Medical Record (EMR) analysis were to understand patient characteristics within current clinical care, to optimize the study design, and to reduce burden on sites and patients. Methods: We conducted an analysis of 11 country-specific EMR data sources (USA,
Background:There is limited real-world evidence describing the presentation and treatment patterns of systemic lupus erythematosus (SLE) in the United Kingdom (UK).Objectives:To characterize disease severity, comorbid conditions, treatment patterns, and flares in a longitudinal cohort of adults with SLE in the UK.Methods:Patients aged ≥18 years with SLE were identified in the Clinical Practice Research Datalink – Hospital Episode Statistics database from January 1, 2005, to December 31, 2017. Patients were required to have ≥12 months of data before and after index date (date of earliest SLE diagnosis available). SLE disease severity and flares were classified as mild, moderate, or severe using adapted claims-based algorithms1,2that use SLE-related conditions (eg, end-stage renal disease), medications (eg, antimalarials, immunosuppressants, and corticosteroids), and health service use (eg, hospitalizations and emergency department visits).Results:Of 802 patients with SLE, 369 (46.0%) had mild, 345 (43.0%) had moderate, and 88 (11.0%) had severe SLE at baseline. In total, 692 (86.3%) patients were treated with SLE medications in the first year after SLE diagnosis. Among the total population (802), 557 (69.5%) patients received antimalarials, 203 (25.3%) received immunosuppressants, and 416 (51.9%) received corticosteroids (prednisolone); patients may have received ≥1 type of drug. Information on biologic use in hospitals is unavailable in these data. The mean (standard deviation [SD]) time to initiating any medication from index date was 177 (385.3) days (Figure 1A). The median time to first flare from index date was 63 days (95% confidence interval 57–71) (Figure 1B). A majority of patients (750/802, 93.5%) experienced ≥1 flare during follow-up; the first flare was mild for 73.2% of patients (549/750), moderate for 15.5% (116/750), and severe for 11.3% (85/750). The mean (SD) annual overall flare rate in the first year after index date was 3.5 (2.5) (mild flares: 2.6 [2.5]; moderate flares: 0.7 [1.5]; severe flares: 0.2 [0.6]) (Figure 2). A shorter median time to first flare was significantly associated with moderate or severe disease (P<0.001) and the presence of comorbid conditions (P<0.001).Conclusion:Our findings suggest some delay in SLE treatment initiation in the UK. Most patients with SLE experience flares within 2 months from diagnosis. Early treatment may delay or reduce the severity of the first SLE flare after diagnosis and may translate to slower disease progression, lower organ damage accrual, and better outcomes.References:[1]Garris C, et al.J Med Econ. 2013;16:667–77.[2]Nightingale AL, et al.Lupus Sci Med. 2017;4:e000172.Disclosure of Interests:Julia Langham Consultant of: AstraZeneca, Volkan Barut Employee of: AstraZeneca, Mihail Samnaliev Consultant of: AstraZeneca, Sue Langham Consultant of: AstraZeneca, Sharada Weir Consultant of: AstraZeneca, Xia Wang Employee of: AstraZeneca, Barnabas Desta Employee of: AstraZeneca, Edward R. Hammond Employee of: AstraZeneca
Background:There is limited real-world evidence demonstrating the long-term direct costs associated with systemic lupus erythematosus (SLE) in the United Kingdom (UK).Objectives:To describe health care resource utilization and costs in adults with SLE in the UK over time and document costs by disease severity and type of encounter, including primary care, hospitalizations, outpatient visits, and prescription drugs.Methods:Patients aged ≥18 years with SLE were identified in the linked Clinical Practice Research Datalink – Hospital Episode Statistics database from January 1, 2005, to December 31, 2017. Patients were required to have data from ≥12 months before and after the index date, defined as the date of earliest diagnosis available in the data set. Patients were classified as having mild, moderate, or severe disease using an adapted claims-based algorithm.1Costs were calculated in 2017 UK pounds from the UK national health care system perspective. We estimated all-cause health care costs and incremental costs associated with each year of follow-up compared with a baseline year (3 years before index) using each patient as his or her own control and adjusting for age, sex, disease severity, and comorbid conditions.Results:Of the 802 patients identified, 369 (46.0%) had mild SLE, 345 (43.0%) had moderate SLE, and 88 (11.0%) had severe SLE. The mean all-cause cost increased in the 3 years before diagnosis and, in the first year after diagnosis, amounted to £7532 (standard deviation [SD] £9634). This cost varied by disease severity: mild SLE, £5221 (£8064); moderate SLE, £8323 (£9846); and severe SLE, £14,125 (£11,267) (Figure 1). Adjusted total mean annual increase in costs per patient in the overall study population was £4476 (95% confidence interval £3809–5143) greater in the year of diagnosis compared with the baseline year (P<0.0001), adjusted for age, sex, disease severity, and comorbid conditions. Primary care utilization was the leading component of costs during the first year after diagnosis, followed by prescriptions, outpatient care, and inpatient care (Figure 2). Information on biologic use in hospitals is unavailable in these data.Conclusion:The direct costs of health care for patients with SLE in the UK are substantial and persist over the years after diagnosis. Patients with moderate or severe SLE have higher all-cause costs over time compared with patients with mild SLE. Earlier diagnosis and treatment may reduce disease severity and occurrence of comorbidities, and the associated high health care costs.References:[1]Garris C, et al.J Med Econ. 2013;16:667–677.[2]Department of Health. NHS reference costs 2017/18.https://improvement.nhs.uk/resources/reference-costs/#rc1718;2018 [accessed May 11, 2019].Disclosure of Interests:Mihail Samnaliev Consultant of: AstraZeneca, Volkan Barut Employee of: AstraZeneca, Sharada Weir Consultant of: AstraZeneca, Julia Langham Consultant of: AstraZeneca, Sue Langham Consultant of: AstraZeneca, Xia Wang Employee of: AstraZeneca, Barnabas Desta Employee of: AstraZeneca, Edward R. Hammond Employee of: AstraZeneca
BackgroundSLE is a severe, chronic autoimmune disease of the connective tissue involving multiple organ systems. Understanding the economic burden of SLE in the context of disease severity is important when considering new therapeutic options.ObjectivesHCRU and costs associated with SLE were examined retrospectively using anonymized data from a German Sickness Fund database.MethodsReal-world claims for adult (≥18 years old) patients (pts) with SLE from a German Sickness Fund database of company health insurance schemes were analysed. HCRU and costs were assessed annually for 2009–2014 for pts diagnosed with SLE in 2009 and validated using repeated SLE-related claims, co-diagnosis codes, laboratory tests, prescription treatment, and the diagnosing physician’s specialty. Pts had to have data available for 2009 and ≥3 years before the index quarter in 2009. HCRU and costs for SLE cases were compared with those of controls matched (4:1) by age, sex, and baseline Charlson Comorbidity Index (CCI). Continuous outcomes were compared with a nonparametric test (e.g., Wilcoxon–Mann-Whitney) because most outcome distributions were positively skewed.ResultsOf the 3,290,701 persons with data available for 2009 and ≥3 years prior, 1228 had an SLE diagnosis in 2009. SLE prevalence steadily increased from 37.32/100,000 (incidence: 5.96/100,000 per year) in 2009 to 47.36/100,000 in 2014. The final sample comprised 1,160 SLE-confirmed pts (mean age: 52 years; females: 84%; baseline CCI range: 1–13). Most (85%) pts were diagnosed with SLE before 2009 SLE disease severity at baseline was classified as mild for 148, moderate for 484, and severe for 528 pts using a combination of International Classification of Diseases-10 GM and medication/procedures codes. Compared with matched controls, SLE pts, overall and those with moderate and severe disease, had significantly greater mean annual medical costs in 2009 (all SLE: €6895 vs. €3,692; moderate SLE: €4867 vs. €3,380; severe SLE: €10 001 vs. €4,239; p<0.0001 for each comparison) and each year thereafter. Mean costs, total number of hospital days, numbers of outpatient visits, hospital stays, and outpatient prescriptions, and other benefits were significantly greater for all pts with SLE and for those with moderate and severe disease vs. matched controls. For example, for pts with severe SLE vs. controls, mean costs for hospital stays, outpatient prescriptions, and other benefits were €4335 vs. €1,414, €2582 vs. €1,087, and €1068 vs. €691, respectively, in 2009.ConclusionsIn Germany, the economic burden of moderate and severe SLE was greater than that of sociodemographic- and morbidity-adjusted controls between 2009 and 2014. Pts with SLE incurred greater HCRU and total annual medical costs vs. matched controls. HCRU increased with increasing SLE disease severity, with the greatest burden among pts with severe disease. New treatments could reduce HCRU and future costs.Disclosure of InterestE. Hammond Employee of: AstraZeneca, H. Friedel: None declared, E. Garal-Pantaler: None declared, M....
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