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Patients with active subacute CLE or discoid lupus erythematosus were randomized to receive 100 or 150 mg PD-0360324 or placebo via intravenous infusion every 2 weeks for 3 months. Blood and urine samples were obtained pre- and post-treatment to analyse pharmacokinetics and pharmacodynamic changes in CD14+ CD16+ monocytes, urinary N-terminal telopeptide (uNTX), alanine\/aspartate aminotransferases (ALT\/AST) and creatine kinase (CK); tissue biopsy samples were taken to evaluate macrophage populations and T cells using immunohistochemistry. Clinical efficacy assessments included the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI). Among 28 randomized\/analysed patients, peak\/trough plasma concentrations increased in a greater-than-dose-proportional manner with dose increases from 100 to 150 mg. Statistically significant differences were observed between active treatment and placebo groups in changes from baseline in CD14+ CD16+ cells, uNTX, ALT, AST and CK levels at most time-points. The numbers, density and activation states of tissue macrophages and T cells did not change from baseline to treatment end. No between-group differences were seen in CLASI. Patients receiving PD-0360324 reported significantly more adverse events than those receiving placebo, but no serious adverse events. In patients with CLE, 100 and 150 mg PD-0360324 every 2 weeks for 3 months suppressed a subset of circulating monocytes and altered activity of some tissue macrophages without affecting cell populations in CLE skin lesions or improving clinical end-points.<\/jats:p>","DOI":"10.1111\/cei.12705","type":"journal-article","created":{"date-parts":[[2015,9,16]],"date-time":"2015-09-16T16:22:53Z","timestamp":1442420573000},"page":"258-270","source":"Crossref","is-referenced-by-count":26,"title":["Monoclonal antibody against macrophage colony-stimulating factor suppresses circulating monocytes and tissue macrophage function but does not alter cell infiltration\/activation in cutaneous lesions or clinical outcomes in patients with cutaneous lupus erythematosus"],"prefix":"10.1093","volume":"183","author":[{"given":"K","family":"Masek-Hammerman","sequence":"first","affiliation":[{"name":"Drug Safety Research and Development, Pfizer, Andover, MA, 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