Systemic Lupus Erythematosus (SLE) is a chronic, multisystem, inflammatory autoimmune disease which leads to weakening of the immune system. It results in systemic inflammation which affects multiple organs such as kidneys, the tissue lining the lungs (pleura), heart (pericardium), and brain. Acute Cutaneous Lupus, Chronic or Discoid Lupus, Lupus Panniculitis, Lupus Pernio, Subacute Cutaneous Lupus and Tumid Lupus are the most common form of Systemic Lupus Erythematosus.

According to the latest report of DelveInsight, “Systemic Lupus Erythematosus (SLE) – Market Insights, Epidemiology and Market Forecast-2025”, the prevalent population of SLE is expected to grow at a CAGR of 3.02% from 2015-2025. The prevalence of SLE is observed to be higher in the United States as compared to EU5 and Japan. With very less approved drugs SLE market was dominated by off-label drugs before the approval of Benlysta in 2011. GSK’s (Benlysta) is the second drug approved by the FDA after Plaquenil (Hydrochloroquine; Sanofi-Aventis) that received approval in 1955 and was the first drug approved for the treatment of SLE. Some of the off-label therapies include Corticosteroids, NSAIDs, Anti-malarials, Biologics (mainly, rituximab) and Immunosuppressants.

Some of the major upcoming targeted therapies include Anifrolumab (AstraZeneca), Lupuzor (ImmuPharma), Atacicept (Merck KgaA), IFN? KINOID (Neovacs), Vobarilizumab (Ablynx-Abbvie) and CC-220 (Celgene). With the approval of upcoming drugs the market size of SLE is expected to grow at a CAGR of 19% from 2015-2025. There were many other molecules that were considered to be a game changer but failed to work like one. Therapies that failed to become a game changer are Blisibimod (Anthera/Amgen), Abatacept (BMS) and even Rituximab. The respective companies have discontinued the development of Blisibimod, Abatacept for the treatment of SLE. However, Rituximab is still extensively used as ‘off-label’ drug for the treatment.