Background: Infants treated have been followed for one year in order to assess conditions of use of palivizumab, safety, tolerability, and its impact on respiratory syncytial virus (RSV) hospitalisation rate.
Patients and methods: Patients who received palivizumab during the epidemic season 2005-2006 were eligible. Follow-up was carried out 12 months after initiation of prophylaxis.
Results: Sixty-four neonatal level II and III centers, pulmonary and cardiology units enrolled 1420 children. Mean follow-up was 10.9+/-0.2 months, mean gestational age (GA) 30+/-4 weeks and mean age at the start of prophylaxis was 5 months. Median number of injections was 5 and mean time interval between 2 consecutive injections was 30+/-6 days. Treatment was prescribed in accordance with the marketing authorisation indications (MA) for 84% of patients. For preterm infants born before 35 SA and less than 6 months of age, 60% was born before 33 SA and without BDP. The global readmission rate (for more than 24h) for documented RSV infection during the period of protection by palivizumab was 2.7% (37 in 1371) for all treated children: respectively 2% [IC(95%)=1.3-3.2], 2.7% [IC(95%)=0.7-4.7] and 3.7% [IC(95%)=0.8-6.6] for preterm infants less than 6 months of age, preterm from 6 to 24 months of age and for children with congenital cardiopathy. Palivizumab safety and tolerability were good.
Conclusion: Evaluation of palivizumab prophylaxis in clinical practice confirms the clinical characteristics of treated infants, outlines their evolution and confirms safety of treatment. MA were generally well observed and a registry could be usefull to track the impact of the treatment out of MA.