Palivizumab: new indication. Moderate reduction in hospitalisation rate.
(1) Respiratory syncytial virus (RSV) infection is common in infants; it is usually mild except in high risk children. (2) Palivizumab, a monoclonal antibody against RSV, was the first preventive treatment to be marketed in France. The licence was recently extended in France to cover children under 2 years of age who have haemodynamically significant congenital heart disease. (3) Follow-up data from Spanish cohorts of premature infants and infants with bronchopulmonary dysplasia are now available. The data tend to agree, albeit with different levels of evidence, that palivizumab reduces the risk of hospitalisation for RSV infection (3.95% of infants treated with palivizumab, 13.25% of untreated infants), but has no impact on the need for intensive care or on overall mortality. There are no data on the overall risk of hospitalisation. (4) In a randomised double-blind placebo-controlled trial in 1287 infants under 2 years of age with haemodynamically significant heart disease, palivizumab had no effect on mortality. But it did reduce the rate of hospitalisation both for RSV infection (5.3% versus 9.7%) and for all causes (54.9% versus 62.3%). (5) Few adverse effects have been reported after five years of use. The estimated risk of anaphylactic reactions is less than 1 per 100 000 infants. The risk of adverse effects when an infant is treated during a second season is poorly documented. (6) Treatment costs about 5000 euros per season for a 6 kg child. (7) In practice, palivizumab seems useful for the following categories of infants: those aged less than 6 months who were born with a gestational age of less than 32 weeks and who had bronchopulmonary dysplasia at birth; formerly premature infants under 2 years of age who are receiving long-term treatment for pulmonary sequelae; and infants with haemodynamically significant heart disease.
D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000009:adverse effects / Q000191:economics / Q000493:pharmacokinetics / Q000627:therapeutic use; D002170:Canada; D002648:Child; D002675:Child, Preschool; D003327:Coronary Disease; D004311:Double-Blind Method; D017277:Drug Approval; D005602:France; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D018357:Respiratory Syncytial Virus Infections / Q000188:drug therapy* / Q000191:economics / Q000453:epidemiology / Q000517:prevention & control; D012307:Risk Factors; D013030:Spain; D014481:United States
D000911:Antibodies, Monoclonal; D000998:Antiviral Agents