European real-world data sources to characterise flares in patients with systemic lupus erythematosus: a review

Langham J, Langham S. European real-world data sources to characterise flares in patients with systemic lupus erythematosus: a review. Value Health 2017;20(9):A571

Abstract

Objectives: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that is characterised by periods of mild disease activity alternating with flares of increased disease activity causing significant morbidity. There are limited data on the characteristics of and impact of flares on clinical and economic outcomes in patients with SLE in Europe. We carried out a review of registries and databases that could potentially be used to investigate flares in patients with SLE in the UK, Germany, Italy, Spain and France.

Methods: A comprehensive literature review to identify observational studies describing characteristics (clinical, demographic, interventions, costs and outcomes) of patients with SLE (with or without flares) in EMBASE and Medline (2000 to 2017). A list of registries and databases were identified from included studies and assessed for suitability.

Results: Of 2387 titles and abstracts screened, nine registries and databases were identified that met the inclusion criteria. None of the publications pertaining to these registries to date have been used to investigate flares, however several were identified as being potentially suitable for future research. These included general databases (e.g. Clinical Practice Research Datalink), disease-specific registries (e.g. Spanish Society of Rheumatology Registry of Patients with SLE) or treatment-specific registries (e.g. The German Registry for AutoImmune Disease). Suitability assessment identified potential challenges to the use of some of these data sources, including accessibility and the ability to define flares and assess periods of remission.

Conclusions: This review identified nine registries and databases that have published data on patients with SLE. No publications identified reported flare or remission activity longitudinally. Our findings represent a potentially valuable source of real world evidence for use in research on characterising flares and describing their predictors, management, outcomes, and economic impact. Such information would help guide resourcing decisions and management of patients with this chronic autoimmune disease.