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Etanercept treatment in children with new-onset type 1 diabetes: pilot randomized, placebo-controlled, double-blind
Lucy Mastrandrea1, Jihnhee Yu, Torsten Behrens
1Department of Pediatrics, School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.
Insights
Etanercept therapy in children with new-onset type 1 diabetes showed promise in preserving beta-cell function, leading to lower A1C and increased insulin production. Further research is warranted to confirm these findings.
Area of Science:
- Immunology
- Endocrinology
- Pediatric Diabetes Research
Background:
- Type 1 diabetes (T1D) is an autoimmune disease characterized by the destruction of insulin-producing beta cells.
- Preserving residual beta-cell function is crucial for improving glycemic control and reducing long-term complications in pediatric T1D.
- Etanercept, a tumor necrosis factor inhibitor, has immunomodulatory properties that may protect beta cells from autoimmune attack.
Purpose of the Study:
- To evaluate the feasibility and efficacy of etanercept in prolonging endogenous insulin production in newly diagnosed pediatric patients with T1D.
- To gather preliminary data on the impact of etanercept on glycemic control (A1C) and beta-cell function (C-peptide).
Main Methods:
- A 24-week, double-blind, randomized, placebo-controlled pilot study.
- Eighteen pediatric patients (aged 7.8-18.2 years) with newly diagnosed T1D received either etanercept or placebo.
- Key inclusion criteria included antibody positivity, A1C >6%, and requirement for insulin injections.
Main Results:
- Etanercept group showed significantly lower A1C at 24 weeks (5.91% vs. 6.98% placebo; P < 0.05).
- Increased C-peptide area under the curve observed in the etanercept group (39% increase) compared to a decrease in the placebo group (20% decrease; P < 0.05).
- Insulin dose decreased by 18% in the etanercept group versus a 23% increase in the placebo group (P < 0.05).
Conclusions:
- Etanercept therapy in pediatric T1D patients demonstrated potential in lowering A1C and enhancing endogenous insulin production.
- These findings suggest that etanercept may help preserve beta-cell function in new-onset T1D.
- A larger study is recommended to further investigate the safety and efficacy of etanercept for T1D treatment.
Objective:
To gather preliminary data on the feasibility and efficacy of etanercept therapy to prolong endogenous insulin production in pediatric patients with newly diagnosed type 1 diabetes.
Research Design And Methods:
This was a 24-week double-blind, randomized, placebo-controlled study conducted at the Diabetes Center, Women and Children's Hospital of Buffalo. Eighteen subjects (11 male and 7 female, aged 7.8-18.2 years) were randomly assigned to receive either placebo or etanercept. Inclusion criteria included age 3-18 years, GAD-65 and/or islet cell antibody positivity, A1C >6%, three insulin injections per day, white blood cell count 3,000-10,000, platelets >100,000, and normal liver and renal function. Intention-to-treat analysis was used.
Results:
A1C at week 24 was lower in the etanercept group (5.91 +/- 0.5%) compared with that in the placebo group (6.98 +/- 1.2%; P < 0.05) with a higher percent decrease from baseline than in the placebo group (etanercept 0.41 +/- 0.1 vs. placebo 0.18 +/- 0.21; P < 0.01). The percent change in C-peptide area under the curve from baseline to week 24 showed a 39% increase in the etanercept group and a 20% decrease in the placebo group (P < 0.05). From baseline to week 24 insulin dose decreased 18% in the etanercept group compared with a 23% increase in the placebo group (P < 0.05). Seventeen patients completed the study, and none withdrew because of adverse events.
Conclusions:
In this small pilot study, treatment of pediatric patients newly diagnosed with type 1 diabetes with etanercept resulted in lower A1C and increased endogenous insulin production, suggesting preservation of beta-cell function. A larger study is needed to further explore safety and efficacy.
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