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Effectiveness of Palivizumab in High-risk Infants and Children: A Propensity Score Weighted Regression Analysis
Evan J Anderson1, Phyllis Carosone-Link, Ram Yogev
1From the Departments of *Pediatrics and †Medicine, Emory University School of Medicine, Atlanta, Georgia; ‡Department of Pediatrics, Children's Hospital Colorado, Aurora, Colorado; §Department of Pediatrics, Ann and Robert H Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, Illinois; ¶Department of Pediatrics, The University of Colorado School of Medicine, Aurora, Colorado; and ‖Department of Epidemiology, Center for Global Health, Colorado School of Public Health, Aurora, Colorado.
Insights
Palivizumab effectively prevents respiratory syncytial virus (RSV) hospitalizations and intensive care unit admissions in high-risk infants. This study confirms palivizumab
Area of Science:
- Pediatrics
- Infectious Diseases
- Immunology
Background:
- Infants born prematurely (≤35 weeks gestational age), with chronic lung disease of prematurity, or congenital heart disease face heightened risks of lower respiratory tract infections.
- Respiratory Syncytial Virus (RSV) is a significant pathogen causing hospitalization in these vulnerable infants.
- While randomized trials show palivizumab prevents RSV, its effectiveness in large clinical settings remains understudied.
Purpose of the Study:
- To evaluate the real-world effectiveness of palivizumab in preventing RSV-related hospitalizations and intensive care unit (ICU) admissions.
- To assess palivizumab effectiveness (PE) in a large cohort of high-risk infants.
- To determine PE using a test-negative case-control design.
Main Methods:
- A multicenter test-negative case-control study was conducted on high-risk infants (<24 months) hospitalized with lower respiratory tract infections.
- Nasopharyngeal aspirates were tested for RSV and human metapneumovirus (HMPV).
- An inverse propensity score weighted (IPSW) multiple logistic regression model was used to adjust for confounding factors and determine PE.
Main Results:
- Of 849 eligible children, 434 (51%) received palivizumab. RSV was detected in 403 (47%) infants.
- The adjusted palivizumab effectiveness (PE) was 58% (95% CI, 43%-69%) in preventing RSV hospitalization.
- Palivizumab demonstrated significant effectiveness in preventing ICU admissions (PE, 62%; 95% CI, 35%-78%) and was particularly effective in infants born at 29-35 weeks gestational age without comorbidities (PE, 74%; 95% CI, 56%-85%).
Conclusions:
- This study confirms that palivizumab is effective in preventing RSV hospitalizations and ICU admissions in high-risk infants.
- The test-negative case-control design with molecular RSV detection provides robust evidence of palivizumab's real-world effectiveness.
- Findings support the continued use of palivizumab for RSV prophylaxis in eligible high-risk infant populations.
Background:
Infants with premature birth ≤35 weeks gestational age, chronic lung disease of prematurity and congenital heart disease are at an increased risk for lower respiratory tract infections and hospitalization from respiratory syncytial virus (RSV), which has been shown in randomized trials to be prevented by palivizumab. However, palivizumab effectiveness (PE) has not been studied in a large clinical setting.
Methods:
A multicenter study among high-risk US and Canadian children younger than 24 months hospitalized with lower respiratory tract infection and whose nasopharyngeal aspirates were tested for human metapneumovirus (HMPV) and RSV were the subjects of the trial. We conducted a test-negative case-control study in these subjects to determine PE. We used an inverse propensity score weighted (IPSW) multiple logistic regression model to adjust PE.
Results:
Palivizumab was used in 434 (51%) of 849 eligible children. RSV was identified in 403 (47%) children. The unadjusted PE was 43% [95% confidence interval (CI), 34%-51%)]. After IPSW adjustment, the adjusted PE was 58% (95% CI, 43%-69%). Palivizumab prevented intensive care unit admissions (PE, 62%; 95% CI, 35%-78%). PE for 29-35 weeks gestational age and ≤6 months of chronologic age without chronic lung disease of prematurity or congenital heart disease was 74% (95% CI, 56%-85%).
Conclusions:
Using a test-negative case-control design with RSV molecular detection, palivizumab is shown to prevent RSV hospitalizations and intensive care unit admissions in high-risk infants.
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