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Palivizumab Outcomes Registry
Frogel M, Nerwen C, Cohen A, et al. Prevention of hospitalization due to respiratory syncytial virus: results from the Palivizumab Outcomes Registry. Full Text | PDF
Objective: The Palivizumab Outcomes Registry contains data on infants and young children who received palivizumab for the prevention of respiratory syncytial virus (RSV) that causes serious lower respiratory tract illness.
Study Design: Prospective observational registry enrolling those who received ≥1 dose of palivizumab during any RSV season (2000 to 2004) at participating US sites.
Result: Of 19 548 subjects enrolled, 40% were born before 32 weeks', 48% between 32 and 35 weeks' and 12% after 35 weeks' gestation. Risk factors included child-care attendance, prematurity, chronic lung disease (CLD) and congenital heart disease (CHD). The RSV hospitalization rate of palivizumab recipients was 1.3%. Gender, gestational age <32 weeks, CLD, CHD, congenital airway abnormality, severe neuromuscular disease, Medicaid insurance and >2 children in household were associated with significantly higher rates. Home-care prophylaxis with palivizumab was associated with reduced hospitalization rates.
Conclusion: Data on the use of palivizumab prophylaxis in primarily high-risk infants confirm low RSV hospitalization rates.
Comments. This study comes from a company-sponsored post-licensure registry of Palivizumab (SynagisŪ) use in nearly 20,000 patients at risk for RSV disease over a 4 year period. The data substantiates the efficacy of this drug at preventing hospitalizations for RSV infections, and showed a dose-response relationship to that protection (i.e. the more doses received, the lower the risk of hospital admission). Interestingly, patients who received the drug in a home healthcare setting were better protected than those who were immunized in an office of clinic. It is not clear whether this was due to better compliance with dosing at home, or greater exposure to RSV in the office setting. No cost-benefit analysis was presented as part of this study. ABK
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