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
Authors' conclusion
In children and young adults with new-onset T1D, golimumab preserved endogenous β-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.
Study context
- Population
- Participants aged 6–21 years diagnosed with T1D within 100 days of randomization
- Comparison
- Golimumab vs placebo for 52 weeks, followed by 52 weeks off therapy
Methodological detailsphase 2, placebo-controlled, off-therapy follow-up
- Phase 2
- Placebo-controlled
- Off-therapy follow-up
Primary result
As reported in the abstract
Reduction from baseline in 4-h C-peptide AUC · weeks 78 and 104
Golimumab
0.31 and 0.41
nmol/L
Placebo
0.64 and 0.74
nmol/L
Further findings
Insulin use, peak C-peptide and partial remission
- Trends in less insulin use, higher peak C-peptide levels and more in partial remission with golimumab
Golimumab responders (increase or minimal loss of C-peptide AUC and/or partial remission at week 52)
- Even greater improvements in most metabolic parameters on and off therapy and less hypoglycemia off therapy vs placebo
Safety
Adverse events, including infections · all study periods
- Similar between the groups
Original publication
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. Diabetes Care. Published 28 December 2022. doi:10.
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