March 2012
Volume 53, Issue 14
Free
ARVO Annual Meeting Abstract  |   March 2012
A Safety Review Of Bevacizumab And Ranibizumab: Off-label Versus Goldstandard
Author Affiliations & Notes
  • Christine Schmucker
    Department of Medical Biometry, German Cochrane Centre, Freiburg, Germany
  • Yoon K. Loke
    School of Medicine, University of East Anglia, Norwich, United Kingdom
  • Hansjuergen T. Agostini
    University Eye Hospital, University Medical Centre, Freiburg, Germany
  • Lutz L. Hansen
    University Eye Hospital, University Medical Centre, Freiburg, Germany
  • Monika Lelgemann
    Health Technology Assessment Centre, Bremen, Germany
  • Gerd Antes
    Department of Medical Biometry, German Cochrane Centre, Freiburg, Germany
  • Christoph Ehlken
    University Eye Hospital, University Medical Centre, Freiburg, Germany
  • Footnotes
    Commercial Relationships  Christine Schmucker, None; Yoon K. Loke, None; Hansjuergen T. Agostini, None; Lutz L. Hansen, None; Monika Lelgemann, None; Gerd Antes, None; Christoph Ehlken, None
  • Footnotes
    Support  BMBF
Investigative Ophthalmology & Visual Science March 2012, Vol.53, 3806. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Christine Schmucker, Yoon K. Loke, Hansjuergen T. Agostini, Lutz L. Hansen, Monika Lelgemann, Gerd Antes, Christoph Ehlken; A Safety Review Of Bevacizumab And Ranibizumab: Off-label Versus Goldstandard. Invest. Ophthalmol. Vis. Sci. 2012;53(14):3806.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose: : We set out a systematic review to assess whether adverse effects (AE) differ between off-label bevacizumab and goldstandard ranibizumab in the treatment of age-related macular degeneration (AMD).

Methods: : Medline, Embase and the Cochrane Library were searched with no limitations of language and year of publication. We included randomised trials (RCTs) with a minimum follow-up of 1 year which investigated bevacizumab or ranibizumab in direct comparison or against any other control group (indirect comparison).

Results: : Of 1185 citations retrieved, 12 RCTs met the inclusion criteria (for direct comparison: 3 RCTs with a total of 1356 patients, for indirect comparison: 6 RCTs evaluating ranibizumab with a total of 4072 patients and 3 RCTs evaluating bevacizumab with a total of 244 patients). Direct comparison: The 1 year data show a significantly higher rate of serious ocular AE with bevacizumab compared to ranibizumab (RR 4.90, 95% CI 1.67 to 14.35). The proportion of patients with serious systemic AE (infections e.g.,pneumonia; gastrointestinal disorders e.g., haemorrhage) was also higher with bevacizumab than with ranibizumab (24.1% vs 19.0%, RR 1.29 95% CI 1.01 to 1.66). Arteriothrombotic events were equally distributed among the groups, at 2 to 3%. Socioeconomic differences and unmasked patients which could have impact on the safety outcomes have not been adequately considered in the head-to-head trials. Indirect comparison: The 2 year results of phase III trials evaluating ranibizumab against PDT or sham showed that while absolute rates of serious ocular AE were low (≤2.1%), relative harm was significantly raised (RR 3.13, 95% CI 1.10 to 8.92). A significant increase in non-ocular haemorrhage was also observed with ranibizumab (RR 1.62, 95% CI 1.03 to 2.55). We were unable to judge the safety of bevacizumab due to the poor quality of AE monitoring and reporting in the trials.

Conclusions: : Bevacizumab studies for indirect comparison show too many methodological limitations to rule out any major safety concerns. Evidence from head-to-head trials raises concerns about an increased risk of ocular and systemic (infections and gastrointestinal disorders) AEs with bevacizumab which warrants further investigation.

Keywords: age-related macular degeneration • vascular endothelial growth factor • clinical (human) or epidemiologic studies: outcomes/complications 
×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×