31341 BIIB059 reduces disease activity over 16 weeks in active cutaneous lupus erythematosus (CLE): Results from part B of phase 2 LILAC study

Abstract

Part B of the phase 2 LILAC (NCT02847598) study demonstrated at week 16 the efficacy of BIIB059 50, 150, and 450 mg versus placebo (CLASI-50 response [450 mg; P = .024]) subcutaneously administered every 4 weeks (with 1 additional dose at week 2) in CLE participants with active SCLE and/or chronic CLE lesions. In these exploratory analyses, we evaluated the proportion of participants with a 20% (CLASI-20 response) or 70% (CLASI-70 response) improvement in CLASI-A score over 16 weeks. Among 132 participants, 26, 25, 48, and 33 received BIIB059 50, 150, and 450 mg and placebo, respectively. For BIIB059 50, 150, and 450 mg versus placebo, the proportion of participants who achieved CLASI-20 response was 15.4%, 28.0%, and 33.3% versus 15.2% at week 2; 42.3%, 64.0%, and 56.3% versus 30.3% at week 4; 50.0%, 76.0%, and 52.1% versus 42.4% at week 8; 50.0%, 80.0%, and 56.3% versus 42.4% at week 12; and 46.2%, 72.0%, and 72.1% versus 43.8% at week 16. For the same treatment groups, the proportion of participants who achieved CLASI-70 response was 3.8%, 0, and 0 versus 0 at week 2; 3.8%, 12.0%, and 10.4% versus 0 at week 4; 19.2%, 24.0%, and 18.8% versus 6.1% at week 8; 19.2%, 24.0%, and 14.6% versus 6.1% at week 12; and 15.4%, 32.0%, and 27.9% versus 9.4% at week 16. A greater proportion of CLE participants treated with BIIB059 versus placebo had improvement in disease activity over time using different thresholds for CLASI-A response.