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

Author

Listed:
  • Janet Sultana

    (University of Messina)

  • Francesco Giorgianni

    (U.O.S.D. Farmacologia Clinica, A.O.U. Policlinico “G. Martino”
    Jewish General Hospital-Lady Davis Institute)

  • 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
    McGill University
    McGill University)

  • Gianluca Trifirò

    (University of Messina
    U.O.S.D. Farmacologia Clinica, A.O.U. Policlinico “G. Martino”)

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.

Suggested Citation

  • Janet Sultana & Francesco Giorgianni & Giulia Scondotto & Valentina Ientile & Pasquale Cananzi & Olivia Leoni & Sebastiano Walter Pollina Addario & Giovanbattista Sarro & Adele Francesco & Maria Rosa , 2020. "Association Between Intravitreal Aflibercept and Serious Non-ocular Haemorrhage Compared with Intravitreal Ranibizumab: A Multicentre Observational Cohort Study," Drug Safety, Springer, vol. 43(9), pages 943-952, September.
    • Handle: RePEc:spr:drugsa:v:43:y:2020:i:9:d:10.1007_s40264-020-00956-x
    DOI: 10.1007/s40264-020-00956-x
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