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RealWorld Dynamix: Systemic Lupus Erythematosus US

It is estimated that 1.5 million American have some form of lupus, largely affecting women of child-bearing age and minority populations. Lupus is a chronic disease with significant symptoms in which there is currently no cure. GSK’s Benlysta (belimumab) gained FDA approval in 2011, and to date is the only systemic agent approved for the treatment of Systemic Lupus Erythematosus (SLE) in the United States. SLE patients often display heterogenous manifestations of the disease and with limited available options, treating the disease is often extremely difficult. Due to this limitation, physicians regularly prescribe off-label agents, as well as various combination regimens in an effort to best manage their SLE patients. With one of the highest physician rated unmet needs, it is no surprise that SLE has a vast and dynamic pipeline with a variety of agents under investigation. This study provides a deep assessment of the highly varied patient profiles, their treatment regimens and their candidacy for late stage assets.

RealWorld Dynamix™: Systemic Lupus Erythematosus (US) is based on a robust and deep patient chart analysis of ~1,000 patients who have been diagnosed with moderate to severe systemic lupus erythematosus and are either currently treated with Benlysta or considered candidates for systemic treatments. Each physician completes an in-depth medical history of their last five to seven patients who met the study inclusion criteria. In addition to patient clinical and non-clinical demographics, lab tests at time of diagnosis and at most recent visits are included to provide insight into the clinical course of the disease. Pharmacological agents currently prescribed, as well as treatment history, disease activity, specific symptoms, organ involvement, and manifestations are documented to develop a full understanding of this complex disease.

This is the first wave of the report (fielded 2018).

Learn more about RealWorld Dynamix™ reports here.

  • What is the patient profile of an SLE patient, including demographics, comorbidities, risk factors, and the extent of lab monitoring?
  • How does patient severity vary depending on organ involvement?
  • How aligned are clinical trial populations to real world patient populations?
  • How do physicians assess the severity of a flare and how do flares prompt treatment changes? What is the steroid burden in these patients?
  • To what extent do rheumatologists co-manage their SLE patients with other physicians?
  • What labs are utilized to assess patient severity and lupus manifestations? Are lab metrics perceived as accurate and reliable?
  • What are the differences between community rheumatologists and academic rheumatologists with regard to treatment patterns?
  • How do treatment regimens vary according to specific organ involvements and severities?
  • What is the patient profile of a Benlysta patient and/or Benlysta candidate?

Commercial Products
GSK (Benlysta)

Pipeline Agents
Ablynx (vobarilizumab), Amgen/Astra Zeneca(AMG557, AMG570), AstraZeneca/MedImmune (anifrolumab, MEDl0700), Boston Pharmaceuticals (BOS161721), Celgene (CC-220), EMD Serono (atacicept, evobrutinib), Eli Lilly (baricitinib), ImmuPharma (Lupuzor), Invion (INV103), Janssen (Stelara), Pfizer (PF-06823859), Roche/Genentech (obinutuzumab, GDC-0853)


Analysis of Over 1,000 Systemic Lupus Erythematosus Patients Reveals Real World Patient Populations are Not Representative of Clinical Trial Samples – July 24, 2018