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Anakinra Provides Sustained Benefits for Diabetes

Posted: Wednesday, September 30, 2009

Months after withdrawal of the interleukin-1 receptor antagonist (IL-1Ra) anakinra, patients with Type 2 diabetes still show improvements in beta cell function, hemoglobin A1c levels, and markers of systemic inflammation, according to a new published report.

Dr. Thomas Mandrup-Poulsen from the Hagedorn Research Institute and Steno Diabetes Center in Gentofte, Denmark, stated that, "Type 2 diabetes is in part caused by an inflammatory process in the islets in which IL-1 seems to be a key mediator."

Dr. Mandrup-Poulsen and his colleagues had shown previously that 13 weeks of anakinra treatment improved these three parameters (beta-cell function, A1c and systemic inflammation) in Type 2 diabetics. Of the 70 patients originally randomized to treatment with anakinra or placebo, 64 remained in the study to the end of the 39-week follow-up period.

Thirty-nine weeks after withdrawal of anakinra, the proinsulin/insulin ratio remained significantly lower in the former anakinra-treated patients than in the former placebo-treated patients, the authors report. The same was true of C-reactive protein and IL-6 levels.

At the end of the 13-week lead-in period, there had not been any between-group difference in A1c reduction, insulin sensitivity, average increase in daily insulin dose, or average increase in daily metformin dose. At 39 weeks after anakinra withdrawal, however, previous responders had maintained their improved beta-cell function and had achieved their target hemoglobin A1c levels with significantly lower increases in their insulin doses, compared to anakinra-unresponsive patients.

In subgroup analyses, low baseline serum IL-1Ra levels predicted the metabolic response, in association with the C allele of an IL1RN single nucleotide polymorphism.

"The disease may in fact be an autoinflammatory disorder belonging to a subgroup of the deficiency of IL-1Ra diseases (DIRA) in that genetic variations in the IL-1Ra gene cause IL-1Ra deficiency in about 40% of Type 2 patients which therefore will benefit from IL-1Ra substitution therapy," Dr. Mandrup-Poulsen explained.

"We suggest that a short course of IL-1 blockade could be envisaged as add on to existing antidiabetic therapy to break the vicious cycle of glucose induced IL-1 and IL-1 autoinduction in beta-cells," he continued.

"We have moved on with a phase II trial in Type 1 diabetes of recent onset," Dr. Mandrup-Poulsen added.

Kineret® (anakinra) is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease-modifying antirheumatic drugs (DMARDs). Kineret® can be used alone or in combination with DMARDs other than tumor necrosis factor (TNF) blocking agents.

Source: Diabetes In Control: Diabetes Care Sept. 2009;32:1663-1668.

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