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Haller, Michael J; Gitelman, Stephen E; Gottlieb, Peter A; Michels, Aaron W; Perry, Daniel J; Schultz, Andrew R; Hulme, Maigan A; Shuster, Jonathan J; Zou, Baiming; Wasserfall, Clive H; Posgai, Amanda L; Mathews, Clayton E; Brusko, Todd M; Atkinson, Mark A; Schatz, Desmond A
Diabetes (New York, N.Y.), 12/2016, Letnik: 65, Številka: 12Journal Article
Low-dose antithymocyte globulin (ATG) plus pegylated granulocyte colony-stimulating factor (G-CSF) preserves β-cell function for at least 12 months in type 1 diabetes. Herein, we describe metabolic and immunological parameters 24 months following treatment. Patients with established type 1 diabetes (duration 4-24 months) were randomized to ATG and pegylated G-CSF (ATG+G-CSF) (N = 17) or placebo (N = 8). Primary outcomes included C-peptide area under the curve (AUC) following a mixed-meal tolerance test (MMTT) and flow cytometry. "Responders" (12-month C-peptide ≥ baseline), "super responders" (24-month C-peptide ≥ baseline), and "nonresponders" (12-month C-peptide < baseline) were evaluated for biomarkers of outcome. At 24 months, MMTT-stimulated AUC C-peptide was not significantly different in ATG+G-CSF (0.49 nmol/L/min) versus placebo (0.29 nmol/L/min). Subjects treated with ATG+G-CSF demonstrated reduced CD4 T cells and CD4 /CD8 T-cell ratio and increased CD16 CD56 natural killer cells (NK), CD4 effector memory T cells (Tem), CD4 PD-1 central memory T cells (Tcm), Tcm PD-1 expression, and neutrophils. FOXP3 Helios regulatory T cells (Treg) were elevated in ATG+G-CSF subjects at 6, 12, and 18 but not 24 months. Immunophenotyping identified differential HLA-DR expression on monocytes and NK and altered CXCR3 and PD-1 expression on T-cell subsets. As such, a group of metabolic and immunological responders was identified. A phase II study of ATG+G-CSF in patients with new-onset type 1 diabetes is ongoing and may support ATG+G-CSF as a prevention strategy in high-risk subjects.
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