Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma

• Published in: Journal of allergy and clinical immunology Vol. 132; no. 6; pp. 1295 - 1302.e3
• Main Authors: Wechsler, Michael E., Laviolette, Michel, Rubin, Adalberto S., Fiterman, Jussara, Lapa e Silva, Jose R., Shah, Pallav L., Fiss, Elie, Olivenstein, Ronald, Thomson, Neil C., Niven, Robert M., Pavord, Ian D., Simoff, Michael, Hales, Jeff B., McEvoy, Charlene, Slebos, Dirk-Jan, Holmes, Mark, Phillips, Martin J., Erzurum, Serpil C., Hanania, Nicola A., Sumino, Kaharu, Kraft, Monica, Cox, Gerard, Sterman, Daniel H., Hogarth, Kyle, Kline, Joel N., Mansur, Adel H., Louie, Brian E., Leeds, William M., Barbers, Richard G., Austin, John H.M., Shargill, Narinder S., Quiring, John, Armstrong, Brian, Castro, Mario
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.12.2013; Elsevier; Elsevier Limited
• Subjects: adrenal cortex hormones; Adrenal Cortex Hormones - therapeutic use; Adrenergic beta-Agonists - therapeutic use; Adult; Alair System; Allergy and Immunology; Asthma; Asthma - epidemiology; Asthma - therapy; asthma exacerbation; beta-adrenergic agonists; Biological and medical sciences; Bronchial thermoplasty; bronchoscopic procedure; computed tomography; Disease Progression; Drug Resistance; durability; Electric Stimulation Therapy - methods; Emergency Medical Services - statistics & numerical data; Female; Follow-Up Studies; Fundamental and applied biological sciences. Psychology; Fundamental immunology; health services; Hospitalization; Hospitalization - statistics & numerical data; Humans; Male; Medical sciences; Medical treatment; Middle Aged; patients; Recurrence; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; therapeutics; Time Factors; Treatment Outcome; Young Adult; AE; Bronchial thermoplasty; asthma; AQLQ; BT; AIR2; LABA; ICS; asthma exacerbation; Alair System; HRCT; NAEPP; bronchoscopic procedure; OCS; ED; Inhaled corticosteroid; Adverse event; Asthma Intervention Research 2; National Asthma Education and Prevention Program; Asthma Quality of Life Questionnaire; Oral corticosteroid; High-resolution computed tomography; Long-acting β 2-agonist; Emergency department; Human; Immunopathology; Toxicity; Long term; Exacerbation; Immunology; Treatment; Efficiency; Severe asthma; Long-acting β-agonist
• ISSN: 0091-6749; 1097-6825; 1097-6825
• DOI: 10.1016/j.jaci.2013.08.009

Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV1 values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β2-agonists.