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Biogen’s Litifilimab Demonstrates Rapid and Durable Efficacy in New 52-Week Phase 2 Data from Ongoing Phase 2/3 AMETHYST Study, Reinforcing Its Potential as a First-in-Class Therapy for Cutaneous Lupus Erythematosus

Continued improvement: An increased response was seen in participants on litifilimab from week 24 through week 52, with more individuals achieving clear or almost clear skin (27.2%; CLA IGA 0-1) and improvements in disease activity (28.8%; CLASI-70) than at week 24 (19.0% and 21.7%, respectively) Rapid onset: Participants that switched from placebo to litifilimab experienced improvements […]

Biogen Inc. has unveiled new 52-week Phase 2 data from the AMETHYST study for its investigational drug litifilimab, which demonstrates rapid and durable efficacy in treating cutaneous lupus erythematosus (CLE). The study, presented at the EADV 2026 Congress, builds upon previous data and provides the longest dataset for litifilimab in CLE patients.

Participants receiving litifilimab in the double-blind, placebo-controlled phase showed continued improvement in skin disease activity up to Week 52. Notably, those who began treatment with litifilimab after switching from placebo at Week 24 experienced a rapid onset of treatment effects within just four weeks.

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