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Impact of Early Versus Late Systemic Lupus Erythematosus Diagnosis on Clinical and Economic Outcomes

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Abstract

Background and Objectives

Systemic lupus erythematosus (SLE) is a multisystem complex autoimmune disease that often mimics symptoms of other illnesses, which complicates the ability of healthcare providers to make the diagnosis. The objective of this study was to assess clinical outcomes, resource utilization, and costs between patients with earlier versus later SLE diagnosis.

Methods

Patients aged 18–64 years were identified from a large US commercial claims database between January 2000 and June 2010. Confirmed SLE diagnosis with a claims-based algorithm required either three or more claims for a visit to a rheumatologist on separate dates with an SLE diagnosis (International Classification of Diseases [ICD-9] code 710.0x), two or more claims for visits to a rheumatologist at least 60 days apart with SLE diagnoses, or two or more claims for visits to rheumatologist less than 60 days apart with SLE diagnoses with at least one dispensing for a typical SLE medication. SLE probable onset date was identified during the 12-month baseline period by the second claim for antinuclear antibody tests or prodromal symptoms of SLE. Patients were stratified into early or late diagnosis groups based on time between probable SLE onset and diagnosis (<6 months or ≥6 months, respectively). Each patient observation period began on the date of the first medical claim, with a diagnosis code for SLE that satisfied the inclusion criteria, and ended on the earliest date between health plan disenrollment and 30 June 2010. Patients in each group were propensity-score matched on age, gender, diagnosis year, region, health plan type, and comorbidities. Flare rates and resource utilization were compared post-diagnosis between groups using rate ratios. All-cause and SLE-related costs (adjusted to 2010 US dollars) per patient per month (PPPM) were calculated.

Results

There were 4,166 matched patients per group. Post-SLE diagnosis, the early diagnosis group had lower rates of mild (rate ratio [RR] 0.95; 95 % CI 0.93–0.96), moderate (RR 0.96; 95 % CI 0.94–0.99), and severe (RR 0.87; 95 % CI 0.82–0.93) flares compared with the late diagnosis group. The rates of hospitalizations (RR 0.80; 95 % CI 0.75–0.85) were lower for the early diagnosis group than the late diagnosis group. Compared with late diagnosis patients, mean all-cause inpatient costs PPPM were lower for the early diagnosis patients (US$406 vs. US$486; p = 0.016). Corresponding SLE-related hospitalization costs were also lower for early compared with late diagnosis patients (US$71 vs. US$95; p = 0.013). Results were consistent for other resource use and cost categories.

Conclusions

Patients diagnosed with SLE sooner may experience lower flare rates, less healthcare utilization, and lower costs from a commercially insured population perspective. This finding needs to be further explored within the context of background SLE disease activity.

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Acknowledgments

This study was funded by GlaxoSmithKline (GSK), Collegeville, PA, USA. The funding from GSK was not contingent upon the study results. GSK and Human Genome Sciences (HGS) participated in the study design, results interpretation, and manuscript preparation, as reflected in the authorship by GSK and HGS employees, Alan Oglesby and Gregory Dennis, respectively. A human monoclonal antibody, belimumab (Benlysta), was developed by GSK and HGS, and was recently approved for SLE treatment in the US, Canada, and Europe. Caroline Korves, François Laliberté, Sapna Rao, and Mei Sheng Duh are employees of Analysis Group, Inc., which received a research grant from GSK for this study. Ellison Dial Suthoff and Robert Wei were employees of Analysis Group, Inc. at the time this study was conducted.

Parts of the manuscript were presented as posters at the Annual European League Against Rheumatism (EULAR) Congress, Berlin, Germany, 6–9 June 2012, and at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 17th Annual International Meeting, Washington, DC, USA, 2–6 June 2012.

Author Contributions

Study concept and design and data interpretation were primarily the work of Alan Oglesby, Mei Sheng Duh, François Laliberté, and Gregory Dennis, with assistance from the other authors. Caroline Korves, Sapna Rao, Ellison Dial Suthoff, and Robert Wei performed the data collection. Writing of the manuscript was shared by Caroline Korves, François Laliberté, and Mei Sheng Duh. Revision of the manuscript was shared by Alan Oglesby, Mei Sheng Duh, and Gregory Dennis.

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Correspondence to François Laliberté.

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Appendix

Appendix

Systemic lupus erythematosus severity (as defined by Garris et al. [16])a

Moderate

Moderate Rx or moderate medical condition

Rx

Oral corticosteroid dose ≥7.5 mg/day to <60 mg/day

Immunosuppressive agent (excluding cyclophosphamide)

Medical condition

Cardiorespiratory: myocarditis, pericarditis, pleurisy/pleural effusion, vasculitis (excluding aortitis)

Constitutional: hepatitis (non-viral)

Gastrointestinal: acute pancreatitis, lupus enterititis/colitis

Hematology: hemolytic anemia

Musculoskeletal: ischemic necrosis of bone

Neuropsychiatric: demyelinating syndrome/acute inflammatory demyelinating polyradiculoneuropathy, mononeuropathy/polyneuropathy, myelopathy, pseudotumor cerebri, seizure

High

Intensive Rx or severe medical condition

Rx

Oral corticosteroid dose ≥60 mg/day

Cyclophosphamide

Rituximab

Medical condition

Cardiorespiratory: aortitis, arterial/ venous thrombosis, cardiac tamponade, pulmonary hemorrhage, stroke/transient ischemic attack

Gastrointestinal: intestinal pseudo-obstruction

Neuropsychiatric: acute confusional state/psychosis, aseptic meningitis, cranial neuropathy

Ophthalmic: optic neuritis

Renal: end stage renal disease

  1. aMild systemic lupus erythematosus severity is defined as not moderate or high severity

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Oglesby, A., Korves, C., Laliberté, F. et al. Impact of Early Versus Late Systemic Lupus Erythematosus Diagnosis on Clinical and Economic Outcomes. Appl Health Econ Health Policy 12, 179–190 (2014). https://doi.org/10.1007/s40258-014-0085-x

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  • DOI: https://doi.org/10.1007/s40258-014-0085-x

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