Improved outcomes with home-based administration of palivizumab: results from the 2000-2004 Palivizumab Outcomes Registry.
BACKGROUND: Palivizumab Outcomes Registry data collected during 4 years were examined to assess compliance and respiratory syncytial virus (RSV) hospitalization rates in high-risk children receiving palivizumab prophylaxis at home compared with an outpatient setting.
METHODS: Prospective observational registry enrolling high-risk infants who received > or = 1 dose of palivizumab throughout the 2000-2001 to 2003-2004 RSV seasons at participating U.S. pediatric sites.
RESULTS: Registry data were analyzed for compliance and RSV hospitalization outcomes in 19,548 infants receiving doses at home versus an outpatient setting. Compliance with the injection regimen was determined by comparing the number of palivizumab injections received versus the projected number of anticipated doses and by comparing infants receiving all injections within a 35-day interval. Compliance was significantly greater for infants who received palivizumab at home (n = 1226) as compared with those who received palivizumab in a clinic or office (n = 17,641), whether measured by the number of doses received (88% versus 81%, P < 0.0001) or by the timing of doses (73% versus 66%, P < 0.0001). Infants who received palivizumab at home also had fewer RSV-associated hospitalizations compared with those who received palivizumab in a clinic or office [0.4% (5/1226) versus 1.2% (207/17,641), P = 0.0139].
CONCLUSIONS: Home administration of palivizumab was associated with a significantly higher rate of compliance and lower hospitalization rate for RSV illness in high-risk infants.