December 3, 2019
The Lupus Research Alliance (LRA) is pleased to share positive results reported by Biogen Inc. from the Phase 2 LILAC study which tested the effectiveness and safety of a potential lupus treatment, BIIB059.
BIIB059 is a monoclonal antibody that targets BDCA2, a protein found on cells known as plasmacytoid dendritic cells, which are the major producers of type I interferons (IFNs). These proteins of the immune system play a major role in causing inflammation and are key drivers of lupus
“Pioneering work funded by the Lupus Research Alliance over a decade ago identified type I interferons as major drivers of the inflammatory process in lupus,” commented Dr. Teodora Staeva, Chief Scientific Officer of the LRA. “These Phase 2 results provide further support for targeting Type I IFNs in lupus and suggest that BIIB059 may offer a new treatment option for people with lupus.”
LILAC compared BIIB059 at three dosages versus placebo among 132 people with active cutaneous lupus erythematosus (CLE) affecting their skin. The second part of the study tested BIIB059 among 132 people with active systemic lupus erythematosus (SLE) who have skin and joint symptoms.
The CLE part of the study met its primary endpoint of lessening skin symptoms according to a standard measurement tool Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A). Response to treatment was seen among 40.9 percent of those given BIIB059 at 50 mg, 48.0 percent of those given 150 mg and 42.5 percent of those given 450 mg versus 14.5 percent of patients who responded to placebo.
The SLE part of the study also met its primary endpoint of lowering the number of swollen or tender joints in people with SLE treated with BIIB059 at the 450 mg dose. Improvements in skin disease and overall disease activity were also seen.
Biogen reported that “the safety and tolerability profile of BIIB059 supports its continued development.” The safety profile is the potential for medical risk, and the tolerability refers to the degree to which side effects can be tolerated by the patients.
“We look forward to the further clinical testing of BIIB059 for our lupus community of people living with this complex, chronic and challenging disease with too few treatment options,” noted Dr. Staeva.