Five-year data from the Asthma Intervention Research 2 (AIR2) clinical trial presented today demonstrated that the Boston Scientific Corporation (NYSE: BSX) Alair® Bronchial Thermoplasty (BT) System continues to show therapy benefits in adult patients with severe uncontrolled asthma. Bronchial Thermoplasty was shown to provide long term asthma control, demonstrated by a sustained reduction in the rate of severe exacerbations (asthma attacks) and emergency room (ER) visits over a five year period after treatment. The AIR2 trial is the fourth in a series of clinical trials that have completed five years of follow-up and the first to evaluate persistence of effect for patients treated with BT. Results were presented at the annual meeting of the American Thoracic Society (ATS) in Philadelphia by Michael E. Wechsler, M.D., director of the Asthma Program in the Department of Medicine at National Jewish Health in Denver and an investigator in the AIR2 trial.
"With the availability of the new long term data demonstrating that the benefits of Bronchial Thermoplasty persist for at least five years, I can confidently recommend BT as a therapeutic option to patients whose asthma is poorly controlled with medications alone," said Dr. Wechsler. "This is very important because minimizing the risk of recurrent asthma attacks and the associated need for oral steroid treatment in this patient population is a primary goal in asthma therapy. Bronchial Thermoplasty represents a one time, long term option for achieving better asthma control in a select population of patients. Left uncontrolled, these patients contribute to a disproportionate share of the costs associated with treating asthma."
The data are based on an open-label study following BT-treated patients who completed the one-year portion of the AIR2 trial for a total of five years. The goal of the study was to demonstrate that the percentage of patients experiencing severe exacerbations over the five years following BT was not substantially worse than the percentage of patients having exacerbations in the first year after BT. The data demonstrated that over five years following BT there was a:
- 44 percent average decrease in percent of patients having severe exacerbations compared to the year prior to BT
- 48 percent average decrease in severe exacerbation event rates compared to the year prior to BT
- 88 percent average decrease in ER visit event rates compared to the year prior to BT
"We are pleased to see the significant benefits of Bronchial Thermoplasty persist out to five years in patients with severe asthma," said David Pierce, president, Endoscopy, Boston Scientific. "These clinically meaningful improvements demonstrate that Bronchial Thermoplasty improves patient outcomes and quality of life. In addition, by significantly reducing health care utilization, Bronchial Thermoplasty presents an opportunity to reduce overall health care costs for asthma." Separately, the Asthma and Allergy Foundation of America (AAFA) recently released its list of 2013 Asthma Capitals, an assessment of the most challenging places to live with asthma in the United States (https://www.asthmacapitals.com). For the first time, this year AAFA added a new factor to the ranking assessment: ER visits for asthma. About five percent of the asthma population is considered to have the most severe form of asthma and often does not respond well to conventional asthma treatments. People with severe asthma are likely to have more asthma attacks, visit ERs or be hospitalized more frequently, and are at greater risk of death.
Bronchial Thermoplasty, delivered by the Alair System, is a safe, outpatient procedure proven to provide a long lasting reduction in asthma attacks and ER visits for patients with severe asthma. The Alair System delivers thermal energy to the airway wall in a precisely controlled manner to reduce excessive airway smooth muscle. It is designed to decrease the airway's ability to constrict, thereby reducing asthma attack frequency and severity. Fewer asthma attacks mean less need for the associated oral steroid treatment—and its side effects. To learn more about Bronchial Thermoplasty, visit www.BTforAsthma.com.
In summary, BT is a novel bronchoscopic procedure providing long lasting asthma control that has demonstrated a strong long term safety and efficacy profile out to at least five years in four consecutive clinical trials.
Asthma is one of the most common and costly diseases in the world. The prevalence of asthma has grown in recent decades, and there is no cure. According to the Asthma and Allergy Foundation of America, more than 20 million Americans have asthma. Managing asthma consumes more than $18 billion of healthcare resources each year in the United States. Uncontrolled asthma results in approximately 10 million unscheduled physician office visits, two million ER visits, 500,000 hospitalizations and 4,000 deaths annually in the United States. Five to 10 percent of those suffering from asthma in the United States are diagnosed with severe persistent asthma