Update: Potential Drug for Systemic Lupus Found Safe and Effective in Phase 2 Trial, Now in Phase 3
Update 6/22/2021
Research of the drug BIIB059 expanded scope of investigation to systemic lupus erythematosus (SLE), the most common form of lupus. The Phase 3 TOPAZ-1 study dosed its first patient and aims to enroll 540 adults with active lupus across 135 sites worldwide. Participants will be studied for 52 weeks with the goal of demonstrating reduction in disease activity. The expansion is based on positive Phase 2 LILAC results of BIIB059 for treatment of lupus and lupus skin disease.
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.
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.