New Data Presented at Neonatology Conference Suggest More Needs to Be Done To Protect At-Risk Infants From Respiratory Syncytial
12 Dicembre 2003 - 1:00PM
PR Newswire (US)
New Data Presented at Neonatology Conference Suggest More Needs to
Be Done To Protect At-Risk Infants From Respiratory Syncytial Virus
Start of RSV Season Puts Infants at Risk of Infection WASHINGTON,
Dec. 12 /PRNewswire-FirstCall/ -- New clinical data provide
additional evidence that premature [i.e., less than or equal to 35
weeks gestational age (wGA)] infants are at elevated risk for
respiratory syncytial virus (RSV)-related morbidity and mortality.
Data presented this week by a panel of leading neonatologists and
infectious disease specialists at an international neonatology
conference identify those infants at greatest risk for serious
disease and alert physicians that the RSV season is underway in the
northern hemisphere. "These new findings help raise awareness of
the risks of RSV in premature babies," said Jessie Groothuis, M.D.,
global medical director, Immunology Development, Abbott
Laboratories. "Preventive treatments can help protect these already
vulnerable infants against RSV, a serious lower respiratory tract
disease." RSV is the most common cause of lower respiratory tract
infections (LRTI) such as bronchiolitis and pneumonia in infants
and children worldwide, with infections predominantly occurring
between the autumn and spring. Nearly 50 percent of bronchiolitis
and 25 percent of pneumonia hospitalizations in young children are
caused by RSV. The global annual infection and mortality figures
for RSV are estimated to be as high as 64 million and 160,000,
respectively. Those considered at the highest risk for RSV disease
include preterm infants and infants with hemodynamically
significant congenital heart disease (CHD). Synagis(R)
(palivizumab), approved in Europe in 1999 and in the United States
in 1998 to prevent serious RSV infections in high-risk premature
infants, was recently approved in Europe for expanded use in
children up to 2 years of age with CHD (October 2003), and in the
United States for use in infants and young children up to the age
of 2 years with CHD (September 2003). Three international studies
presented for the first time at Hot Topics, an international
conference held this week in Washington, D.C., underline the need
for high-risk infants to receive preventive treatments, which may
result in fewer RSV-related hospitalizations. In addition, data
being released for the first time target specific risk factors for
RSV hospitalization in premature infants. Danish Study Shows RSV
Prophylaxis Encouraged Findings from a recent Danish study of
extremely premature infants, with or without chronic lung disease,
indicated that these patients are at unusually high risk of
rehospitalization and are often in need of respiratory support due
to complications resulting from RSV infection. The study authors
concluded that consideration should be given to more widespread
application of RSV prophylaxis in this high-risk patient
population. Spanish Study Shows Synagis Results in 70 Percent Fewer
Hospitalizations Results from a four-year Spanish study, published
in the October 2003 issue of Pediatric Infectious Disease Journal,
demonstrated that premature infants less than or equal to 32 wGA
prophylaxed with the monoclonal antibody Synagis experienced 70
percent fewer RSV-related hospitalizations than those not receiving
Synagis. Overall, infants who did not receive Synagis were almost
four times more likely to have RSV-related hospitalizations.
International Studies Identify New Risk Factors for RSV in
Premature Infants A recent study published in The Journal of
Pediatrics demonstrated that infants born 33-35 wGA experience
severe hospital outcomes comparable to infants less than 33 wGA. At
Hot Topics, investigators from Canada and Spain presented separate
studies designed to identify the risk factors most likely to
contribute to RSV infection and hospitalization in infants born at
33-35 wGA. According to data presented by Drs. Barbara Law of
Canada and Xavier Carbonell of Spain, risk factors for
hospitalization included siblings in day care, household crowding,
the presence of smokers in the home, male gender, multiple health
conditions, an age of 10 weeks or younger at the start of the RSV
season, and early discontinuation of breastfeeding. RSV and
High-Risk Infants Preterm infants represent the largest group of
children at high risk for serious RSV infection, re-infection and
hospitalization. Studies have shown that children at increased risk
of complications from RSV disease include infants born prematurely.
RSV infection, when severe enough to result in hospitalization, may
require intensive care and mechanical ventilation. High-risk
infants who contract RSV are significantly more likely than
healthy, term infants to develop LRTI such as bronchiolitis and
pneumonia, conditions that often require lengthy and costly
hospitalizations. Over the long term, RSV infection has been linked
to chronic wheezing and coughing similar to childhood asthma. RSV
Prophylaxis with Synagis (palivizumab) Synagis, a humanized
monoclonal anti-RSV antibody, is currently the only preventive
regimen against LRTI hospitalization caused by RSV. Prophylaxis
with Synagis involves monthly intramuscular injections throughout
the RSV season. Synagis has been proven to bind to all clinical RSV
isolates collected worldwide and is licensed in more than 50
countries. Synagis is indicated for children less than 2 years of
age with bronchopulmonary dysplasia/chronic lung disease, premature
infants less than or equal to 35 wGA, and for infants and children
2 years of age or younger with hemodynamically significant CHD.
Previous clinical studies have demonstrated that Synagis is
effective and well-tolerated. Common adverse events included fever
and injection site reactions but these were not significantly
greater than placebo. Abbott Laboratories has exclusive rights to
Synagis in markets outside of the United States. In the United
States, MedImmune Inc. (Gaithersburg, MD, USA) and Abbott have an
exclusive agreement to co-promote Synagis. Abbott Laboratories is a
global, broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals,
nutritionals, and medical products, including devices and
diagnostics. The company employs more than 70,000 people and
markets its products in more than 130 countries. Abbott's news
releases and other information are available on the company's Web
site at http://www.abbott.com/ . DATASOURCE: Abbott Laboratories
CONTACT: Media, Donna Lindquist, +1-847-936-1192, or Financial
Community, John Thomas, +1-847-938-2655, both of Abbott
Laboratories Web site: http://www.abbott.com/ Company News On-Call:
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