Asthma and lower airway disease
Acute and chronic systemic corticosteroid–related complications in patients with severe asthma

https://doi.org/10.1016/j.jaci.2015.07.046Get rights and content

Background

Many patients with severe asthma require maintenance treatment with systemic corticosteroids (SCSs) to control daily symptoms and prevent serious acute exacerbations, but chronic SCS use is associated with complications.

Objective

We sought to evaluate the risk of SCS-related complications by SCS exposure and quantify the associated health care costs and resource use in patients with severe asthma.

Methods

We performed a longitudinal, open-cohort, observational study using health insurance claims data (1997-2013: Medicaid) from Florida, Iowa, Kansas, Missouri, Mississippi, and New Jersey. Eligible patients were 12 years old or older with 2 or more asthma diagnoses and had more than 6 months of continuous SCS use. An open-cohort approach was used to classify patients' follow-up into low, medium, and high SCS exposure (≤6, >6-12, and >12 mg/d, respectively). Multivariate generalized estimating equation models were used to estimate the adjusted risk of SCS-related complications for patients with medium and high exposure compared with patients with low exposure and quantify the resulting health care resource use and costs.

Results

The study included 3628 patients (mean age, 57.6 years; 68% female). Patients with medium and high SCS exposure had significantly higher risks of SCS-related complications, including infections and cardiovascular, metabolic, psychiatric, ocular, gastrointestinal, and bone-related complications (odds ratio, 1.23-2.12 by complication; P < .05 for all but one) versus those with low (reference group) SCS exposure. Medium and high SCS exposure were also associated with significantly more emergency department visits (incidence rate ratios, 1.31 [P = .0004] and 1.78 [P < .0001]) and inpatient visits (incidence rate ratios, 1.25 [P < .0001] and 1.59 [P < .0001]) versus low SCS exposure.

Conclusions

A significant dose-response relationship was demonstrated between chronic SCS use and risk of SCS-related complications in patients with severe asthma. Effective SCS-sparing strategies might reduce the burden associated with SCS-related complications in patients with severe asthma.

Section snippets

Data source

This study used claims data from Medicaid health insurance beneficiaries from 6 US states: Florida (2001-2012), Iowa (1998-2013), Kansas (2001-2013), Missouri (1997-2013), Mississippi (2006-2013), and New Jersey (1997-2013). This data set was chosen because of the long enrollment duration of Medicaid recipients, which permitted observation of both short- and long-term SCS-related complications. Data elements used in the present analysis included information on enrollment history, patient

Baseline characteristics

A total of 3628 patients were included in the study (see Fig E2 in this article's Online Repository at www.jacionline.org). Table I presents their baseline characteristics grouped by SCS exposure at the index date (low, 368 [10.1%] patients; medium, 1630 [45.0%] patients; high, 1630 [45.0%] patients). Lower SCS exposure subgroups were older on average (low, 62.4 years; medium, 60.0 years; high, 54.2 years), included more female subjects (low, 70.7%; medium, 69.7%; high, 66.4%), and had a longer

Discussion

Because of established clinical efficacy, SCSs are widely used to treat numerous inflammatory diseases, including asthma. However, their chronic use can lead to troublesome and severe complications.8 This is the first longitudinal observational study evaluating the risk of SCS-related complications and their associated health care resource use and costs in a large US cohort of Medicaid beneficiaries with severe asthma and chronic SCS use.

Systematic literature reviews on SCS-related

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    Supported by GlaxoSmithKline (study no. HO-13-12748). Editorial support was also funded by GlaxoSmithKline.

    Disclosure of potential conflict of interest: P. Lefebvre and M.-N. Robitaille have received research support from GlaxoSmithKline. M. S. Duh has received research support from GlaxoSmithKline, Janssen, Novo Nordisk, Novartis, Ariad, Pfizer, Sanofi, and Bayer. M.-H. Lafeuille, L. Gozalo, and U. Desai are employed by Groupe d'analyse, a research company that has received research grants from GlaxoSmithKline. F. Albers, S. Yancey, H. Ortega, M. Forshag, X. Lin, and A. A. Dalal are employed by and have stock/stock options in GlaxoSmithKline.

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