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Title: Palivizumab (Synagis) Prophylaxis Appears to Protect Children With Cystic Fibrosis From Respiratory Syncytial Virus Lower Respiratory Tract Infection: Presented at AAP

"Palivizumab (Synagis) Prophylaxis Appears to Protect Children With Cystic Fibrosis From Respiratory Syncytial Virus Lower Respiratory Tract Infection: Presented at AAP"

By Bruce Sylvester ATLANTA, GA -- October 10, 2006 -- Children with cystic fibrosis (CF) have a higher risk of hospitalization due to lower respiratory tract infection (LRTI) with respiratory syncytial virus (RSV) than the general pediatric population, but new research suggests that palivizumab (Synagis) treatment significantly reduces that risk. Researchers reported this finding here on October 7[^th at the American Academy of Pediatrics (AAP) National Conference & Exhibition.

"We saw a dramatic difference between the treated and untreated populations," said lead investigator Michael Speer, MD, professor of pediatrics, Baylor College of Medicine, Houston, Texas. "None of the cystic fibrosis patients identified retrospectively from a large public registry who had received prophylactic palivizumab prior to the RSV season were hospitalized for it during the season. These are high-risk infants."

The researchers evaluated information from the 2000-2003 Outcomes Registry of children treated with pavilizumab to determine the RSV LRTI histological response (HR). They compared the HR for treated CF subjects to the rate seen in untreated CF subjects in previously published studies.1,2

Out of the 13,498 infants enrolled in the Registry, there was a CF diagnosis for 60 (0.5%). Of these, 12 (0.6%) were diagnosed in 2000-2001, 21 (0.4%) in 2001-2002, and 27 (0.4%) in 2002-2003.

Chronic lung disease was diagnosed in 35% of patients with CF and coronary heart disease in 7% of the CF subjects.

None of the pavilizumab-treated CF infants were hospitalized due to RSV LRTI.

In the prior studies of untreated CF subjects, Abman et al. reported that out of 48 CF infants, 14.6% were hospitalized secondary to RSV LRTI. Armstrong et al. reported a HR of 8.75% in a group of 80 CF subjects.

Comparing HRs from RSV LRTI in the 3 groups, the authors reported that, "a significant reduction was found in those infants who had received palivizumab."

"A much higher percentage of cystic fibrosis babies who had not been treated prophylactically were hospitalized during such an RSV season; they got RSV disease. This has important implications and needs to be studied further," Dr. Speer added.

REFERENCES:
1. Abman et al. J Pediatr.1988;113:826-30.
2. Armstrong, et al. Pediatr Pulmonol.1998;26:371-379.

[Presentation title: Palivizumab Prophylaxis in Infants With Cystic Fibrosis. Poster 10]

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