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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.
Rigby, Mark R; Hayes, Beverly; Li, Yinglei; Vercruysse, Frank; Hedrick, Joseph A; Quattrin, Teresa.
Afiliación
  • Rigby MR; 1Janssen Pharmaceuticals Inc. Research and Development, Springhouse, PA.
  • Hayes B; 1Janssen Pharmaceuticals Inc. Research and Development, Springhouse, PA.
  • Li Y; 1Janssen Pharmaceuticals Inc. Research and Development, Springhouse, PA.
  • Vercruysse F; 2Janssen Pharmaceuticals Inc. Research and Development, Beerse, Belgium.
  • Hedrick JA; 1Janssen Pharmaceuticals Inc. Research and Development, Springhouse, PA.
  • Quattrin T; 3The Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY.
Diabetes Care ; 46(3): 561-569, 2023 03 01.
Article en En | MEDLINE | ID: mdl-36576974
OBJECTIVE: The T1GER (A Study of SIMPONI to Arrest ß-Cell Loss in Type 1 Diabetes) study showed many metabolic benefits of the tumor necrosis factor-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 within 100 days of randomization. Assessments occurred during the 52-week on-therapy and 52-week off-therapy periods. RESULTS: After treatment was stopped, C-peptide area under the curve (AUC) remained greater in the treatment versus control group. At weeks 78 and 104, the golimumab group had lower reductions in the 4-h C-peptide AUC baseline than the placebo group, where specifically the golimumab group had reductions of 0.31 and 0.41 nmol/L, and 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 ß-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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 1 Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adolescent / Adult / Child / Humans Idioma: En Revista: Diabetes Care Año: 2023 Tipo del documento: Article Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Diabetes Mellitus Tipo 1 Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Adolescent / Adult / Child / Humans Idioma: En Revista: Diabetes Care Año: 2023 Tipo del documento: Article Pais de publicación: Estados Unidos