Palivizumab prophylaxis of respiratory syncytial virus disease from 1998 to 2002: results from four years of palivizumab usage

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Abstract
Objectives. In 1998the Food and Drug Administration approved palivizumab (Synagis) for the prevention of severe lower respiratory tract infection secondary to respiratory syncytial virus (RSV) in pediatric patients at high risk for developing disease that required hospitalization. In the immediate aftermath of that approval, two retrospective reviews were conducted on 4669 medical records of patients who received at least 1 dose of palivizumab during the 1998 to 1999 and 1999 to 2000 RSV seasons, respectively. These analyses captured data on rates of RSV hospitalization, length of hospital stay, intensive care unit admission and compliance with palivizumab administration. Two prospective US multicenter registry trials followed, during the RSV seasons of 2000 to 2001 and 2001 to 2002. The registries characterized the demographics and outcomes of a total of 7207 high risk infants and children who received prophylaxis for RSV, the risk factors for RSV hospitalization and the patterns and scope of palivizumab usage across 63 and 116 US health care sites, respectively. 1998 to 1999 palivizumab first season of general use. Nine US study sites engaged in a retrospective chart review of infants and children with a gestational age of ≤35 weeks and a chronologic age of 35 weeks. For the 2049 subjects with available follow-up data, the overall confirmed RSV hospitalization rate was 2.9%. Palivizumab Outcomes Registry: 2001 to 2002. Between June 1, 2001 and May 15, 2002, 116 health care centers across the US enrolled 5091 infants in the second prospective Palivizumab Outcomes Registry. As its primary outcome the study measured the occurrence of RSV hospitalization with secondary variables of risk factors for RSV bronchiolitis and compliance with the projected number of palivizumab injections based on month of initial dose. Forty-nine percent (n = 2,501) of the infants were born between 32 and 35 weeks gestational age, 40% (n = 2020) were born at a gestational age of 35 weeks gestational age. Nineteen percent (n = 964) of these children were deemed at sufficient risk to warrant palivizumab prophylaxis for a second season. Seventy-six of 5084 enrolled subjects experienced a total of 78 RSV-related hospital admissions, for an overall hospitalization rate of 1.5%. Four years of retrospective and prospective data on the use of palivizumab in clinical practice has accumulated a wealth of “real life” information on the clinical effectiveness of RSV immunoprophylaxis in a large cohort of high risk infants from geographically diverse pediatric offices and clinics throughout the United States.

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