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Palivizumab Prophylaxis in Preterm Infants and Subsequent Recurrent Wheezing. Six-Year Follow-up Study
Hiroyuki Mochizuki1, Satoshi Kusuda2, Kenji Okada3
11 Department of Pediatrics and.
Insights
Palivizumab (an anti-RSV antibody) did not prevent atopic asthma in preterm infants. However, it significantly reduced the incidence of recurrent wheezing by age 6.
Area of Science:
- Pediatric Pulmonology
- Infectious Diseases
- Immunology
Background:
- Respiratory Syncytial Virus (RSV) is linked to infantile wheezing and potentially atopic asthma.
- Preventive measures against RSV in infancy may influence the development of later respiratory conditions.
Purpose of the Study:
- To investigate if palivizumab, an anti-RSV monoclonal antibody, impacts the development of recurrent wheezing and atopic asthma at age 6.
- To assess the long-term effects of preventing severe RSV disease in preterm infants.
Main Methods:
- A prospective, multicenter, case-control study followed 444 preterm infants (33-35 weeks gestation) from birth to 6 years.
- Palivizumab treatment decisions were based on standard medical practice.
- Recurrent wheezing and atopic asthma incidence were primary endpoints, with data collected via physician assessment and parent reporting.
Main Results:
- Atopic asthma incidence at 6 years was similar between palivizumab-treated (15.3%) and untreated (18.2%) groups (P=0.57).
- Recurrent wheezing was significantly lower in the palivizumab-treated group (15.3%) compared to the untreated group (31.6%) (P=0.003).
Conclusions:
- Palivizumab prophylaxis in preterm infants did not prevent the onset of atopic asthma.
- Palivizumab significantly reduced the incidence of recurrent wheezing in the first 6 years of life.
Rationale:
Respiratory syncytial virus (RSV) induces not only infantile recurrent wheezing but also potentially atopic asthma.
Objectives:
To test the effect of RSV infection on development of subsequent atopic asthma, we evaluated whether palivizumab, an anti-RSV monoclonal antibody, by preventing severe RSV disease in the first year of life, could impact subsequent recurrent wheezing and atopic asthma at 6 years of age.
Methods:
During the 2007 to 2008 RSV season, the decision to administer palivizumab was made based on standard medical practice and an observational prospective multicenter (n = 52) case-control study in preterm infants with a gestational age between 33 and 35 weeks followed from 0 to 3 years (preceding Committee on Recurrent Wheezing study). The 52 investigators at hospitals then followed these subjects until 6 years of age, reported here (Effects of Preventive Treatment for Respiratory Syncytial [RS] Virus Infection During Infancy on Later Atopic Asthma in Preterm Infants; Scientific Committee for Elucidation of Infantile Asthma). Parents of study subjects reported the infants' physicians' assessment of recurrent wheezing, using a report card and a novel mobile phone-based reporting system using the Internet. The primary endpoint was the incidence of atopic asthma.
Measurements And Main Results:
Of 444 preterm infants enrolled, 349 received palivizumab during the first year of life. At 6 years, atopic asthma was not different in the groups: 15.3 and 18.2% of infants in the treated and untreated groups, respectively (P = 0.57). On the other hand, physician-diagnosed recurrent wheezing was observed in 15.3 and 31.6% in the treated and untreated groups, respectively (P = 0.003).
Conclusions:
Palivizumab prophylaxis administered to preterm infants did not suppress the onset of atopic asthma but resulted in a significantly lower incidence of recurrent wheezing during the first 6 years. Clinical trial registered with www.clinicaltrials.gov (NCT 01545245).
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