Results Reveal Significantly Compromised Physical Health in AAT Deficient Patients Compared to General Population
MONTREAL, Nov. 2, 2005 – Ongoing treatment with alpha1-proteinase inhibitor (A1PI) augmentation therapy may slow decline of health-related quality of life (HRQoL) in patients with alpha1-antitrypsin (AAT) deficiency, according to preliminary results presented today by the University of New Mexico College of Pharmacy at the annual international scientific assembly of the American College of Chest Physicians (ACCP). The study, funded by Baxter Healthcare Corporation and conducted by Coram, Inc., a leading provider of specialty home infusion services, is the first U.S.-based longitudinal patient outcome study evaluating HRQoL in AAT deficient patients receiving augmentation therapy.
“This study was designed to determine the impact of augmentation therapy with regard to health-related quality of life,” said Matthew Borrego, Ph.D., associate professor at the University of New Mexico College of Pharmacy. “Initial results suggest the importance of augmentation therapy in slowing further decline in health-related quality of
life. As this study progresses, we will have a better understanding of the long-term HRQoL of patients with AAT deficiency and clinically evident emphysema who are receiving augmentation therapy.”
In the preliminary study results presented at today’s meeting, 82 subjects with AAT deficiency with clinically evident emphysema began treatment with ARALAST® [Alpha 1–Proteinase Inhibitor (Human)], which is indicated for chronic augmentation therapy in patients having congenital deficiency of A1PI with clinically evident emphysema. These subjects responded to interviewer-administered questionnaires, which were used to collect demographic information, clinical outcomes, healthcare resource utilization and HRQoL data. The questionnaires were administered at baseline (start of augmentation therapy) and at six-month intervals between April of 2004 and July of 2005.
Overall, the data shows that physical functioning of AAT deficient patients is significantly impaired compared to the general population. However, HRQoL health status scores and physical and mental component summary scores in patients receiving ARALAST remained stable from baseline to six-month follow-up, indicating that augmentation therapy may help stabilize or prevent further negative changes in HRQoL. In addition, the study’s active surveillance to date indicates no serious adverse events. “
Augmentation therapy for patients with AAT deficiency is based on the concept that if an AAT-deficient patient’s serum level of A1PI is increased, it will lead to higher A1PI concentrations in the lungs,” said study co-author David Gelmont, M.D., medical director, Global Research & Development in Baxter’s BioScience business. “This, in turn, may slow the destruction of lung tissue and the clinical course of this disease.”
AAT deficiency affects an estimated 60,000-100,000 people in the United States, making it one of the most common genetically linked disorders. It is estimated that up to 95 percent of those with AAT deficiency are undiagnosed. If untreated, AAT deficiency can result in early onset emphysema and premature death.
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, please visit www.aralast.com/safety.html or call 1-866-ARALAST.
About Baxter
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.