A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard.

<h4>Background</h4>We set out a systemic review to evaluate whether off-label bevacizumab is as safe as licensed ranibizumab, and whether bevacizumab can be justifiably offered to patients as a treatment for age-related macular degeneration with robust evidence of no differential risk.&l...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Christine Schmucker, Christoph Ehlken, Hansjuergen T Agostini, Gerd Antes, Gerta Ruecker, Monika Lelgemann, Yoon K Loke
Formato: article
Lenguaje:EN
Publicado: Public Library of Science (PLoS) 2012
Materias:
R
Q
Acceso en línea:https://doaj.org/article/c5e008556eeb4130b932c3f8d52cf1c0
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
id oai:doaj.org-article:c5e008556eeb4130b932c3f8d52cf1c0
record_format dspace
spelling oai:doaj.org-article:c5e008556eeb4130b932c3f8d52cf1c02021-11-18T07:09:40ZA safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard.1932-620310.1371/journal.pone.0042701https://doaj.org/article/c5e008556eeb4130b932c3f8d52cf1c02012-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/22880086/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>We set out a systemic review to evaluate whether off-label bevacizumab is as safe as licensed ranibizumab, and whether bevacizumab can be justifiably offered to patients as a treatment for age-related macular degeneration with robust evidence of no differential risk.<h4>Methods and findings</h4>Medline, Embase and the Cochrane Library were searched with no limitations of language and year of publication. We included RCTs with a minimum follow-up of one year which investigated bevacizumab or ranibizumab in direct comparison or against any other control group (indirect comparison). Direct comparison (3 trials, 1333 patients): The one year data show a significantly higher rate of ocular adverse effects (AE) with bevacizumab compared to ranibizumab (RR = 2.8; 95% CI 1.2-6.5). The proportion of patients with serious infections and gastrointestinal disorders was also higher with bevacizumab than with ranibizumab (RR = 1.3; 95% CI 1.0-1.7). Arterial thromboembolic events were equally distributed among the groups. Indirect comparison: Ranibizumab versus any control (5 trials, 4054 patients): The two year results of three landmark trials showed that while absolute rates of serious ocular AE were low (≤ 2.1%), relative harm was significantly raised (RR = 3.1; 95% CI 1.1-8.9). A significant increase in nonocular haemorrhage was also observed with ranibizumab (RR = 1.7; 95% CI 1.1-2.7). Bevacizumab versus any control (3 trials, 244 patients): We were unable to judge the safety profile of bevacizumab due to the poor quality of AE monitoring and reporting in the trials.<h4>Conclusions</h4>Evidence from head-to-head trials raises concern about an increased risk of ocular and multiple systemic AE with bevacizumab. Therefore, clinicians and patients should continue to carefully weight up the benefits and harms when choosing between the two treatment options. We also emphasize the need for studies that are powered not just for efficacy, but for defined safety outcomes based on the signals detected in this systematic review.Christine SchmuckerChristoph EhlkenHansjuergen T AgostiniGerd AntesGerta RueckerMonika LelgemannYoon K LokePublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 7, Iss 8, p e42701 (2012)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Christine Schmucker
Christoph Ehlken
Hansjuergen T Agostini
Gerd Antes
Gerta Ruecker
Monika Lelgemann
Yoon K Loke
A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard.
description <h4>Background</h4>We set out a systemic review to evaluate whether off-label bevacizumab is as safe as licensed ranibizumab, and whether bevacizumab can be justifiably offered to patients as a treatment for age-related macular degeneration with robust evidence of no differential risk.<h4>Methods and findings</h4>Medline, Embase and the Cochrane Library were searched with no limitations of language and year of publication. We included RCTs with a minimum follow-up of one year which investigated bevacizumab or ranibizumab in direct comparison or against any other control group (indirect comparison). Direct comparison (3 trials, 1333 patients): The one year data show a significantly higher rate of ocular adverse effects (AE) with bevacizumab compared to ranibizumab (RR = 2.8; 95% CI 1.2-6.5). The proportion of patients with serious infections and gastrointestinal disorders was also higher with bevacizumab than with ranibizumab (RR = 1.3; 95% CI 1.0-1.7). Arterial thromboembolic events were equally distributed among the groups. Indirect comparison: Ranibizumab versus any control (5 trials, 4054 patients): The two year results of three landmark trials showed that while absolute rates of serious ocular AE were low (≤ 2.1%), relative harm was significantly raised (RR = 3.1; 95% CI 1.1-8.9). A significant increase in nonocular haemorrhage was also observed with ranibizumab (RR = 1.7; 95% CI 1.1-2.7). Bevacizumab versus any control (3 trials, 244 patients): We were unable to judge the safety profile of bevacizumab due to the poor quality of AE monitoring and reporting in the trials.<h4>Conclusions</h4>Evidence from head-to-head trials raises concern about an increased risk of ocular and multiple systemic AE with bevacizumab. Therefore, clinicians and patients should continue to carefully weight up the benefits and harms when choosing between the two treatment options. We also emphasize the need for studies that are powered not just for efficacy, but for defined safety outcomes based on the signals detected in this systematic review.
format article
author Christine Schmucker
Christoph Ehlken
Hansjuergen T Agostini
Gerd Antes
Gerta Ruecker
Monika Lelgemann
Yoon K Loke
author_facet Christine Schmucker
Christoph Ehlken
Hansjuergen T Agostini
Gerd Antes
Gerta Ruecker
Monika Lelgemann
Yoon K Loke
author_sort Christine Schmucker
title A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard.
title_short A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard.
title_full A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard.
title_fullStr A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard.
title_full_unstemmed A safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard.
title_sort safety review and meta-analyses of bevacizumab and ranibizumab: off-label versus goldstandard.
publisher Public Library of Science (PLoS)
publishDate 2012
url https://doaj.org/article/c5e008556eeb4130b932c3f8d52cf1c0
work_keys_str_mv AT christineschmucker asafetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
AT christophehlken asafetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
AT hansjuergentagostini asafetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
AT gerdantes asafetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
AT gertaruecker asafetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
AT monikalelgemann asafetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
AT yoonkloke asafetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
AT christineschmucker safetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
AT christophehlken safetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
AT hansjuergentagostini safetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
AT gerdantes safetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
AT gertaruecker safetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
AT monikalelgemann safetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
AT yoonkloke safetyreviewandmetaanalysesofbevacizumabandranibizumabofflabelversusgoldstandard
_version_ 1718423880142422016