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Palivizumab use in infants with Down syndrome—report from the German Synagis™ Registry 2009–2016

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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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Notes

  1. Synagis®; formerly licensed by Abbot Laboratories Limited, UK, now licensed by Medimmune/AbbVie®).

Abbreviations

BPD:

bronchopulmonary dysplasia

CHD:

congenital heart disease

CLD:

chronic lung disease of prematurity

eCRF:

electronic case report form

DS:

Down syndrome

LRTI:

lower respiratory tract infection

PMOS:

postmarketing observational study

RSV:

respiratory syncytial virus

RSVHR:

respiratory syncytial virus hospitalization rate

RTI:

respiratory tract infection

SAE:

serious adverse event

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Funding

The German Synagis Registry is supported by an unrestricted scientific grant of AbbVie GmbH, Wiesbaden, Germany.

Author information

Authors and Affiliations

Authors

Contributions

AS is the scientific advisor of the German Synagis Registry, developed the online eCRF together with SG and wrote the draft of the manuscript. SG coordinated the internal review of the manuscript. GW and SW performed the statistical data analysis. All authors contributed to the final version of the manuscript.

Corresponding author

Correspondence to Arne Simon.

Ethics declarations

Conflict of interest

AbbVie Deutschland GmbH & Co KG, Wiesbaden, Germany provided financial support for this Registry. AbbVie participated in the review and approval of the manuscript. Susanne Gehrmann is Medical Unit Leader in the Medical Affairs Department of AbbVie Deutschland GmbH & Co.KG, Wiesbaden and may own AbbVie stock or stock options. Arne Simon has received scientific grants from Abbott GmbH, Wiesbaden for the DSM RSV Paed Study and honoraria for the development and scientific administration of Internet-based Version of the German Synagis™ Registry from AbbVie Deutschland GmbH & Co.KG, Wiesbaden, Germany. Stefan Wagenpfeil has received scientific grants from AbbVie Deutschland GmbH & Co. KG for epidemiologic evaluation of the German Synagis™ Registry. Gudrun Wagenpfeil has no conflicts of interest to declare.

Informed consent

Parents/legal guardians provided written informed consent for data recording on the eCRF and anonymized data analysis and publication for scientific purposes. Before the practical implementation of the protected Internet data entry platform, the medical advisor of the study (AS) obtained approval for the POMS by the Ethics Committee of the Medical Faculty, University of Bonn, Germany (reference no. 132/08). This approval was prolonged to July 2012 on September 9, 2010. After a change of affiliation to the University Hospital Homburg/Saar, approval for the study was obtained by the Ethics Committee of the Medical Association of the Saarland on April 13, 2013 (reference no. Ha89/13).

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Communicated by Nicole Ritz

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Simon, A., Gehrmann, S., Wagenpfeil, G. et al. Palivizumab use in infants with Down syndrome—report from the German Synagis™ Registry 2009–2016. Eur J Pediatr 177, 903–911 (2018). https://doi.org/10.1007/s00431-018-3142-x

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  • DOI: https://doi.org/10.1007/s00431-018-3142-x

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