AstraZeneca PLC Release: New Data Shows Frequent ICU Admissions From Severe RSV Disease Among Preterm Infants In The First Three Months Of Life

SENTINEL1 Respiratory Syncytial Virus (RSV) Data presented at IDWeek 2016

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced data from the second season of its SENTINEL1 study, the largest study ever to examine laboratory-confirmed respiratory syncytial virus hospitalizations (RSVH) among US preterm infants 29-35 weeks gestational age (wGA) who were <12 months of age at the time of their RSVH admission.^1,2 Infants enrolled did not receive immunoprophylaxis (IP) within 35 days before the onset of RSV disease symptoms during the 2014-2015 or 2015-2016 RSV seasons.^1,2 Study results were presented at IDWeek 2016 in New Orleans, LA.

“SENTINEL1 highlights the physical, emotional and financial burden severe RSV disease may have on high-risk infants and their caregivers. The data show the broader impact of the RSV disease burden on US preterm infants that should be considered.”

RSV is a leading cause of hospitalization for babies in the US during their first year of life, creating a high unmet medical need, especially among high-risk infants.³

At the 42 hospitals involved in the study during the 2015-2016 RSV season, 678 infants were found to have been hospitalized with community-acquired RSV, and 78% of these infants were <6 months of age when hospitalized.²

Among those hospitalized, intensive care unit (ICU) admission was required for 48% of infants and invasive mechanical ventilation (IMV) was required for 19% of infants.² ICU admission and IMV were most frequent in infants <3 months of age.²

• Among infants 29-32 wGA and <3 months, 69% were admitted to the ICU and 36% required IMV²
• Among infants 33-34 wGA and <3 months, 60% were admitted to the ICU and 30% required IMV²
• Among infants 35 wGA and <3 months, 53% were admitted to the ICU and 24% required IMV²

The 2015-2016 study results are similar to those observed in the 2014-2015 RSV season of the SENTINEL1 study which found that RSV hospitalizations, ICU admission and IMV are more frequent in preterm infants at a younger chronologic age.²

Lead study investigator, Evan J. Anderson, MD, Associate Professor of Pediatrics at Emory University School of Medicine, stated: “SENTINEL1 highlights the physical, emotional and financial burden severe RSV disease may have on high-risk infants and their caregivers. The data show the broader impact of the RSV disease burden on US preterm infants that should be considered.”

Emotional Burden High Among Parents and Caregivers

In addition to the important insights regarding increased rates of ICU admission and IMV from SENTINEL1, a separate analysis of the data highlights the extended impact RSVH has on parents and caregivers, an area where there are currently few contemporary data.

Self-reported responses were collected from parents and caregivers participating in the SENTINEL1 study and found that RSVH have a considerable impact on caregivers and their infants, including continued medical concerns, emotional burden and financial implications, that continued through one month post-discharge.⁴

• For the 212 infants whose parents/guardians enrolled them in the study to provide detailed data regarding their experience, 86% of caregivers provided responses at discharge, with the highest percentage reporting impact on emotions (54%), routine disruptions (36%), family relationships (31%) and financial burdens (30%) at discharge⁴
• At one month after discharge, caregivers expressed the highest impact on emotions (33%), routine disruptions (20%) and medical concerns (13%)⁴

The growing body of evidence from SENTINEL1 and other studies will help the medical community better understand the current impact of severe RSV disease on US preterm infants and their families.

Details around these data presentations can be accessed below or on the IDWeek 2016 website here.

• SENTINEL1: An Ongoing Multicenter Observational Study of Respiratory Syncytial Virus Hospitalizations Among US Infants Born at 29–35 Weeks’ Gestational Age Not Receiving Immunoprophylaxis in 2014–2016 (Clinical Infectious Diseases: Respiratory Infections Session, Poster Number 1279, Friday, October 28, 12:30-2:00 PM ET)
• “Caregiver Impact of Respiratory Syncytial Virus Hospitalizations among US Preterm Infants 29–35 Weeks’ Gestational Age” (Clinical Infectious Diseases: Respiratory Infections Session, Poster Number 1287, Friday, October 28, 12:30-2:00 PM ET)

NOTES TO EDITORS

About SENTINEL1

SENTINEL1 is an ongoing retrospective and prospective study aimed to characterize RSV-confirmed hospitalizations among US preterm infants born at 29-35 weeks gestation who did not receive immunoprophylaxis within 35 days before the onset of RSV disease symptoms during the 2014-2015 and 2015-2016 RSV season.¹ The eligibility criteria for SENTINEL1 include preterm infants 29-35 wGA who were <12 months of age at the time of their RSVH admission and had been hospitalized for =24 hours due to laboratory-confirmed RSV disease.¹ SENTINEL1 evaluated gestational age, chronologic age, hospital length of stay (LOS), ICU admission, ICU LOS, need for IMV, and survival.¹

About IDWeek

IDWeek 2016™ is an annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA) and the Pediatric Infectious Diseases Society (PIDS). With the theme “Advancing Science, Improving Care,” IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment, and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2016 takes place October 26-30 at the Ernest N. Morial Convention Center in New Orleans. For more information, visit www.idweek.org.

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 1-2 weeks.^5,6,7 In certain high-risk babies, however, RSV can lead to a serious lung infection and hospitalization.^8,9 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.¹⁰

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.

References

1. Anderson E, Krilov L, DeVincenzo J, et al. SENTINEL1: An observational study of respiratory syncytial virus hospitalizations among US infants born at 29 to 35 weeks’ gestational age not receiving immunoprophylaxis. Am J Perinatol. In press.
2. Anderson EJ, DeVincenzo JP, Checchia PA, et al. SENTINEL1: An Ongoing Multicenter Observational Study of Respiratory Syncytial Virus Hospitalizations Among US Infants Born at 29-35 Weeks’ Gestational Age Not Receiving Immunoprophylaxis in 2014-2016. Poster Number 1279. Poster presented at IDWeek 2016 Meeting, October 26-30, 2016.
3. Leader S, Kohlhase K. Respiratory syncytial virus-coded pediatric hospitalizations, 1997 to 1999. Pediatr Infect Dis J. 2002; 21:629-632.
4. Pokrzywinski RM, Swett LL, Yi J, et al. Caregiver Impact of Respiratory Syncytial Virus Hospitalizations among US Preterm Infants 29-35 Weeks’ Gestational Age. Poster Number 1287. Poster presented at IDWeek 2016 Meeting, October 26-30, 2016.
5. Centers for Disease Control and Prevention. Infection and Incidence. http://www.cdc.gov/rsv/about/infection.html. Accessed October 14, 2016.
6. Glezen WP, Taber LJ, Frank AL, Kasel JA. Risk of Primary Infection and Reinfection with Respiratory Syncytial Virus. Am J Dis Child. 1986; 140:543-546.
7. Hall CB, Weinberg GA, Iwane MK, et al. The Burden of Respiratory Syncytial Virus Infection in Young Children. N Engl J Med. 2009; 360:588-598.
8. Boyce TG, et al. Rates of hospitalizations for respiratory syncytial virus infection among children in Medicaid. J Pediatr. 2000; 137:865-70.
9. Centers for Disease Control and Prevention. Preterm Birth. http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm. Accessed October 14, 2016.
10. Langston C, Kida K, Reed M, Thurlbeck WM. Human lung growth in late gestation and in the neonate. Am Rev Respir Dis. 1984; 129:607-613.

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