Effect of iberdomide on cutaneous manifestations in systemic lupus erythematosus: A randomized phase 2 clinical trial

作者：Victoria P. Werth, Joan T. Merrill, Richard Furie, Thomas E. Dorner, Ronald van Vollenhoven, Peter E. Lipsky, Michael Weiswasser, Shimon Korish, Peter Schäfer, MARK B. STERN, Stan Z. Li, Nikolay Delev · 发表于：Journal of the American Academy of Dermatology · 年份：2024 · DOI：10.1016/j.jaad.2024.09.074 · 被引用次数：7 · 研究领域：Systemic Lupus Erythematosus Research、Systemic Sclerosis and Related Diseases、Rheumatoid Arthritis Research and Therapies

BACKGROUND: Iberdomide, a cereblon modulator, promotes degradation of transcription factors Ikaros and Aiolos. OBJECTIVE: Evaluate iberdomide efficacy and safety in cutaneous lupus erythematosus (CLE) in a phase 2 study. METHODS: Patients were randomized (2:2:1:2) to iberdomide 0.45 (n = 81), 0.30 (n = 82), or 0.15 mg (n = 42) or placebo (n = 83) daily while continuing background lupus medications. RESULTS: The mean (SD) baseline Cutaneous Lupus Area and Severity Index Activity (CLASI-A) score was 6.9 (7.0); 28% of patients had a score ≥8; 56% had acute CLE, 29% chronic CLE, and 16% subacute CLE. Mean CLASI-A improvement in patients with baseline score ≥8 was 39.7% for iberdomide 0.45 mg versus 20.1% for placebo at week 4 (P = .032), with continued improvement through week 24 (66.7% vs 54.2%; P = .295). Proportions of patients achieving ≥50% CLASI-A reduction from baseline at week 24 were significantly greater for iberdomide 0.45 mg versus placebo for patients with subacute (91.7% vs 52.9%, P = .035) and chronic (62.1% vs 27.8%; P = .029) CLE but not for the overall population (55.6% vs 44.6%) or patients with baseline CLASI-A ≥8 (66.7% vs 50.0%). LIMITATIONS: Small patient subgroups of CLE subtypes. CONCLUSIONS: Iberdomide showed beneficial effects when added to background lupus medications in patients with subacute and chronic CLE.