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US database may show difference in risk rates between anti-VEGFs
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LONDON — Significantly fewer endophthalmitis events were associated with ranibizumab injections than aflibercept injections among patients with wet age-related macular degeneration, according to a presentation here.
The findings of “real-world” endophthalmitis rates between the two licensed treatments for wet AMD “underline the importance of real-world, post-market approval of observational monitoring of novel medicines,” authors Simon P. Kelly and colleagues wrote in a poster presented at the Euretina meeting.
Simon P. Kelly
Using the Integrated Data Warehouse, a large database of pre-reimbursement medical claims in the U.S., Kelly and colleagues calculated event rates per 1,000 injections and relative risks for Eylea (aflibercept, Regeneron) and Lucentis (ranibizumab, Genentech). Events were not clinically confirmed, and there was no distinction between infectious and sterile cases in the database, according to the researchers.
In both groups — 253,647 ranibizumab injections and 179,147 aflibercept injections — 88% of patients received more than one injection during follow-up.
During the primary analysis, 162 first-recorded claims of endophthalmitis events were recorded for ranibizumab injections and 189 were recorded for aflibercept, with an event rate of 0.64 per 1,000 injections for ranibizumab and 1.06 per 1,000 injections for aflibercept.“The relative risk of aflibercept claims of 189 claims in nearly 200,000 injections is 1.65 times that of Lucentis,” Kelly said in a separate media event hosted by Novartis/Alcon. “What that means, in plain language, is that it is 65% more likely in the VERO study that there was a claim for the treatment of severe ocular inflammation or endophthalmitis in the month following such injection.”
Disclosure: Kelly is on the advisory board for and a consultant for Bayer and Novartis; receives speaker fees from Novartis; receives conference and travel frees from Alcon, Bayer and Novartis; and is involved in research supported by Allergan, Bayer and Novartis. The VERO study was sponsored by Novartis.