New Study in Journal of Pediatrics Suggests Synagis (Palivizumab) May Reduce Subsequent Recurrent Wheezing in Preterm InfantsProphylaxis with Synagis Decreases Incidence of Recurrent Wheeze by Almost Half
ABBOTT PARK, Ill. and GAITHERSBURG, Md., June 29, 2007 /PRNewswire-FirstCall/ -- Abbott and MedImmune today announced results of a new study, published in the July issue of Journal of Pediatrics, showing that treatment with Synagis(R) (palivizumab) may reduce recurrent wheezing in premature infants by almost half.
Specifically, the study showed that premature infants without chronic lung disease who received Synagis prior to the study had a 49 percent reduction in the incidence of recurrent wheezing compared to preterm infants who did not receive Synagis. The two-year study also found a 51 percent reduction in the incidence of physician-diagnosed recurrent wheezing in the Synagis group compared to untreated infants.
Wheezing is a whistling sound made by air passing through airways narrowed by inflammation or muscle spasms. Children who wheeze are frequently seen by physicians to determine the cause of their wheezing.
Synagis is a biologic therapy known as a monoclonal antibody administered monthly to premature infants to prevent serious lower respiratory tract infection caused by respiratory syncytial virus (RSV), a leading cause of viral respiratory infection among infants.
According to the World Health Organization, 64 million people are infected with RSV each year, and 160,000 will die from this disease. 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.
'With this new study we see that, by preventing the most serious forms of RSV infections from progressing to its most serious form, Synagis may help protect premature children without chronic lung disease from recurrent wheezing in the first few years of life,' said Eric Simoes, MD, professor, Department of Pediatric Infectious Diseases, University of Colorado School of Medicine and lead investigator in the study.
RSV infection usually manifests as an upper respiratory tract infection with symptoms resembling a cold. In preterm infants, however, the infection has an increased risk of progressing to a lower respiratory tract infection that sometimes requires hospitalization, mechanical ventilation and intensive care. Beyond the acute consequences of infection, epidemiologic data suggest a link between early RSV-associated hospitalization and chronic respiratory complications, such as recurrent wheezing and asthma, which may extend into adolescence.
Synagis, when administered to preterm infants as RSV prophylaxis, has previously shown a 55 percent reduction in hospitalizations due to RSV. Researchers in the current study hypothesized that Synagis, by preventing serious RSV disease, may be responsible for a reduction in recurrent wheezing later in life.
Clinical Trial Design
The study published today was conducted at 27 locations in Spain, Germany, The Netherlands, Canada, Poland and Sweden. Researchers prospectively followed a group of preterm infants (born <35 weeks gestational age) who received at least three doses of Synagis for RSV prophylaxis during their first year of life, and a matched group of preterm infants not treated with Synagis. The Synagis group consisted of 191 preterm infants who were less than 36 months of age and who were not hospitalized for RSV. The control group included 230 preterm children who were matched by chronologic and gestational age: 76 had been hospitalized for RSV and 154 had not. Study subjects were followed for 24 months beginning at a mean age of 19 months.
The primary endpoint of the study was the incidence of recurrent wheezing, defined as three or more episodes of wheezing in the preceding 12 months. An episode of wheezing was defined as one or more consecutive days of wheezing, preceded and followed by a healthy period of at least one week. The study also evaluated the incidence of physician-diagnosed recurrent wheezing, defined as three or more episodes of wheezing in the prior 12 months, as verified by a physician at a physician's office, emergency room or hospital.
Clinical Trial Results
After following these infants for two years, the results showed the following key findings:
The incidence of recurrent wheezing was 49 percent lower among children who received Synagis compared to those who did not (13 percent vs. 26 percent, p=0.001). There was also significantly less physician-diagnosed recurrent wheezing in the group that received Synagis (8 percent vs. 16 percent, p=0.011).
In addition, infants who received Synagis had a significantly longer time to onset of both recurrent wheezing and physician-diagnosed recurrent wheezing, compared with the combined non-prophylaxed group.
Synagis is the only monoclonal antibody approved by the U.S. Food and Drug Administration (FDA) to help prevent an infectious disease. Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease.
Synagis was approved for use in the United States in 1998, Europe in 1999, and Japan in 2002. Synagis is currently available in 62 countries.
The safety and efficacy of Synagis were established in infants with bronchopulmonary dysplasia, infants with a history of prematurity (less than or equal to 35 weeks gestational age), and children with hemodynamically significant congenital heart disease. The first dose of Synagis should be administered prior to commencement of the RSV season, which usually starts in the fall and runs through the spring. Patients, including those who develop an RSV infection, should continue to receive monthly doses throughout the season.
Abbott has exclusive rights to Synagis in markets outside the United States. MedImmune promotes Synagis in the United States.
Important Safety Information
Globally, prescribing information varies; refer to the individual country product label for complete information. For U.S. safety information, visit http://www.medimmune.com. Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) severe acute hypersensitivity reactions have been reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe hypersensitivity reactions occurred on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reaction occurs, caution should be used on re-administration of Synagis.
In clinical trials, the most common adverse events occurring at least 1 percent more frequently in Synagis-treated patients than controls were upper respiratory infection, otitis media, fever and rhinitis. Cyanosis and arrhythmia were seen in children with CHD.
MedImmune strives to provide better medicines to patients, new medical options for physicians, and rewarding careers to employees. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases, cancer and inflammatory diseases. With more than 2,500 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company's Web site at http://www.medimmune.com.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 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.
CONTACT: international media, Annamaria Pastore of Abbott,+1-847-937-9794; or U.S. media, Kate Barrett of MedImmune, +1-301-398-4320;or financial, John Thomas of Abbott, +1-847-938-2655; or Peter Vozzo ofMedImmune, +1-301-398-4358
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Posted: June 2007