Objective To evaluate from a European perspective the effectiveness of palivizumab, a respiratory syncytial virus- (RSV-) specific monoclonal antibody, which has been approved in Europe for the prevention of RSV lower respiratory tract infection in infants born prematurely and with bronchopulmonary dysplasia (BPD) since 1998 and in infants with hemodynamically significant congenital heart disease (CHD) since 2003.

Methods RSV hospitalization data were collected from available European registries following the outcomes of children who received palivizumab prophylaxis.

Results Six registries from seven countries followed 16,929 infants (Belgium/Luxembourg n = 166, France n = 1233, Germany n = 10,627, Italy n = 1722, Portugal n = 1262 and Spain n = 1919) who received palivizumab prophylaxis over 7 respiratory virus seasons. Infants who received palivizumab were classified as being premature (82.6%), having BPD (38.9%) and/or having CHD (22.8%). Overall and country specific rates of RSV hospitalization were as follows: overall (2.0%), Belgium/Luxembourg (2.4%), France (3.1%), Germany (1.6%), Italy (2.3%), Portugal (1.3%) and Spain (4.0%). Rates of RSV hospitalization did not vary by RSV season 2000/2001 (3.7%), 2001/2002 (4.0%), 2002/2003 (2.0%), 2003/2004 (1.8%), 2004/2005 (1.6%), 2005/2006 (1.5%) and 2006/2007 (2.1%).

Conclusions Palivizumab is effective in preventing RSV hospitalization. Infants who receive RSV prophylaxis with palivizumab according to local guidelines and practice experienced low rates of RSV hospitalization. Rates were similar to or lower than the rates demonstrated in the palivizumab pivotal trials (4.8% and 5.3%), and consistent across geographic regions and respiratory seasons.

This study was sponsored by Abbott.