Systemic lupus erythematosus (SLE) is a complex autoimmune disease that can affect nearly any organ or system in the body. As a result, its course, manifestations, and treatment approach can be highly variable between patients. This lack of consistency has made clinical trial design, as well as understanding the potential market for therapies in SLE, a unique challenge. To date, GlaxoSmithKline’s Benlysta (2011) is the only drug to have launched for SLE in the G7 in more than 50 years; however, its modest efficacy is a deterrent to uptake. Of note, the FDA and MHLW have recently approved AstraZeneca’s Saphnelo (anifrolumab) for use in the nonrenal SLE population. Additionally, GlaxoSmithKline’s Benlysta and Aurinia’s Lupkynis (voclosporin) have been approved for the treatment of adult patients with active lupus nephritis (LN). Several therapies (i.e., anifrolumab, baricitinib, dapirolizumab pegol, voclosporin, obinutuzumab, secukinumab, and BIIB059) in development for moderate to severe SLE without active renal disease and/or lupus nephritis are expected to fulfill the high unmet need for this condition. The Disease Landscape & Forecast provides detailed analyses of current medical practice, key unmet needs, and new developments in the SLE space, along with an analysis of the opportunities and obstacles facing emerging agents.
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, and Japan.
Primary research: Approximately 26 country-specific interviews with rheumatologists and nephrologists.
Epidemiology: Diagnosed prevalence of SLE by country and subpopulations (nonrenal SLE and LN).
Population segments in market forecast: Total population, nonrenal SLE population, renal SLE (LN) population.
Emerging therapies: Phase II: 24 drugs; Phase III: 7 drugs.