LILAC phase II post hoc analysis: Litifilimab skin outcomes in CLE

Results from a post hoc analysis of the randomized, double-blind, placebo-controlled phase II LILAC study (NCT02847598), evaluating litifilimab in adults with cutaneous lupus erythematosus (CLE), were published in the Journal of the European Academy of Dermatology and Venereology by Werth et al. This analysis assessed additional skin-specific outcomes in 132 participants who received 50 mg (n = 26), 150 mg (n = 25), or 450 mg (n = 48) litifilimab, or placebo (n = 33). Endpoints were assessed over 16 weeks and included Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI‑A) response rates; skin-related health, as evaluated by the Physician’s Global Assessment (PGA) of CLE; and the Physician’s Global Impression (PGI) of change in CLE. 

Key data: All groups treated with litifilimab had greater percentage improvements in CLASI‑A from baseline compared with placebo, regardless of baseline CLASI‑A score, concomitant systemic lupus erythematosus (SLE), or concomitant discoid lupus erythematosus (DLE). At Week 16, 45.8%, 60.0%, and 50.0% of patients had their overall skin condition rated as “mild” by the PGA in the 50 mg, 150 mg, and 450 mg litifilimab groups, respectively, vs 28.0% of patients receiving placebo. A numerically higher proportion of patients receiving 50 mg (25.0%), 150 mg (48.0%), or 450 mg (30.0%) litifilimab demonstrated a “much improved” PGI change vs placebo (16.0%).  

Key learning: Results from this analysis provide additional evidence supporting litifilimab efficacy in clearing skin disease activity in CLE, with improvements observed across multiple assessment measures independent of baseline characteristics.