interested in whether the monoclonal antibodies differ in terms of safety and efficacy. A review of relevant clinical studies that examined their safety and efficacy was carried out. The primary database used for obtaining articles was the PubMed. We reviewed the results based on search keywords. Using predefined inclusion and exclusion criteria, we conducted a detailed review of the relevant clinical studies and compared their outcomes. The clinical studies demonstrated the efficacy of all four monoclonal antibodies, as they reduced the number of migraine days per month, decreased the need for acute treatment of migraine, had a high treatment response rate, and the results reported by patients also showed a favorable impact on their quality of life and functioning. The incidence of adverse effects after treatment initiation and serious adverse effects was comparable to that of placebo, and most of these were not associated with the active substance being investigated. Monoclonal antibodies for migraine prophylaxis thus represent an important option for preventive treatment of both episodic and chronic migraine, not only due to their efficacy but also because of their favorable safety profile.

• Keywords: calcitonin gene-related peptide (CGRP), migraine, monoclonal antibody, preventive treatment of migraine