Provides "risk factors and possible mechanism" for Beovu-related Retinal Vasculitis and Retinal Vascular Occlusion
We use the word "finally" because it was back in May 2021, when Novartis stopped three Beovu clinical trials for safety reasons, that Novartis first said it would update the Beovu drug label.... Further, over in Europe, Novartis sent out a November 2021 “Dear Doctor” Letter about Beovu, which was followed by an MHRA January 2022 Drug Safety Update item for Beovu....
We have finally seen the first Beovu drug label change which had been anticipated since Novartis said in May 2021 that the company "will pursue an update to the Beovu prescribing information globally." As previewed in a Novartis November 2021 "Dear Doctor" letter about Beovu and announced in an MHRA January 2022 Drug Safety Update item for Beovu, there is a revised Beovu Product Information document ("Date of revision of the text: 08 December 2021"). This Beovu drug label change reflects additional information about Beovu vision loss side effects such as intraocular inflammation, including retinal vasculitis and retinal vascular occlusion. We point out, however, that as of this time a similar Beovu drug label change has not been issued by Novartis in the US, yet.
From this Drug Safety Update, "Brolucizumab (Beovu▼): risk of intraocular inflammation and retinal vascular occlusion increased with short dosing intervals", issued January 18, 2022, by the UK's Medicines and Healthcare products Regulatory Agency (MHRA), we get the following:
New information on [the Beovu adverse events retinal vasculitis and retinal vascular occlusion], including risk factors and possible mechanism, was considered in a recent European safety review and ophthalmologists were informed of the new recommendations in a letter in November 2021. The product information of [Beovu (brolucizumab)] will also be updated to reflect this information.
Here are some details about the "risk factors" for those Beovu vision loss side effects from the so-called "Dear Doctor" letter about Beovu that Novartis UK sent on November 2, 2021, to healthcare professionals in the UK:
Risk factors identified
Novartis conducted non‐interventional retrospective real‐world evidence studies in patients with neovascular (wet) age‐related macular degeneration (nAMD) to better understand the incidence of adverse events/safety signal after initiating treatment with [Beovu (brolucizumab)] for up to 6 months. Each of the two studies consisted of retrospective analysis of large United States real‐world databases, the IRIS Registry® [Study HEORUSV201342] and Komodo Healthcare Map™ [Study HEORUSV201368], respectively. Both assessments were conducted in parallel and were nearly identical to the extent the data permitted.
The results of this retrospective analysis in nAMD patients suggest that patients with a medical history of intraocular inflammation and/or retinal vascular occlusion in the year prior to treatment with [Beovu (brolucizumab)] were more likely to present with similar events after [Beovu (brolucizumab)] injection, as compared to nAMD patients with no history of these events.
In addition, a gender difference with a higher risk for IOI (including RV) and/or RO in females has been observed in the two retrospective studies but also in clinical trials. A higher incidence was also observed in Japanese patients.
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And here is some information about the "possible mechanism" for those Beovu vision loss side effects from that same November 2021 Beovu "Dear Doctor" letter:
Results of the mechanistic study BASICHR0049 based on an analysis of blood samples from five nAMD patients exposed to [Beovu (brolucizumab)] who subsequently developed retinal vasculitis (RV) and/or retinal vascular occlusion (RO), taken together with accumulated data regarding the association of treatment‐emergent immunogenicity and intraocular inflammation (IOI), indicate a causal link between the treatment‐emergent immune reaction against [Beovu (brolucizumab)] and [Beovu-related] “retinal vasculitis and/or retinal vascular occlusion, typically in presence of IOI”.
In this study, blood samples were collected from the five case patients [retinal vasculitis (RV) and/or retinal vascular occlusion(RO)]and from six control patients who had no signs/symptoms of IOI while still receiving [Beovu (brolucizumab)] treatment....
... In the samples from five patients who experienced the RV and/or RO adverse events a humoral and cellular immune response against [Beovu (brolucizumab)] was identified 3‐5 months after the last [Beovu (brolucizumab)] dose and occurrence of the event. Data showed the presence of high titre ADAs, with a polyclonal and diverse IgG‐driven response against multiple B cell epitopes on the [Beovu (brolucizumab)] molecule, as well as memory T cell activation induced by unstressed and heat‐ or mechanically‐stressed [Beovu (brolucizumab)] preparations.
In the samples from patients from the control group, ADAs, when present, had lower titres.
We expect that a similar Beovu drug label change, and a possible associated Beovu "Dear Doctor" letter, will be issued by Novartis here in the US soon.
Be assured we will continue to monitor the drug safety regulatory sector for further developments regarding Beovu vision loss side effects such as intraocular inflammation, retinal vasculitis, and retinal vascular occlusion.
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