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@article{2249063,
author = {Stepanov, Alexandr and Studnicka, Jan and Veith, Miroslav and Nemec, Pavel and Vysloužilová, Daniela and Koubek, Michal and Nemcansky, Jan},
article_location = {LONDON},
article_number = {2},
doi = {http://dx.doi.org/10.1177/11206721221132619},
keywords = {anti-VEGF therapy; brolucizumab; neovascular age-related macular degeneration; real-life practice; adverse event; switch},
language = {eng},
issn = {1120-6721},
journal = {European Journal of Ophthalmology},
title = {Incidence of adverse events after loading phase of the brolucizumab therapy of neovascular AMD: Real-life evidence in the Czech Republic},
url = {https://journals.sagepub.com/doi/10.1177/11206721221132619},
volume = {33},
year = {2023}
}
TY - JOUR
ID - 2249063
AU - Stepanov, Alexandr - Studnicka, Jan - Veith, Miroslav - Nemec, Pavel - Vysloužilová, Daniela - Koubek, Michal - Nemcansky, Jan
PY - 2023
TI - Incidence of adverse events after loading phase of the brolucizumab therapy of neovascular AMD: Real-life evidence in the Czech Republic
JF - European Journal of Ophthalmology
VL - 33
IS - 2
SP - 1097-1104
EP - 1097-1104
PB - SAGE PUBLICATIONS LTD
SN - 11206721
KW - anti-VEGF therapy
KW - brolucizumab
KW - neovascular age-related macular degeneration
KW - real-life practice
KW - adverse event
KW - switch
UR - https://journals.sagepub.com/doi/10.1177/11206721221132619
N2 - Aim To evaluate the incidence of ocular adverse events after loading phase of the brolucizumab therapy in patients with neovascular age-related macular degeneration (nAMD) in real-life clinical practice - in treatment-naive patients and in patients after switching from another anti-VEGF agent. Another aim was to evaluate treatment outcomes in patients with adverse events. Methods This is a multicentre, retrospective, observational study from 16 application centres in the Czech Republic. Patients diagnosed with nAMD were treated with brolucizumab in a fixed regimen of loading phase (3 injections administered at one-month intervals) and the mean follow-up period was 120 +/- 10 days after the first injection. The incidence of adverse events and the development of best corrected visual acuity (BCVA) and central retinal thickness (CRT) in patients with complications were evaluated. A total of 1,098 eyes were followed up, of which 783 were treatment-naive and 315 eyes were after switching from another anti-VEGF agent. Results Adverse events were recorded in 42 eyes (3.83%), of which 30 eyes were treatment-naive (2.7%) and 12 eyes were post-switch (1.09%). The mean baseline BCVA +/- SD was 56.7 +/- 10.7 ETDRS chart letters in the group of patients with adverse events, 58.8 +/- 10.1 letters in treatment-naive patients, and 51.4 +/- 10.2 letters in patients after switch from another anti-VEGF agent. The mean baseline CRT +/- SD was 432.2 +/- 154.7 mu m, being 435.8 +/- 137.3 mu m in treatment-naive patients and 424.5 +/- 186.6 mu m in patients after switch from another anti-VEGF agent. At the end of the follow-up, the mean BCVA +/- SD was 53.4 +/- 9.5 ETDRS charts letters in patients with adverse events, 55.6 +/- 10 letters in treatment-naive patients, and 47.6 +/- 10 letters in patients after switching from another anti-VEGF agent. The mean CRT +/- SD at the end of the follow-up was 300.7 +/- 115.7 mu m in the total patient cohort, 285.2 +/- 78.8 mu m in treatment-naive patients and 334.5 +/- 165.4 mu m in patients after switching from another anti-VEGF agent. Conclusion We observed the development of adverse events in the form of intraocular inflammation or vasculitis with subsequent decrease in BCVA in 3.83% of cases after loading phase of the brolucizumab therapy. The decrease in BCVA was reversible in most cases after initiation of anti-inflammatory steroid treatment. From a functional and morphological point of view, we did not demonstrate any statistically significant difference between the groups of treatment-naive patients and patients after switching from another anti-VEGF agent.
ER -
STEPANOV, Alexandr, Jan STUDNICKA, Miroslav VEITH, Pavel NEMEC, Daniela VYSLOUŽILOVÁ, Michal KOUBEK a Jan NEMCANSKY. Incidence of adverse events after loading phase of the brolucizumab therapy of neovascular AMD: Real-life evidence in the Czech Republic. \textit{European Journal of Ophthalmology}. LONDON: SAGE PUBLICATIONS LTD, 2023, roč.~33, č.~2, s.~1097-1104. ISSN~1120-6721. Dostupné z: https://dx.doi.org/10.1177/11206721221132619.
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