Objective:

To evaluate the efficacy and safety of monoclonal antibodies (mAbs) against respiratory syncytial virus (RSV) disease in premature infants.

Approach:

• Literature Search: A comprehensive search was conducted across PubMed, Cochrane Library, and Embase databases from inception through December 2025.
• Statistical Analysis: Effect estimates were expressed as relative risk (RR) with 95% confidence intervals, and treatment rankings were evaluated using the surface under the cumulative ranking curve (SUCRA) probability.
• Study Inclusion: Included 7 randomized controlled trials involving 4 drugs and 11,319 infants.

Key Findings:

• Nirsevimab, motavizumab, and palivizumab reduced RSV-related hospitalization rates compared to placebo (nirsevimab: RR 0.20, 95% CI: 0.09-0.45; motavizumab: RR 0.32, 95% CI: 0.19-0.53; palivizumab: RR 0.43, 95% CI: 0.30-0.61).
• Nirsevimab showed the most significant effect on RSV-related hospitalization rates (RR: 0.20) and ICU admissions (RR: 0.09).
• No significant differences were found in mechanical ventilation use, RSV-related deaths, and drug-related adverse events.

Interpretation:

Nirsevimab, motavizumab, and palivizumab are effective in reducing RSV-related hospitalizations and ICU admissions in preterm infants, with nirsevimab showing the greatest effect.

Limitations:

• Further studies are needed to confirm these findings.
• The analysis is limited to randomized controlled trials and may not represent all clinical scenarios.

Conclusion:

Nirsevimab, motavizumab, and palivizumab are effective in reducing RSV-related hospitalizations and ICU admissions in preterm infants, with nirsevimab showing the greatest effect.

Sources:

• Systematic Review Registration