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Palivizumab does not improve long-term outcomes in kids with cystic fibrosis
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Palivizumab — a monoclonal antibody that prevents respiratory syncytial virus, or RSV, in high-risk infants — did not improve long-term outcomes like respiratory function in children with cystic fibrosis.
The AAP does not recommend routine use of palivizumab for RSV prophylaxis in young children with cystic fibrosis (CF). However, the academy recommends that children with evidence of lung disease or nutritional compromise should be considered for the drug.
Aliza K. Fink, DSc, director of epidemiology at the Cystic Fibrosis Foundation, and colleagues analyzed data collected through the CF Foundation’s Patient Registry. They focused on 4,267 children born between 2008 and 2015 who were diagnosed with CF within the first 6 months of life. Fink and colleagues specifically examined the relationship between palivizumab administration by age 2 years and lung function at age 7 years, time to first positive Pseudomonas respiratory culture and pulmonary-related hospitalizations by age 7 years.
Palivizumab was given to 1,588 (37%) infants with CF during the study period, the researchers said. The average percent forced expiratory volume in 1 second predicted at age 7 years was similar between children who were given palivizumab and those who were not prescribed the drug (98.2 [95% CI; 96.9-99.5] vs. 97.3 [95% CI, 96.1-98.5]). Additionally, Fink and colleagues found that the time to first positive culture for P. aeruginosa — a bacterial pathogen that poses a serious risk to patients with CF — and the annual risk for hospitalization were both similar between the two groups.
Leonard R. Krilov, MD, FAAP, FIDSA, FPIDS, an Infectious Diseases in Children Editorial Board member and chairman of the department of pediatrics at New York University’s Winthrop Hospital, wrote in a related editorial that although palivizumab was approved by the FDA in 1998, optimal indications for its use remain uncertain in this group of children.
In an interview, he told Infectious Diseases in Children that the AAP’s guidelines may be too restrictive.
“I think the first step is to realize that RSV is still a significant disease for premature babies even beyond 29 weeks’ gestational age,” he said. “Revisiting the epidemiology has really supported that.”
However, Krilov said it is unclear at this point what the right changes in the guidance should be. He suggested that a multidisciplinary group from the academy, including experts in infectious diseases, neonatology, pulmonology and general pediatrics, reevaluate the current recommendations.
The AAP told Infectious Diseases in Children that its “recommendations for RSV prophylaxis will remain the same for the upcoming season.” – by Katherine Bortz
Resources:
Fink AK, et al. Pediatrics. 2019;doi:10.1542/peds.2018-3495.
Krilov LR. Pediatrics. 2019;doi:10.1542/peds.2019-0153.
Disclosures: Fink reports no relevant financial disclosures. Krilov reports being a consultant for Pfizer and has received clinical trial support from AstraZeneca (MedImmune) and Regeneron.