Prior intraocular inflammation cited as risk factor for adverse reaction to brolucizumab
Ongoing investigations of real-world data show patients with prior intraocular inflammation may be at higher risk for retinal vasculitis and/or retinal vascular occlusion after brolucizumab injections, according to a speaker.
“The majority of brolucizumab patients experience benefits without severe adverse events. Ongoing real-world analyses identified prior intraocular inflammation and/or prior vascular occlusion as the highest observed risk rate for RV/RO,” Jeffrey S. Heier, MD, said at Retina Subspecialty Day at the virtual American Academy of Ophthalmology meeting.
Using real-world data obtained from the IRIS Registry of 12,000 patients treated with Beovu (brolucizumab, Novartis), researchers determined the highest observed risk for retinal vasculitis and/or retinal vascular occlusion (RV/RO) within 6 months was prior intraocular inflammation and/or prior retinal occlusion occurring 12 months before the first injection, he said.
Additionally, researchers found 60% of patients in the HAWK and HARRIER phase 3 trials with at least one RV/RO event had a boosted or induced anti-drug antibody (ADA) response before or proximal to the event, he said.
A multivariate analysis of gender and Japanese race in the HAWK and HARRIER phase 3 trials was conducted to further understand the association of boosted or induced ADA response and the occurrence of RV/RO cases, he said.
“Neutralizing antibodies, or NAbs, are specific types of ADA that block the ability of brolucizumab to bind to VEGF. It is possible that presence of NAbs may be associated with these events,” Heier said.
The analysis found 29% of patients with RV/RO were NAb positive at baseline, while 57% of patients with RV/RO converted to NAb positive status after treatment with brolucizumab. Overall, 86% of patients with at least one RV/RO event were NAb positive at baseline and/or after baseline, he said.
“Investigations are ongoing to further understand the role of ADA and NAb and the adverse events of interest,” Heier said.
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Heier JS. Assessing characteristics of patients with or without intraocular inflammation (IOI) in the brolucizumab treatment arms from the HAWK and HARRIER phase 3 studies. Presented at: American Academy of Ophthalmology annual meeting; Nov. 13-15, 2020 (virtual meeting).
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