Acute and chronic systemic corticosteroid–related complications in patients with severe asthma

Lefèbvre, Patrick; Duh, Mei Sheng; Lafeuille, Marie-Hélène; Gozalo, Laurence; Desai, Urvi; Robitaille, Marie-Noëlle; Albers, Frank C.; Yancey, Steve; Ortega, Héctor; Forshag, Mark; Lin, Xiwu; Dalal, Anand A.

doi:10.1016/j.jaci.2015.07.046

Cited by 178 publications

(173 citation statements)

References 25 publications

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“…Use of OCS has previously been associated with greatly enhanced risk of osteoporosis and diabetes [15, 16] and in our study, the majority of costs for these diseases were attributed to the regular OCS group. However, the cost of both depression and heart failure seemed to be evenly distributed between the three groups in the present study, contradicting previous reports [17, 29].…”

Section: Discussionsupporting

confidence: 59%

Health care resource utilization and cost for asthma patients regularly treated with oral corticosteroids – a Swedish observational cohort study (PACEHR)

et al. 2018

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BackgroundPatients with severe uncontrolled asthma may receive oral corticosteroid (OCS) treatment regularly. The present study investigated the health care resource utilization and cost in regularly OCS treated Swedish asthma patients.Methods Primary care medical records data were linked to data from Swedish national health registries. Patients ≥18 years with a drug claim for obstructive pulmonary diseases during 2007–2009 (index date) and a prior asthma diagnosis, were classified by their OCS claims during the 12-months’ post index period: regular OCS equals ≥5 mg per day; periodic OCS less than 5 mg per day; or non-OCS users. Cost of asthma- and OCS-morbidity-related health care resource utilization were calculated.ResultsA total of 15,437 asthma patients (mean age 47.8, female 62.6%), whereof 223 (1.44%) were regular OCS users, 3054 (19.7%) were periodic, and 12,160 (78.7%) were non-OCS users. Regular OCS users were older and more often females, had lower lung function, greater eosinophil count and more co-morbidities at baseline compared with the other groups. Age-adjusted annual total health care cost was three-times greater in the regular OCS group (€5615) compared with the non-OCS users (€1980) and twice as high as in the periodic OCS group (€2948). The major cost driver in the non-OCS and periodic OCS groups were primary care consultations, whereas inpatient costs were the major cost driver in the regular OCS group. The asthma related costs represented 10–12% of the total cost in all three groups.ConclusionIn this real-life asthma study in Sweden, the total yearly cost of health care resource utilization for a regular OCS user was three times greater than for a patient with no OCS use, indicating substantial economic and health care burden for asthma patients on regular oral steroid treatment.

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Section: Discussionsupporting

confidence: 59%

Health care resource utilization and cost for asthma patients regularly treated with oral corticosteroids – a Swedish observational cohort study (PACEHR)

et al. 2018

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“…19 There appears to be a dose-response relationship between the maintenance OCS dose and its associated side effect profile. 20 The use of OCS therapy chronically is not only associated with a significant increase in adverse events but is also associated with an increased economic burden. 21 In addition, there are individuals who elect not to use maintenance controller therapy but would rather use frequent courses of OCS to treat exacerbations.…”

Section: Corticosteroid-dependent Asthmamentioning

confidence: 99%

Recognition and management of severe asthma: A Canadian Thoracic Society position statement

FitzGerald

Lemière

Lougheed

et al. 2017

Canadian Journal of Respiratory, Critical Care, and Sleep Medic

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RATIONALE: While severe asthma affects approximately 5% of all individuals with asthma, this small minority of individuals accounts for a large proportion of the asthma-related costs. Greater understanding of the pathophysiology of asthma combined with the emergence of novel biologic therapies for severe asthma supported the need for a thorough review of the diagnosis, investigation, phenotyping, and management of severe asthma. OBJECTIVES: We aimed to propose a practical approach to distinguish uncontrolled asthma due to inadequate asthma management from severe asthma despite optimal asthma management. Moreover, based on emerging scientific evidence, we sought to provide guidance for characterizing individuals with severe asthma and considering a phenotype-specific management. We also aimed to review other novel new potential therapeutic approaches. METHODS: We systematically reviewed the relevant literature focusing on randomized controlled trials and when available, systematic reviews of randomized controlled trials. The proposed key messages, based on scientific evidence and expert opinion, were agreed upon by unanimous consensus. MAIN RESULTS: We defined severe asthma and outlined its significant impact from the societal and patient perspectives. We outlined a practical approach to distinguish severe from uncontrolled but not severe asthma, based on stepwise investigation and management of potential reasons for uncontrolled asthma. After reviewing the current evidence we concluded that: 1) Several biomarkers (e.g. sputum or blood eosinophil count, total IgE, or FeNO) can help identify potential responders to new therapeutic options; 2) Tiotropium may be considered as an add-on therapy for individuals 12 years of age and over with severe asthma uncontrolled despite combination ICS/LABA therapy; 3) The chronic use of macrolides may decrease asthma exacerbations in individuals 18 years of age and over with severe asthma independent of their inflammatory profile; 4) Children aged 6 years and older and adults who are sensitized to at least one relevant perennial allergen and who remain poorly controlled asthmatics despite high dose ICS and a second controller can benefit from the addition of anti-IgE therapy to reduce asthma exacerbations; due to the known risk of side effects associated with high-dose ICS in children, omalizumab should also be considered in children and adolescents who repeatedly exacerbate or have poor control when therapy is stepped down from high-dose to moderate-dose ICS and at least one other controller; 5) Anti-IL5 therapies may be considered for adults 18 years of age and over with severe eosinophilic asthma who experience recurrent asthma exacerbations in spite of high doses of ICS in addition to at least one other controller; and 6) Although bronchial thermoplasty has shown a decrease in asthma exacerbations in one study, its role in the treatment of severe asthma remains uncertain. CONCLUSIONS: After reviewing existing and emerging therapies for severe asthma, we developed ke...

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“…We followed patients from the time of SCS initiation until the time they experienced an event or were otherwise censored. The use of large UK databases containing longitudinal medical record data allowed us to examine a median of almost 10 years before the first SCS prescription to exclude prior SCS use, with subsequent follow-up of a median of 7 years, much longer than prior studies in asthma with reported mean and median follow-up periods of 1–5 years 7–9,15,25. Moreover, earlier studies examined effects of ongoing (rather than initiating) SCS exposure7,8,25–27 or ruled out previous exposure for only ≤12 months before the index prescription 9,15…”

Section: Discussionmentioning

confidence: 99%

“…Most prior studies included limited patient populations, ie, those classified as having severe asthma7–9,25 or those prescribed SCS for prespecified lengths of time 26,27. Studies from the USA included low-income7,8 or employed15,25–28 populations, selective populations with limited or better-than-average access to care, respectively.…”

Section: Discussionmentioning

confidence: 99%

Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study

Price¹,

Trudo²,

Voorham³

et al. 2018

JAA

301

319

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PurposePrior work suggests a threshold of four courses/year of systemic corticosteroid (SCS) therapy is associated with adverse consequences. The objective of this study was to investigate the onset of adverse outcomes beginning at SCS initiation in a broad asthma population.Patients and methodsThis historical matched cohort study utilized anonymized, longitudinal medical record data (1984–2017) of patients (≥18 years) with active asthma. Matched patients with first SCS prescription (SCS arm) and no SCS exposure (non-SCS arm) were followed until first outcome event. Associations between time-varying exposure measures and onset of 17 SCS-associated adverse outcomes were estimated using Cox proportional hazard regression, adjusting for confounders, in separate models.ResultsWe matched 24,117 pairs of patients with median record availability before SCS initiation of 9.9 and 8.7 years and median follow-up 7.4 and 6.4 years in SCS and non-SCS arms, respectively. Compared with patients in the non-SCS arm, patients prescribed SCS had significantly increased risk of osteoporosis/osteoporotic fracture (adjusted hazard ratio 3.11; 95% CI 1.87–5.19), pneumonia (2.68; 2.30–3.11), cardio-/cerebrovascular diseases (1.53; 1.36–1.72), cataract (1.50; 1.31–1.73), sleep apnea (1.40; 1.04–1.86), renal impairment (1.36; 1.26–1.47), depression/anxiety (1.31; 1.21–1.41), type 2 diabetes (1.26; 1.15–1.37), and weight gain (1.14; 1.10–1.18). A dose-response relationship for cumulative SCS exposure with most adverse outcomes began at cumulative exposures of 1.0–<2.5 g and for some outcomes at cumulative exposures of only 0.5–<1 g (vs >0–<0.5 g reference), equivalent to four lifetime SCS courses.ConclusionOur findings suggest urgent need for reappraisal of when patients need specialist care and consideration of nonsteroid therapy.

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Acute and chronic systemic corticosteroid–related complications in patients with severe asthma

Abstract: 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.

Cited by 178 publications

References 25 publications

Health care resource utilization and cost for asthma patients regularly treated with oral corticosteroids – a Swedish observational cohort study (PACEHR)

Health care resource utilization and cost for asthma patients regularly treated with oral corticosteroids – a Swedish observational cohort study (PACEHR)

Recognition and management of severe asthma: A Canadian Thoracic Society position statement

Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study

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