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Palivizumab prophylaxis reduces hospitalization due to respiratory syncytial virus in young children with hemodynamically significant congenital heart disease.

AbstractOBJECTIVES:
To evaluate the safety, tolerance, and efficacy of palivizumab in children with hemodynamically significant congenital heart disease (CHD).
STUDY DESIGN:
A randomized, double-blind, placebo-controlled trial included 1287 children with CHD randomly assigned 1:1 to receive 5 monthly intramuscular injections of 15 mg/kg palivizumab or placebo. Children were followed for 150 days. The primary efficacy end point was antigen-confirmed respiratory syncytial virus (RSV) hospitalization.
RESULTS:
Palivizumab recipients had a 45% relative reduction in RSV hospitalizations (P=.003), a 56% reduction in total days of RSV hospitalization per 100 children (P=.003), and a 73% reduction in total RSV hospital days with increased supplemental oxygen per 100 children (P=.014). Adverse events were similar in the treatment groups; no child had drug discontinued for a related adverse event. Serious adverse events occurred in 55.4% of palivizumab recipients and 63.1% of placebo recipients (P<.005); none were related to palivizumab. Twenty-one children (3.3%) in the palivizumab group and 27 (4.2%) in the placebo group died; no deaths were attributed to palivizumab. The rates of cardiac surgeries performed earlier than planned were similar in the treatment groups.
CONCLUSIONS:
Monthly palivizumab (15 mg/kg IM) was safe, well-tolerated, and effective for prophylaxis of serious RSV disease in young children with hemodynamically significant CHD.
AuthorsTimothy F Feltes, Allison K Cabalka, H Cody Meissner, Franco M Piazza, David A Carlin, Franklin H Top Jr, Edward M Connor, Henry M Sondheimer, Cardiac Synagis Study Group
JournalThe Journal of pediatrics (J Pediatr) Vol. 143 Issue 4 Pg. 532-40 (Oct 2003) ISSN: 0022-3476 [Print] United States
PMID14571236 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antiviral Agents
  • Palivizumab
Topics
  • Antibodies, Monoclonal (therapeutic use)
  • Antibodies, Monoclonal, Humanized
  • Antiviral Agents (therapeutic use)
  • Comorbidity
  • Double-Blind Method
  • Heart Defects, Congenital (epidemiology, surgery)
  • Hospitalization (statistics & numerical data)
  • Humans
  • Palivizumab
  • Respiration, Artificial
  • Respiratory Syncytial Virus Infections (epidemiology, prevention & control, therapy)
  • Risk Factors

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