AstraZeneca (AZN) Announces Data from Second-Season SENTINEL1 Study; Says Results Similar to Prior Season

October 28, 2016 8:11 AM EDT

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AstraZeneca (NYSE: AZN) 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.

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)

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