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Market Dynamix: Lupus and Lupus Nephritis US

Systemic lupus erythematosus (SLE, “Lupus”) is an autoimmune condition which affects approximately 1.5 million Americans. Each year, close to 16,000 new cases are diagnosed. Involvement of end organs is common and complicates the management; up to half of the patients will develop kidney involvement, with up to 30% of these patients potentially developing end-stage renal disease requiring dialysis. The disease disproportionately affects females and patients of African American and Asian descent. SLE is typically managed by a rheumatologist and if the patient develops renal symptoms, a nephrologist is also typically involved in patient management.

Market Dynamix™: Lupus and Lupus Nephritis (US) combines qualitative feedback from leading opinion leaders and other stakeholders with large scale quantitative feedback of “in the trenches” nephrologists (n=101) and rheumatologists (n=100). In addition, select data points from RealWorld Dynamix: SLE, a large-scale patient chart audit of patients with moderate to severe SLE (n=1,032) completed by the managing rheumatologist is included.
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  • What is the comparative level of unmet need for new products to treat lupus and lupus nephritis? Which lupus manifestations are the most challenging to manage?
  • What does current treatment looks like for patients with lupus and lupus nephritis, including off-label regimens? What percentage of patients are on chronic corticosteroids?
  • Among current SLE patients, what percentage are currently treated with Benlysta? What percentage are candidates but not on drug? What are the barriers to increased use of Benlysta?
  • What is the clinical status of current patients? How many have had lupus flares in the past year? How severe were the flares?
  • Which pipeline agents are rheumatologists and nephrologists most familiar with for SLE (rheumatologists) and LN (nephrologists)? Which MOAs are most appealing?
  • What percentage of SLE patients would be candidates for Lilly’s Olumiant and Janssen’s Stelara, assuming these agents win FDA approval?
  • What percentage of LN patients would likely be treated with Benlysta assuming it receives an indication for LN?
  • What is nephrologists’ reaction to the profile of voclosporin, a novel calcineurin inhibitor in development for the treatment of LN?
  • Who do rheumatologists and nephrologists consider to be the key opinion leaders for SLE and LN?
  • What do these experts think about pipeline agents and where they may fall in the treatment paradigm?

Benlysta (GSK)

Off-label rituximab, HP Acthar gel

Development for SLE:
Olumiant (Lilly), Stelara (Janssen), filgotinib (Gilead/Galapagos), Atacicept (EMD Serono), Dapirolizumab (UCB/Biogen), Evobrutinib (EMD Serono), Fenebrutinib (Roche), Lupuzor (ImmuPharma), BMS-986165 (BMS), BIIB059 (Biogen), CC-220 (Celgene), anifrolumab (AstraZeneca)

Development for lupus nephritis:
Benlysta (GSK), voclosporin (Aurinia), anifrolumab (AstraZeneca), obinituzumab (Roche), BI-655604 (Boehringer Ingelheim), CFZ553 (Novartis), mizoribine (Asahi Kasei Pharma)

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