Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme
Identifieur interne : 000050 ( France/Analysis ); précédent : 000049; suivant : 000051Safety of ranibizumab in routine clinical practice: 1-year retrospective pooled analysis of four European neovascular AMD registries within the LUMINOUS programme
Auteurs : Frank G. Holz [Allemagne] ; Francesco Bandello [Italie] ; Mark Gillies [Australie] ; Paul Mitchell [Australie] ; Aaron Osborne [Suisse] ; Tom Sheidow [Canada] ; Eric Souied [France] ; Marta S. Figueroa [Espagne] ; Francesco Bandello ; Christopher Brand ; Mark Gillies ; Frank G. Holz ; Adrian Koh ; Paul Mitchell ; Aaron Osborne ; Ursula Schmidt-Erfurth ; N. Sharma ; Tom Sheidow ; Eric Souied ; Marta S. Figueroa ; Steve WinyardSource :
- British Journal of Ophthalmology [ 0007-1161 ] ; 2013-09.
Abstract
Purpose Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. Methods The LUMINOUS programme comprises a prospective observational study assessing ranibizumab ‘real-world’ safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Results Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0–0.5%). Conclusions Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in ‘real-life’ settings. The 5-year LUMINOUS prospective observational study will address this need.
Url:
DOI: 10.1136/bjophthalmol-2013-303232
Affiliations:
- Allemagne, Australie, Canada, Espagne, France, Italie, Suisse
- Communauté de Madrid, District de Cologne, Lombardie, Rhénanie-du-Nord-Westphalie
- Bonn, Créteil, Madrid, Milan
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Figueroa</name><affiliation wicri:level="3"><country xml:lang="fr">Espagne</country><wicri:regionArea>Servicio de Oftalmologia, Ramon y Cajal University Hospital, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author wicri:is="80%"><name sortKey="Bandello, Francesco" sort="Bandello, Francesco" uniqKey="Bandello F" first="Francesco" last="Bandello">Francesco Bandello</name></author><author wicri:is="80%"><name sortKey="Brand, Christopher" sort="Brand, Christopher" uniqKey="Brand C" first="Christopher" last="Brand">Christopher Brand</name></author><author wicri:is="80%"><name sortKey="Gillies, Mark" sort="Gillies, Mark" uniqKey="Gillies M" first="Mark" last="Gillies">Mark Gillies</name></author><author wicri:is="80%"><name sortKey="Holz, Frank G" sort="Holz, Frank G" uniqKey="Holz F" first="Frank G" last="Holz">Frank G. Holz</name></author><author wicri:is="80%"><name sortKey="Koh, Adrian" sort="Koh, Adrian" uniqKey="Koh A" first="Adrian" last="Koh">Adrian Koh</name></author><author wicri:is="80%"><name sortKey="Mitchell, Paul" sort="Mitchell, Paul" uniqKey="Mitchell P" first="Paul" last="Mitchell">Paul Mitchell</name></author><author wicri:is="80%"><name sortKey="Osborne, Aaron" sort="Osborne, Aaron" uniqKey="Osborne A" first="Aaron" last="Osborne">Aaron Osborne</name></author><author wicri:is="80%"><name sortKey="Schmidt Erfurth, Ursula" sort="Schmidt Erfurth, Ursula" uniqKey="Schmidt Erfurth U" first="Ursula" last="Schmidt-Erfurth">Ursula Schmidt-Erfurth</name></author><author wicri:is="80%"><name sortKey="Sharma, N" sort="Sharma, N" uniqKey="Sharma N" first="N" last="Sharma">N. Sharma</name></author><author wicri:is="80%"><name sortKey="Sheidow, Tom" sort="Sheidow, Tom" uniqKey="Sheidow T" first="Tom" last="Sheidow">Tom Sheidow</name></author><author wicri:is="80%"><name sortKey="Souied, Eric" sort="Souied, Eric" uniqKey="Souied E" first="Eric" last="Souied">Eric Souied</name></author><author wicri:is="80%"><name sortKey="Figueroa, Marta S" sort="Figueroa, Marta S" uniqKey="Figueroa M" first="Marta S" last="Figueroa">Marta S. Figueroa</name></author><author wicri:is="80%"><name sortKey="Winyard, Steve" sort="Winyard, Steve" uniqKey="Winyard S" first="Steve" last="Winyard">Steve Winyard</name></author></analytic><monogr></monogr><series><title level="j">British Journal of Ophthalmology</title><title level="j" type="abbrev">Br J Ophthalmol</title><idno type="ISSN">0007-1161</idno><idno type="eISSN">1468-2079</idno><imprint><publisher>BMJ Publishing Group Ltd.</publisher><pubPlace>BMA House, Tavistock Square, London, WC1H 9JR</pubPlace><date type="published" when="2013-09">2013-09</date><biblScope unit="volume">97</biblScope><biblScope unit="issue">9</biblScope><biblScope unit="page" from="1161">1161</biblScope></imprint><idno type="ISSN">0007-1161</idno></series><idno type="istex">BFB0E7EC9349D8A814B7FA0790E0390D696E5A43</idno><idno type="DOI">10.1136/bjophthalmol-2013-303232</idno><idno type="href">bjophthalmol-97-1161.pdf</idno><idno type="ArticleID">bjophthalmol-2013-303232</idno><idno type="PMID">23850682</idno><idno type="local">bjophthalmol;97/9/1161</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0007-1161</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Purpose Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice. Methods The LUMINOUS programme comprises a prospective observational study assessing ranibizumab ‘real-world’ safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence. Results Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0–0.5%). Conclusions Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in ‘real-life’ settings. The 5-year LUMINOUS prospective observational study will address this need.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>Espagne</li><li>France</li><li>Italie</li><li>Suisse</li></country><region><li>Communauté de Madrid</li><li>District de Cologne</li><li>Lombardie</li><li>Rhénanie-du-Nord-Westphalie</li></region><settlement><li>Bonn</li><li>Créteil</li><li>Madrid</li><li>Milan</li></settlement></list><tree><noCountry><name sortKey="Bandello, Francesco" sort="Bandello, Francesco" uniqKey="Bandello F" first="Francesco" last="Bandello">Francesco Bandello</name><name sortKey="Brand, Christopher" sort="Brand, Christopher" uniqKey="Brand C" first="Christopher" last="Brand">Christopher Brand</name><name sortKey="Figueroa, Marta S" sort="Figueroa, Marta S" uniqKey="Figueroa M" first="Marta S" last="Figueroa">Marta S. Figueroa</name><name sortKey="Gillies, Mark" sort="Gillies, Mark" uniqKey="Gillies M" first="Mark" last="Gillies">Mark Gillies</name><name sortKey="Holz, Frank G" sort="Holz, Frank G" uniqKey="Holz F" first="Frank G" last="Holz">Frank G. Holz</name><name sortKey="Koh, Adrian" sort="Koh, Adrian" uniqKey="Koh A" first="Adrian" last="Koh">Adrian Koh</name><name sortKey="Mitchell, Paul" sort="Mitchell, Paul" uniqKey="Mitchell P" first="Paul" last="Mitchell">Paul Mitchell</name><name sortKey="Osborne, Aaron" sort="Osborne, Aaron" uniqKey="Osborne A" first="Aaron" last="Osborne">Aaron Osborne</name><name sortKey="Schmidt Erfurth, Ursula" sort="Schmidt Erfurth, Ursula" uniqKey="Schmidt Erfurth U" first="Ursula" last="Schmidt-Erfurth">Ursula Schmidt-Erfurth</name><name sortKey="Sharma, N" sort="Sharma, N" uniqKey="Sharma N" first="N" last="Sharma">N. Sharma</name><name sortKey="Sheidow, Tom" sort="Sheidow, Tom" uniqKey="Sheidow T" first="Tom" last="Sheidow">Tom Sheidow</name><name sortKey="Souied, Eric" sort="Souied, Eric" uniqKey="Souied E" first="Eric" last="Souied">Eric Souied</name><name sortKey="Winyard, Steve" sort="Winyard, Steve" uniqKey="Winyard S" first="Steve" last="Winyard">Steve Winyard</name></noCountry><country name="Allemagne"><region name="Rhénanie-du-Nord-Westphalie"><name sortKey="Holz, Frank G" sort="Holz, Frank G" uniqKey="Holz F" first="Frank G" last="Holz">Frank G. Holz</name></region></country><country name="Italie"><region name="Lombardie"><name sortKey="Bandello, Francesco" sort="Bandello, Francesco" uniqKey="Bandello F" first="Francesco" last="Bandello">Francesco Bandello</name></region></country><country name="Australie"><noRegion><name sortKey="Gillies, Mark" sort="Gillies, Mark" uniqKey="Gillies M" first="Mark" last="Gillies">Mark Gillies</name></noRegion><name sortKey="Mitchell, Paul" sort="Mitchell, Paul" uniqKey="Mitchell P" first="Paul" last="Mitchell">Paul Mitchell</name></country><country name="Suisse"><noRegion><name sortKey="Osborne, Aaron" sort="Osborne, Aaron" uniqKey="Osborne A" first="Aaron" last="Osborne">Aaron Osborne</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Sheidow, Tom" sort="Sheidow, Tom" uniqKey="Sheidow T" first="Tom" last="Sheidow">Tom Sheidow</name></noRegion></country><country name="France"><noRegion><name sortKey="Souied, Eric" sort="Souied, Eric" uniqKey="Souied E" first="Eric" last="Souied">Eric Souied</name></noRegion></country><country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Figueroa, Marta S" sort="Figueroa, Marta S" uniqKey="Figueroa M" first="Marta S" last="Figueroa">Marta S. Figueroa</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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