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Universal palivizumab prophylaxis for children with Down syndrome in Japan: analysis with interrupted time-series

Masato Takeuchi1, Koji Kawakami1

  • 1Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan.

Human Vaccines & Immunotherapeutics
|September 22, 2020
PubMed

Insights

Universal palivizumab prophylaxis for children with Down syndrome (DS) in Japan did not significantly reduce hospitalizations for respiratory syncytial virus (RSV) lower respiratory infections. The policy

Area of Science:

  • Pediatrics
  • Infectious Diseases
  • Public Health

Background:

  • Down syndrome (DS) is a significant risk factor for severe respiratory syncytial virus (RSV) infections.
  • Palivizumab is the sole pharmacological intervention for passive immunization against severe RSV disease.
  • Japan expanded insurance coverage for palivizumab prophylaxis to all children with DS since 2013, irrespective of other standard risk factors.

Purpose of the Study:

  • To evaluate the effectiveness of the universal palivizumab prophylaxis policy for children with Down syndrome in Japan.
  • To determine if the policy reduced RSV-related hospitalizations in this vulnerable population.

Main Methods:

  • Retrospective analysis of a nationwide database.
  • Inclusion of children with Down syndrome hospitalized for RSV-related lower respiratory infections (LRTIs) between April 2010 and January 2019.
  • Interrupted time-series analysis comparing data before (pre-2013) and after (post-2013) policy implementation.

Main Results:

  • A total of 152 RSV-related LRTIs were identified in 147 children with DS.
  • Time-series analysis revealed no significant change in the level (P = .11) or slope (P = .30) of RSV-related hospitalizations before and after 2013.
  • The universal palivizumab prophylaxis program was not associated with a reduction in hospitalizations.

Conclusions:

  • The expansion of palivizumab prophylaxis to all children with Down syndrome in Japan did not lead to a significant decrease in RSV-related hospitalizations.
  • Further research may be needed to explore alternative or complementary strategies for preventing severe RSV disease in children with DS.

Keywords:
Respiratory syncytial virusa quasi-experimental study designhospitalizationlower respiratory infectionpassive immunization

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