Biogen Presents Positive Phase 2 Cutaneous Lupus Erythematosus (CLE) Data at European E-Congress of Rheumatology (EULAR) 2020 - Seite 2

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.

About BIIB059
BIIB059, discovered and developed exclusively by Biogen, is an investigational fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) currently being evaluated for the treatment of CLE and SLE. BDCA2 is a receptor that is uniquely 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 the Phase 2 LILAC Study
The Phase 2 LILAC study (NCT02847598) was a randomized, parallel, double-blind, placebo-controlled two-part study that enrolled 264 participants to evaluate the safety and efficacy of BIIB059 versus placebo in participants with active CLE, including chronic and subacute subtypes, with or without systemic manifestations and in participants with SLE with active joint and skin manifestations.

The CLE part of the study, which enrolled 132 participants, investigated either a BIIB059 50 mg, 150 mg or 450 mg dose administered subcutaneously every 4 weeks with an additional dose at week 2 versus placebo in participants with active CLE. The primary endpoint was dose-response of BIIB059 as measured by percent change from baseline in the CLASI-A Score at Week 16.

About Cutaneous Lupus Erythematosus (CLE)
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 of the chronic forms of the disease, people may experience scarring, skin atrophy and alopecia.