Journal of the American Academy of Dermatology · 2026
Efficacy and safety of litifilimab in cutaneous lupus erythematosus: 24-week results of the randomized phase 2 study, AMETHYST.
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Merola Joseph F, Werth Victoria P, Chong Benjamin F, Nyberg Filippa, Morand Eric F, Fivenson David, Chasset Francois, Carroll Hua, Li Qianyun, Schindelar Michael, Pournara Effie, Yang Weihong, AMETHYST Part A Study Group
Аннотация
BACKGROUND: Cutaneous lupus erythematosus (CLE) is a serious autoimmune disease with no approved targeted treatments.
OBJECTIVE: Evaluate the efficacy and safety of litifilimab in AMETHYST Part A (Phase 2).
METHODS: AMETHYST is a randomized, double-blind, placebo-controlled, Phase 2/3 study that investigates litifilimab in participants with CLE. Participants were randomized to receive litifilimab 225 mg or placebo every 4 weeks during Weeks 0-24. The primary endpoint was the Cutaneous Lupus Activity Investigator's Global Assessment-Revised (CLA-IGA-R) erythema score of 0-1 at Week 16, with several Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-based endpoints at Week 24 as secondary endpoints. Safety was also assessed.
RESULTS: Significantly more participants treated with litifilimab achieved clear/almost clear skin (CLA-IGA-R erythema 0-1) than those treated with placebo at Week 16 (14.7% vs 2.9%, P= .0263). Additionally, more participants treated with litifilimab achieved CLASI-70 response vs placebo at Week 24 (21.7% vs 5.8%, P = .0195). Litifilimab was generally well tolerated; safety data were consistent with prior studies.
LIMITATIONS: Study was not powered to detect statistically significant differences in secondary endpoints.
CONCLUSION: Litifilimab treatment led to greater improvements in skin disease activity vs placebo and was well tolerated in participants with CLE through Week 24.
OBJECTIVE: Evaluate the efficacy and safety of litifilimab in AMETHYST Part A (Phase 2).
METHODS: AMETHYST is a randomized, double-blind, placebo-controlled, Phase 2/3 study that investigates litifilimab in participants with CLE. Participants were randomized to receive litifilimab 225 mg or placebo every 4 weeks during Weeks 0-24. The primary endpoint was the Cutaneous Lupus Activity Investigator's Global Assessment-Revised (CLA-IGA-R) erythema score of 0-1 at Week 16, with several Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-based endpoints at Week 24 as secondary endpoints. Safety was also assessed.
RESULTS: Significantly more participants treated with litifilimab achieved clear/almost clear skin (CLA-IGA-R erythema 0-1) than those treated with placebo at Week 16 (14.7% vs 2.9%, P= .0263). Additionally, more participants treated with litifilimab achieved CLASI-70 response vs placebo at Week 24 (21.7% vs 5.8%, P = .0195). Litifilimab was generally well tolerated; safety data were consistent with prior studies.
LIMITATIONS: Study was not powered to detect statistically significant differences in secondary endpoints.
CONCLUSION: Litifilimab treatment led to greater improvements in skin disease activity vs placebo and was well tolerated in participants with CLE through Week 24.