Litifilimab efficacy on skin outcomes in cutaneous lupus erythematosus in the Phase 2 LILAC study.

In 30 seconds

This post hoc analysis of Part B of the randomized, double-blind, placebo-controlled Phase 2 LILAC trial assessed additional skin outcomes in adults with histologically confirmed cutaneous lupus erythematosus (CLE) and baseline CLASI-A scores ≥8. Participants received subcutaneous litifilimab at 50, 150 or 450 mg, or placebo, every 4 weeks through Week 16. At Week 16, greater proportions of litifilimab-treated participants achieved CLASI-20/50/70/90 responses (3.8%-72.1%) than placebo-treated participants (0%-43.8%); differences for CLASI-20/50 were significant from Week 4. Other skin-status and physician-assessed outcomes also generally favoured litifilimab.

Key findings

• At Week 16, CLASI-20/50/70/90 responses occurred in 3.8%-72.1% of litifilimab-treated participants versus 0%-43.8% with placebo.
• From Weeks 4 to 16, ≥7-point CLASI-A decreases occurred in 13.8%-43.9% with litifilimab and 10.5%-21.1% with placebo.
• At Week 16, more litifilimab-treated participants achieved clear or almost-clear skin status than placebo-treated participants.
• Physician assessments showed more shifts from moderate or severe disease to almost-clear status and more reports of much improved skin with litifilimab.

Why it matters

CLE has no approved targeted therapies, and skin disease activity can be assessed through validated severity scores as well as global physician ratings. These post hoc findings suggest that litifilimab may improve several dimensions of skin activity, including substantial score reductions and clearer skin status. They add detail to the Phase 2 efficacy signal but do not establish long-term benefit or confirm effectiveness in broader clinical populations.

What to keep in mind

These were post hoc analyses of a Phase 2 trial, and the abstract does not provide participant counts or detailed estimates for the additional outcomes.