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A new monoclonal antibody is turning heads in lupus treatment. Daxdilimab, which targets and depletes plasmacytoid dendritic cells, significantly reduced disease activity in patients with moderate-to-severe discoid lupus erythematosus over 24 weeks. In the phase 2 trial, roughly 62% of treated patients achieved at least a 50% reduction in disease activity scores, compared to just 24% on placebo — with a clean safety profile to boot.
Daxdilimab, an investigational monoclonal antibody, delivered impressive results in a phase 2 trial for moderate-to-severe discoid lupus erythematosus (DLE) — a chronic, scarring skin condition that can be notoriously difficult to treat. Presented at the EADV 2026 Congress in Vienna, the trial enrolled 72 adults with treatment-refractory DLE and randomized them to low-dose daxdilimab, high-dose daxdilimab, or placebo over 24 weeks.
The drug works by targeting ILT7, a molecule found on plasmacytoid dendritic cells (pDCs) — key drivers of inflammation in cutaneous lupus — and depleting them. Responses were visible as early as week 4, and both doses outperformed placebo on every major endpoint by week 24. No serious adverse events or deaths were reported.
By the Numbers:
Why it matters: DLE patients often exhaust available therapies with limited relief. Daxdilimab's strong efficacy and favorable safety profile could fill a major treatment gap — and Amgen has already signaled plans to move it into a registrational trial phase.