Biogen says litifilimab posts sustained skin clearance in 52-week Phase 2 cutaneous lupus study
BIIB•Biogen said 52-week Phase 2 AMETHYST results showed sustained skin-clearance benefits with litifilimab for cutaneous lupus, with no new safety signals. Phase 3 results are expected in the first half of 2027; the FDA granted the drug Breakthrough Therapy Designation in January 2026.
1. Phase 2 results
Biogen reported 52-week Phase 2 AMETHYST data showing that patients who switched from placebo had rapid symptom improvement, with benefits sustained through one year of treatment. More patients reached clearer skin over time, and safety remained consistent with earlier studies, with no new safety signals.
2. Next study
Biogen said Phase 3 results are expected in the first half of 2027. Litifilimab received FDA Breakthrough Therapy Designation in January 2026.
