Etanercept Can Benefit New-Onset Type 1’s

Treatment with etanercept in pediatric patients with newly diagnosed Type 1 diabetes lowers A1c and increases ……

Dr. Teresa Quattrin, of State University of New York at Buffalo, states that, “Type 1 diabetes is a T-cell-mediated autoimmune disease characterized by selective destruction of insulin-producing beta-cells within the pancreatic islet.… Tumor necrosis factor-alpha (TNF-alpha) and other cytokines play a role in the autoimmune process leading to pancreatic destruction.… Etanercept is a recombinant soluble TNF-alpha receptor fusion protein that binds to TNF-alpha.”

The researchers conducted a 24-week, double-blind, placebo-controlled study to determine the ability of etanercept to prolong endogenous insulin production in 18 newly diagnosed Type 1 diabetes patients between 3 and 18 years old. The children were randomized to either etanercept or placebo.

Inclusion criteria for the study included GAD-65 and/or islet cell antibody positivity, A1c >6% at diagnosis, three insulin injections per day, a white blood cell count of 3,000 to 10,000, platelets >100,000, and normal liver and renal function.

At week 24, A1c values were significantly lower in the etanercept group compared with the placebo group (5.91% versus 6.98%; p < 0.05). The percent decrease from baseline was higher in the etanercept group than in the placebo group (0.41 versus 0.18; p < 0.01).

The etanercept group showed a greater percent change in C-peptide area under the curve from baseline to week 24 (39% increase in etanercept group versus 20% decrease in placebo group; p < 0.05). Insulin use decreased by 18% in the etanercept group and increased by 23% in the placebo group (p < 0.05).

No severe adverse events were observed in either group. The frequency of events was generally similar between the two groups.

Dr. Quattrin stated that, “There are many ongoing studies that are trying to test new therapies that could preserve or improve the endogenous insulin production in patients newly diagnosed with Type 1 diabetes.… By achieving this goal, patients with new-onset diabetes could maintain optimal blood sugar control for a longer time,” she explained.

“Our data indicate that etanercept has the potential to be a therapy that could be used alone or in combination to preserve or improve endogenous insulin production,” Dr. Quattrin said. “Moreover, since the process leading to pancreatic islet cell destruction takes many years, it is possible that etanercept may be of help for patients who are known to be at high risk for developing Type 1 diabetes, to slow down the islet cell production.”