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Haller, Michael J.; Long, S. Alice; Blanchfield, J. Lori; Schatz, Desmond A.; Skyler, Jay S.; Krischer, Jeffrey P.; Bundy, Brian N.; Geyer, Susan M.; Warnock, Megan V.; Miller, Jessica L.; Atkinson, Mark A.; Becker, Dorothy J.; Baidal, David A.; DiMeglio, Linda A.; Gitelman, Stephen E.; Goland, Robin; Gottlieb, Peter A.; Herold, Kevan C.; Marks, Jennifer B.; Moran, Antoinette; Rodriguez, Henry; Russell, William E.; Wilson, Darrell M.; Greenbaum, Carla J.; [...]

Low-Dose Anti-Thymocyte Globulin Preserves C-Peptide, Reduces HbA1c, and Increases Regulatory to Conventional T-Cell Ratios in New-Onset Type 1 Diabetes: Two-Year Clinical Trial Data

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  • Medientyp: E-Artikel
  • Titel: Low-Dose Anti-Thymocyte Globulin Preserves C-Peptide, Reduces HbA1c, and Increases Regulatory to Conventional T-Cell Ratios in New-Onset Type 1 Diabetes: Two-Year Clinical Trial Data
  • Beteiligte: Haller, Michael J.; Long, S. Alice; Blanchfield, J. Lori; Schatz, Desmond A.; Skyler, Jay S.; Krischer, Jeffrey P.; Bundy, Brian N.; Geyer, Susan M.; Warnock, Megan V.; Miller, Jessica L.; Atkinson, Mark A.; Becker, Dorothy J.; Baidal, David A.; DiMeglio, Linda A.; Gitelman, Stephen E.; Goland, Robin; Gottlieb, Peter A.; Herold, Kevan C.; Marks, Jennifer B.; Moran, Antoinette; Rodriguez, Henry; Russell, William E.; Wilson, Darrell M.; Greenbaum, Carla J.; [...]
  • Erschienen: American Diabetes Association, 2019
  • Erschienen in: Diabetes
  • Sprache: Englisch
  • DOI: 10.2337/db19-0057
  • ISSN: 0012-1797; 1939-327X
  • Schlagwörter: Endocrinology, Diabetes and Metabolism ; Internal Medicine
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:p>A three-arm, randomized, double-masked, placebo-controlled phase 2b trial performed by the Type 1 Diabetes TrialNet Study Group previously demonstrated that low-dose anti-thymocyte globulin (ATG) (2.5 mg/kg) preserved β-cell function and reduced HbA1c for 1 year in new-onset type 1 diabetes. Subjects (N = 89) were randomized to 1) ATG and pegylated granulocyte colony-stimulating factor (GCSF), 2) ATG alone, or 3) placebo. Herein, we report 2-year area under the curve (AUC) C-peptide and HbA1c, prespecified secondary end points, and potential immunologic correlates. The 2-year mean mixed-meal tolerance test–stimulated AUC C-peptide, analyzed by ANCOVA adjusting for baseline C-peptide, age, and sex (n = 82) with significance defined as one-sided P &amp;lt; 0.025, was significantly higher in subjects treated with ATG versus placebo (P = 0.00005) but not ATG/GCSF versus placebo (P = 0.032). HbA1c was significantly reduced at 2 years in subjects treated with ATG (P = 0.011) and ATG/GCSF (P = 0.022) versus placebo. Flow cytometry analyses demonstrated reduced circulating CD4:CD8 ratio, increased regulatory T-cell:conventional CD4 T-cell ratios, and increased PD-1+CD4+ T cells following low-dose ATG and ATG/GCSF. Low-dose ATG partially preserved β-cell function and reduced HbA1c 2 years after therapy in new-onset type 1 diabetes. Future studies should determine whether low-dose ATG might prevent or delay the onset of type 1 diabetes.</jats:p>
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