Admin_Adham
TOPLINE
Litifilimab, a monoclonal antibody targeting plasmacytoid dendritic cells, led to significantly greater skin clearance in patients with cutaneous lupus erythematosus (CLE) compared with placebo in a phase 2 study.
METHODOLOGY
- Researchers conducted a randomized double-blind, placebo-controlled phase 2 AMETHYST Part A study across Latin America, North America, Asia Pacific, and Europe between September 2022 and June 2024.
- A total of 93 adults with moderate-to-severe active subacute or chronic CLE that was refractory or intolerant to antimalarials (74.2% were women and 66.7% were White) were randomly assigned 2:1 to receive subcutaneous litifilimab 225 mg or placebo every 4 weeks for 24 weeks, along with standard nonbiologic therapy.
- The primary endpoint was a Cutaneous Lupus Activity Investigator’s Global Assessment–Revised (CLA-IGA-R) erythema score of 0-1 (clear or almost clear skin) at week 16.
- Secondary outcomes at week 24 included CLA-IGA-R erythema 0-1, CLA-IGA-R other morphological characteristics 0, 70% improvement in the Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI-A) score, CLASI-A 0-1, CLASI-A 0-3, and CLASI-A 0-5.
TAKEAWAY
- At week 16, significantly more participants treated with litifilimab achieved clear/almost clear skin compared with those who received with placebo (14.7% vs 2.9%; P = .0263).
- At week 24, participants receiving litifilimab had a greater least-squares mean percent change from baseline in CLASI-A scores compared with placebo (–45.1% vs –26.4%; P = .0143). More patients receiving litifilimab than placebo had minimal or no skin disease activity at week 24, based on three CLASI-A thresholds: scores of 0-1 (7.3% vs 0%; P = .0387), 0-3 (16.3% vs 0%; P = .0006), and 0-5 (24.9% vs 6.2%; P = .0069) and at least 70% reductions in the CLASI-A scores (21.7% vs 5.8%; P = .0195).
- Similar findings were observed for CLA-IGA-R erythema (clear or almost clear: 19.0% vs 4.2%; P = .0110) and other morphological characteristics (clear: 14.2% vs 0.0%, P = .0017) scores with litifilimab vs placebo at week 24.
- Adverse events occurred in 74.6% with litifilimab and 64.7% with placebo; serious events occurred in 6.8% vs 2.9%, none of the serious events were treatment-related or fatal.
IN PRACTICE
"Litifilimab use resulted in rapid improvement in skin disease activity and was generally well tolerated with no new safety signals," the authors wrote.
SOURCE
The study was led by Joseph F. Merola, MD, MMSc, Department of Dermatology, UT Southwestern Medical Center, Dallas. It was published online on October 14 in the Journal of the American Academy of Dermatology.
LIMITATIONS
The phase 2 study had a limited sample size and could be underpowered for secondary endpoints.
DISCLOSURES
The study was funded by Biogen and multiple authors reported being employees and shareholders of Biogen. Merola and several authors reported receiving consulting fees, research support, honoraria, investigator fees, advisory fees, and grants from Biogen and other pharmaceutical companies. Full disclosures are reported in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
