Biogen announced positive data from the 24-week systemic lupus erythematosus (SLE) portion of the Phase 2 LILAC study (part A) demonstrating that BIIB059 was associated with a statistically significant reduction in total active joint count. These data, along with the previously reported findings from the cutaneous lupus erythematosus (CLE) portion of the LILAC study, will be presented at the American College of Rheumatology’s ACR Convergence 2020, being held virtually from November 5-9, 2020.
LILAC was a two-part, randomized, double-blind, placebo-controlled study that enrolled 264 patients with active cutaneous lupus erythematosus (CLE), including chronic and subacute subtypes, with or without systemic manifestations (part B) and in individuals with systemic lupus erythematosus (SLE) with active joint and skin manifestations (part A). The study was designed to assess the safety and efficacy of BIIB059 versus placebo.
The SLE part of the study, which enrolled 132 patients, evaluated a BIIB059 450 mg dose versus placebo injected subcutaneously once every four weeks with an additional dose at week 2 in individuals with active SLE. The primary endpoint was change from baseline in total active joint count at Week 24. Total active joint count is the total number of tender or swollen joints, one of the most common symptoms in people living with SLE. A statistically significant difference in change from baseline of 3.4 in total active joint count was observed at week 24 between patients who received BIIB059 versus placebo.
The study also met the secondary endpoint of SLE Responder Index-4 (SRI-4), resulting in an overall reduction in disease activity in participants who received BIIB059 versus placebo. There was a 26.35 percent higher SRI-4 response rate among participants who received BIIB059 (56.77%) versus placebo (30.42%). The SRI-4 is a composite measure comprising criteria from different internationally validated indices of systemic disease activity.
Biogen is currently planning to initiate a Phase 3 program for BIIB059.
BIIB059 is a humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2). BDCA2 is a receptor that is exclusively expressed on a subset of human immune cells called Plasmacytoid Dendritic Cells (pDCs), and it has been shown to reduce inflammatory cytokine production from pDCs, including type-I IFN (IFN-I). Inflammatory mediators are thought to play a major role in the pathogenesis of lupus.
About Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE)
SLE is a chronic autoimmune disease that affects multiple organ systems, with periods of illness or flares alternating with periods of remission. SLE can present itself in several ways including rash, arthritis, anemia, thrombocytopenia, serositis, nephritis, seizures or psychosis. SLE is associated with a greater risk of death from causes such as infection and cardiovascular disease.
CLE is a chronic autoimmune disease where 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 forms of the disease, patients may experience scarring, skin atrophy and alopecia. CLE may occur in the presence of, or more frequently, in the absence of systemic disease.