Lupus & antiphospholipid syndrome
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
Authors' conclusion
Administration of litifilimab resulted in reductions in both IFNGS scores and IFNα concentrations, pharmacodynamic effects that correlated with clinical responses.
Study context
- Population
- Participants with systemic lupus erythematosus (SLE) (part A) or cutaneous lupus erythematosus (CLE) with or without SLE (part B) of the phase 2 LILAC trialIFN gene signature (IFNGS): 120 (part A), 131 (part B)
- Comparison
- Litifilimab vs placebo
- Primary endpoint
- Pharmacodynamic effects on type I interferon (IFN) response (IFNGS scores, IFNα and IFN-regulated cytokine concentrations) and correlations with clinical outcomes
Methodological detailsplacebo-controlled, phase 2, pharmacodynamic analysis
- Placebo-controlled
- Phase 2
- Pharmacodynamic analysis
Primary result
As reported in the abstract
Rapid, significant and sustained reductions vs placebo with litifilimab 450 mg in part A and 150 mg and 450 mg in part B
nominal P < 0.05
Further findings
- Most participants IFNGS-high
- 79-91%
- No baseline IFNGS-low participant results reported
Original publication
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. Arthritis Rheumatol. Published 18 September 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →