Association Between Intravitreal Aflibercept and Serious Non-ocular Haemorrhage Compared with Intravitreal Ranibizumab: A Multicentre Observational Cohort Study

Janet Sultana (), Francesco Giorgianni, Giulia Scondotto, Valentina Ientile, Pasquale Cananzi, Olivia Leoni, Sebastiano Walter Pollina Addario, Giovanbattista Sarro, Adele Francesco, Maria Rosa Puzo, Christel Renoux and Gianluca Trifirò
Additional contact information
Janet Sultana: University of Messina
Francesco Giorgianni: U.O.S.D. Farmacologia Clinica, A.O.U. Policlinico “G. Martino”
Giulia Scondotto: U.O.S.D. Farmacologia Clinica, A.O.U. Policlinico “G. Martino”
Valentina Ientile: U.O.S.D. Farmacologia Clinica, A.O.U. Policlinico “G. Martino”
Pasquale Cananzi: Regional Pharmacovigilance Centre
Olivia Leoni: Regional Pharmacovigilance Centre
Sebastiano Walter Pollina Addario: Sicilian Regional Healthcare Centre
Giovanbattista Sarro: Catanzaro University
Adele Francesco: Mater Domini Hospital
Maria Rosa Puzo: Regional Pharmacovigilance Centre
Christel Renoux: Jewish General Hospital-Lady Davis Institute
Gianluca Trifirò: University of Messina

Drug Safety, 2020, vol. 43, issue 9, No 10, 943-952

Abstract: Abstract Introduction Intravitreal anti-vascular endothelial growth factor (VEGF) drugs aflibercept and ranibizumab are used in neovascular retinal diseases but may be associated with non-ocular haemorrhage. Aims Our objective was to compare the risk of non-ocular haemorrhage with intravitreal aflibercept versus intravitreal ranibizumab and with individual intravitreal anti-VEGFs versus intravitreal dexamethasone. Methods A retrospective cohort study was conducted using four Italian claims databases, covering 18 million inhabitants from 2011 to 2016. Incident aflibercept users were matched 1:4 to incident ranibizumab users. The outcome was incident non-ocular haemorrhage requiring hospitalisation. Incidence per 1000 person-years (PYs) was estimated. Patients were followed for 180 days using an intention-to-treat (ITT) approach. An as-treated (AT) approach was also employed, using grace periods of 60 or 90 days. Analyses were repeated for aflibercept versus dexamethasone and ranibizumab versus dexamethasone. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using Cox proportional hazards models. Results We identified incident users of intravitreal ranibizumab (n = 21,766), aflibercept (n = 3150) and dexamethasone (n = 3900). The incidence of haemorrhage was four events per 1000 PYs for each drug. Aflibercept was not associated with increased risk versus ranibizumab at 180 days (HR 0.97 [95% CI 0.37–2.56]). Results were consistent in the AT analysis (HR 1.19 [95% CI 0.52–2.75]). No increased risk was found for aflibercept and ranibizumab at 180 days versus dexamethasone (HR 0.70 [95% CI 0.30–2.60] and HR 0.67 [95% CI 0.33–1.38], respectively). Conclusion No association was identified between intravitreal aflibercept and non-ocular haemorrhage versus ranibizumab. A comparable risk for these intravitreal anti-VEGFs and intravitreal dexamethasone was observed.

Date: 2020
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DOI: 10.1007/s40264-020-00956-x

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