Klin Padiatr 2018; 230(05): 263-269
DOI: 10.1055/a-0595-7771
Original Article
© Georg Thieme Verlag KG Stuttgart · New York

Use of Palivizumab in Germany – Report from the German Synagis™ Registry 2009 – 2016

Einsatz von Palivizumab in Deutschland– Ergebnisse des Deutschen Synagis™ Patientenregisters 2009–2016
Arne Simon
1   Children's Hospital Medical Center, Paediatric Hematology and Oncology, Homburg, Germany
,
Susanne Gehrmann
2   Medical Unit Leader in the Medical Affairs Department, AbbVie Deutschland GmbH & Co.KG, Wiesbaden, Wiesbaden, Germany
,
Gudrun Wagenpfeil
3   Institutes for Medical Biometry, Epidemiology and Medical Informatics (IMBEI), Saarland University, Campus Homburg, Homburg, Germany
,
Stefan Wagenpfeil
3   Institutes for Medical Biometry, Epidemiology and Medical Informatics (IMBEI), Saarland University, Campus Homburg, Homburg, Germany
› Author Affiliations
Further Information

Publication History

Publication Date:
16 April 2018 (online)

Abstract

Background Following national recommendations, palivizumab is administered in Germany to high-risk infants to prevent hospitalizations related to Respiratory Syncytial Virus infection.

Methods In this post marketing observational study (German SYNAGIS™ Registry) data on risk factors and the clinical course of children, who received at least one palivizumab injection between 2009–2016 (01 September to June 30) were entered into an internet-based data entry system by the attending physicians after informed consent.

Results 63 572 immunizations were documented for 12 729 evaluable patients (EVP) from 2009 to 2016, with an average of 5.0 immunizations per patient per season. 45% of infants received more than 5 injections. The predominant primary reason for immunization was premature birth (74%). In the EVP the rate of hospitalizations with causal relationship to RSV was 0.7% (=92/12 729) or 1.2% in a worst case scenario including patients with missing RSV test. In patients with hemodynamically significant congenital heart disease as main indication, RSV-related hospitalization rate was 0.8%. Intensive care was necessary in 16.9% (median duration 3 days), mechanical ventilation in 8.0%. No death related to RSV infection was reported.

Conclusion Keeping in mind the limitations of an uncontrolled prospective observational study, our results confirm the effectiveness and safety of palivizumab prophylaxis. The total number of patients with hsCHD is lower than expected. A better adjustment to the regional epidemiology would probably reduce the need for more than 5 injections.

Zusammenfassung

Hintergrund Palivizumab wird in Deutschland Hochrisikokindern nach den Empfehlungen der Fachgesellschaften verabreicht um Hospitalisierungen zu verhindern, die durch eine RSV Infektion bedingt sind.

Methoden In einer prospektiven Post-Marketing Surveillance Studie (Deutsches SYNAGIS™ Register) wurden Daten zu Risikofaktoren und zum Verlauf von Kindern erhoben, die zwischen 2009 und 2016 (1. Sept. – 30. Juni) mindestens eine Gabe Palivizumab erhalten haben. Nach Zustimmung der Sorgeberechtigten wurden die Daten von den behandelnden Ärzten in ein internetbasiertes Register eingegeben.

Ergebnisse Insgesamt erhielten zwischen 2009 und 2016 12 729 auswertbare Patienten (EVP) 63 572 Palivizumab Injektionen (im Mittel 5.0/Patient und Saison); 45% erhielten mehr als 5 Gaben. Frühgeburtlichkeit war die Hauptindikation (74%). Die Rate der RSV-bedingten Hospitalisierungen in der EVP betrug 0,7% (=92/12 729) bzw.1,2% in einem Worst-Case Szenario unter Einschluss der Patienten ohne RSV Test. Bei Patienten mit hämodynamisch signifikanter angeborener Herzerkrankung (hsCHD) betrug die RSV-bedingte Rehospitalisierungsrate 0,8%. Eine Intensivtherapie war in 16,9% erforderlich (mediane Dauer 3 Tage), invasive Beatmung in 8%. Es wurden keine RSV-bedingten Todesfälle berichtet.

Schlussfolgerung Vorbehaltlich der Limitationen eines nicht kontrollierten prospektiven Registers bestätigen die aktuellen Daten des Deutschen Synagis™ die Effektivität der Palivizumab Prophylaxe. Die absolute Anzahl der Kinder mit Hauptindikation hsCHD ist kleiner, als erwartet. Eine bessere Anpassung an die lokale Epidemiologie würde wahrscheinlich die Notwendigkeit von mehr als 5 Gaben pro Saison reduzieren.

 
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