dc.contributor | Hospital General de Granollers |
dc.contributor.author | Fonollosa, Alex |
dc.contributor.author | Gallego-Pinazo, Roberto |
dc.contributor.author | Sararols, Laura |
dc.contributor.author | Adán, Alfredo |
dc.contributor.author | López Gálvez, María Isabel |
dc.contributor.author | Figueroa, Marta |
dc.date.accessioned | 2022-07-29T08:02:51Z |
dc.date.available | 2022-07-29T08:02:51Z |
dc.date.issued | 2022-07-23 |
dc.identifier.citation | Fonollosa A, Gallego-Pinazo R, Sararols L, Adán A, López-Gálvez M, Figueroa MS. Guidance on brolucizumab management recommendations. Arch Soc Esp Oftalmol (Engl Ed). 2022 Jul 23;S2173-5794(22)00084-6. |
dc.identifier.uri | https://hdl.handle.net/11351/7946 |
dc.description | Brolucizumab; Intraocular inflammation; Patient management |
dc.description.abstract | Purpose: Brolucizumab, a new generation anti-VEGF, has demonstrated efficacy and safety in AMD in the pivotal HAWK and HARRIER trials. Post-marketing, previously undetected adverse events related to intraocular inflammation have been reported. An independent post hoc review of the pivotal trials puts the rate of IOI at 4.6%. The aim of this paper is to propose a set of recommendations for implementing the management of brolucizumab in clinical practice.
Methods: The recommendations made by the authors are based on their clinical experience, critical review of (i) the pivotal trials, the post-hoc analysis of the Safety Review Committee, (ii), and (iii) the published literature.
Results: In the pivotal trials, brolucizumab showed sustained functional gains, superior anatomical outcomes with potentially longer intervals between injections and a well-tolerated overall safety profile. Adverse events reported post-marketing include retinal vasculitis and retinal vascular occlusion. Based on the available information, experts recommend (i) ruling out non-recommended patient profiles (prior history of ORI), (ii) screening the patient prior to each injection to rule out active ORI, (iii) monitoring the patient for early warning signs, and (iv) treating immediately should any adverse events develop.
Conclusions: The adverse events reported are rare, but may be associated with severe and irreversible loss of visual acuity. The recommendations made are intended to facilitate the management of brolucizumab in the routine practice of retinologists, to ensure patient safety and, should any adverse events occur, to minimise their impact on vision. |
dc.language.iso | eng |
dc.publisher | Elsevier |
dc.relation.ispartofseries | Archivos de la Sociedad Española de Oftalmología (English Edition); |
dc.rights | Attribution 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ |
dc.source | Scientia |
dc.subject | Retina - Inflamació |
dc.subject | Medicaments |
dc.subject | Ulls - Malalties |
dc.subject.mesh | Retinal Vasculitis |
dc.title | Guidance on brolucizumab management recommendations |
dc.title.alternative | Guía de recomendaciones para el manejo de brolucizumab |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1016/j.oftale.2022.05.006 |
dc.subject.decs | vasculitis retiniana |
dc.relation.publishversion | https://doi.org/10.1016/j.oftale.2022.05.006 |
dc.type.version | info:eu-repo/semantics/acceptedVersion |
dc.audience | Professionals |
dc.contributor.authoraffiliation | [Fonollosa A] Servicio de Oftalmología, Hospital Universitario de Cruces, Barakaldo, Spain. Instituto Oftalmológico Bilbao, Bilbao, Spain. [Gallego-Pinazo R] Unidad de Mácula y Ensayos Clínicos, Clínica Oftalvist, Valencia, Spain. [Sararols L] Servicio de Oftalmología, Hospital General de Granollers, Granollers, Spain. Servicio de Oftalmología, Hospital Universitario General de Cataluña, Sant Cugat del Vallès, Spain. [Adán A] Institut Clínic d’Oftalmologia (ICOF), Hospital Clínic, Barcelona, Spain. Instituto de Investigaciones Biomédicas August Pi i Sunyer (IDIBAPS), Barcelona, Spain. [López-Gálvez M] Servicio de Oftalmología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. Instituto de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Valladolid, Spain. Servicio de Oftalmología, Hospital Universitario Ramón y Cajal, Madrid, Spain. [Figueroa MS] Unidad de Retina, Clínica Baviera, Madrid, Spain. Servicio de Oftalmología, Hospital Universitario Ramón y Cajal, Madrid, Spain |
dc.identifier.pmid | 35882576 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |