Acta paediatrica (Oslo, Norway : 1992) · 2025
The Safety and Efficacy of Anti-Vascular Endothelial Growth Factor Biosimilars in Retinopathy of Prematurity.
СтатьяСистематический обзорНазвание и аннотация: Перевод в очереди
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Tsivitanidou Elektra, Shakeel Abdullah, Warda Omar
Аннотация
AIM: Biosimilar anti-vascular endothelial growth factor agents are cheaper alternatives to current treatments, but their safety and efficacy are unknown. This review aims to evaluate the safety and efficacy of biosimilar anti-vascular endothelial growth factors in the management of retinopathy of prematurity.
METHODS: A systematic review of the current literature was undertaken to identify studies that reported safety and efficacy outcomes of intravitreal administration anti-vascular endothelial growth factor biosimilars in preterm infants with retinopathy of prematurity. Data were synthesised to assess safety, success and retreatment rates using random forest plots.
RESULTS: Five studies met the inclusion criteria (382 eyes); three studies used bevacizumab biosimilars (217 eyes) and two used ranibizumab biosimilars (118 eyes). The overall adverse event rate was 0.5%. The pooled treatment success rates were 65% (95% CI: 58%-71%) with bevacizumab biosimilars and 46% (95% CI: 2%-95%) with ranibizumab biosimilars. Five eyes (1%) in the whole cohort required surgery: four in the bevacizumab and one in the ranibizumab group.
CONCLUSIONS: Biosimilar anti-vascular endothelial growth factor agents demonstrated safety and reasonable efficacy. Biosimilars are a cost-effective alternative and may improve clinical outcomes in low-income countries. Randomised controlled trials should compare biosimilars to their reference biologic.
TRIAL REGISTRATION: PROSPERO: CRD420251010789.
METHODS: A systematic review of the current literature was undertaken to identify studies that reported safety and efficacy outcomes of intravitreal administration anti-vascular endothelial growth factor biosimilars in preterm infants with retinopathy of prematurity. Data were synthesised to assess safety, success and retreatment rates using random forest plots.
RESULTS: Five studies met the inclusion criteria (382 eyes); three studies used bevacizumab biosimilars (217 eyes) and two used ranibizumab biosimilars (118 eyes). The overall adverse event rate was 0.5%. The pooled treatment success rates were 65% (95% CI: 58%-71%) with bevacizumab biosimilars and 46% (95% CI: 2%-95%) with ranibizumab biosimilars. Five eyes (1%) in the whole cohort required surgery: four in the bevacizumab and one in the ranibizumab group.
CONCLUSIONS: Biosimilar anti-vascular endothelial growth factor agents demonstrated safety and reasonable efficacy. Biosimilars are a cost-effective alternative and may improve clinical outcomes in low-income countries. Randomised controlled trials should compare biosimilars to their reference biologic.
TRIAL REGISTRATION: PROSPERO: CRD420251010789.