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Babies Treated with Synagis Show No Lasting Benefits in Lung Health as 7-Year-Olds, Real-world Study

Treating infants with cystic fibrosis (CF) with the antiviral therapy Synagis(palivizumab) does not improve long-term outcomes in lung health, real-world data show.

Routine use of Synagis is not recommended by the American Academy of Pediatrics for babies with CF, although its use can be considered in those at risk of chronic lung disease. These findings suggest that for most of these children the therapy does not carry benefits lasting into childhood.

The study “Palivizumab and Long-term Outcomes in Cystic Fibrosis” was published in the journal Pediatrics.

Synagis, marketed by AstraZeneca, is an engineered antibody designed to block the proliferation of cells infected by the respiratory syncytial virus (RSV), and prevent serious respiratory problems in premature infants, and in infants born with lung or heart disease.

It is recommended for the treatment of at-risk children to reduce hospitalizations triggered by pulmonary exacerbations. However, it is not recommended to treat infants with CF due to concerns for potential side effects.

U.S. researchers in collaboration with the Cystic Fibrosis Foundation reviewed clinical records of CF children, including those treated with Synagis for at least one year over the first two years of life. All children analyzed were enrolled in the Cystic Fibrosis Foundation Patient Registry, and born between 2008 and 2015.

The analysis included data collected from a total of 4,267 infants with CF, of whom 1,588 (37%) were treated with Synagis.

Infants who received the treatment were more likely to be born between 2008 and 2012, and during the months of April to September (before RSV season). They were also more likely be born preterm, have two CF-causing mutations, and asthma.

Children were followed through Dec. 31 of the year they turned 7. Data collected showed similar lung function, as determined by predicted mean percent forced expiratory volume in 1 second (FEV1), among those treated with Synagis and those who were not.

Analysis also found that 1,865 children (52%) developed Pseudomonas aeruginosa lung infections. Treatment with Synagis did not prevent these infections from occurring.

Hospitalization rates were also similar between Synagis-treated and non-treated CF children, regardless of their age.

Overall, the study “found no association between palivizumab [Synagis] and lung function at age 7, time to first Pseudomonas aeruginosa–positive culture result, or rate of pulmonary-related hospitalizations,” the researchers wrote.

No evidence of “long-term benefits” associated with Synagis treatment was observed “in infants with CF on a population level,” they added. But additional studies are warranted to explore if the treatment may help high-risk infants.

“Concise case definitions for chronic lung disease and nutritional compromise for infants with CF need to be developed” to better identify those who may benefit most from treatment, the researchers suggested.

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