Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK

Jaco Voorham; Nicolas Roche; Hicham Benhaddi; Marianka van der Tol; Victoria Carter; Job F. M. van Boven; Leif Bjermer; Marc Miravitlles; David B. Price

doi:10.1136/bmjopen-2018-022051

Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK

Jaco Voorham (Corresponding Author), Nicolas Roche, Hicham Benhaddi, Marianka van der Tol, Victoria Carter, Job F. M. van Boven, Leif Bjermer, Marc Miravitlles, David B. Price

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Abstract

OBJECTIVES: Budesonide/formoterol (BF) Spiromax ® is an inhaled corticosteroid/long-acting β2-agonist fixed-dose combination (FDC) inhaler, designed to minimise common inhaler errors and provide reliable and consistent dose delivery in asthma and chronic obstructive pulmonary disease (COPD). We evaluated non-inferiority of BF Spiromax after changing from another FDC inhaler, compared with continuing the original inhaler.

METHODS: Patients with asthma and/or COPD who switched to BF Spiromax were matched (1:3) with non-switchers. Data were obtained from the Optimum Patient Care Research Database and Clinical Practice Research Datalink in the UK. The primary end point was the proportion of patients achieving disease control (using the risk domain control (RDC) algorithm); secondary end points were: exacerbation rate, short-acting β2-agonist (SABA) use and treatment stability (achieved RDC; no maintenance treatment change). Non-inferiority was defined as having 95% CI lower bound above -10%, using conditional logistic regression and adjusted for relevant confounders.

RESULTS: Comparing 385 matched patients (asthma 253; COPD 132) who switched to BF Spiromax with 1091 (asthma 743; COPD 348) non-switchers, non-inferiority of BF Spiromax in RDC was demonstrated (adjusted difference: +6.6%; 95% CI -0.3 to 13.5). Among patients with asthma, switchers to BF Spiromax versus BF Turbuhaler® reported fewer exacerbations (adjusted rate ratio (RR) 0.76;95% CI 0.60 to 0.99; p=0.044); were less likely to use high daily doses of SABA (adjusted OR 0.71;95% CI 0.52 to 0.98; p=0.034); used fewer SABA inhalers (adjusted RR 0.92;95% CI 0.86 to 0.99; p=0.019); and were more likely to achieve treatment stability (adjusted OR 1.44;95% CI 1.02 to 2.04; p=0.037). No significant differences in these end points were seen among patients with COPD.

CONCLUSIONS: Among UK patients with asthma and COPD, real-world use of BF Spiromax was non-inferior to BF Turbuhaler in terms of disease control. Among patients with asthma, switching to BF Spiromax was associated with reduced exacerbations, reduced SABA use and improved treatment stability versus continuing on BF Turbuhaler.

Original language	English
Article number	e022051
Pages (from-to)	1-12
Number of pages	12
Journal	BMJ Open
Volume	8
Issue number	10
Early online date	27 Oct 2018
DOIs	https://doi.org/10.1136/bmjopen-2018-022051
Publication status	Published - Oct 2018

Bibliographical note

Acknowledgements: The authors thank Derek Skinner, Francis Appiagyei and
Tanith Hjelmbjerg of the Observational and Pragmatic Research Institute for
providing assistance with data analysis. The authors also thank Ian Grieve and
Bill Watkins of Ashfield Healthcare Communications, part of UDG Healthcare, for
providing medical writing support. The authors thank Teva Pharmaceuticals for
providing a full review of the article.
Funding: This study was supported by Teva Pharmaceuticals and undertaken by
OPRI (http://opri.sg). Medical writing support was funded by Teva Pharmaceuticals

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Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK
© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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Cite this

Voorham, J., Roche, N., Benhaddi, H., van der Tol, M., Carter, V., van Boven, J. F. M., Bjermer, L., Miravitlles, M., & Price, D. B. (2018). Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK. BMJ Open, 8(10), 1-12. Article e022051. https://doi.org/10.1136/bmjopen-2018-022051

@article{914d48e975e54bac8fff895cabfa76ad,

title = "Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK",

abstract = "OBJECTIVES: Budesonide/formoterol (BF) Spiromax {\textregistered} is an inhaled corticosteroid/long-acting β2-agonist fixed-dose combination (FDC) inhaler, designed to minimise common inhaler errors and provide reliable and consistent dose delivery in asthma and chronic obstructive pulmonary disease (COPD). We evaluated non-inferiority of BF Spiromax after changing from another FDC inhaler, compared with continuing the original inhaler.METHODS: Patients with asthma and/or COPD who switched to BF Spiromax were matched (1:3) with non-switchers. Data were obtained from the Optimum Patient Care Research Database and Clinical Practice Research Datalink in the UK. The primary end point was the proportion of patients achieving disease control (using the risk domain control (RDC) algorithm); secondary end points were: exacerbation rate, short-acting β2-agonist (SABA) use and treatment stability (achieved RDC; no maintenance treatment change). Non-inferiority was defined as having 95% CI lower bound above -10%, using conditional logistic regression and adjusted for relevant confounders.RESULTS: Comparing 385 matched patients (asthma 253; COPD 132) who switched to BF Spiromax with 1091 (asthma 743; COPD 348) non-switchers, non-inferiority of BF Spiromax in RDC was demonstrated (adjusted difference: +6.6%; 95% CI -0.3 to 13.5). Among patients with asthma, switchers to BF Spiromax versus BF Turbuhaler{\textregistered} reported fewer exacerbations (adjusted rate ratio (RR) 0.76;95% CI 0.60 to 0.99; p=0.044); were less likely to use high daily doses of SABA (adjusted OR 0.71;95% CI 0.52 to 0.98; p=0.034); used fewer SABA inhalers (adjusted RR 0.92;95% CI 0.86 to 0.99; p=0.019); and were more likely to achieve treatment stability (adjusted OR 1.44;95% CI 1.02 to 2.04; p=0.037). No significant differences in these end points were seen among patients with COPD.CONCLUSIONS: Among UK patients with asthma and COPD, real-world use of BF Spiromax was non-inferior to BF Turbuhaler in terms of disease control. Among patients with asthma, switching to BF Spiromax was associated with reduced exacerbations, reduced SABA use and improved treatment stability versus continuing on BF Turbuhaler.",

author = "Jaco Voorham and Nicolas Roche and Hicham Benhaddi and {van der Tol}, Marianka and Victoria Carter and {van Boven}, {Job F. M.} and Leif Bjermer and Marc Miravitlles and Price, {David B.}",

note = "Acknowledgements: The authors thank Derek Skinner, Francis Appiagyei and Tanith Hjelmbjerg of the Observational and Pragmatic Research Institute for providing assistance with data analysis. The authors also thank Ian Grieve and Bill Watkins of Ashfield Healthcare Communications, part of UDG Healthcare, for providing medical writing support. The authors thank Teva Pharmaceuticals for providing a full review of the article. Funding: This study was supported by Teva Pharmaceuticals and undertaken by OPRI (http://opri.sg). Medical writing support was funded by Teva Pharmaceuticals",

year = "2018",

month = oct,

doi = "10.1136/bmjopen-2018-022051",

language = "English",

volume = "8",

pages = "1--12",

journal = "BMJ Open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "10",

}

TY - JOUR

T1 - Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK

AU - Voorham, Jaco

AU - Roche, Nicolas

AU - Benhaddi, Hicham

AU - van der Tol, Marianka

AU - Carter, Victoria

AU - van Boven, Job F. M.

AU - Bjermer, Leif

AU - Miravitlles, Marc

AU - Price, David B.

N1 - Acknowledgements: The authors thank Derek Skinner, Francis Appiagyei and Tanith Hjelmbjerg of the Observational and Pragmatic Research Institute for providing assistance with data analysis. The authors also thank Ian Grieve and Bill Watkins of Ashfield Healthcare Communications, part of UDG Healthcare, for providing medical writing support. The authors thank Teva Pharmaceuticals for providing a full review of the article. Funding: This study was supported by Teva Pharmaceuticals and undertaken by OPRI (http://opri.sg). Medical writing support was funded by Teva Pharmaceuticals

PY - 2018/10

Y1 - 2018/10

N2 - OBJECTIVES: Budesonide/formoterol (BF) Spiromax ® is an inhaled corticosteroid/long-acting β2-agonist fixed-dose combination (FDC) inhaler, designed to minimise common inhaler errors and provide reliable and consistent dose delivery in asthma and chronic obstructive pulmonary disease (COPD). We evaluated non-inferiority of BF Spiromax after changing from another FDC inhaler, compared with continuing the original inhaler.METHODS: Patients with asthma and/or COPD who switched to BF Spiromax were matched (1:3) with non-switchers. Data were obtained from the Optimum Patient Care Research Database and Clinical Practice Research Datalink in the UK. The primary end point was the proportion of patients achieving disease control (using the risk domain control (RDC) algorithm); secondary end points were: exacerbation rate, short-acting β2-agonist (SABA) use and treatment stability (achieved RDC; no maintenance treatment change). Non-inferiority was defined as having 95% CI lower bound above -10%, using conditional logistic regression and adjusted for relevant confounders.RESULTS: Comparing 385 matched patients (asthma 253; COPD 132) who switched to BF Spiromax with 1091 (asthma 743; COPD 348) non-switchers, non-inferiority of BF Spiromax in RDC was demonstrated (adjusted difference: +6.6%; 95% CI -0.3 to 13.5). Among patients with asthma, switchers to BF Spiromax versus BF Turbuhaler® reported fewer exacerbations (adjusted rate ratio (RR) 0.76;95% CI 0.60 to 0.99; p=0.044); were less likely to use high daily doses of SABA (adjusted OR 0.71;95% CI 0.52 to 0.98; p=0.034); used fewer SABA inhalers (adjusted RR 0.92;95% CI 0.86 to 0.99; p=0.019); and were more likely to achieve treatment stability (adjusted OR 1.44;95% CI 1.02 to 2.04; p=0.037). No significant differences in these end points were seen among patients with COPD.CONCLUSIONS: Among UK patients with asthma and COPD, real-world use of BF Spiromax was non-inferior to BF Turbuhaler in terms of disease control. Among patients with asthma, switching to BF Spiromax was associated with reduced exacerbations, reduced SABA use and improved treatment stability versus continuing on BF Turbuhaler.

AB - OBJECTIVES: Budesonide/formoterol (BF) Spiromax ® is an inhaled corticosteroid/long-acting β2-agonist fixed-dose combination (FDC) inhaler, designed to minimise common inhaler errors and provide reliable and consistent dose delivery in asthma and chronic obstructive pulmonary disease (COPD). We evaluated non-inferiority of BF Spiromax after changing from another FDC inhaler, compared with continuing the original inhaler.METHODS: Patients with asthma and/or COPD who switched to BF Spiromax were matched (1:3) with non-switchers. Data were obtained from the Optimum Patient Care Research Database and Clinical Practice Research Datalink in the UK. The primary end point was the proportion of patients achieving disease control (using the risk domain control (RDC) algorithm); secondary end points were: exacerbation rate, short-acting β2-agonist (SABA) use and treatment stability (achieved RDC; no maintenance treatment change). Non-inferiority was defined as having 95% CI lower bound above -10%, using conditional logistic regression and adjusted for relevant confounders.RESULTS: Comparing 385 matched patients (asthma 253; COPD 132) who switched to BF Spiromax with 1091 (asthma 743; COPD 348) non-switchers, non-inferiority of BF Spiromax in RDC was demonstrated (adjusted difference: +6.6%; 95% CI -0.3 to 13.5). Among patients with asthma, switchers to BF Spiromax versus BF Turbuhaler® reported fewer exacerbations (adjusted rate ratio (RR) 0.76;95% CI 0.60 to 0.99; p=0.044); were less likely to use high daily doses of SABA (adjusted OR 0.71;95% CI 0.52 to 0.98; p=0.034); used fewer SABA inhalers (adjusted RR 0.92;95% CI 0.86 to 0.99; p=0.019); and were more likely to achieve treatment stability (adjusted OR 1.44;95% CI 1.02 to 2.04; p=0.037). No significant differences in these end points were seen among patients with COPD.CONCLUSIONS: Among UK patients with asthma and COPD, real-world use of BF Spiromax was non-inferior to BF Turbuhaler in terms of disease control. Among patients with asthma, switching to BF Spiromax was associated with reduced exacerbations, reduced SABA use and improved treatment stability versus continuing on BF Turbuhaler.

U2 - 10.1136/bmjopen-2018-022051

DO - 10.1136/bmjopen-2018-022051

M3 - Article

C2 - 30368448

SN - 2044-6055

VL - 8

SP - 1

EP - 12

JO - BMJ Open

JF - BMJ Open

IS - 10

M1 - e022051

ER -

Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK

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