Abstract Background Cutaneous lupus erythematosus (CLE) has no approved targeted therapies. In Part B of the randomized, double‐blind, placebo‐controlled, Phase 2 LILAC study, litifilimab demonstrated a dose–response relationship for percentage change in Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI‐A) score from baseline to Week 16. Objectives These post hoc analyses of Part B of the LILAC study aimed to assess the efficacy of litifilimab on additional skin‐specific outcomes. Methods Adult participants with baseline CLASI‐A score ≥8 and histologically confirmed CLE, with/without systemic manifestations, received litifilimab 50 mg, 150 mg or 450 mg, or placebo subcutaneously every 4 weeks through Week 16. Analyses included CLASI‐20/50/70/90 responses (≥20%/50%/70%/90% decrease improvement from baseline in CLASI‐A score), 7‐point improvement from baseline in CLASI‐A score, subgroup analyses of percentage change in CLASI‐A scores by baseline characteristics and achievement of ‘clear’ (CLASI‐A scores of 0–1) or ‘almost clear’ (0–3) skin status. Shifts from baseline in skin condition were evaluated by the Physician's Global Assessment (PGA) of CLE and the Physician's Global Impression (PGI) of change in CLE. Results Greater proportions of litifilimab‐treated participants achieved CLASI‐20/50/70/90 responses (3.8%–72.1%) than placebo‐treated participants (0%–43.8%) at Week 16, with significant differences observed from Week 4 for CLASI‐20/50. From Weeks 4 to 16, more litifilimab‐treated participants had ≥7‐point CLASI‐A score decreases from baseline (13.8%–43.9%) compared with placebo (10.5%–21.1%). At Week 16, compared with placebo, more litifilimab‐treated participants achieved ‘clear’ or ‘almost clear’ skin status; CLASI‐A score improvements for subgroups were numerically higher with litifilimab, more litifilimab‐treated participants shifted from ‘severe’ or ‘moderate’ to ‘almost clear’ skin status based on PGA of CLE, and more litifilimab‐treated participants were ‘much improved’ based on PGI results. Conclusions These analyses provide additional evidence to support litifilimab efficacy in clearing skin disease activity, as demonstrated in the LILAC study.
Werth et al. (Fri,) studied this question.