Impact of Unapproved Dosing of RSV Immunoprophylaxis Presented at Pediatric Academic Societies’ Annual Meeting.
MedImmune, the global biologics arm of AstraZeneca, announced results from a new retrospective database cohort study of 8,443 high-risk infants receiving palivizumab in Medicaid programs across 12 states. Approximately 67% of infants were non-compliant with palivizumab.
Non-compliance with the FDA-approved dosing of Synagis® (palivizumab), defined as not receiving at least 5 doses or having dosing gaps, significantly increased likelihood of hospitalization from respiratory syncytial virus (RSV) among high-risk infants in a Medicaid population. The percentage of RSV-related hospitalization (RSV-H) was significantly higher among non-compliant vs. compliant infants (12.0% vs. 7.4%, P<0.001) respectively.1-6 These data were presented today at the 2012 Pediatric Academic Societies (PAS) Annual Meeting in Boston.
“These results suggest that inconsistent dosing or dosing less than approved in the FDA label for Synagis is correlated to the risk of RSV hospitalization for high-risk infants,” said Parthiv Mahadevia, MD, MPH, senior health economist and outcomes researcher at MedImmune.
The FDA-approved labeling for Synagis, Section 2.1 – Dosing Information, states, “The efficacy of Synagis at doses less than 15 mg/kg, or of dosing less frequently than monthly throughout the RSV season, has not been established.” In these analyses, the population under study was infants born with prematurity (34 weeks gestational age or less), congenital heart disease (CHD) or chronic lung disease of prematurity.
“These infants are recommended to receive palivizumab as per the product’s label and our findings demonstrate the need for full protection against RSV throughout the season,” said Mahadevia.
Also presented at PAS, were two additional sub-analyses of the data:
- Non-Compliance with Palivizumab Among Racial Minorities in A Medicaid Population, Tuesday May1, 10:00 AM (Abstract 184)
- Factors Associated with Non-Compliance with Palivizumab Among Medicaid Infants, Saturday April 28 , 1:00 PM (Abstract 287)
RSV is the most common respiratory infection in infancy; approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second birthday.7,8
In most children, RSV presents mild symptoms similar to the common cold and doesn’t require medical attention.
However, certain infants—particularly premature infants and babies with congenital heart disease (CHD) and chronic lung disease (CLD) of prematurity—are at increased risk of developing a serious infection from RSV, often requiring hospitalization.9,10
Serious RSV infection is the leading cause of infant hospitalization in the U.S.,11, 12 and is the cause of one of every 13 pediatrician visits and one of every 38 emergency room trips.13
About the Studies
Compliance with Synagis dosing was evaluated across six RSV seasons (2003-2009), with RSV season typically running from November through March. Babies were required to have been discharged between May 1 and September 30 and to have received one or more doses of Synagis during their first RSV season (October through April) with no gaps of > 35 days between any dose. Inclusion criteria were defined as infants born with prematurity (34 weeks gestational age or less), congenital heart disease (CHD), or chronic lung disease of prematurity (CLDP).
Important Safety Information
What is Synagis® (palivizumab)?
Synagis is a prescription medication that is used to help prevent a serious lung disease caused by respiratory syncytial virus (RSV) in children at high risk for severe lung disease from RSV.
Who should not receive Synagis?
Children should not receive Synagis if they have ever had a severe allergic reaction to it. Signs and symptoms of a severe allergic reaction could include: itchy rash; swelling of the face; difficulty swallowing; difficulty breathing; bluish color of the skin; muscle weakness or floppiness; a drop in blood pressure and/or unresponsiveness. If your child has any of these signs or symptoms of a severe allergic reaction after getting Synagis, be sure to tell your child’s healthcare provider or get medical help right away.
How is Synagis given?
Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. Your child should receive their first Synagis shot before the RSV season starts to help protect them before RSV becomes active. When RSV is most active, your child will need to receive Synagis shots every 28-30 days to help protect your child from severe RSV disease for about a month. Your child should continue to receive monthly shots of Synagis until the end of RSV season. Your child may still get severe RSV disease after receiving Synagis. If your child has an RSV infection, they should continue to get their monthly shots throughout the season.
The efficacy of Synagis shots given less than monthly throughout the RSV season has not been established.
What are the side effects of Synagis?
Possible, serious side effects include severe allergic reaction which may occur after any dose of Synagis. Such reactions may be life-threatening or cause death. Unusual bruising and/or groups of tiny red spots on the skin have also been reported.
Common side effects of Synagis include fever and rash. Other possible side effects include skin reactions around the area where the shot was given (like redness, swelling, warmth or discomfort).
Please see accompanying full prescribing information, including patient information at http://www.synagis.com.
MedImmune, the global biologics arm for AstraZeneca PLC, has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune’s website at http://www.medimmune.com/
- Non-Compliance with Palivizumab and Increased Risk of Respiratory Syncytial Virus Hospitalization Among a Medicaid Population. Krilov, Weiner, Wade, Smith, et. al. SUNY Stony Brook School of Medicine,Mineloa,NY,SUNYUpdateMedicalUniversity,Syracuse,NY.
- Sigurs N et al. Am J Crit Care Med. 2000; 161:1501-1507.
- Stein RT et al. The Lancet. 1999; 354:541-545.
- Sampalis JS. Morbidity and mortality after RSV-associated hospitalizations among premature Canadian infants. J Pediatr. 2003: 143:S150-S156.
- Non-Compliance with Palivizumab Among Racial Minorities in a Medicaid Population. Masaquel, Krilov, Wade, Smith et. Al. MedImmune, Gaithersburg, MD, SUNY Stony Brook School of Medicine, Mineola, NY.
- Factors associated with Non-Compliance with Palivizumab among Medicaid infants. Masaquel, Krilov, Wade, Smith, et. al. MedImmune, Gathersburg, MD, SUNY Stony Brook School of Medicine, Mineloa, NY.
- Glezen WP, et al. AJDC. 1986; 140: 543 – 546.
- Centers for Disease Control and Prevention (CDC). Respiratory syncytial virus infection (RSV): frequently asked questions. http://www.cdc.gov/rsv/about/faq.html. Accessed September 26, 2011.
- Yeung CY, Hobbs JR. Serum-gamma-G-globulin levels in normal premature, post-mature and “small for dates”newborn babies. Lancet.1968;7557:11 67-11 70.
- Langston C, Kida K, Reed M, Thurlbeck WM. Human lung growth in late gestation and in the neonate. Am Rev Respir Dis. 1984;129:607-613
- Leader S, Kohlhase K. Ped Infec Dis J. 2002;21:629-632.
- Shay DK, Holman RC, Newman RD, et al. JAMA. 1999;282:1440-1446.
- Hall CB, Weinberg GA, Iwane MK, et al. N Engl J Med. 2009;360:588-598