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AAP revisions to monoclonal antibody dosage explained
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NEW YORK—There has been dramatic progress in the development of immunoprophylaxis for respiratory syncytial virus (RSV) in the past 15 years, and as a result, the AAP updated its guidelines in December 2009 regarding administration of the monoclonal antibody palivizumab, according to a presentation.
“There are three reasons why the guidelines were modified,” said H. Cody Meissner, MD, chief of pediatric infectious diseases at Tufts University Medical Center. “The first reason is the availability of additional data from the CDC on the seasonality of RSV. The second reason is recognition of the limitation of the available data for children born at 32 weeks and 0 days to 34 weeks and 6 days gestational age. The third reason is additional data on the cost-benefit of palivizumab which demonstrates that the cost of prophylaxis far exceeds any cost saving from reduced hospitalization. In addition, prophylaxis has no measurable impact on RSV mortality.”
There was no change in the recommendation for prophylaxis in infants who have hemodynamically significant congenital heart disease or chronic lung disease of prematurity or for infants born before 32 weeks gestational age. These groups are still recommended to receive five doses of palivizumab (Synagis, MedImmune) to reduce the risk of hospitalization due to RSV, regardless of geographic location. However, the December 2009 AAP Policy does modify the recommendation for prophylaxis for children in the 32 week, 0 day to <35 weeks (34 weeks, 6 days) gestational age cohort. The modification ensures prophylaxis for a larger number of infants during the period of greatest risk.
“This age group comprises approximately three-quarters of all premature infants, and if we were to give five doses of palivizumab to all infants in this gestational age group, it would cost approximately $1.4 billion,” Meissner said. “Ideally, we would like to identify those children at greatest risk for hospitalization, ICU admission or mechanical ventilation. Unfortunately, careful review of the literature does not enable us to identify these children.”
Therefore, the guidelines published in December 2009 are designed to offer prophylaxis to a large number of infants in this gestational age group during the time of greatest risk of RSV hospitalization, specifically the first 90 days of life.
The 2009 AAP guidelines advise that those children with a gestational age of 32 weeks through 34 weeks and 6 days who are born within 3 months of the onset of the RSV season or during the RSV season, should receive a maximum of three doses of prophylaxis if they either attend childcare or have at least one sibling aged younger than 5 years living in their household.
“Most RSV hospitalizations occur within the first 90 days of life, and the objective of this modification is to capture more children in the 32- to <35-week gestational age risk group who are most likely to be hospitalized due to RSV,” Meissner said.
For more information:
- Meissner HC. 2009 Modification of RSV Prophylaxis Recommendations: Why was it done and what does it mean to you? Presented at: the 23rd Annual Infectious Diseases in Children Symposium; Nov. 20-21, 2010; New York.
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