Predictors of flare-related inpatient or emergency department stay in systemic lupus erythematosus: A real-world analysis of Medicaid claims in the United States.

BACKGROUND: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by multisystem inflammation. Medical management of SLE is based on reducing inflammation and tissue damage in the affected organs; however, medications used to treat SLE have been found to contribute to additional organ damage. Therefore, finding new ways to predict and prevent flares that require an inpatient (IP) stay or emergency department (ED) visit is critical for reducing the clinical and economic burden in patients with SLE. OBJECTIVE: To identify risk factors of SLE flares requiring an IP/ED visit among a Medicaid-insured population with SLE. METHODS: This retrospective study included patients from the Merative MarketScan Medicaid database (2013-2019). To capture patients at all stages of their SLE journey, all SLE claims for a patient were captured, and the index date was randomly selected among those claims that were at least 12 months after the first evidence of SLE. Patients were required to be continuously enrolled 1-year pre-index (year 1) and post-index (year 2). Demographics, clinical characteristics, and health care use and costs were measured in year 1, and flares requiring an IP/ED visit were identified in year 2 using the Garris algorithm. Multivariable logistic regression and classification and regression tree (CART) modeling were used to identify year 1 predictors and combination of factors, respectively, associated with flares-related IP/ED visits. RESULTS: Of the 8,083 patients included in the study, 37.6% of patients (n = 3,039) had a flare. Logistic regression identified ED visits in year 1 as one of the strongest predictors of flares-related IP/ED visits in year 2 (odds ratio = 2.19 [95% CI = 1.93-2.49]). SLE treatment progression to biologics (0.54 [0.42-0.70]) was the strongest predictor of decreased odds. Other strong predictors included other neurological disorders (1.63 [1.43-1.87]), Black race (1.49 [1.32-1.68]), chronic kidney disease/renal failure (1.35 [1.10-1.66]), and opioid use (1.30 [1.17-1.45]). CART modeling identified patients with an ED visit, an IP admission, and a diagnosis of Elixhauser Comorbidity Index-defined other neurological disorders in year 1 as having the highest probability of a flare-related IP/ED visit in year 2 (probability = 0.708), whereas patients without an ED visit had the lowest probability (probability = 0.185). CONCLUSIONS: Patients with the highest risk of a flare that required an IP/ED visit were those with a prior ED visit, IP admission, and other neurological disorders. Modeling also identified patients with prior opioid use, Black patients, and patients without SLE medications as subgroups with a high risk of a flare requiring an IP/ED visit.

Clinical and economic characterization of mild, moderate, and severe systemic lupus erythematosus: Real-world observation across payer channels in the United States.

BACKGROUND: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting as many as 322,000 people in the United States. Because of heterogeneity in both disease course and clinical manifestations, it is critical to identify a prevalent SLE population that includes patients with moderate or severe disease. Additionally, differences in the clinical and economic burden of SLE may exist across payer channels, yet to date this has not been reported in any previous studies. OBJECTIVE: To characterize the clinical and economic burden of SLE across disease severity and payer channels. METHODS: This retrospective study included patients from Merative MarketScan Commercial, Medicare Supplemental, and Medicaid databases from 2013 to 2020 (Commercial/Medicare) or 2013 to 2019 (Medicaid), with at least 1 inpatient or at least 2 outpatient SLE claims and no invalid steroid claims. The index date was a random SLE claim with at least 12 months of disease history. Patients were continuously enrolled 1 year pre-index (baseline) and 1 year post-index and classified with mild, moderate, or severe disease using a published algorithm. Baseline demographics, clinical characteristics, flares, and utilization/costs were compared across disease severity. RESULTS: 22,385 Commercial, 2,035 Medicare, and 8,083 Medicaid patients had SLE. Most Medicaid patients (51.1%) had severe disease. Comorbidity scores increased with disease severity (P < 0.001). 30.7% of Commercial, 34.1% Medicare, and 51.3% Medicaid patients had opioids, which increased with disease severity (P < 0.001). All-cause costs ranged from 1.8- to 2.3-fold for moderate vs mild and 4.2- to 6.5-fold for severe vs mild. Outpatient medical costs accounted for the highest proportion of all-cause costs, except Medicaid patients with severe disease, for whom inpatient costs were highest. Mean (SD) SLE-related annual costs were $23,030 (43,304) vs $1,738 (4,427) in severe vs mild for Commercial, $12,264 (31,896) vs $2,024 (4,998) for Medicare, and $7,572 (27,719) vs $787 (3,797) for Medicaid (P < 0.001). For patients with severe disease in Medicaid, 16.5% and 60.1% had inpatient and emergency department (ED) visits, respectively, vs 10.3% and 26.5% Commercial vs 10.6% and 24.6% Medicare. Mean [SD] flares per year in the baseline period increased from 2.5 [1.7] in mild to 4.6 [1.9] in severe for Commercial, 3.2 [1.9] to 5.0 [2.1] for Medicare, and 2.0 [1.6] to 4.5 [2.0] for Medicaid. CONCLUSIONS: Patients with severe SLE experienced more comorbidities, flares, and utilization/costs. Outpatient costs were the largest driver of all-cause costs for Commercial and Medicare (and Medicaid for mild to moderate SLE). Medicaid beneficiaries had the highest rate of severe SLE, highest use of ED and inpatient services, and highest oral corticosteroid and opioid use but the lowest utilization of disease-modifying treatments. Results demonstrate an unmet need in SLE treatment, especially among patients with moderate to severe disease or Medicaid coverage. DISCLOSURES: This study was funded by AstraZeneca. Drs Wu and Bryant are current employees of AstraZeneca and may own stock and/or options. At the time of the study, Ms Perry and Mr Tkacz were employed by IBM Watson Health, which received funding from AstraZeneca to conduct this study.

Real-world burden of systemic lupus erythematosus in the USA: a comparative cohort study from the Medical Expenditure Panel Survey (MEPS) 2016-2018.

OBJECTIVE: SLE is a chronic, multiorgan, autoimmune disease; however, current prevalence estimates are dated and often from non-generalisable patient populations, and quality of life and patient-reported outcomes in the real-world SLE population are not well-published. The present study used the Medical Expenditure Panel Survey (MEPS), a generalisable US data source encompassing a representative sample of regions/payers, to estimate SLE prevalence and characterise disease burden compared with non-SLE respondents. METHODS: Retrospective population-based survey data weighted to the full US population from MEPS for the calendar years 2016-2018, pooled over the full study period, was used. The primary inclusion criteria included adults with self-reported SLE and either a record of SLE-related medication and/or rheumatologist visit in the calendar year. A matched-control cohort was created and the general non-SLE MEPS population was matched to MEPS SLE respondents by gender, age, region and MEPS reporting year using a 1:5 ratio. RESULTS: From 2016 to 2018, 96 996 adults reported annual data in MEPS, of whom 154 respondents met the primary SLE definition, equivalent to 490 385 weighted number of adults with SLE. The prevalence of SLE was 195 (95% CI 149 to 242) per 100000, with greater prevalence observed in the US South, African-American/black and publicly insured people and females. SLE respondents reported limitations in physical function at 3 times greater rate (45% vs 15%; p<0.0001), higher rates of pain-limiting work (67% vs 39%; p<0.001) and feeling depressed 'nearly every day' (7% vs 2%; p<0.001) compared with non-SLE respondents. All-cause healthcare and prescription expenses were significantly higher in SLE respondents (US$17 270 vs US$8350 (p<0.0001) and US$4512 vs US$1952 (p<0.001), respectively, in 2018 US dollars). CONCLUSION: Wide variation of SLE prevalence exists among patients of different regional, demographic and payer groups; SLE is associated with adverse quality of life, productivity and economic outcomes compared with non-SLE respondents.