Last week, an overview of systematic reviews and meta-analyses investigating systemic adverse events associated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatments was published in JAMA Ophthalmology.
Last week, an overview of systematic reviews and meta-analyses investigating systemic adverse events associated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatments was published in JAMA Ophthalmology. The review encompassed adverse events (AEs) in patients with neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) being treated with the intravitreal anti-VEGF agents ranibizumab and bevacizumab.
Researchers analyzed 21 systematic reviews published between January 1, 2011, and June 30, 2016. Of these, 11 analyzed serious AEs as the primary outcome, and the remaining 10 considered serious AEs secondary endpoints. The reviews were screened for quality.
This research found that the studies investigated largely agreed that anti-VEGF treatments were not associated with an increased risk of serious AEs in eye indications; 10 reviews studied patients with AMD that included 2 to 12 randomized controlled trials (RCTs) each, and overlapping comparisons were observed for 7 reviews. Six reviews studied patients with DME, and included 4 to 18 RCTs each, with overlapping comparisons found in 4 reviews. Lastly, 3 reviews analyzed serious AEs as the primary outcome and included patients with all 3 diseases.
In total, 19 serious AEs were reported in the AMD group (among 15,102 patients), 7 were reported in the DME group (among 5357 patients), and 6 were reported in the RVO group (among 1349 patients). Eight were reported in a grouped analysis of patients with AMD, DME, and RVO.
The authors noted some potential limitations of the study: reviews were only included if they reported 95% confidence intervals for serious AEs. In addition, researchers did not re-extract data from original research, which was deemed to be outside the scope of their review. Finally, the risks related to the duration of various treatments as well as AEs related to drug doses were not analyzed due to data not being reported in the included meta-analyses.
The overview of prior reviews and meta-analyses suggests that anti-VEGF treatments do not increase the risk of AEs. However, the authors advise caution in older patients with AMD who may be at a higher risk of hemorrhagic events when taking ranibizumab.
Reference
Thulliez M, Angoulvant D, Pisella PJ, et al. Overview of systematic reviews and meta-analyses on systemic adverse events associated with intravitreal anti-vascular endothelial growth factor medication use. JAMA Opthalmol. Published online March 22, 2018. doi:10.1001/jamaophthalmol.2018.0002.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry
Published: October 29th 2024 | Updated: October 29th 2024Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.
Samsung Bioepis Report Showcases Adalimumab Biosimilar Growth in Market Share
October 11th 2024Adalimumab biosimilars have seen a significant increase in market share, from 2% in early 2024 to 22%, as payers and pharmacy benefit managers begin to prioritize these biosimilars over the reference product, Humira.