Pharmacodynamic Effects of Litifilimab in Lupus in a Randomized, Placebo-Controlled Phase 2 Study: Rapid and Sustained Reductions in Type I Interferon-Associated Gene Expression and Cytokines.

ABSTRACT:

Objective

The pharmacodynamic effects of litifilimab on type I interferon (IFN) response and correlations with clinical outcomes were investigated in systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE).

Methods

Participants from part A (SLE) or part B (CLE with or without SLE) of the randomized phase 2 LILAC trial who received litifilimab (at 50 mg, 150 mg, or 450 mg) or a placebo were included. IFN gene signature (IFNGS) scores were assessed from whole-blood samples using a 22-gene panel in 120 and 131 participants (parts A and B, respectively). IFNα and other IFN-regulated cytokine concentrations were measured in serum in 112 and 131 participants (parts A and B, respectively).

Results

Most participants were IFNGS-high at baseline (79-91%), and

SUBMITTER: Furie R 

PROVIDER: S-EPMC12750138 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature