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
U2 - 10.4168/aair.2017.9.2.116
DO - 10.4168/aair.2017.9.2.116
M3 - Article
VL - 9
SP - 116
EP - 125
JO - Allergy, Asthma & Immunology Research
JF - Allergy, Asthma & Immunology Research
SN - 2092-7355
IS - 2
M1 - e45
ER -