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Identifier 000456052
Title Μακροχρόνια ασφάλεια και παράγοντες κινδύνου ανάπτυξης ανεπιθύμητων ενεργειών σε ασθενείς με Iδιοπαθείς Φλεγμονώδεις Νόσους του εντέρου που λαμβάνουν αγωγή με βιολογικούς παράγοντες
Alternative Title Long term safety and risk factors of adverse events of biologics in patients with inflammatory bowel disease
Author Θεοδωράκη, Ειρήνη
Thesis advisor Κουτρουμπάκης , Ιωάννης
Reviewer Μουζάς, Ιωάννης
Ρωμανός, Ιωάννης
Καλαϊτζάκης, Ευάγγελος
Τζαρδή, Μαρία
Κοφτερίδης, Διαμαντής
Abstract Biological agents have been used in the last decades at an increasing rate for the treatment of inflammatory bowel diseases (IBD). However, several adverse reactions (AE) have been described concerning all drugs but mainly anti-TNF (anti - tumor necrosis factor – a) agents, possibly due to their long-term use. The reactions described apply to almost all systems. Reactions from the skin, cardiovascular effects, musculoskeletal effects, neurological manifestations, hypersensitivity reactions or those related to the immune stimulation that may be caused by biological agents, infections and malignancies have been described. The aim of this thesis is to study the long - term adverse events of biological agents and search for possible risk factors associated with their occurrence. In the 1st work, a specially designed questionnaire was used, which included all the possible side effects the patient can identify. It was answered by 147 patients with IBD under biological agents and an attempt was made to correlate the adverse effects, based on the answers given, with demographic or clinical data of the patients. Smoking was found to have a significant role on the occurrence of arthralgias or skin lesions in these patients. In addition, a significant correlation of female gender and the intensified dose of the biological drug with the occurrence of arthralgias was found. This work shows that the occurrence of adverse events (AE) can probably be predicted in some cases of patients, such as smokers. In the published 2nd work, a retrospective search was made of the adverse events of patients under infliximab and an attempt was made to correlate them with the available clinical or demographic characteristics. The original hypothesis mainly concerned the levels of the drug and antibodies against it in the patients' serum. The results showed that the occurrence of adverse effects was not associated with drug levels or antibodies against it. However, the occurrence of AEs is associated with the duration of the disease (in years). This result is useful in the treatment of our patients, so that there is no hesitation in cases where an intensified dosage of the biological agent is required. The 3rd work aimed to search for a possible correlation of the detection of positive antinuclear antibodies in the serum of patients with IBD under infliximab or adalimumab with any of the available clinical laboratory or demographic factors of these patients. Antinuclear antibodies (ANA)-positive detection was found to be associated with low serum biologic drug levels and positive antibody titer, mainly for patients on infliximab. This work shows that we can possibly predict the unsatisfactory response of the disease to the drug, through an adverse event such as the detection of ANA in the serum, especially in the cases where therapeutic drug monitoring is not available. In conclusion, with these works the adverse effects of biological agents were studied both in terms of their possible correlations with clinical and demographic characteristics, as well as in terms of using them helpfully for the treatment of our patients.
Language Greek, English
Subject Crohns disease
Ulcerative Colitis
Βιολογικοί παράγοντες
Ελκώδεις κολίτιδα
Νόσος Crohn
Issue date 2023-07-28
Collection   School/Department--School of Medicine--Department of Medicine--Doctoral theses
  Type of Work--Doctoral theses
Permanent Link https://elocus.lib.uoc.gr//dlib/9/4/c/metadata-dlib-1686723123-844627-22429.tkl Bookmark and Share
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