Potential Drug for Cutaneous Lupus Found Safe and Effective in Phase 2 Trial
Investigational drug BIIB059 shows promise as a potential treatment for skin disease in lupus known as cutaneous lupus erythematosus (CLE). In Phase 2 of the LILAC study, the drug was found to demonstrate a dose response, promoting statistically significant improvements in CLE disease activity from baseline compared to placebo.
The trial included 132 participants with active CLE who were randomized to receive either BIIB059 (at doses of 50, 100, or 150 mg) or a placebo treatment. After a 16-week trial period, all three groups receiving the experimental treatment benefitted from statistically significant reductions in skin disease activity compared to those receiving the placebo. Disease activity was measured by the Cutaneous Lupus Disease Severity Index-Activity (CLASI-A), a clinical tool that quantifies disease activity and damage in CLE.
“This is the first successful Phase 2 trial specifically targeting patients with cutaneous lupus erythematosus. There is a large need for safe and rapidly effective therapy for CLE. Given the lack of any approved medications for hydroxychloroquine-refractory CLE patients, the results of the BIIB059 study are very exciting,” shared study author Victoria Werth, MS, MD, Lupus Foundation of America Medical-Scientific Advisory Council Member.
About two-thirds (66%) of people with lupus will develop CLE, but there are few treatments specifically approved for this disease. The encouraging LILAC Phase 2 study results suggest that BIIB059 shows promise as a potential new treatment. Continue to follow the Lupus Foundation of America for updates on this investigational therapy and learn how lupus affects the skin.