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- Title
Low-Dose ATG/GCSF in Established Type 1 Diabetes: A Five-Year Follow-up Report.
- Authors
Lin, Andrea; Mack, Jasmine A.; Bruggeman, Brittany; Jacobsen, Laura M.; Posgai, Amanda L.; Wasserfall, Clive H.; Brusko, Todd M.; Atkinson, Mark A.; Gitelman, Stephen E.; Gottlieb, Peter A.; Gurka, Matthew J.; Mathews, Clayton E.; Schatz, Desmond A.; Haller, Michael J.
- Abstract
Previously, we demonstrated low-dose antithymocyte globulin (ATG) and granulocyte colony-stimulating factor (GCSF) immunotherapy preserved C-peptide for 2 years in a pilot study of patients with established type 1 diabetes (n 5 25). Here, we evaluated the long-term outcomes of ATG/GCSF in study participants with 5 years of available follow-up data (n 5 15). The primary end point was area under the curve (AUC) C-peptide during a 2-h mixed-meal tolerance test. After 5 years, there were no statistically significant differences in AUC C-peptide when comparing those who received ATG/GCSF versus placebo (P = 0.41). A modeling framework based on mean trajectories in C-peptide AUC over 5 years, accounting for differing trends between groups, was applied to recategorize responders (n 5 9) and nonresponders (n 5 7). ATG/GCSF reponders demonstrated nearly unchanged HbA1c over 5 years (mean [95% CI] adjusted change 0.29% [-0.69%, 1.27%]), but the study was not powered for comparisons against nonresponders 1.75% (-0.57%, 4.06%) or placebo recipients 1.44% (0.21%, 2.66%). These data underscore the importance of long-term follow-up in previous and ongoing phase 2 trials of low-dose ATG in recent-onset type 1 diabetes.
- Publication
Diabetes, 2021, Vol 70, Issue 5, p1123
- ISSN
0012-1797
- Publication type
Article
- DOI
10.2337/db20-1103