April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
Gastrointestinal serious adverse events in patients treated with intraocular ranibizumab or bevacizumab for age-related choroidal neovascularisation, what do the recent trials tell us?
Author Affiliations & Notes
  • Lauren Scott
    Clinical Trials and Evaluation Unit, University of Bristol, Bristol, United Kingdom
  • Usha Chakravarthy
    Institute of Clinical Science, The Queen’s University of Belfast, Belfast, United Kingdom
  • Rachel Nash
    Clinical Trials and Evaluation Unit, University of Bristol, Bristol, United Kingdom
  • Susan M Downes
    Department of Ophthalmology, University of Oxford, Oxford, United Kingdom
  • Simon P Harding
    Department of Eye and Vision, University of Liverpool, Liverpool, United Kingdom
  • Barney Reeves
    Clinical Trials and Evaluation Unit, University of Bristol, Bristol, United Kingdom
  • Chris Rogers
    Clinical Trials and Evaluation Unit, University of Bristol, Bristol, United Kingdom
  • Footnotes
    Commercial Relationships Lauren Scott, None; Usha Chakravarthy, Allergan (R), Allimera Sciences (R), Bayer (R), Novartis (F), Novartis (R), Roche (R); Rachel Nash, None; Susan Downes, Novartis (F); Simon Harding, Novartis (F); Barney Reeves, None; Chris Rogers, Novartis (F)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 1648. doi:
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      Lauren Scott, Usha Chakravarthy, Rachel Nash, Susan M Downes, Simon P Harding, Barney Reeves, Chris Rogers, ; Gastrointestinal serious adverse events in patients treated with intraocular ranibizumab or bevacizumab for age-related choroidal neovascularisation, what do the recent trials tell us?. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1648.

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

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Abstract

Purpose: Adverse events involving the gastrointestinal (GI) tract have been identified as an area of concern in studies where bevacizumab was administered systemically. The purpose of this study was to synthesize the evidence on the frequency of reported GI events in head-to-head randomised controlled trials (RCTs) of ranibizumab versus bevacizumab administered intraocularly for treatment of age-related choroidal neovascularisation.

Methods: We collated the results from five recently conducted comparative effectiveness RCTs of ranibizumab versus bevacizumab and undertook a meta-analysis to quantify the incidence and risk of a GI event.

Results: Data from the CATT, IVAN, Gefal, MANTA and LUCAS RCTs were included. Collectively these trials randomised 1533 patients to ranibizumab and 1496 to bevacizumab. CATT and IVAN followed patients for two years; one year results were available for the Gefal, MANTA and LUCAS trials. On pooling the results from the five trials, 24 (1.6%) patients randomised to ranibizumab and 46 (3.1%) randomised to bevacizumab reported a GI serious adverse event (SAE) during follow-up. The risk of a GI SAE was estimated to be almost double with bevacizumab compared to ranibizumab (relative risk 1.94, 95% CI 1.20 to 3.14), which was statistically significant at the 5% level (p=0.007). Information published in the CATT and IVAN trials on the nature of the SAEs revealed no clear patterns, with vomiting, abdominal pain, intestinal obstruction and perforation all reported.

Conclusions: The risk of a GI related SAE is significantly higher with bevacizumab compared to ranibizumab, but the overall incidence is low. The nature of the SAE is diverse and the severity is variable.

Keywords: 412 age-related macular degeneration • 462 clinical (human) or epidemiologic studies: outcomes/complications • 754 visual acuity  
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