Biogen to Present Positive Phase 2 Systemic Lupus Erythematosus Data at American College of Rheumatology 2020 Meeting
In Phase 2 LILAC study, BIIB059 demonstrated a statistically significant reduction in joint disease activity compared to placebo in systemic lupus erythematosus patients
Positive results build on previously reported cutaneous lupus erythematosus data and underscore Biogen’s commitment to the lupus community
Systemic lupus erythematosus is a chronic and debilitating autoimmune disease that affects multiple organ systems, with periods of illness or flares alternating with periods of remission
CAMBRIDGE, Mass., Nov. 03, 2020 (GLOBE NEWSWIRE) — Today, Biogen Inc. (Nasdaq: BIIB) announced positive data from the 24-week systemic lupus erythematosus (SLE) portion of the Phase 2 LILAC study (part A) demonstrating that BIIB059 (anti-BDCA2) was associated with a statistically significant reduction in total active joint count. The study evaluated the efficacy and safety of BIIB059, a humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) expressed exclusively on plasmacytoid dendritic cells. 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.
“People living with systemic lupus erythematosus suffer from chronic and debilitating symptoms that impact multiple organ systems as well as their social and emotional well-being,” said Nathalie Franchimont, M.D., Ph.D., Vice President and Head of the Multiple Sclerosis and Immunology Development Unit at Biogen. “These latest data highlight the potential of BIIB059 to impact disease activity and, together with the earlier cutaneous lupus erythematosus findings, reflect Biogen’s commitment to drive therapeutic innovation for lupus patients who have limited treatment options.”
The Phase 2 LILAC study (part A) met its primary endpoint of reducing joint disease activity in individuals with SLE, as measured by total active joint count. A statistically significant difference in change from baseline of 3.4 in total active joint count was observed at week 24 between participants who received BIIB059 450 mg administered subcutaneously every 4 weeks with an additional dose at week 2 versus placebo (p=0.037). Total active joint count is the total number of tender or swollen joints. Tender or swollen joints are one of the most common symptoms impacting quality of life in people living with SLE.
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 percent) versus placebo (30.42 percent [odds ratio=3.49, p=0.003]). The SRI-4 is a composite measure comprising criteria from different internationally validated indices of systemic disease activity.
An additional secondary endpoint from part A of the study in individuals with SLE evaluated the effect of BIIB059 on skin disease activity using the CLE Activity Disease Area and Severity Index-Activity (CLASI-A) score in a subgroup of participants with a baseline CLASI-A score of ≥8. There was a 20 percent higher response rate among participants who received BIIB059 (69.10 percent) versus placebo (49.10 percent) who achieved at