Title Imunogenost lijekova koji sadrže monoklonska protutijela Title (english) Immunogenicity of medicinal products containing monoclonal antibodies Author Eleonora Lekić Mentor Siniša Tomić (mentor)Committee member Siniša Tomić (predsjednik povjerenstva)Committee member Miranda Mladinić Pejatović (član povjerenstva)Committee member Jurica Novak (član povjerenstva)Committee member Duško Čakara (član povjerenstva)Granter University of Rijeka Defense date and country 2023-09-12, Croatia Scientific / art field, BIOTECHNICAL SCIENCES Abstract Lijekovi koji sadrže monoklonska protutijela su visoko specifični te se
poglavito u proteklih desetak godina, koriste u svrhe dijagnostike i terapije
autoimunih bolesti te raka. Primjena monoklonskih protutijela može
uzrokovati reakcije preosjetljivosti. Takve reakcije najčešće se očituju na
koži i općenito imaju povoljne ishode. Ipak, potrebno je sustavno praćenje
reakcija preosjetljivosti kako bi se optimizirao omjer koristi i štetnosti
njihove primjene. Bazu podataka o svim nuspojavama, pa tako i reakcijama
preosjetljivosti, vodi Hrvatska agencija za lijekove i medicinske proizvode
(HALMED). U ovom diplomskom radu analizirane su prijavljene reakcije
preosjetljivosti na lijekove koje sadrže monoklonska protutijela prijavljenih
HALMED-u. Prijave nuspojava analizirane su po godini zaprimanja,
prijavitelju, ozbiljnosti, kriteriju ozbiljnosti, dobi, spolu, preferiranom
pojmu (eng. Preferred term) kao i samoj djelatnoj tvari. HALMED je do 15.
svibnja 2023. godine zaprimio 3859 prijava nuspojava na monoklonska
protutijela, od kojih je 62,3% bilo ozbiljno. 796 prijava iz navedenog
razdoblja (20,6% svih prijava) odnosilo se na reakcije preosjetljivosti na
monoklonska protutijela. Najčešći prijavitelji reakcija preosjetljivosti bili su
liječnici (86,3%). Najviše prijava reakcija preosjetljivosti je zabilježeno kod
ženske populacije (49,1%) i kod odraslih pacijenata u dobi od 45 do 64
godina (29,8%). Više od polovice (54,1%) prijavljenih slučajeva reakcija
preosjetljivosti nije bio ozbiljan. Najčešće prijavljene nuspojave koje
spadaju u reakcije preosjetljivosti bile su osip, eritem i svrbež. Najveći broj
reakcija preosjetljivosti prijavljen je za sljedeće djelatne tvari: infliksimab,
pembrolizumab i adalimumab. Prema rezultatima ovog diplomskog rada
reakcije preosjetljivosti su često prijavljivane nuspojave dok u usporedbi s
drugim nuspojavama, manji udio nuspojava je ocijenjen ozbiljnim. Ovi
rezultati naglašavaju važnost sveobuhvatnog praćenja i evaluacije reakcija
preosjetljivosti na lijekove koji sadrže monoklonska protutijela kako bi se
osigurala njihova sigurna i učinkovita uporaba u kliničkoj praksi.
Abstract (english) Medicinal products containing monoclonal antibodies are highly specific and
they have been used mainly for the diagnosis and therapy of autoimmune
diseases and cancer for the past ten years. However, the use of monoclonal
antibodies can cause hypersensitivity reactions. Typically, these reaction
manifest on the skin and generally have favorable outcomes. Nevertheless,
systematic monitoring of hypersensitivity reactions is necessary in order to
optimize the benefit-harm ratio of their use. The Croatian Agency for
Medicines and Medical Products (HALMED) maintains a comprehensive
database encompassing all adverse effects, including hypersensitivity
reactions. This thesis analyzes cases of reported hypersensitivity reactions
to monoclonal antibody-based medications reported to HALMED. Adverse
reaction reports were analyzed by year of receipt, reporter, seriousness,
seriousness criteria, age and gender of a patient, preferred term, as well
as the active substance. By May 15, 2023, HALMED had received 3,859
reports of adverse reactions to monoclonal antibodies, with 62.3%
classified as serious. Of these reports, 796 (equivalent to 20.6% of all
reports) corresponded to hypersensitivity reactions to monoclonal
antibodies. Medical professionals constituted the primary reporters of
hypersensitivity reactions, accounting for 86.3% of the reports.
Hypersensitivity reactions were more frequently reported among female
patients (49.1%) and adults aged 45 to 64 (29.8%). A majority of the
documented hypersensitivity cases were categorized as non-serious
(54.1%). Commonly reported symptoms included rash, erythema, and
pruritus. The active substances most frequently associated with
hypersensitivity reactions were infliximab, pembrolizumab, and
adalimumab. According to the results of this thesis, hypersensitivity
reactions are frequently reported side effects, while compared to other
reported side effects, a smaller proportion of reported side effects are
assessed as serious. These results highlight the importance of
comprehensive monitoring and evaluation of hypersensitivity reactions to
medicinal products containing monoclonal antibodies to ensure their safe
and effective utillization in clinical practice.
Keywords
monoklonska protutijela
imunogenost
indikacije
nuspojave
reakcije preosjetljivosti
Keywords (english)
monoclonal antibodies
immunogenicity
indications
adverse events
hypersensitivities
Language croatian URN:NBN urn:nbn:hr:193:911468 Study programme Title: Drug research and development Type of resource Text File origin Born digital Access conditions Open access Terms of use Created on 2023-10-16 08:13:56
