Reference of this article: González de Dios J, Ochoa Sangrador C, Balaguer Santamaría A. Respiratory syncytial virus prophylaxis with monoclonal antibodies (palivizumab) in congenital cardiopathies: critical review of efficacy, effectiveness, efficiency and safety. Rev Pediatr Aten Primaria. 2007;9:71-100.
Published in Internet: 31-03-2007
Introduction and objectives. The most used immunoprophylaxis against respiratory syncytial
virus (SRV) bronchiolitis are monoclonal antibodies (palivizumab), that already has been
used in preterm infants and, recently, its use has began in newborns and infants with congenital
cardiopathies (CC). The aim of this study is to make a systematic and critical review to the
structured clinical question: is the palivizumab prophylaxis against RSV in infants with CC a good
clinical practice in terms of efficacy, effectiveness, efficiency and safety?
Methods. Structured review of biomedical bibliography, as much primary as secondary databases,
and critical appraisal by means of methodology of the Evidence Based Medicine Working
Results. The efficacy is verified with the only clinical trial that exist, that although a 45%
relative risk reduction in hospitalization is described, only a 4,4% absolute risk reduction is calculated
with a number needed to treat ?NNT? of 23 (95% CI 16-67), with worse results in cyanotic
(NNT = 43, 95% CI 17-72) than acyanotic cardiopathies (NNT = 15, 95% CI 9-40). Effectiveness
is lower in clinical practice, depending on the basal rate of SRV admissions. Efficiency
is based on a theoretical economic model, that assumes costs of 100,338 $/life-year saved and
114,337 $/QALY, clearly non cost-effective. Safety of palivizumab in the short-term is correct,
although there is not experience about the long-term safety.
Conclusions. The possible indications of palivizumab in CC seem limited. In any case, it
must carefully incorporate criteria of effectiveness and efficacy, ant to promote a rational use of
this biotechnological drug.
Keywords● Bronchiolitis ● Effectiveness ● Efficiency ● Evidence-based medicine ● Palivizumab ● Respiratory syncytial virus ● Safety ● Treatment outcome