[Palivizumab immunoprophylaxis: use in clinical practice, safety and beneficial effects in France].
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.


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.


CONCLUSIONS
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.
Pinquier
D
D
Service de pédiatrie néonatale et réanimation, institut hospitalo-universitaire de recherche biomédicale, EA 4309, CHU Charles-Nicolle, université de Rouen, 1 rue Germont, Rouen, France.
Gouyon
J-B
JB
Fauroux
B
B
Mons
F
F
Vicaut
E
E
Bendjenana
H
H
Rouffiac
E
E
Marret
S
S
Aujard
Y
Y
D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001997:Bronchopulmonary Dysplasia / Q000150:complications; D004196:Disease Outbreaks; D005260:Female; D005500:Follow-Up Studies; D005602:France; D005865:Gestational Age; D006330:Heart Defects, Congenital / Q000150:complications; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007223:Infant; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000276:immunology / Q000517:prevention & control*; D008297:Male; D015337:Multicenter Studies as Topic; D000069455:Palivizumab; D011446:Prospective Studies; D018357:Respiratory Syncytial Virus Infections / Q000276:immunology / Q000517:prevention & control*; D012189:Retrospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000998:Antiviral Agents; D000069455:Palivizumab