BIIB059 demonstrated efficacy against BDCA2 in patients with active cutaneous lupus erythematosus (CLE) regardless of concomitant systemic lupus erythematosus (SLE), according to study results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held online from April 23 to April 25, 2021.
This phase 2, 2-part, double-blind, randomized controlled trial included 132 patients in the following treatment categories: BIIB059 50 mg, BIIB059 150 mg, BIIB059 450 mg, and placebo. Among this population, 57 patients had SLE and 75 did not; 106 patients had baseline CLE Disease Area and Severity Index Activity (CLASI-A) scores of at least 10, and 26 patients had scores below 10. Least squares mean differences were computed with 95% CI for 16-week percentage change from baseline in CLASI-A scores.
Among those with SLE, 16-week least squares mean differences in percentage CLASI-A change were -31.01% for BIIB059 50mg; -34.93 for BIIB059 150 mg; and -19.04 for BIIB059 450 mg. Among those without SLE, these changes were -21.08 for BIIB059 50 mg, -33.58 for BIIB059 150 mg, and -36.52 for BIIB059 450 mg.
At week 16, these differences for those with CLASI-A ≥10 were 23.48 for BIIB059 50 mg, 28.08 for BIIB059 150 mg, and 26.21 for BIIB059 450 mg. For CLASI-A <10, the percentage changes were 25.38 for BIIB059 50 mg, 59.37 for BIIB059 150 mg, and 28.64 for BIIB059 450 mg. Among those in the placebo group, 66.7% experienced any adverse event; among those treated with BIIB059, it was 71.7%.
The study researchers concluded that “[treatment] with BIIB059 reduced skin disease activity compared with placebo, regardless of concomitant SLE or disease severity at baseline.” Small sample sizes limited subgroup analyses, but researchers indicated that “results were consistent with the overall CLE population from the LILAC study Part B.” Adverse events were largely mild or moderate and were similar between placebo and treatment groups.
Disclosures: Some study authors declared affiliations with the pharmaceutical industry. Please see the reference for a full list of authors’ disclosures.
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Werth VP, Furie RA, Sofen H, et al. Efficacy of the BIIB059 monoclonal antibody against BDCA2 in active cutaneous lupus erythematosus (CLE): subgroup analyses of participants with or without systemic LE (SLE) and with different levels of disease activity. Presented at: AAD VMX 2021; April 23-25, 2021. Abstract/Poster 27475.