Systemic lupus erythematosus (SLE) is a serious autoimmune disease that affects multiple body systems including the skin, joints, heart, lungs, blood, and kidneys. There is a lack of evidence from real-world data about how the disease is managed, typical disease progression and the severity of disease activity (flares).
Our study proposes to use routinely collected health information from the Clinical Practice Research Datalink to identify and describe characteristics of SLE patients, to describe the clinical pathways, including longer-term outcomes and related costs.
The aim of the study is to improve understanding of disease activity and treatment and to investigate whether it is possible to determine risk factors for disease activity to enable early identification of patients at risk of poor outcomes.
Objectives: (1) The primary objective is to (1.1) characterise a population-based cohort of systemic lupus erythematosus/lupus nephritis (SLE/LN) patients; and describe (1.2) disease severity (mild, moderate, severe); and (1.3) disease activity (frequency of flares, length of remission periods, severity of flares).
(2) Secondary objectives are to describe (2.1) medicinal management, (2.2) key outcomes (comorbidities and organ system involvement) and (2.3) healthcare resource utilisation (HCRU) in SLE/LN patients, by disease severity and disease activity.
Methods: This study is a non-interventional (observational) retrospective cohort study of adult patients with SLE/LN in the UK identified in the CPRD between 2005-2015.
Analysis: Standard exploratory and descriptive analyses will be used to gain an understanding of the qualitative and quantitative nature of the data collected and of the characteristics of the sample studied. Time to event (such as flare and mortality) will be estimated using Kaplan-Meier (KM) survival analysis and plotted using KM survival curves. We will report median time to event and incidence rates at select time points (e.g., 1, 3, 6 months). Cox proportional hazard regression models will be considered to control for covariates and to estimate the hazard of event and differences in the hazard across subgroups/strata.
SLE disease severity
- SLE flare activity
- Comorbidities
- Organ system involvement
- Mortality
- Medicinal treatment
- Healthcare resource utilisation
- Cause of death
Heide Stirnadel-Farrant - Chief Investigator - AstraZeneca Ltd - UK Headquarters
Julia Langham - Corresponding Applicant - Maverex Ltd
Mihail Samnaliev - Collaborator - Maverex Ltd
Sharada Weir - Collaborator - Maverex Ltd
Xia Wang - Collaborator - Astra Zeneca Inc - USA
Edward Hammond - Chief Investigator - Astra Zeneca Inc - USA
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data