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Abstract
Objectives: Although systemic glucocorticoids (SGCs) are efficacious, their chronic use is associated with a range of complications. Yet limited data are available about the risks following chronic use in patients with severe asthma, who are at risk of long-term SGC-related complications. This study was carried out to investigate the risks of developing SGC-related complications, and to quantify the associated healthcare resource utilization and costs for patients with severe asthma in the United States.
Methods: This was a longitudinal, open-cohort, observational study. Medicaid claims data (1997–2013) for patients ≥12 years old with ≥2 asthma diagnoses were used. A total of 26,987 SGC non-users were identified for inclusion in the study, alongside 3628 SGC users with ≥6 months’ continuous SGC use.
Results: Multivariate generalized estimating equation models were used to estimate the adjusted risk of developing SGC-related complications, and to quantify the associated healthcare resource utilization and costs. This analysis compared SGC users with SGC non-users, and found that SGC users had an increased likelihood of developing complications. A significant dose–response relationship was demonstrated between chronic SGC use and risk of developing any complications (odds ratios for low, medium, and high SGC exposure were 2.03 [p = .0511], 2.85 [p < .0001], and 3.64 [p < .0001], respectively, vs. SGC non-users). The increased likelihood of SGC-related complications translated into estimated annual healthcare costs for SGC users of $2712 to $8560 above those of SGC non-users. A key limitation of this study is the disparity in age between the SGC users and the SGC non-users; however, age was included as a confounding factor in the analysis.
Conclusions: These findings confirm the risk associated with chronic use of SGCs, irrespective of dose level, and highlight the need for new SGC-sparing treatment strategies for patients with severe asthma.
Transparency
Declaration of funding
Funding for this study was provided by GSK (study number HO-13-12748). P.L. had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Additionally, all listed authors meet the criteria for authorship set forth by the International Committee for Medical Journal Editors.
Declaration of financial/other relationships
P.L., M.S.D., M.-H.L., L.G., U.D., and M.-N.R. have disclosed that they are employees of Analysis Group Inc., a contract research organization that has received research grants from GSK. F.A., S.Y., M.F., H.O., and X.L. have disclosed that they are employees of GSK and own company stock. A.A.D. is a former employee of GSK and may own company stock. A.A.D. was employed by GSK at the time of study conduct.
CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgments
Editorial support in the form of writing assistance, assembling tables and figures, collating author comments, grammatical editing, and referencing was provided by Cheryl Wright PhD, at Gardiner-Caldwell Communications (Macclesfield, UK); this support was funded by GSK.
