Palivizumab use in infants with Down syndrome—report from the German Synagis™ Registry 2009–2016
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%.
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.
KeywordsDown syndrome Respiratory syncytial virus Palivizumab prophylaxis RSV-related hospitalization Bronchiolitis
congenital heart disease
chronic lung disease of prematurity
electronic case report form
lower respiratory tract infection
postmarketing observational study
respiratory syncytial virus
respiratory syncytial virus hospitalization rate
respiratory tract infection
serious adverse event
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.
Compliance with ethical standards
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.
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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