CAMBRIDGE, Mass.—Biogen Inc. recently shared positive data from the 16-week cutaneous lupus erythematosus (CLE) portion of the Phase 2 LILAC study. The study evaluated the efficacy and safety of BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) expressed on plasmacytoid dendritic cells (pDCs). The data were presented at the European E-Congress of Rheumatology (EULAR) 2020, which was held virtually from June 3-6.
“We are encouraged by the CLE results from the BIIB059 Phase 2 lupus study presented at the 2020 virtual EULAR congress,” said Dr. Nathalie Franchimont, vice president of the multiple sclerosis and immunology development unit at Biogen. “These data underscore our goal of delivering meaningful new therapies to people living with lupus, who currently have limited treatment options.”
CLE is, essentially, lupus affecting the skin. It is a chronic autoimmune disease in which the body’s immune system attacks healthy skin, often causing rashes and skin lesions which can be painful or itchy. CLE is associated with a decrease in quality of life and increased depression. In some of the chronic forms of the disease, people may experience scarring, skin atrophy and alopecia.
The CLE part of the LILAC study met its primary endpoint (p<0.001) by demonstrating a dose response of BIIB059 on the percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at week 16 in people with CLE. Study participants with CLE that received 50 mg, 150 mg and 450 mg of BIIB059 experienced reductions in CLASI-A scores of 38.8 percent (p=0.015), 47.9 percent (p<0.001) and 42.5 percent (p=0.001), respectively, versus 14.5 percent with placebo. CLASI-A is a well-defined and reliable outcome measure that has been shown to detect change in CLE skin disease activity.
With respect to the secondary endpoint of CLASI-50 response, statistical significance was achieved in study participants who received 450 mg of BIIB059; 23.3 percent (p=0.024) more participants achieved CLASI-50 response versus placebo. While not statistically significant, more participants treated with BIIB059 50 mg (15.8 percent) and 150 mg (21.2 percent) achieved a CLASI-50 response versus placebo. A CLASI-50 response is defined as a 50 percent improvement from baseline in CLASI-A score.
The majority of adverse events in the LILAC study were mild or moderate and the incidence of serious adverse events was 7.1 percent versus 9.1 percent in participants that received BIIB059 versus placebo. Rate of infections was 34.3 percent versus 30.3 percent in participants that received BIIB059 versus those given placebo; no significant increased risk of infection has been identified. Eight participants, who all received BIIB059, discontinued study drug due to side effects. Overall, the safety and tolerability results further support the continued development of BIIB059.
LILAC was a randomized, parallel, double-blind, placebo-controlled two-part study that evaluated BIIB059 versus placebo in participants with active CLE, including chronic and subacute subtypes, with or without systemic manifestations and in participants with systemic lupus erythematosus (SLE) with active joint and skin manifestations.
Final results from the SLE part of the LILAC study will be presented at a future medical congress.