Summary

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• Beyfortus (nirsevimab-alip) is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and for the prevention of RSV lower respiratory tract disease in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
• This summary is based on the review of three systematic review(s)/meta-analysis(es). ^[1-3]
• Nirsevimab significantly reduced the risk of medically attended RSV-related infections among infants (RR: 0.26; 95% CI: 0.18-0.38) and demonstrated a 79.5% relative reduction in RSV-related lower respiratory tract infections (LRTI) compared to placebo (RRR: 79.5%; 95% CI: 65.9-87.7).
• Nirsevimab was associated with a significant reduction in RSV-related hospitalizations, with a risk reduction of 76% (RR: 0.24; 95% CI: 0.13-0.47) and a decrease of 54 hospitalizations per 1000 participants (95% CI: -64 to -38). Fewer hospital admissions were also observed for RSV LRTI in the nirsevimab group compared to placebo (RRR: 77.3%; 95% CI: 50.3-89.7).
• Additional effectiveness measures showed a significant reduction in supplemental oxygen use per 1000 participants (−59; 95% CI: −65 to −40) and in various respiratory-related outcomes, including a 43.8% reduction in hospital admissions for any-cause respiratory illness (RRR: 43.8%; 95% CI: 18.8-61.1) and a 41.9% reduction in outpatient visits for LRTI (RRR: 41.9%; 95% CI: 25.7-54.6).
• No significant difference in adverse events leading to death was found between nirsevimab and placebo (RR: 0.78, 95% CI: 0.20-2.98).
• Nirsevimab demonstrated a similar safety profile to palivizumab, with no significant differences in adverse events of special interest (RR: 0.92, 95% CI: 0.25-3.38), consistent across various infant subgroups, including those with chronic lung disease, congenital heart disease, or born extremely preterm.
• Nirsevimab demonstrated consistent efficacy in reducing RSV LRTI, hospital admissions, and severe RSV across all subgroups studied, including healthy infants born preterm or at full term, as well as those with chronic lung disease, congenital heart disease, or extremely preterm birth; serum exposure levels exceeded the efficacious target in more than 80% of these populations, specifically 94% in infants with chronic lung disease, 80% in those with congenital heart disease, and 94% in those born extremely preterm.