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
Key Highlights
- ➤Week 52 clear/almost clear skin reached 27.2%, up from 19.0% at Week 24
- ➤Week 52 CLASI-70 response reached 28.8%, up from 21.7% at Week 24
- ➤Placebo-to-litifilimab crossover participants saw skin improvements as early as four weeks
- ➤Serious adverse events occurred in 3.4% (3/88); no new safety signals identified
- ➤Phase 3 AMETHYST results expected in the first half of 2027
Expert Statements
Joseph F Merola, Dermatologist, rheumatologist and President of the Rheumatologic Dermatology Society, Lupus Foundation Medical and Scientific Board
“Access to 52-week data is critical when evaluating a treatment for a lifelong, chronic disease like cutaneous lupus erythematosus, which can cause permanent scarring and disfigurement that many patients will carry with them forever. That is why achieving clear or almost clear skin, which is rarely seen in CLE, is a truly transformative treatment goal for this disease”
Joseph F Merola, Dermatologist, rheumatologist and President of the Rheumatologic Dermatology Society, Lupus Foundation Medical and Scientific Board
“It is highly encouraging to see continued improvement in skin clearance with litifilimab treatment – with over a quarter of participants reaching clear or almost clear skin – and data supporting litifilimab's long-term safety profile.”
Daniel Quirk, Chief Medical Officer at Biogen
“Living with cutaneous lupus erythematosus carries a heavy physical toll, including dyspigmentation, pain, and scarring, which can be associated with comorbidities like depression and anxiety that can have a profound impact on daily life. These 52-week data reinforce litifilimab's potential to deliver rapid improvement and demonstrate its durable skin clearance effects”
Daniel Quirk, Chief Medical Officer at Biogen
“We are encouraged by these results that build on findings in earlier studies as we anticipate the upcoming Phase 3 study results that reflect our commitment to advancing targeted therapies for serious autoimmune conditions.”
Albert T Roy, President and CEO of the Lupus Research Alliance
“People living with cutaneous lupus erythematosus face debilitating symptoms, including scarring, hair loss, and extreme sensitivity to light, yet they have long relied on treatments not specifically developed or studied for CLE”
Albert T Roy, President and CEO of the Lupus Research Alliance
“The new data on litifilimab are encouraging because they point to the potential for both rapid symptom relief and durable improvement for people living with this condition. We look forward to seeing additional data from the Phase 3 study.”
* 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 in skin disease activity in as early as four weeks -- consistent with results seen in participants who started on litifilimab reported earlier this year * Consistent safety: Litifilimab's safety profile remained consistent with previous studies, with no new safety signals identified * Results from the Phase 3 part of AMETHYST are expected in the first half of 2027; in January 2026 the FDA granted Breakthrough Therapy Designation to litifilimab in CLE CAMBRIDGE, Mass., Oct. 02, 2026 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced 52-week results from the Phase 2 part of the ongoing AMETHYST Phase 2/3 study (Part A) of litifilimab in people living with cutaneous lupus erythematosus (CLE). The updated results, presented at the European Academy of Dermatology and Venereology (EADV) 2026 Congress in Vienna, Austria, represent the longest dataset reported for litifilimab in CLE and further support its potential to achieve rapid and durable improvements in skin disease activity. In the study, participants treated with litifilimab in the double-blind, placebo-controlled period showed continued clinical improvements in skin disease activity through Week 52. Notably, participants who switched from placebo to litifilimab treatment at Week 24 experienced a rapid onset of treatment effect as early as four weeks.
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