Pregled kliničnih vrednotenj učinkovitosti in varnosti monoklonskih protiteles za blaženje atopijskega dermatitisa

Bernik, Teja (author), Bratkovič, Tomaž (mentor)

Incidenca kožnih obolenj, od preprostih rdečic in nadležnega srbenja do vedno več primerov kožnega raka, se z leti povečuje. Eno od teh številnih kožnih obolenj je tudi atopijski dermatitis, incidenca katerega se je v zadnjih 30 letih trikrat povečala. Skoraj 60 % novorojenčkov ima suho kožo, kar je prvi korak k razvoju te bolezni. Na splošno pa za boleznijo trpi med 15 in 30 % otrok ter med 1 in 3 % odraslih na svetovni ravni. Večina bolnikov z atopijskim dermatitisom trpi za različnimi alergijami na hrano, od 50 do 60 % bolnikov pa lahko kasneje razvije astmo. Ker je za nastanek bolezni odgovornih več dejavnikov, zaenkrat nimamo univerzalnega zdravila, temveč lahko pomagamo le pri blaženju bolezni, ampak tudi to se v zadnjih letih s pomočjo bioloških zdravil počasi spreminja. Leta 2017 in 2021 sta na svetovni trg prišli dve biološki zdravili, natančneje dve monoklonski protitelesi za blaženje zmerne do hude oblike atopijskega dermatitisa, ki ju predpisujemo bolnikom, neodzivnim na dermalna zdravila, ki so primerni kandidati za sistemsko zdravljenje. Namen diplomske naloge je bil pregled kliničnih raziskav, kjer so preverjali učinkovitost in varnost registriranih monoklonskih protiteles, dupilumaba in tralokinumaba, za zdravljenje atopijskega dermatitisa. Ugotovili smo, da sta ti dve zdravili dolgoročno učinkoviti in kljub nekaterim neželenim učinkom varni, zaradi česar sta tako FDA kot EMA odobrili njun vstop na trg. Poleg tega smo pregledali tudi dostopne rezultate kliničnih raziskav vrednotenja učinkovitosti in varnosti nemolizumaba in lebrikizumaba, ki sta še v fazi razvoja, a razvijalci predvidevajo, da bosta tudi ti dve zdravili kmalu vstopili na trg.

• Language: Slovenian
• Keywords: atopijski dermatitis, monoklonska protitelesa, klinične raziskave, učinkovitost, varnost
• Work type: Bachelor thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2022
• PID: 20.500.12556/RUL-139947
• Publication date in RUL: 09.09.2022

Secondary language

• Language: English
• Title: Review of clinical trials evaluating efficacy and safety of monoclonal antibodies for mitigation of atopic dermatitis

Abstract

In recent years, the incidence of skin diseases, from simple redness and irritable itching to more and more cases of skin cancer, is increasing. One of the many skin conditions is atopic dermatitis, the incidence of which has tripled in the last 30 years. Nearly 60% of new-borns have dry skin, which is the first step towards development of atopic dermatitis. In general, there are between 15 to 30% children, and between 1 to 3% adults, suffering from the disease worldwide. Most patients with atopic dermatitis suffer from various food allergies, and 50 to 60% of patients later develops asthma. Since several factors are responsible for the onset of the disease, we currently do not have a universal cure, but can only help alleviate the disease, although this has been slowly changing in recent years, thanks to biological drugs. In 2017 and 2021, two monoclonal antibodies used for the mitigation of moderate to severe atopic dermatitis, entered the global market and can be used in patients who are suitable candidates for systemic treatment, due to their unresponsiveness to topical drugs. The purpose of this bachelor’s degree was to review clinical trials evaluating efficacy and safety of registered monoclonal antibodies for the treatment of atopic dermatitis – dupilumab and tralokinumab. We found these two drugs to be long-term effective and, despite some adverse effects, safe. As a result, both the FDA and the EMA approved their entry into the market. In addition, we also reviewed clinical trials assessing efficacy and safety of nemolizumab and lebrikizumab, which are still in the development phase, but it is anticipated that these two drugs will also enter the market soon.

• Keywords: atopic dermatitis, monoclonal antibodies, clinical trials, efficacy, safety