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

• Published in: The Journal of pediatrics Vol. 143; no. 4; pp. 532 - 540
• Main Authors: Feltes, Timothy F, Cabalka, Allison K, Meissner, H.Cody, Piazza, Franco M, Carlin, David A, Top, Franklin H, Connor, Edward M, Sondheimer, Henry M, for the Cardiac Synagis Study Group
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01-10-2003; Elsevier
• Subjects: Antibodies, Monoclonal - therapeutic use; Antibodies, Monoclonal, Humanized; Antiviral Agents - therapeutic use; Biological and medical sciences; Comorbidity; Double-Blind Method; General aspects; Heart Defects, Congenital - epidemiology; Heart Defects, Congenital - surgery; Hospitalization - statistics & numerical data; Humans; Medical sciences; Palivizumab; Respiration, Artificial; Respiratory Syncytial Virus Infections - epidemiology; Respiratory Syncytial Virus Infections - prevention & control; Respiratory Syncytial Virus Infections - therapy; Risk Factors; RSV-IGIV; RSV; CHD; COSTART; Human; Human respiratory syncytial virus; Pediatrics; Pneumovirinae; Cardiovascular disease; Hospitalization; Respiratory system; Paramyxoviridae; Virus; Prevention; Respiratory tract; Mononegavirales; Chemotherapy; Palivizumab; Treatment; Pneumovirus; Congenital cardiopathy; Child
• DOI: 10.1067/S0022-3476(03)00454-2
• EISSN: 1097-6833
• ISSN: 0022-3476

To evaluate the safety, tolerance, and efficacy of palivizumab in children with hemodynamically significant congenital heart disease (CHD).
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.
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.
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.