ASRS, Novartis independent committees review safety, risks of Beovu
Click Here to Manage Email Alerts
A dominant topic for the ASRS Research and Safety in Therapeutics committee has been brolucizumab-related issues, particularly the risk for occlusive vasculitis and vision loss following treatment for neovascular AMD.
“Brolucizumab was approved in October 2019, and shortly thereafter the ReST committee started receiving reports of inflammation,” including intraocular inflammation (IOI) with and without vasculitis, said Paul Hahn, MD, PhD, who moderated a panel on drug safety at the virtual American Society of Retina Specialists meeting.
Beovu (brolucizumab, Novartis) is the newest available anti-VEGF agent, whose FDA labeling indicates a 4% rate of inflammation. A 1% rate of inflammation is attributed to aflibercept, to which brolucizumab was compared in the HAWK and HARRIER trials.
As the ReST committee undertook analysis of reports about Beovu, so, too, did Novartis initiate an independent safety review committee.
“To Novartis’ credit, [it] was empowered to function autonomous to Novartis oversight regardless of those findings,” Hahn said.
The Novartis safety review committee identified a rate of 4.6% of IOI of all types.
“Of that, there was a subgroup of patients who developed occlusive vasculitis, in 2.1% of patients,” Hahn said.
In terms of risk, 1 in 200 represents the overall risk of any patient beginning brolucizumab therapy losing six or more lines of vision due to occlusive vasculitis.
“Alternatively, if you have a patient who presents to your office having occlusive vasculitis following recent Beovu, that patient has a 1 in 5 risk of at least six-line vision loss,” Hahn said.
The Novartis safety review committee also reported that IOI can occur 12 to 18 months after initiation of treatment. Vision loss can be seen out to 6 to 12 months, but more typically occurs in the first 6 months, Hahn said.
“In terms of understanding the problem, Novartis has established a process where they’ve brought together epidemiologists, immunologists, manufacturing specialists and clinical trialists to try to examine root causes, risk factors, mitigation and potential treatment protocols, because without these, ... it’s very challenging to use a drug that has this safety profile,” Jeffrey S. Heier, MD, chair of the safety review committee said.
Reference:
www.brolucizumab.info/. Accessed July 25, 2020.
www.brolucizumab.info/dist/files/ASRS_SRC_report.pdf. Accessed July 25, 2020.
Collapse
ReST committee drug safety update. Presented at: American Society of Retina Specialists annual meeting; July 24-26, 2020 (virtual meeting).
Read more about
Click Here to Manage Email Alerts