AstraZeneca Announces New Data Showing US Preterm Infants at Significantly Greater Risk of RSV Hospitalizations Following 201...
October 18 2017 - 1:05PM
Business Wire
Data demonstrate a greater increase in RSV
hospitalization risk during the 2015-2016 RSV season compared to
recently published data from the prior season
AstraZeneca today announced new results of a study that
investigated respiratory syncytial virus (RSV) hospitalization risk
and costs during the 2014-2016 RSV seasons compared to the
2012-2014 RSV seasons. Results of the study were presented as a
poster on Wednesday, October 18 at the Academy of Managed Care
Pharmacy (AMCP) Nexus meeting in Dallas, TX. This study is the
first national analysis of serious RSV disease in US preterm
infants from the two seasons following the 2014 American Academy of
Pediatrics (AAP) guidance that recommended against the use of RSV
immunoprophylaxis in preterm infants born at 29-34 weeks
gestational age (wGA). The 2014 guidance asserted that 29-34 wGA
infants were not at a significantly increased risk of RSV
hospitalization relative to full-term (FT) infants.
The study demonstrated that RSV immunoprophylaxis use declined
dramatically in preterm infants born at 29-34 wGA in 2014-2016
relative to 2012-2014, consistent with recommendations in the 2014
guidance. Associated with this decline, RSV hospitalization risks
increased among infants 29-34 wGA who were <6 months of age for
both Commercial-insured and Medicaid-insured infants. Preterm
infants 29-34 wGA who were <6 months of age were approximately
2.5 to 5 times more likely to be hospitalized than FT infants in
2014-2015, which increased to approximately 3.5 to 5.5 times more
likely in 2015-2016. These risks were higher than those observed in
seasons prior to the guidance change.
This study confirms and extends the results of a recently
published study that similarly demonstrated a significant national
increase in RSV hospitalizations among infants 29-34 wGA who were
<3 months of age during the 2014-2015 RSV season compared to the
previous four seasons.
Greg Keenan, Vice President, US Medical Affairs, AstraZeneca
said: “The results from this study emphasize that preterm infants
are at substantially elevated risk of RSV hospitalization compared
to full-term infants. As a science-led organization, AstraZeneca
remains committed to partnering with the academic community to
conduct research that characterizes and ultimately reduces the
burden of disease for this vulnerable population of patients.”
The study examined national US Commercial and Medicaid insurance
claims databases containing data from more than 1.5 million claims
of infants <1 year of age. In addition to the increased RSV
hospitalization risks among preterm infants, the study found that
RSV hospitalization costs were also higher. The average RSV
hospitalization cost during the 2014-2016 RSV seasons for
Commercial infants <3 months of age at first RSV hospitalization
was $17,416 for FT infants and $39,174 for infants 29–34 wGA. The
average cost for Medicaid infants <3 months of age at first RSV
hospitalization was $9,824 for FT infants and $22,316 for infants
29-34 wGA. RSV hospitalizations were identified using ICD-9-CM
diagnosis codes on inpatient claims; confirmatory laboratory
results were not available for this study, as insurance claims
databases do not provide these results.
Utilization of inpatient RSV immunoprophylaxis among infants
<3 months of age discharged from their birth hospitalization
during the RSV season is not recorded in claims databases, and this
could impact rates of RSV hospitalization in this subgroup. RSV
immunoprophylaxis use prior to discharge would be expected to
reduce RSV hospitalization rates in infants <3 months of
age.
Dr. Mitchell Goldstein, from Loma Linda University Children’s
Hospital, Loma Linda, CA and the lead author of the study, said:
“RSV is the leading cause of hospitalization for infants in their
first year of life in the United States and can be especially
severe for preterm infants during the first months of life. These
data build on previous studies and should prompt additional
discussion of the importance of RSV prevention efforts among these
high-risk infants. This is an important topic among advocates for
preterm infant health and the health care community.”
NOTES TO EDITORS
About the study
Between July 1, 2012 and June 30, 2016, RSV hospitalization
risks were evaluated during the RSV season of each year. Rates were
calculated per 100 infant-seasons. RSV hospitalization costs for
the 2014–2016 seasons were averaged separately for FT and preterm
infants by age at first RSV hospitalization.
Children with chronic lung disease of prematurity or
hemodynamically significant congenital heart disease were not
studied. These populations have risks of severe RSV disease above
those observed with otherwise healthy preterm infants and continue
to be recommended for RSV immunoprophylaxis.
Results of the study were presented as a poster on Wednesday,
October 18 at the Academy of Managed Care Pharmacy (AMCP) Nexus
meeting in Dallas, TX.
About RSV
RSV is a contagious, seasonal respiratory virus that nearly 100%
of children will contract, at varying levels of severity, by the
age of two and most will recover from within one to two weeks. In
certain high-risk babies, however, RSV can lead to a serious lung
infection and hospitalization. Preterm infants are at increased
risk of developing severe RSV disease because their lung volume is
significantly less than that of full-term infants, and their
airways are smaller and narrower than those of a baby born at
term.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas – Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit www.astrazeneca-us.com and follow us on Twitter
@AstraZenecaUS.
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