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Use of Palivizumab in Germany - Report from the German Synagis™ Registry 2009 - 2016

Arne Simon1, Susanne Gehrmann2, Gudrun Wagenpfeil3

  • 1Children's Hospital Medical Center, Paediatric Hematology and Oncology, Homburg, Germany.

Klinische Padiatrie
|April 17, 2018
PubMed

Insights

Palivizumab effectively prevents Respiratory Syncytial Virus (RSV) hospitalizations in high-risk infants in Germany. The study confirms palivizumab

Area of Science:

  • Pediatrics
  • Infectious Diseases
  • Public Health

Background:

  • Palivizumab is recommended in Germany for high-risk infants to prevent Respiratory Syncytial Virus (RSV) related hospitalizations.
  • This study analyzes data from the German SYNAGIS™ Registry.

Purpose of the Study:

  • To evaluate the effectiveness and safety of palivizumab prophylaxis in high-risk infants in Germany.
  • To assess risk factors and clinical outcomes of RSV infection in infants receiving palivizumab.

Main Methods:

  • An observational, post-marketing study using data from the German SYNAGIS™ Registry (2009-2016).
  • Data collected from attending physicians on infants receiving at least one palivizumab injection.
  • Informed consent obtained from participants.

Main Results:

  • 63,572 immunizations were documented for 12,729 infants.
  • RSV-related hospitalization rate was 0.7% (0.8% for infants with congenital heart disease).
  • No deaths related to RSV infection were reported; intensive care was needed in 16.9%.

Conclusions:

  • Palivizumab prophylaxis demonstrates effectiveness and safety in high-risk infants.
  • The study suggests a need for better regional epidemiological adjustment to optimize palivizumab use.
  • Fewer patients with hemodynamically significant congenital heart disease (hsCHD) were observed than anticipated.
Abstract

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