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

Abstract

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.

Question 1: Palivizumab for all children with Down syndrome?

“…They found a 3.6-fold reduction in the RSV-related hospitalisation rate in those treated with the vaccine. Children with DS receiving prophylaxis are less likely to require admission; the German Synagis Registry 2009–2016 reported that again palivizumab was effective in reducing admission rates due to RSV in DS, but also that the vaccine was safe with few adverse effects observed 21. In another observational postmarketing study, Kashiwagi et al 22 examined the clinical efficacy of palivizumab in children with DS without significant CHD and found that the intervention was well tolerated and effective in this cohort (table 1).…”

Respiratory Syncytial Virus-related Death in Children With Down Syndrome

“… 33 On the other hand, some countries have included DS as possible indication for palivizumab prophylaxis in their guidelines, acknowledging that randomized controlled trials are challenging to conduct due to the projected large sample size and ethical concerns. 37 Nevertheless, palivizumab is costly and therefore barely available in low-income and lower-middle-income countries.…”

Palivizumab for children with Down syndrome: is the time right for a universal recommendation?

“…The results potentially provide stronger evidence of the risk of RSVH and associated burden of RSV-related illness than a single trial. The current data also indicate that the use of palivizumab has been successfully negotiated and approved in some Canadian provinces, Japan, Germany and Italy for children with DS both with and without risk factors and is of greater benefit versus harm,14–20 and the impact of RSV disease through non-intervention is steadily increasing and has significant clinical, healthcare costs and socioeconomic implications 16. Doucette et al 21 reported that in a sample of paediatric patients from more than 4100 US hospitals that participated in the Healthcare Cost and Utilisation Project, the RSVH rate for children with DS without CHD, increased by 7.6% between 1997 and 2012 compared with corresponding decreases in children with chronic lung disease (−47.0%) and both higher risk and lower risk CHD (−49.7% and −5.7%, respectively).…”