Data Demonstrating the Burden of Severe RSV Disease in Preterm Infants Published in American Journal of Perinatology
Waltham, Mass., April 30, 2019— Sobi, an international biopharmaceutical company transforming the lives of people affected by rare diseases, announced today the publication of data demonstrating the continued burden of severe lower respiratory tract infection due to respiratory syncytial virus (RSV) in preterm infants in the U.S.
The data represent the results of the SENTINEL1 study, in which 46 hospitals across the U.S. collected observational data on preterm infants born at 29-35 weeks gestation who did not receive immunoprophylaxis for RSV and were subsequently hospitalized for RSV disease during the 2014-2015 or 2015-2016 RSV seasons (roughly October through April). A total of 1,378 infants with community-acquired RSV hospitalization were evaluated; of these, 45% were admitted to the intensive care unit (ICU), 19% required invasive mechanical ventilation (IMV), and two infants passed away. In the subset of earlier and younger preterm infants (born at 29-32 weeks gestation and less than 3 months old when hospitalized for RSV), the burden was more severe, with 69% of these infants admitted to the ICU and 41% requiring IMV; the two deaths both occurred in this earlier and younger preterm group.
The study also found that among preterm infants discharged from the hospital after birth during the RSV season (November 1 – March 31, for this analysis) and subsequently readmitted due to RSV infection, 46% were readmitted within 30 days and 82% were readmitted within 60 days. For the subset of earlier and younger preterm infants, the mean hospital charge incurred across both seasons was $122,301.
The results were similar across both the 2014-2015 and 2015-2016 seasons, indicating the continued burden of severe RSV disease on preterm infants born in the U.S. and on the healthcare system. SENTINEL1 represents the largest study ever conducted in the U.S. of preterm infants hospitalized with laboratory-confirmed severe RSV disease. The data were published in the American Journal of Perinatology in April 2019 and are available online via open access.
“RSV is the most common cause of infant hospitalization in the U.S. Despite remarkable advances in the care of preterm infants over the past two decades, this study demonstrates that RSV causes significant morbidity among preterm infants who do not receive RSV immunoprophylaxis. This morbidity translates into a substantial burden on the healthcare system,” said Evan J. Anderson, M.D., lead author on the paper and Associate Professor of Pediatrics and Medicine at Emory University School of Medicine.
About Respiratory Syncytial Virus (RSV)
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) in infants and young children worldwide and is the most common cause of infant hospitalization in the U.S. Preterm infants are at higher risk of being hospitalized for an LRTI resulting from RSV infection than infants born at term. There is currently no specific treatment approved for RSV once it is contracted, other than supportive care while the disease runs its course, making the availability of RSV prophylaxis a critical public health priority.1
About Sobi in North America
As the North American affiliate of international biopharmaceutical company Sobi™, our team is committed to Sobi’s vision of providing sustainable access to innovative therapies and transforming the lives of people affected by rare diseases. We bring something rare to rare diseases – a belief in the strength of focus, the power of agility and the potential of the people we are dedicated to serving. Our product portfolio includes multiple approved treatments, focused on immunology and genetics/metabolism. With North American headquarters in the Boston area, Canadian headquarters in the Toronto area, and field sales, medical and market access representatives spanning North America, our growing team has a proven track record of commercial excellence. More information is available at www.sobi-northamerica.com. For more information about Sobi, visit www.sobi.com.
- Adamko DJ, Friesen M. Why does respiratory syncytial virus appear to cause asthma? Journal of Allergy and Clinical Immunology. 2012;130(1):101-102. doi:10.1016/j.jaci.2012.05.024.
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