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

Michael E Wechsler; Michel Laviolette; Adalberto S Rubin; Jussara Fiterman; Jose R Lapa e Silva; Pallav L Shah; Elie Fiss; Ronald Olivenstein; Neil C Thomson; Robert M Niven; Ian D Pavord; Michael Simoff; Jeff B Hales; Charlene McEvoy; Dirk-Jan Slebos; Mark Holmes; Martin J Phillips; Serpil C Erzurum; Nicola A Hanania; Kaharu Sumino; Monica Kraft; Gerard Cox; Daniel H Sterman; Kyle Hogarth; Joel N Kline; Adel H Mansur; Brian E Louie; William M Leeds; Richard G Barbers; John H M Austin; Narinder S Shargill; John Quiring; Brian Armstrong; Mario Castro; Asthma Intervention Research 2 Trial Study Group

doi:10.1016/j.jaci.2013.08.009)

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

Michael E Wechsler, Michel Laviolette, Adalberto S Rubin, Jussara Fiterman, Jose R Lapa e Silva, Pallav L Shah, Elie Fiss, Ronald Olivenstein, Neil C Thomson, Robert M Niven, Ian D Pavord, Michael Simoff, Jeff B Hales, Charlene McEvoy, Dirk-Jan Slebos, Mark Holmes, Martin J Phillips, Serpil C Erzurum, Nicola A Hanania, Kaharu SuminoMonica Kraft, Gerard Cox, Daniel H Sterman, Kyle Hogarth, Joel N Kline, Adel H Mansur, Brian E Louie, William M Leeds, Richard G Barbers, John H M Austin, Narinder S Shargill, John Quiring, Brian Armstrong, Mario Castro, Asthma Intervention Research 2 Trial Study Group

Division of Immunology, Immunity to Infection and Respiratory Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

BACKGROUND: Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.

OBJECTIVE: We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.

Original language	English
Pages (from-to)	1295-1302
Number of pages	8
Journal	Journal of Allergy and Clinical Immunology
Volume	132
Issue number	6
DOIs	https://doi.org/10.1016/j.jaci.2013.08.009) https://doi.org/10.1016/j.jaci.2013.08.009
Publication status	Published - Dec 2013

Keywords

Adrenal Cortex Hormones
Adrenergic beta-Agonists
Adult
Asthma
Disease Progression
Drug Resistance
Electric Stimulation Therapy
Emergency Medical Services
Female
Follow-Up Studies
Hospitalization
Humans
Male
Middle Aged
Recurrence
Time Factors
Treatment Outcome
Young Adult
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Wechsler, M. E., Laviolette, M., Rubin, A. S., Fiterman, J., Lapa e Silva, J. R., Shah, P. L., Fiss, E., Olivenstein, R., Thomson, N. C., Niven, R. M., Pavord, I. D., Simoff, M., Hales, J. B., McEvoy, C., Slebos, D.-J., Holmes, M., Phillips, M. J., Erzurum, S. C., Hanania, N. A., ... Asthma Intervention Research 2 Trial Study Group (2013). Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. Journal of Allergy and Clinical Immunology, 132(6), 1295-1302. https://doi.org/10.1016/j.jaci.2013.08.009), https://doi.org/10.1016/j.jaci.2013.08.009

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title = "Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma",

abstract = "BACKGROUND: Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.OBJECTIVE: We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy.METHODS: 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.RESULTS: 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.CONCLUSIONS: 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.",

keywords = "Adrenal Cortex Hormones, Adrenergic beta-Agonists, Adult, Asthma, Disease Progression, Drug Resistance, Electric Stimulation Therapy, Emergency Medical Services, Female, Follow-Up Studies, Hospitalization, Humans, Male, Middle Aged, Recurrence, Time Factors, Treatment Outcome, Young Adult, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",

author = "Wechsler, {Michael E} and Michel Laviolette and Rubin, {Adalberto S} and Jussara Fiterman and {Lapa e Silva}, {Jose R} and Shah, {Pallav L} and Elie Fiss and Ronald Olivenstein and Thomson, {Neil C} and Niven, {Robert M} and Pavord, {Ian D} and Michael Simoff and Hales, {Jeff B} and Charlene McEvoy and Dirk-Jan Slebos and Mark Holmes and Phillips, {Martin J} and Erzurum, {Serpil C} and Hanania, {Nicola A} and Kaharu Sumino and Monica Kraft and Gerard Cox and Sterman, {Daniel H} and Kyle Hogarth and Kline, {Joel N} and Mansur, {Adel H} and Louie, {Brian E} and Leeds, {William M} and Barbers, {Richard G} and Austin, {John H M} and Shargill, {Narinder S} and John Quiring and Brian Armstrong and Mario Castro and {Asthma Intervention Research 2 Trial Study Group}",

year = "2013",

month = dec,

doi = "10.1016/j.jaci.2013.08.009)",

language = "English",

volume = "132",

pages = "1295--1302",

journal = "Journal of Allergy and Clinical Immunology",

issn = "0091-6749",

publisher = "Elsevier BV",

number = "6",

}

Wechsler, ME, Laviolette, M, Rubin, AS, Fiterman, J, Lapa e Silva, JR, Shah, PL, Fiss, E, Olivenstein, R, Thomson, NC, Niven, RM, Pavord, ID, Simoff, M, Hales, JB, McEvoy, C, Slebos, D-J, Holmes, M, Phillips, MJ, Erzurum, SC, Hanania, NA, Sumino, K, Kraft, M, Cox, G, Sterman, DH, Hogarth, K, Kline, JN, Mansur, AH, Louie, BE, Leeds, WM, Barbers, RG, Austin, JHM, Shargill, NS, Quiring, J, Armstrong, B, Castro, M & Asthma Intervention Research 2 Trial Study Group 2013, 'Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma', Journal of Allergy and Clinical Immunology, vol. 132, no. 6, pp. 1295-1302. https://doi.org/10.1016/j.jaci.2013.08.009), https://doi.org/10.1016/j.jaci.2013.08.009

TY - JOUR

T1 - Bronchial thermoplasty

T2 - Long-term safety and effectiveness in patients with severe persistent asthma

AU - Wechsler, Michael E

AU - Laviolette, Michel

AU - Rubin, Adalberto S

AU - Fiterman, Jussara

AU - Lapa e Silva, Jose R

AU - Shah, Pallav L

AU - Fiss, Elie

AU - Olivenstein, Ronald

AU - Thomson, Neil C

AU - Niven, Robert M

AU - Pavord, Ian D

AU - Simoff, Michael

AU - Hales, Jeff B

AU - McEvoy, Charlene

AU - Slebos, Dirk-Jan

AU - Holmes, Mark

AU - Phillips, Martin J

AU - Erzurum, Serpil C

AU - Hanania, Nicola A

AU - Sumino, Kaharu

AU - Kraft, Monica

AU - Cox, Gerard

AU - Sterman, Daniel H

AU - Hogarth, Kyle

AU - Kline, Joel N

AU - Mansur, Adel H

AU - Louie, Brian E

AU - Leeds, William M

AU - Barbers, Richard G

AU - Austin, John H M

AU - Shargill, Narinder S

AU - Quiring, John

AU - Armstrong, Brian

AU - Castro, Mario

AU - Asthma Intervention Research 2 Trial Study Group

PY - 2013/12

Y1 - 2013/12

N2 - BACKGROUND: Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.OBJECTIVE: We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy.METHODS: 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.RESULTS: 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.CONCLUSIONS: 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.

AB - BACKGROUND: Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.OBJECTIVE: We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy.METHODS: 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.RESULTS: 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.CONCLUSIONS: 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.

KW - Adrenal Cortex Hormones

KW - Adrenergic beta-Agonists

KW - Adult

KW - Asthma

KW - Disease Progression

KW - Drug Resistance

KW - Electric Stimulation Therapy

KW - Emergency Medical Services

KW - Female

KW - Follow-Up Studies

KW - Hospitalization

KW - Humans

KW - Male

KW - Middle Aged

KW - Recurrence

KW - Time Factors

KW - Treatment Outcome

KW - Young Adult

KW - Journal Article

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1016/j.jaci.2013.08.009)

DO - 10.1016/j.jaci.2013.08.009)

M3 - Article

C2 - 23998657

SN - 0091-6749

VL - 132

SP - 1295

EP - 1302

JO - Journal of Allergy and Clinical Immunology

JF - Journal of Allergy and Clinical Immunology

IS - 6

ER -

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

Abstract

Keywords

UN SDGs

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