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Defining CLASI-A improvement in CLE: Phase II AMETHYST trial Part A
Results from an analysis of Part A of the phase II AMETHYST trial (NCT05531565), evaluating litifilimab in patients with active chronic and/or subacute cutaneous lupus erythematosus (CLE), with or without systemic manifestations, who are refractory or intolerant to antimalarial therapy, were presented by François Chasset at the European Academy of Dermatology and Venereology (EADV) Congress 2026, September 30 – October 3, 2026, Vienna, AT. The objective of this analysis was to estimate clinically meaningful improvements in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) Total score.
Key data: All evaluated anchors correlated ≥0.35 with the CLASI-A Total score at ≥1 timepoint(s), with greater correlations observed with Clinician Global Assessment of Skin (CGA) vs Subject Global Assessment of Skin (SGA) and with percentage vs numeric CLASI-A change. Final estimated meaningful within-patient change (MWPC) improvement in CLASI-A Total score ranged from 35% to 55% and from 7.0 to 8.0 for percentage and numeric changes, respectively; mean 1-category improvement estimates were 40% and 8.0, respectively. Across Weeks 16–24, the mean 1-category change from baseline in CLASI-A Total score was −4.5 to −9.1 for numeric change and −19.5 to −50.8 for percentage change.
Key learning: Results from this AMETHYST Part A analysis demonstrate that CLASI-A Total score change from baseline, particularly percentage change, reflects clinician and patient perception of meaningful change, supporting the applicability of CLASI-A change as an endpoint in CLE clinical trials.
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