Pharmacodynamics, Safety, and Clinical Efficacy of AMG 811, a Human Anti-Interferon-γ Antibody, in Patients With Discoid Lupus Erythematosus [skin]. Homo sapiens

This is a phase I randomized, double-blind, placebo-controlled crossover study which sought to evaluate a single dose of AMG 811, an anti-IFNγ antibody, in patients with DLE. The patients in sequence 1 received AMG 811 followed by placebo, while those in sequence 2 received placebo followed by AMG 811. Pharmacodynamic end points included global transcriptional analyses of lesional and nonlesional skin, IFNγ blockade signature (IGBS) transcriptional scores in the skin and blood, keratinocyte IFNγ RNA scores, and serum levels of CXCL10 protein Overall design: Sixteen patients with DLE were enrolled in the study (9 in sequence 1 and 7 in sequence 2). The patients in sequence 1 received AMG 811 (180mg) followed by placebo, while those in sequence 2 received placebo followed by AMG 811 (180 mg). Biopsy specimens of lesional and nonlesional skin were collected at baseline, and biopsy specimens of lesional skin were collected on days 15 and 57 postdosing.