Cutaneous Lupus Erythematosus – Executive Insights – Executive Insights (US)


Cutaneous lupus erythematosus (CLE) is a heterogeneous inflammatory autoimmune disease affecting the skin; discoid lupus erythematosus (DLE) is the most prevalent subtype of CLE. To date, no FDA-approved treatments are available for the treatment of CLE / DLE. The current treatment landscape involves off-label prescribing of calcineurin inhibitors, antimalarials, immunosuppressants, corticosteroids, and sometimes other drug classes, including biologics (e.g., rituximab, ustekinumab). The CLE pipeline holds an array of therapies with unique mechanisms of action, such as an anti-BDCA2 monoclonal antibody (Biogen’s BIIB059), JAK inhibitors (LEO Pharma’s delgocitinib and Gilead / Galapagos’ filgotinib), and a Syk kinase inhibitor (Gilead / Galapagos’ lanraplenib). If proven efficacious, these agents will enjoy a substantial commercial opportunity because of the high unmet need in this space.


  • What are the key areas of unmet need and opportunity in the CLE / DLE market?
  • How are patients with CLE / DLE treated?
  • What is the approximate size of the diagnosed prevalent CLE and DLE populations in the United States?
  • What is the expected impact of novel therapies on the CLE / DLE market?
  • What is the current market landscape and how will the landscape change in the in the future ?
  • What are the key drivers of and constraints on the CLE market?


United States Primary Research 3 KOL interviews in January 2020


Biogen, LEO Pharma, Gilead, Galapagos

Key Drugs Covered

Hydroxychloroquine, mycophenolate mofetil, Revlimid, BIIB059, delgocitinib, filgotinib, lanraplenib


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