Lupus affects about five million people worldwide, and the disease manifests in a wide array of symptoms. To date, there is no cure. Real-world data (RWD) plays a vital role in fully comprehending and documenting the patient experience in lupus, the impact of treatments, and the connection between product development and patients’ day-to-day lives.

RWD provides insight into the effectiveness, safety, and usage of new treatments, beyond what is typically determined in the clinical trial process. In lupus, this is particularly important due to the complexity of this disease. Pharma and biotech companies can leverage RWD to measure how lupus affects patients and the burden of this disease. RWD may encompass healthcare utilization, quality of life, related symptoms and comorbidities, and adherence, as well as socioeconomic factors affecting patients.

This article explores the benefits of RWD in lupus, the value of leveraging RWD throughout the lupus product lifecycle, and the RWD sources available in this indication. 

Leveraging RWD in the Product Lifecycle

Pharma and biotech companies can leverage RWD throughout the product lifecycle, beginning with the clinical trial phase, to improve trial strategy and execution with information on the disease burden, including the medical, economic, and human impacts on patients.

RWD is also valuable beyond the clinical development stage of a treatment. It helps to measure patient and caregiver quality of life as well as the economic impact on healthcare systems, so it is important for market access. RWD also enables companies to study a broader group than is possible in a clinical trial, which can help with decision-making, planning, and strategy when bringing a treatment to market and achieving better patient outcomes.

In lupus, RWD is especially vital because the Food & Drug Administration has only approved two biologics for systemic lupus erythematosus (SLE) – belimumab (Benlysta, manufactured by GSK) and anifrolumab (Saphnelo^®, manufactured by AstraZeneca). Although clinical trials tend to focus on efficacy with a small group of patient participants, a wider population of lupus patients typically begin using these treatments once approved. RWD can help fill in the gaps when it comes to understanding their usefulness in lupus in patient populations outside of the clinical trial cohort and can help expand a product’s label to new groups of patients. 

RWD helps companies monitor treatment safety and understand how the treatment is impacting patients’ quality of life. These lupus treatments tend to have high costs and, often, limited patient access; RWD can demonstrate how they perform in the real world and what benefits they offer patients, which can help with price, reimbursement, and access.

Sources for RWD in Lupus

Therapy area-agnostic claims and clinical databases can provide companies with observational data for a broad overview of diagnoses, interventions, and outcomes. But these administrative datasets are not always sufficient for conditions like lupus, where companies developing treatments need key information such as symptoms, quality of life, and social determinants of health. Usually, genomic and molecular data are also missing from these sources.

With a complex disease such as lupus, companies often need specialized, specific data sources that include the details necessary for a comprehensive picture of the disease and the patients, with not only clinical data but also social, economic, and genomic/molecular data. A lupus-specific registry with patient-reported data can provide the relevant information that more generic databases and databases with only claims or clinical data lack, ultimately advancing solutions for those affected by this challenging, complex disease.

How Alira Health Can Help

Alira Health has partnered with FORWARD, the National Databank for Rheumatic Diseases, the largest patient-reported research databank for rheumatic disorders in the US. Our collaboration on the lupus registry provides comprehensive, de-identified data from thousands of people with lupus and includes extensive patient experience data to improve understanding of patient needs. The result is better insight into and understanding of lupus and its impact on patients, enabling more effective, targeted research and development of solutions.