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

Article in a journal

Field of Study

30207 Ophthalmology

Country of publisher

United Kingdom of Great Britain and Northern Ireland

Confidentiality degree

is not subject to a state or trade secret

References:

URL

Impact factor

Impact factor: 1.500

RIV identification code

RIV/00216224:14110/23:00130213

Organization unit

Faculty of Medicine

DOI

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

UT WoS

000869431600001

EID Scopus

2-s2.0-85140226335

Keywords in English

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

Abstract

In the original language

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.

Cite

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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