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Use of palivizumab in Germany: data from 2002-2007
1Pediatric Hematology and Oncology, Children's Hospital Medical Center, Kirrberger Strasse, Homburg, Germany. Arne.Simon@uks.eu
Klinische Padiatrie
|April 22, 2011
Summary
The German Palivizumab Registry tracked palivizumab use for respiratory syncytial virus (RSV) over five seasons. Data showed low serious adverse events and a 2.5% RSV rehospitalisation rate in treated infants.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacovigilance
- Respiratory Syncytial Virus (RSV) Research
Background:
- The German Palivizumab Registry was a post-marketing observational study.
- It collected data over five consecutive respiratory syncytial virus (RSV) seasons (2002/2003 - 2006/2007).
Purpose of the Study:
- To document palivizumab administration in a real-world setting.
- To identify risk factors for complicated RSV disease.
- To assess rehospitalisation rates and parental adherence to RSV prophylaxis.
Main Methods:
- Documented 49,608 palivizumab administrations in 10,686 patients.
- Collected data on patient demographics, risk factors, and adherence.
- Analyzed drug administration and outcomes.
Main Results:
- 35% of infants received more than five monthly injections.
- Key patient characteristics included median gestational age of 29 weeks and 31% with congenital heart disease.
- The risk of serious adverse events was 0.2 per 1000 administrations; RSV-related rehospitalisation was 2.5%.
Conclusions:
- The registry provides a comprehensive dataset on palivizumab use in Germany (2002-2007).
- Identified areas for improvement can enhance future palivizumab utilization.
- Findings support ongoing monitoring of RSV prophylaxis effectiveness and safety.
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