Litifilimab in Cutaneous Lupus Erythematosus Save

Biogen has announced positive results of their Phase 2 study, evaluating litifilimab in patients with active cutaneous lupus erythematosus (CLE), presented at the recent American Academy of Dermatology (AAD) Annual Meeting.

Litifilimab is an investigational monoclonal antibody that targets BDCA2 on Plasmacytoid Dendritic Cells (PDCs) and is being studied in CLE and SLE. 

Dr. Joseph Merola (see video) from UT Southwestern presented the results of the 24 week, phase 2 AMETHYST study, showing CLE skin activity improved at week 16 (compared to placebo).  The study included patients with active subacute cutaneous lupus erythematosus (SCLE) and/or chronic cutaneous lupus erythematosus (CCLE) who are refractory or intolerant to antimalarial therapy.

Participants are randomized to receive subcutaneous treatment with litifilimab with standard of care (SoC) or placebo every four weeks in addition to SoC for 24 weeks (Part A of the study). After week 24 all patients will receive litifilimab during from Weeks 24 to 48 (part B; phase 3 part of the study).

The primary endpoint and CLE efficacy, assessed using Cutaneous Lupus Activity Investigators Global Assessment Revised (CLA-IGA-R) erythema score of 0-1 (clear/almost clear), at week 16 was better in litifilimab, compared to placebo (14.7% vs. 2.9%). The Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity-50 (CLASI-50) response through Week 24 was also superior with litifilimab (40.8% vs. 21%). 

Most adverse events (AEs) were mild to moderate in severity in both groups. Serious adverse events occurred in 6.8% (4/59) and 2.9% (1/34) of participants receiving litifilimab and placebo, respectively.