Meanwhile, Still Waiting for the Anticipated Beovu Label Change That Was Previewed by Novartis Back in May 2021
As the year 2021 draws to an end, we point out some Beovu safety developments which were presented last month by the JAMA Ophthalmology medical journal. We have been tracking Beovu safety issues since February 2020, when we posted this article, "Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug".
We begin our latest article about Beovu safety issues with this Original Investigation item published November 24, 2021, by the medical journal JAMA Ophthalmology, "Safety Outcomes of Brolucizumab in Neovascular Age-Related Macular Degeneration".
From the Abstract for this November 2021 JAMA Ophthalmology article, we point out these selected parts:
- Importance: Limited data exist on the real-world safety outcomes of patients with neovascular age-related macular degeneration treated with brolucizumab (Beovu).
- Objective: To determine the real-world incidence of intraocular inflammation (IOI), including retinal vasculitis (RV) and/or retinal vascular occlusion (RO), for patients with neovascular age-related macular degeneration who underwent [Beovu (brolucizumab)] treatment. Additionally, potential risk factors associated with these adverse events were evaluated.
- Conclusions and Relevance: The incidence rate of IOI and/or RO was approximately 2.4%. Patient eyes with IOI and/or RO in the 12 months prior to first [Beovu (brolucizumab)] injection had the highest observed risk rate for IOI and/or RO in the early months after the first [Beovu (brolucizumab)] treatment. However, given study limitations, the identified risk factors cannot be used as predictors of IOI and/or RO events, and causality with [Beovu (brolucizumab)] cannot be assessed.
The full text of that JAMA Ophthalmology medical journal article ends as follows:
In conclusion, data from the IRIS Registry and Komodo Healthcare Map provided insights into the safety of patients with neovascular AMD who initiated [Beovu (brolucizumab)]. Patient eyes with IOI and/or RO in the 12 months prior to the first [Beovu (brolucizumab)] injection had the highest estimated incidence rate for an event of any form of IOI and/or RO in the 6 months after first [Beovu (brolucizumab)] treatment. Similar findings were observed among patients with RV and/or RO events. Additional studies with longer follow-up intervals are needed to assess the long-term safety of [Beovu (brolucizumab)] treatment. These results represent early findings that explore potential risk factors for inflammation-associated AEs that may occur following real-world treatment with [Beovu (brolucizumab)]. However, because of study limitations, the identified risk factors cannot be used as predictors of IOI and/or RO events and the causality with [Beovu (brolucizumab)] cannot be assessed.
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Next, there is an Invited Commentary piece related to the above medical journal article which was also published November 24, 2021, by the medical journal JAMA Ophthalmology titled "Risk Factors for Intraocular Inflammation After Brolucizumab Treatment", written by Caroline R. Baumal, MD, of the New England Eye Center, at Tufts Medical Center.
Dr. Baumal's JAMA Ophthalmology piece concludes with this statement:
Looking to the future, there are recently completed and ongoing studies evaluating [Beovu (brolucizumab)] (ClinicalTrials.gov, term brolucizumab) to treat retinal disorders that can be combined to provide further information on the incidence, safety, risk factors, and treatment strategies. The patient should be educated about the potential safety issues, therapeutic options, and symptoms of IOI. Clinicians should maintain heightened awareness for RO and/or RV with IOI after [Beovu (brolucizumab)] and be familiar with diagnostic imaging protocols especially widefield fluorescein angiography and recommended treatment algorithms. Based on the current literature, same-day bilateral [Beovu (brolucizumab)] injections should be avoided and [Beovu (brolucizumab)] is contraindicated in eyes with active IOI or a history of IOI related to [Beovu (brolucizumab)]. Based on the study from Khanani and colleagues, a recent history of IOI and/or RO should be considered as another potential risk factor for [Beovu (brolucizumab)]-related IOI.
We will continue to watch for Beovu safety developments which are presented in medical journals or addressed in medical news reports, as well as an anticipated Beovu label change previewed by Novartis back in May 2021 (see: "Beovu Vision Loss Side Effects Continue to Plague Novartis, Ending 3 Key Clinical Trials in May 2021").
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