Study results look to increase awareness of the importance of testing for early diagnosis and treatment
DEERFIELD, Ill., May 24, 2005 – Preliminary results presented today at the annual meeting of the American Thoracic Society (ATS) reveal the prevalence of both potential carriers and patients at risk of developing hereditary emphysema due to deficiency in alpha1-antitrypsin (AAT) in a large cohort of chronic obstructive pulmonary disease (COPD) patients. It has been estimated that up to 3 percent of patients with COPD and incompletely reversible asthma have severe AAT deficiency.
AAT deficiency is a genetic condition characterized by reduced serum levels of AAT, an important blood protein processed in the liver that can protect lung tissue from damage caused by enzymes that are released by white blood cells. Without sufficient quantities of AAT, patients may develop lung damage.
The study, conducted in cooperation with pulmonary medical practices across the country, is part of a nationwide screening program sponsored by Baxter Healthcare Corporation, which implements the ATS and European Respiratory Society (ERS) standards regarding testing for AAT deficiency. Findings were based on the analysis of the participant's demographics, questionnaire responses and AAT levels/phenotypes.
Between July of 2004 and March of 2005, 82 pulmonologists in 23 states participated in one-day screening programs where more than 2,000 patients with COPD were asked to complete a questionnaire regarding demographics, family history and medical history. Blood samples were obtained and sent to a national medical laboratory and a reference laboratory for immunoassay and phenotype testing. Test results were provided back to the originating physician, and the sponsor covered all screening and lab costs.
Preliminary results of the study indicate a prevalence of 43.4 percent of screened COPD patients having AAT levels £ 140 mg/dL. According to ATS/ERS standards, AAT levels < 150 mg/dL have been characterized as a deficiency in AAT. Studies have shown that individuals with AAT deficiency may be at increased risk for early onset emphysema. Data presented also revealed that 80.7 percent of screened subjects had never heard of AAT deficiency.
“As a pulmonologist, I was aware of the standards but did not fully realize the impact the screening could have until one of my own patients was identified with AAT deficiency,” said Dr. John Butler, a physician in Rockford, Ill. who participated in one of the study's screening days. “I have identified more AAT patients in the last year than I had in my prior 20 years of pulmonary practice. I support the program and encourage all physicians to incorporate the recommended ATS/ERS standards for diagnosis and management of AAT deficiency into their practice.”
“Baxter has demonstrated its commitment to the Alpha-1 community by conducting studies in subjects who are or may be affected by AAT deficiency,” said David Gelmont, M.D., medical director, Global Research & Development in Baxter's BioScience business. “Identifying COPD patients with AAT deficiency is of utmost importance because augmentation therapy may attenuate the progression of lung disease.”
AAT deficiency affects an estimated 60,000 people in the United States, making it one of the most common genetically linked disorders. It is estimated that more than 95 percent of those with AAT deficiency are undiagnosed. If untreated, AAT deficiency can result in early onset emphysema and premature death.
AAT deficiency can be augmented by a weekly infusion of an alpha1-proteinase inhibitor (A1PI), such as ARALAST ® . ARALAST [Alpha 1 –Proteinase Inhibitor (Human)] is indicated for chronic augmentation therapy in patients having congenital deficiency of AAT/A 1 PI with clinically evident emphysema. This therapeutic approach is not a cure nor will it reverse lung damage that has already occurred. However, it raises the serum levels of A1PI, making early diagnosis and therapy desirable.
ARALAST is not indicated as therapy for lung disease patients in whom congenital AAT/A1PI deficiency has not been established.
Important Safety Information
ARALAST is contraindicated in individuals with selective IgA deficiencies (IgA level less than 15mg/dL) who have known antibody against IgA, since they may experience severe reactions, including anaphylaxis, to IgA, which may be present. The most common symptoms during the clinical study were headache (0.3%) and somnolence (0.3%). Post market adverse event data have indicated reports of infusion site pain associated with the administration of ARALAST. Pregnancy Category C, reproduction studies have not been conducted with ARALAST. As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated.
For more information on ARALAST, including full prescribing information, or to schedule a screening day at your office, please visit www.aralast.com.
Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE: BAX). Baxter assists healthcare professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients´ lives. For more information about Baxter, please visit www.baxter.com.