Use of palivizumab in Germany: data from 2002-2007.

ABSTRACT

BACKGROUND: The German Palivizumab Registry refers to a post-marketing observational study of palivizumab administration during 5 consecutive respiratory syncytial virus (RSV) seasons (2002/2003 -2006/2007). PATIENTS AND METHODS: The registry provided data on drug administration, risk factors for complicated RSV disease, rehospitalisation rates for infants receiving RSV prophylaxis, and parental adherence. 49608 administrations were documented in 10686 patients (average of 4.6 per patient). RESULTS: 35% of infants received >5 monthly injections. Median gestational age at birth was 29 weeks (range 23-41 weeks), median birth weight was 1350 g (range 320-6620 g), 3% were attending day care, 46% lived in a household with children <12 years, 18% were exposed to tobacco smoke at home, 10% had a family history of asthma, and 31% had congenital heart disease. The risk of serious adverse events possibly or probably related to palivizumab administration was 0.2 per 1000 administrations. According to a worst-case calculation, the rehospitalisation rate related to RSV infection was 2.5% in children who received prophylaxis. CONCLUSION: The German Palivizumab Registry provides a comprehensive dataset describing the use of palivizumab in Germany from 2002 to 2007, and areas for improvement identified in this registry can be applied to enhance the use of palivizumab in the future.