Incidence of adverse events after loading phase of the
brolucizumab therapy of neovascular AMD: Real-life evidence in
the Czech Republic

J 2023

Incidence of adverse events after loading phase of the brolucizumab therapy of neovascular AMD: Real-life evidence in the Czech Republic

STEPANOV, Alexandr, Jan STUDNICKA, Miroslav VEITH, Pavel NEMEC, Daniela VYSLOUŽILOVÁ et. al.

Basic information

Original name

Incidence of adverse events after loading phase of the brolucizumab therapy of neovascular AMD: Real-life evidence in the Czech Republic

Authors

STEPANOV, Alexandr (203 Czech Republic), Jan STUDNICKA (203 Czech Republic, guarantor), Miroslav VEITH (203 Czech Republic), Pavel NEMEC (203 Czech Republic), Daniela VYSLOUŽILOVÁ (203 Czech Republic, belonging to the institution), Michal KOUBEK (203 Czech Republic) and Jan NEMCANSKY (203 Czech Republic)

Edition

European Journal of Ophthalmology, LONDON, SAGE PUBLICATIONS LTD, 2023, 1120-6721

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30207 Ophthalmology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 1.700 in 2022

RIV identification code

RIV/00216224:14110/23:00130213

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1177/11206721221132619

UT WoS

000869431600001

Keywords in English

anti-VEGF therapy; brolucizumab; neovascular age-related macular degeneration; real-life practice; adverse event; switch

Abstract

V originále

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.

Citovat

STEPANOV, Alexandr, Jan STUDNICKA, Miroslav VEITH, Pavel NEMEC, Daniela VYSLOUŽILOVÁ, Michal KOUBEK and Jan NEMCANSKY. Incidence of adverse events after loading phase of the brolucizumab therapy of neovascular AMD: Real-life evidence in the Czech Republic. European Journal of Ophthalmology. LONDON: SAGE PUBLICATIONS LTD, 2023, vol. 33, No 2, p. 1097-1104. ISSN 1120-6721. Available from: https://dx.doi.org/10.1177/11206721221132619.

@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 and 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, vol.~33, No~2, p.~1097-1104. ISSN~1120-6721. Available from: https://dx.doi.org/10.1177/11206721221132619.

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