Golimumab and Beta-Cell Function in Youth with New-Onset Type 1 Diabetes
Serum levels of tumor necrosis factor-α (TNF-α) are usually elevated in patients with new-onset of overt type 1 diabetes. While Golimumab, a human monoclonal antibody specific for TNF α has already been approved for the treatment of several autoimmune conditions in adults and children; its effect in maintaining beta-cell function in young patients with newly diagnosed overt type 1 diabetes is not known. The author Quattrin and colleagues (2020) published research titled “Golimumab and Beta-Cell Function in Youth with New-Onset Type 1 Diabetes” in the New England Journal of Medicine. The summary of this research paper is given below:
Objectives:
To study the effect of golimumab in preserving beta-cell function as well as in improving diabetes-related clinical and metabolic measures in children and young adults with newly diagnosed overt (stage 3) type 1 diabetes.
Method:
It was a multicenter, placebo-controlled, double-blind, parallel-group trial conducted for 52 weeks. Children and young adults who were newly diagnosed with overt type 1 diabetes were randomly assigned in the 2:1 ratio for receiving subcutaneous golimumab or placebo.
Primary outcome- endogenous insulin production, as assessed according to the 4-hour C-peptide AUC at week 52.
Secondary outcome- insulin use, the number of hypoglycemic events, the glycated hemoglobin level, the ratio of fasting proinsulin to C-peptide over time, and response profile.
Findings:
Investigators report better endogenous insulin production, less exogenous insulin use, and improved glycemic control in participants of the golimumab group as compared to the placebo group. Golimumab was also found to increase the period of remission also known as the honeymoon period. Additionally, the ratio of fasting proinsulin to C-peptide was unchanged in golimumab participants whereas it was increased over time among the placebo group. This finding suggests improved beta-cell health.
Limitation:
The study included small sample size and fewer participants with coexisting conditions. Hence, the findings cannot be generalized. Due to the lack of information about continuous insulin infusion or continuous glucose monitoring, the effect of those methods on the results cannot be assessed.
The authors acknowledge future studies to determine the extent of beta-cell preservation and how to improve golimumab efficacy.
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