Antithymocyte globulin plus G-CSF combination therapy leads to sustained immunomodulatory and metabolic effects in a subset of responders with established type 1 diabetes
Open accessAbstract
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+CD56hi 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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Pilot studies found early and lasting benefit from low-dose anti-thymocyte globulin plus granulocyte colony-stimulating factor.
“low-dose anti-thymocyte globulin in combination with granulocyte colony-stimulating factor has shown early and sustained efficacy in pilot studies153,154”
From Type 1 diabetes (2018) · cites this paper as [153]
The Introduction and Conclusions (page numbers not supplied) report preservation of β-cell function for 12 months with low-dose ATG plus G-CSF. The Conclusions report sustained immunomodulatory effects at 24 months, but the difference in β-cell function versus placebo was no longer statistically significant. Thus, the paper does not establish sustained metabolic efficacy for the pilot cohort as a whole. (LLM, conf=0.89)
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- Authors
- Haller, M. J., Gitelman, S. E., Gottlieb, P. A., Michels, A. W., Perry, D. J., Schultz, A. R., Hulme, M. A., Shuster, J. J., Zou, B., Wasserfall, C. H., Posgai, A. L., Mathews, C. E., Brusko, T. M., Atkinson, M. A., & Schatz, D. A.
- Affiliations
- University of Florida Health (US)
- University of California, San Francisco (US)
- University of Colorado Denver (US)
- University of Florida (US)
- Corresponding author
- Haller, Michael J.
- ORCID
- Venue
- Diabetes
- Publisher
- American Diabetes Association
- Published
- 2016-09-26
- Volume
- 65
- Issue
- 12
- Pages
- 3765-3775
- ISSN
- 0012-1797 (ISSN-L)
- 1939-327X
- PMC
- PMC5127248
- OpenAlex
- W2525595583
- Cited by
- 70
- References
- 25
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 5 · 2023: 8 · 2022: 4 · 2021: 10 · 2020: 8 · 2019: 7 · 2018: 14 · 2017: 8
- FWCI
- 7.80
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- Leona M. and Harry B. Helmsley Charitable Trust (2014PG-T1D010, 2015PG-T1D032)
- NIH (2-2012-280, 2-PDF-2016-207-A-N)
- JDRF
- McJunkin Family Charitable Foundation
- National Center for Advancing Translational Sciences (UL1-TR-001427)
- National Center for Research Resources (UL1-TR-000004)
- American Diabetes Association (ADA 7-12-MN-030)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Surgery › Pancreatic function and diabetes
- Life Sciences › Immunology and Microbiology › Immunology › T-cell and B-cell Immunology
- Keywords
- type 1 diabetes, antithymocyte globulin, combination therapy, beta-cell function, C-peptide, immunomodulation, regulatory T cells, PD-1, natural killer cells, T cell subsets, HLA-DR expression, CXCR3, metabolic response, treatment responders
- MeSH terms
- Adolescent, Adult, Antilymphocyte Serum, C-Peptide, Child, Diabetes Mellitus, Type 1, Female, Humans, Immunologic Factors, Killer Cells, Natural, Male, Middle Aged, Monocytes, Polyethylene Glycols, Recombinant Proteins, CD4-Positive T-Lymphocytes, T-Lymphocyte Subsets, Granulocyte Colony-Stimulating Factor, Receptors, IgG, CD8-Positive T-Lymphocytes, CD56 Antigen, Area Under Curve, T-Lymphocytes, Regulatory, Forkhead Transcription Factors, Receptors, CXCR3, Young Adult
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