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Palivizumab use in infants with Down syndrome-report from the German Synagis™ Registry 2009-2016
Arne Simon1, Susanne Gehrmann2, Gudrun Wagenpfeil3
1Department of Pediatric Oncology and Hematology, Children's Hospital Medical Center, University Hospital of Saarland, Homburg, Germany. Arne.Simon@uks.eu.
Insights
Infants with Down syndrome (DS) have higher risks for respiratory infections. Palivizumab prophylaxis is effective in this population, despite increased comorbidities like congenital heart disease.
Area of Science:
- Pediatrics
- Infectious Diseases
- Genetics
Background:
- Infants with Down syndrome (DS) are at increased risk for respiratory tract infections.
- DS is an independent risk factor for complicated respiratory syncytial virus (RSV) infection in infants.
- Palivizumab prophylaxis is used to prevent RSV in high-risk infants.
Purpose of the Study:
- To analyze differences in risk factors and outcomes for infants with DS receiving palivizumab prophylaxis.
- To assess the field effectiveness of palivizumab in infants with DS during RSV seasons.
Main Methods:
- Prospective observational study of 249 infants with DS receiving palivizumab prophylaxis in Germany (2009-2016).
- Data collected on gestational age, birth weight, comorbidities, and RSV-related hospitalizations.
- Comparison of characteristics and outcomes between infants with and without DS.
Main Results:
- Infants with DS had significantly lower gestational age and birth weight compared to those without DS.
- Patients with DS more frequently had congenital heart disease, siblings in school, home oxygen use, immunodeficiency, and neuromuscular impairment.
- RSV-related hospitalization rates were 1.20% in infants with DS and 0.71% in infants without DS, a non-significant difference in breakthrough cases.
Conclusions:
- Significant differences exist in risk factors and indications for palivizumab use between infants with and without DS.
- Palivizumab prophylaxis demonstrates field effectiveness in infants with DS.
- Despite increased comorbidities, RSV-related hospitalization rates were not significantly higher in infants with DS experiencing breakthrough infections.
Abstract:
Infants with Down syndrome (DS) face an increased risk of respiratory tract infections. Recent studies describe DS as independent risk factor for a complicated clinical course in infants with respiratory syncytial virus (RSV) infection. The prospective observational German Synagis™ Registry comprises data from 249 children below 25 months of age with DS and palivizumab prophylaxis 2009-2016 (1191 administrations; mean 4.8 per patient and season). The median gestational age and the birth weight in patients without and with DS were 31 versus 37 weeks (P < 0.001) and 1590 versus 2750 g, respectively (P < 0.001). Patients with DS significantly more often had congenital heart disease (CHD), siblings in kindergarten or school, treatment with oxygen at home, immunodeficiency, and neuromuscular impairment. The RSV-related hospitalization rate in patients with DS was 1.20%; the hospitalization rate in patients without DS was 0.71%.
Conclusion:
Data from 249 children with DS receiving palivizumab prophylaxis in seven consecutive RSV seasons (2009-2016) in Germany reveal important differences between patients with and without DS concerning the main indication for palivizumab use and additional risk factors. Bearing in mind the limitations of an uncontrolled postmarketing observational study, the results confirm the field effectiveness of palivizumab prophylaxis in this special population. What is Known: • Recent studies describe the Down syndrome as independent risk factor for a complicated clinical course in infants with RSV infection. What is New: • Compared with other infants receiving palivizumab prophylaxis, patients with Down syndrome significantly more often had congenital heart disease, siblings in kindergarten or school, treatment with oxygen at home, immunodeficiency, and neuromuscular impairment. • In infants with palivizumab prophylaxis breakthrough, RSV-related hospitalization rates were not significantly higher in those with Down syndrome.
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