American Diabetes Association
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Two-year follow up from the T1GER study: Continued off-therapy metabolic improvements in children and young adults with new onset T1D treated with golimumab and characterization of responders

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posted on 2022-12-28, 18:23 authored by Mark Rigby, Beverly Hayes, Yinglei Liu, Frank Vercruysse, Joseph A. Hedrick, Teresa Quattrin


OBJECTIVE. The T1GER study showed many metabolic benefits of the TNF-α blocker golimumab in children and young adults with Type 1 diabetes (T1D). Off therapy effects are reported. 

RESEARCH DESIGNS AND METHODS. T1GER was a Phase 2, placebo-controlled randomized trial in which golimumab or placebo was administered for 52 weeks to participants 6-21 years old diagnosed with T1D diagnosed within 100 days. Assessments occurred during the 52-week on-therapy and 52-week off-therapy periods. 

RESULTS. After stopping treatment, C-peptide AUCs remained greater in the treatment versus control group. At Weeks 78 and 104 the golimumab group had lower reductions in 4h C-peptide AUC from baseline where the golimumab groups had reductions of 0.31 and 0.41 nmol/L, while the placebo group had reductions of 0.64 and 0.74 nmol/L. There were also trends in less insulin use, higher peak C-peptide levels and those in partial remission and higher peak C-peptide levels in the golimumab group. Golimumab responders, defined as having an increase or minimal loss of C-peptide AUC and/or being in partial remission at Week 52, showed even greater improvements in most metabolic parameters on and off therapy and had less hypoglycemia during the off-therapy period versus placebo. Adverse events, including infections, were similar between the groups during all time periods of the study.

CONCLUSIONS. In children and young adults with new onset T1D, golimumab preserved endogenous beta cell function and resulted in other favorable metabolic parameters on and off therapy. A subpopulation had disease stabilization while on-therapy with improved metabolic parameters off therapy.


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