Asthma-Related Outcomes in Patients Initiating Extrafine Ciclesonide or Fine-Particle Inhaled Corticosteroids

Dirkje S Postma; Richard Dekhuijzen; Thys Van Der Molen; Richard J Martin; Wim van Aalderen; Nicolas Roche; Theresa W Guilbert; Elliot Israel; Daniela  van Eickels; Javaria Mona Khlaid; Ron M C Herings; Jetty A Overbeek; Cristiana Miglio; Victoria Thomas; Catherine Hutton; Elizabeth V Hillyer; David B. Price

doi:10.4168/aair.2017.9.2.116

Asthma-Related Outcomes in Patients Initiating Extrafine Ciclesonide or Fine-Particle Inhaled Corticosteroids

Dirkje S Postma, Richard Dekhuijzen, Thys Van Der Molen, Richard J Martin, Wim van Aalderen, Nicolas Roche, Theresa W Guilbert, Elliot Israel, Daniela van Eickels, Javaria Mona Khlaid, Ron M C Herings, Jetty A Overbeek, Cristiana Miglio, Victoria Thomas, Catherine Hutton, Elizabeth V Hillyer, David B. Price

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Abstract

PurposeExtrafine-particle inhaled corticosteroids (ICS) have greater small airway deposition than standard fine-particle ICS. We sought to compare asthma-related outcomes after patients initiated extrafine-particle ciclesonide or fine-particle ICS (fluticasone propionate or non-extrafine beclomethasone).MethodsThis historical, matched cohort study included patients aged 12-60 years prescribed their first ICS as ciclesonide or fine-particle ICS. The 2 cohorts were matched 1:1 for key demographic and clinical characteristics over the baseline year. Co-primary endpoints were 1-year severe exacerbation rates, risk-domain asthma control, and overall asthma control; secondary endpoints included therapy change.ResultsEach cohort included 1,244 patients (median age 45 years; 65% women). Patients in the ciclesonide cohort were comparable to those in the fine-particle ICS cohort apart from higher baseline prevalence of hospitalization, gastroesophageal reflux disease, and rhinitis. Median (interquartile range) prescribed doses of ciclesonide and fine-particle ICS were 160 (160-160) µg/day and 500 (250-500) µg/day, respectively (P<0.001). During the outcome year, patients prescribed ciclesonide experienced lower severe exacerbation rates (adjusted rate ratio [95% CI], 0.69 [0.53-0.89]), and higher odds of risk-domain asthma control (adjusted odds ratio [95% CI], 1.62 [1.27-2.06]) and of overall asthma control (2.08 [1.68-2.57]) than those prescribed fine-particle ICS. The odds of therapy change were 0.70 (0.59-0.83) with ciclesonide.ConclusionsIn this matched cohort analysis, we observed that initiation of ICS with ciclesonide was associated with better 1-year asthma outcomes and fewer changes to therapy, despite data suggesting more difficult-to-control asthma. The median prescribed dose of ciclesonide was one-third that of fine-particle ICS.

Original language	English
Article number	e45
Pages (from-to)	116-125
Number of pages	10
Journal	Allergy, Asthma & Immunology Research
Volume	9
Issue number	2
Early online date	11 Oct 2016
DOIs	https://doi.org/10.4168/aair.2017.9.2.116
Publication status	Published - Mar 2017

Bibliographical note

Funds to acquire the dataset from the PHARMO Institute were provided by Research in Real-Life, Ltd (RiRL). The study data were provided to the Small Airways Study Group (SASG), which received financial support to conduct the analyses from Takeda Pharmaceuticals International GmbH, Zurich, Switzerland. Two Takeda employees (D.vE. and J.M.K.) are authors of the paper and participated in developing the study protocol and the manuscript. Members of the SASG were reimbursed for travel expenses to attend meetings to discuss this together with several other projects; they were not otherwise compensated for their advisory role.

The authors acknowledge with gratitude the contributions of Dr. Gene Colice to study design and interpretation. We acknowledge Dr. Matthias Binek for contributions to the study design. The authors thank Jenny Fanstone of Fanstone Medical Communications Ltd., UK, for medical writing support for the initial draft, funded by Research in Real-Life.

Keywords

anti-asthmatic agents
comparative effectiveness research
disease exacerbation
small airway

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Asthma-Related Outcomes in Patients Initiating Extrafine
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Final published version, 331 KBLicence: CC BY-NC

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Postma, D. S., Dekhuijzen, R., Van Der Molen, T., Martin, R. J., van Aalderen, W., Roche, N., Guilbert, T. W., Israel, E., van Eickels, D., Khlaid, J. M., Herings, R. M. C., Overbeek, J. A., Miglio, C., Thomas, V., Hutton, C., Hillyer, E. V., & Price, D. B. (2017). Asthma-Related Outcomes in Patients Initiating Extrafine Ciclesonide or Fine-Particle Inhaled Corticosteroids. Allergy, Asthma & Immunology Research, 9(2), 116-125. Article e45. https://doi.org/10.4168/aair.2017.9.2.116

Postma, DS, Dekhuijzen, R, Van Der Molen, T, Martin, RJ, van Aalderen, W, Roche, N, Guilbert, TW, Israel, E, van Eickels, D, Khlaid, JM, Herings, RMC, Overbeek, JA, Miglio, C, Thomas, V, Hutton, C, Hillyer, EV & Price, DB 2017, 'Asthma-Related Outcomes in Patients Initiating Extrafine Ciclesonide or Fine-Particle Inhaled Corticosteroids', Allergy, Asthma & Immunology Research, vol. 9, no. 2, e45, pp. 116-125. https://doi.org/10.4168/aair.2017.9.2.116

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title = "Asthma-Related Outcomes in Patients Initiating Extrafine Ciclesonide or Fine-Particle Inhaled Corticosteroids",

abstract = "PurposeExtrafine-particle inhaled corticosteroids (ICS) have greater small airway deposition than standard fine-particle ICS. We sought to compare asthma-related outcomes after patients initiated extrafine-particle ciclesonide or fine-particle ICS (fluticasone propionate or non-extrafine beclomethasone).MethodsThis historical, matched cohort study included patients aged 12-60 years prescribed their first ICS as ciclesonide or fine-particle ICS. The 2 cohorts were matched 1:1 for key demographic and clinical characteristics over the baseline year. Co-primary endpoints were 1-year severe exacerbation rates, risk-domain asthma control, and overall asthma control; secondary endpoints included therapy change.ResultsEach cohort included 1,244 patients (median age 45 years; 65% women). Patients in the ciclesonide cohort were comparable to those in the fine-particle ICS cohort apart from higher baseline prevalence of hospitalization, gastroesophageal reflux disease, and rhinitis. Median (interquartile range) prescribed doses of ciclesonide and fine-particle ICS were 160 (160-160) µg/day and 500 (250-500) µg/day, respectively (P<0.001). During the outcome year, patients prescribed ciclesonide experienced lower severe exacerbation rates (adjusted rate ratio [95% CI], 0.69 [0.53-0.89]), and higher odds of risk-domain asthma control (adjusted odds ratio [95% CI], 1.62 [1.27-2.06]) and of overall asthma control (2.08 [1.68-2.57]) than those prescribed fine-particle ICS. The odds of therapy change were 0.70 (0.59-0.83) with ciclesonide.ConclusionsIn this matched cohort analysis, we observed that initiation of ICS with ciclesonide was associated with better 1-year asthma outcomes and fewer changes to therapy, despite data suggesting more difficult-to-control asthma. The median prescribed dose of ciclesonide was one-third that of fine-particle ICS.",

keywords = "anti-asthmatic agents, comparative effectiveness research, disease exacerbation, small airway",

author = "Postma, {Dirkje S} and Richard Dekhuijzen and {Van Der Molen}, Thys and Martin, {Richard J} and {van Aalderen}, Wim and Nicolas Roche and Guilbert, {Theresa W} and Elliot Israel and {van Eickels}, Daniela and Khlaid, {Javaria Mona} and Herings, {Ron M C} and Overbeek, {Jetty A} and Cristiana Miglio and Victoria Thomas and Catherine Hutton and Hillyer, {Elizabeth V} and Price, {David B.}",

note = "Funds to acquire the dataset from the PHARMO Institute were provided by Research in Real-Life, Ltd (RiRL). The study data were provided to the Small Airways Study Group (SASG), which received financial support to conduct the analyses from Takeda Pharmaceuticals International GmbH, Zurich, Switzerland. Two Takeda employees (D.vE. and J.M.K.) are authors of the paper and participated in developing the study protocol and the manuscript. Members of the SASG were reimbursed for travel expenses to attend meetings to discuss this together with several other projects; they were not otherwise compensated for their advisory role. The authors acknowledge with gratitude the contributions of Dr. Gene Colice to study design and interpretation. We acknowledge Dr. Matthias Binek for contributions to the study design. The authors thank Jenny Fanstone of Fanstone Medical Communications Ltd., UK, for medical writing support for the initial draft, funded by Research in Real-Life.",

year = "2017",

month = mar,

doi = "10.4168/aair.2017.9.2.116",

language = "English",

volume = "9",

pages = "116--125",

journal = "Allergy, Asthma & Immunology Research",

issn = "2092-7355",

publisher = "Korean Academy of Asthma, Allergy and Clinical Immunology",

number = "2",

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TY - JOUR

T1 - Asthma-Related Outcomes in Patients Initiating Extrafine Ciclesonide or Fine-Particle Inhaled Corticosteroids

AU - Postma, Dirkje S

AU - Dekhuijzen, Richard

AU - Van Der Molen, Thys

AU - Martin, Richard J

AU - van Aalderen, Wim

AU - Roche, Nicolas

AU - Guilbert, Theresa W

AU - Israel, Elliot

AU - van Eickels, Daniela

AU - Khlaid, Javaria Mona

AU - Herings, Ron M C

AU - Overbeek, Jetty A

AU - Miglio, Cristiana

AU - Thomas, Victoria

AU - Hutton, Catherine

AU - Hillyer, Elizabeth V

AU - Price, David B.

N1 - Funds to acquire the dataset from the PHARMO Institute were provided by Research in Real-Life, Ltd (RiRL). The study data were provided to the Small Airways Study Group (SASG), which received financial support to conduct the analyses from Takeda Pharmaceuticals International GmbH, Zurich, Switzerland. Two Takeda employees (D.vE. and J.M.K.) are authors of the paper and participated in developing the study protocol and the manuscript. Members of the SASG were reimbursed for travel expenses to attend meetings to discuss this together with several other projects; they were not otherwise compensated for their advisory role. The authors acknowledge with gratitude the contributions of Dr. Gene Colice to study design and interpretation. We acknowledge Dr. Matthias Binek for contributions to the study design. The authors thank Jenny Fanstone of Fanstone Medical Communications Ltd., UK, for medical writing support for the initial draft, funded by Research in Real-Life.

PY - 2017/3

Y1 - 2017/3

N2 - PurposeExtrafine-particle inhaled corticosteroids (ICS) have greater small airway deposition than standard fine-particle ICS. We sought to compare asthma-related outcomes after patients initiated extrafine-particle ciclesonide or fine-particle ICS (fluticasone propionate or non-extrafine beclomethasone).MethodsThis historical, matched cohort study included patients aged 12-60 years prescribed their first ICS as ciclesonide or fine-particle ICS. The 2 cohorts were matched 1:1 for key demographic and clinical characteristics over the baseline year. Co-primary endpoints were 1-year severe exacerbation rates, risk-domain asthma control, and overall asthma control; secondary endpoints included therapy change.ResultsEach cohort included 1,244 patients (median age 45 years; 65% women). Patients in the ciclesonide cohort were comparable to those in the fine-particle ICS cohort apart from higher baseline prevalence of hospitalization, gastroesophageal reflux disease, and rhinitis. Median (interquartile range) prescribed doses of ciclesonide and fine-particle ICS were 160 (160-160) µg/day and 500 (250-500) µg/day, respectively (P<0.001). During the outcome year, patients prescribed ciclesonide experienced lower severe exacerbation rates (adjusted rate ratio [95% CI], 0.69 [0.53-0.89]), and higher odds of risk-domain asthma control (adjusted odds ratio [95% CI], 1.62 [1.27-2.06]) and of overall asthma control (2.08 [1.68-2.57]) than those prescribed fine-particle ICS. The odds of therapy change were 0.70 (0.59-0.83) with ciclesonide.ConclusionsIn this matched cohort analysis, we observed that initiation of ICS with ciclesonide was associated with better 1-year asthma outcomes and fewer changes to therapy, despite data suggesting more difficult-to-control asthma. The median prescribed dose of ciclesonide was one-third that of fine-particle ICS.

AB - PurposeExtrafine-particle inhaled corticosteroids (ICS) have greater small airway deposition than standard fine-particle ICS. We sought to compare asthma-related outcomes after patients initiated extrafine-particle ciclesonide or fine-particle ICS (fluticasone propionate or non-extrafine beclomethasone).MethodsThis historical, matched cohort study included patients aged 12-60 years prescribed their first ICS as ciclesonide or fine-particle ICS. The 2 cohorts were matched 1:1 for key demographic and clinical characteristics over the baseline year. Co-primary endpoints were 1-year severe exacerbation rates, risk-domain asthma control, and overall asthma control; secondary endpoints included therapy change.ResultsEach cohort included 1,244 patients (median age 45 years; 65% women). Patients in the ciclesonide cohort were comparable to those in the fine-particle ICS cohort apart from higher baseline prevalence of hospitalization, gastroesophageal reflux disease, and rhinitis. Median (interquartile range) prescribed doses of ciclesonide and fine-particle ICS were 160 (160-160) µg/day and 500 (250-500) µg/day, respectively (P<0.001). During the outcome year, patients prescribed ciclesonide experienced lower severe exacerbation rates (adjusted rate ratio [95% CI], 0.69 [0.53-0.89]), and higher odds of risk-domain asthma control (adjusted odds ratio [95% CI], 1.62 [1.27-2.06]) and of overall asthma control (2.08 [1.68-2.57]) than those prescribed fine-particle ICS. The odds of therapy change were 0.70 (0.59-0.83) with ciclesonide.ConclusionsIn this matched cohort analysis, we observed that initiation of ICS with ciclesonide was associated with better 1-year asthma outcomes and fewer changes to therapy, despite data suggesting more difficult-to-control asthma. The median prescribed dose of ciclesonide was one-third that of fine-particle ICS.

KW - anti-asthmatic agents

KW - comparative effectiveness research

KW - disease exacerbation

KW - small airway

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DO - 10.4168/aair.2017.9.2.116

M3 - Article

SN - 2092-7355

VL - 9

SP - 116

EP - 125

JO - Allergy, Asthma & Immunology Research

JF - Allergy, Asthma & Immunology Research

IS - 2

M1 - e45

ER -

Asthma-Related Outcomes in Patients Initiating Extrafine Ciclesonide or Fine-Particle Inhaled Corticosteroids

Abstract

Bibliographical note

Keywords

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