Early Outcomes of Brolucizumab Switch in Wet Age- Related Macular Degeneration: A Tertiary Portuguese Hospital Experience
Autor(a) principal: | |
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Data de Publicação: | 2023 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | https://doi.org/10.48560/rspo.28282 |
Resumo: | INTRODUCTION: Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. The use of anti-vascular endothelial growth factor (VEGF) revolu- tionized the treatment of neovascular AMD (nAMD) despite being a known burden to both patients and healthcare systems. Brolucizumab is a newer anti-VEGF agent, whose noninferiority to aflibercept in visual outcomes in treatment-naïve eyes with nAMD was demonstrated in two clinical trials. A secondary favorable outcome was the extended dosing intervals in more than half of eyes treated with this agent. Although it exhibited a safety profile comparable to aflibercept, the rate of intraocular inflammatory events was superior. Few studies report the outcomes of non-naïve patients after switching to brolucizumab. Our aim is to evaluate the functional and anatomic outcomes, and safety of brolucizumab in nAMD patients previously treated with other anti-VEGF agents with poor response in our center. METHODS: Retrospective and observational study in patients with nAMD receiving intra- vitreal treatment with anti-VEGF that showed no response or persistent presence of significant intra- and/or subretinal fluid despite injections intervals of 6 weeks or less. Those patients switched to therapy with brolucizumab between January to August of 2022. Functional (best corrected visual acuity [BCVA], intraocular pressure [IOP]) and anatomical (central subfield thickness [CST], presence of intra- and/or subretinal fluid and presence of pigment epithelial detachment) outcomes were measured and analyzed both at baseline and at a posterior visit 8-to-12 weeks after the first injection. Any sign of adverse effect was reported. For statistical analysis SPSS v.28 was used. Results were deemed significant if p < 0.05, in the parametric, non-parametric and categori- cal tests used. RESULTS: Thirteen eyes of 12 patients, with a mean age of 77.4 ± 11.6 years and 41.7% of females, switched to brolucizumab during the mentioned period, receiving a mean of 1.77 ± 0.8 injections. Patients were previously followed for a mean of 43.1 ± 25.6 months and received a median of 23 ± 31 other anti-VEGF injections. After the switch, it was observed a significant change in the treatment interval (p = 0.008). A significant mean change in BCVA of -0.17 ± 0.19 logMAR (95% CI: -0.278; -0.053, p = 0.007), as well as in CST of -43.38 ± 57.70 μm (95% CI: -78.25; -8.52; p = 0.019) was found. A significant reduction was observed regarding subretinal fluid (p= 0.031), but no change was observed in the presence of intraretinal fluid or pigment epithelial detachment. There were no reported adverse effects. CONCLUSION: Our results align with previous clinical trials and reports of real-world settings of naïve and non-naïve treatment patients treated with brolucizumab. The improvement in functional and anatomical outcomes in addition to extending treatment interval demonstrates that this agent is a promising treatment against nAMD and reduces the burden of repeated in- travitreal injections. Despite no reports of IOI in this cohort, careful patient selection, a vigilant follow-up and suitable patient education for warning signs is vital. |
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Early Outcomes of Brolucizumab Switch in Wet Age- Related Macular Degeneration: A Tertiary Portuguese Hospital ExperienceEfeitos Precoces do Switch para Brolucizumab na Degenerescência Macular Ligada à Idade: Experiência de um Hospital Terciário PortuguêsArtigos OriginaisINTRODUCTION: Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. The use of anti-vascular endothelial growth factor (VEGF) revolu- tionized the treatment of neovascular AMD (nAMD) despite being a known burden to both patients and healthcare systems. Brolucizumab is a newer anti-VEGF agent, whose noninferiority to aflibercept in visual outcomes in treatment-naïve eyes with nAMD was demonstrated in two clinical trials. A secondary favorable outcome was the extended dosing intervals in more than half of eyes treated with this agent. Although it exhibited a safety profile comparable to aflibercept, the rate of intraocular inflammatory events was superior. Few studies report the outcomes of non-naïve patients after switching to brolucizumab. Our aim is to evaluate the functional and anatomic outcomes, and safety of brolucizumab in nAMD patients previously treated with other anti-VEGF agents with poor response in our center. METHODS: Retrospective and observational study in patients with nAMD receiving intra- vitreal treatment with anti-VEGF that showed no response or persistent presence of significant intra- and/or subretinal fluid despite injections intervals of 6 weeks or less. Those patients switched to therapy with brolucizumab between January to August of 2022. Functional (best corrected visual acuity [BCVA], intraocular pressure [IOP]) and anatomical (central subfield thickness [CST], presence of intra- and/or subretinal fluid and presence of pigment epithelial detachment) outcomes were measured and analyzed both at baseline and at a posterior visit 8-to-12 weeks after the first injection. Any sign of adverse effect was reported. For statistical analysis SPSS v.28 was used. Results were deemed significant if p < 0.05, in the parametric, non-parametric and categori- cal tests used. RESULTS: Thirteen eyes of 12 patients, with a mean age of 77.4 ± 11.6 years and 41.7% of females, switched to brolucizumab during the mentioned period, receiving a mean of 1.77 ± 0.8 injections. Patients were previously followed for a mean of 43.1 ± 25.6 months and received a median of 23 ± 31 other anti-VEGF injections. After the switch, it was observed a significant change in the treatment interval (p = 0.008). A significant mean change in BCVA of -0.17 ± 0.19 logMAR (95% CI: -0.278; -0.053, p = 0.007), as well as in CST of -43.38 ± 57.70 μm (95% CI: -78.25; -8.52; p = 0.019) was found. A significant reduction was observed regarding subretinal fluid (p= 0.031), but no change was observed in the presence of intraretinal fluid or pigment epithelial detachment. There were no reported adverse effects. CONCLUSION: Our results align with previous clinical trials and reports of real-world settings of naïve and non-naïve treatment patients treated with brolucizumab. The improvement in functional and anatomical outcomes in addition to extending treatment interval demonstrates that this agent is a promising treatment against nAMD and reduces the burden of repeated in- travitreal injections. Despite no reports of IOI in this cohort, careful patient selection, a vigilant follow-up and suitable patient education for warning signs is vital.INTRODUÇÃO: A degenerescência macular ligada à idade (DMI) é a principal causa de cegueira nos países desenvolvidos. O uso de agentes anti-vascular endothelial growth factor (VEGF) revolucionou o tratamento da DMI exsudativa, apesar dos importantes encargos para os doentes e sistemas de saúde. O brolucizumab, um novo anti-VEGF, teve em dois ensaios clínicos comprovada a sua eficácia funcional e anatómica. Apesar de um perfil de segurança comparável ao aflibercept, a taxa de inflamação intraocular foi consideravelmente superior. Poucos estudos reportam os resultados do brolucizumab em doentes previamente tratados com outros agentes anti-VEGF e com fraca resposta a esta terapêutica. Neste estudo pretendemos avaliar os resultados clínicos, anatómicos e de segurança do uso de brolucizumab nestes doentes. MÉTODOS: Estudo observacional e retrospectivo em doentes a receber tratamento com injeções intravítreas de anti-VEGF por DMI neovascular, sem resposta ao tratamento ou com presença persistente de fluído intra- e/ou subretiniano apesar de intervalos entre injeções de 6 semanas ou inferior. Estes doentes fizeram o switch para brolucizumab entre Janeiro e Agosto de 2022. A avaliação e comparação incluía dados funcionais (melhor acuidade visual corrigida [MAVC], pressão intraocular [PIO]) e estruturais (espessura foveal central [EFC], presença de fluído intra- e/ou subretiniano e/ou descolamento do epitélio pigmentar) basais e após 8 a 12 semanas da primeira injeção de brolucizumab. Foi reportada a presença de qualquer efeito adverso. A análise estatística foi realizada utilizando a versão 28 do SPSS. Valores de p < 0,05 foram considerados significativos. RESULTADOS: Treze olhos de 12 doentes, com idade média de 77,4 ± 11,6 anos e 41,7% do sexo feminino, realizaram o switch para brolucizumab no período mencionado, recebendo uma média de 1,77 ± 0,8 injeções. Previamente, tinham sido seguidos por uma média de 43,1 ± 25,6 meses e tratados com uma mediana de 23 ± 31 injeções de outros anti-VEGF. Após a altera- ção para brolucizumab foi observada uma mudança significativa no intervalo de tratamento (p = 0,008). Observou-se uma melhoria significativa na MAVC de -0,17 ± 0,19 logMAR (95% IC: -0,278; -0,053; p = 0,007), assim como uma redução na EFC de -43,38 ± 57,70 μm (95% IC: -78,25; -8,52; p = 0,019). A redução de fluído subretiniano também demonstrou ser significativa (p = 0,031), mas não se registaram alterações no fluído intrarretiniano ou descolamento do epitélio pigmentar. Não se registaram efeitos adversos. CONCLUSÃO: Os nossos resultados do uso de brolucizumab equiparam-se à literatura tanto em doentes previamente tratados como não. A melhoria nos resultados funcionais e estruturais, assim como a extensão do intervalo entre injeções demonstra que esta molécula é uma arma promissora no tratamento da DMI neovascular, permitindo reduzir o encargo de injeções intravítreas repetidas. Apesar de no nosso grupo não terem sido registados casos de inflamação intraocular é vital uma adequada seleção de doentes, o seu seguimento cuidadoso e educar os doentes para os seus principais sinais de alarme.Ajnet2023-12-29info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttps://doi.org/10.48560/rspo.28282eng1646-69501646-6950Correia, MartaBaptista, MargaridaCordeiro, MiguelPicoto, MariaVaz, Fernandainfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-01-04T20:30:32Zoai:ojs.revistas.rcaap.pt:article/28282Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T01:30:08.086035Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Early Outcomes of Brolucizumab Switch in Wet Age- Related Macular Degeneration: A Tertiary Portuguese Hospital Experience Efeitos Precoces do Switch para Brolucizumab na Degenerescência Macular Ligada à Idade: Experiência de um Hospital Terciário Português |
title |
Early Outcomes of Brolucizumab Switch in Wet Age- Related Macular Degeneration: A Tertiary Portuguese Hospital Experience |
spellingShingle |
Early Outcomes of Brolucizumab Switch in Wet Age- Related Macular Degeneration: A Tertiary Portuguese Hospital Experience Correia, Marta Artigos Originais |
title_short |
Early Outcomes of Brolucizumab Switch in Wet Age- Related Macular Degeneration: A Tertiary Portuguese Hospital Experience |
title_full |
Early Outcomes of Brolucizumab Switch in Wet Age- Related Macular Degeneration: A Tertiary Portuguese Hospital Experience |
title_fullStr |
Early Outcomes of Brolucizumab Switch in Wet Age- Related Macular Degeneration: A Tertiary Portuguese Hospital Experience |
title_full_unstemmed |
Early Outcomes of Brolucizumab Switch in Wet Age- Related Macular Degeneration: A Tertiary Portuguese Hospital Experience |
title_sort |
Early Outcomes of Brolucizumab Switch in Wet Age- Related Macular Degeneration: A Tertiary Portuguese Hospital Experience |
author |
Correia, Marta |
author_facet |
Correia, Marta Baptista, Margarida Cordeiro, Miguel Picoto, Maria Vaz, Fernanda |
author_role |
author |
author2 |
Baptista, Margarida Cordeiro, Miguel Picoto, Maria Vaz, Fernanda |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Correia, Marta Baptista, Margarida Cordeiro, Miguel Picoto, Maria Vaz, Fernanda |
dc.subject.por.fl_str_mv |
Artigos Originais |
topic |
Artigos Originais |
description |
INTRODUCTION: Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. The use of anti-vascular endothelial growth factor (VEGF) revolu- tionized the treatment of neovascular AMD (nAMD) despite being a known burden to both patients and healthcare systems. Brolucizumab is a newer anti-VEGF agent, whose noninferiority to aflibercept in visual outcomes in treatment-naïve eyes with nAMD was demonstrated in two clinical trials. A secondary favorable outcome was the extended dosing intervals in more than half of eyes treated with this agent. Although it exhibited a safety profile comparable to aflibercept, the rate of intraocular inflammatory events was superior. Few studies report the outcomes of non-naïve patients after switching to brolucizumab. Our aim is to evaluate the functional and anatomic outcomes, and safety of brolucizumab in nAMD patients previously treated with other anti-VEGF agents with poor response in our center. METHODS: Retrospective and observational study in patients with nAMD receiving intra- vitreal treatment with anti-VEGF that showed no response or persistent presence of significant intra- and/or subretinal fluid despite injections intervals of 6 weeks or less. Those patients switched to therapy with brolucizumab between January to August of 2022. Functional (best corrected visual acuity [BCVA], intraocular pressure [IOP]) and anatomical (central subfield thickness [CST], presence of intra- and/or subretinal fluid and presence of pigment epithelial detachment) outcomes were measured and analyzed both at baseline and at a posterior visit 8-to-12 weeks after the first injection. Any sign of adverse effect was reported. For statistical analysis SPSS v.28 was used. Results were deemed significant if p < 0.05, in the parametric, non-parametric and categori- cal tests used. RESULTS: Thirteen eyes of 12 patients, with a mean age of 77.4 ± 11.6 years and 41.7% of females, switched to brolucizumab during the mentioned period, receiving a mean of 1.77 ± 0.8 injections. Patients were previously followed for a mean of 43.1 ± 25.6 months and received a median of 23 ± 31 other anti-VEGF injections. After the switch, it was observed a significant change in the treatment interval (p = 0.008). A significant mean change in BCVA of -0.17 ± 0.19 logMAR (95% CI: -0.278; -0.053, p = 0.007), as well as in CST of -43.38 ± 57.70 μm (95% CI: -78.25; -8.52; p = 0.019) was found. A significant reduction was observed regarding subretinal fluid (p= 0.031), but no change was observed in the presence of intraretinal fluid or pigment epithelial detachment. There were no reported adverse effects. CONCLUSION: Our results align with previous clinical trials and reports of real-world settings of naïve and non-naïve treatment patients treated with brolucizumab. The improvement in functional and anatomical outcomes in addition to extending treatment interval demonstrates that this agent is a promising treatment against nAMD and reduces the burden of repeated in- travitreal injections. Despite no reports of IOI in this cohort, careful patient selection, a vigilant follow-up and suitable patient education for warning signs is vital. |
publishDate |
2023 |
dc.date.none.fl_str_mv |
2023-12-29 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://doi.org/10.48560/rspo.28282 |
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https://doi.org/10.48560/rspo.28282 |
dc.language.iso.fl_str_mv |
eng |
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eng |
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1646-6950 1646-6950 |
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info:eu-repo/semantics/openAccess |
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openAccess |
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Ajnet |
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Ajnet |
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reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
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RCAAP |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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