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Canakinumab, anakinra ineffective for new-onset type 1 diabetes

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In two clinical trials, the inhibition of interleukin-1 beta combined with either canakinumab or anakinra did not slow the decline of beta-cell function in new-onset type 1 diabetes, according to data published in The Lancet.

Researchers enrolled patients in the canakinumab (Ilaris, Novartis) trial (aged 6 to 45 years) between November 2010 and April 2011 and in the anakinra (Kineret, Sobi/Savient Pharmaceuticals) trial (aged 18 to 35 years) between January 2009 and May 2011.

According to data, 69 patients were randomly assigned to 2 mg/kg canakinumab injection (n=47) or placebo (n=22) per month for 12 months, and 69 were randomly assigned to 100 mg anakinra (n=35) or placebo (n=34) daily for 9 months. Primary analyses included 45 canakinumab-treated and 21 placebo-treated patients in the canakinumab trial and 25 anakinra-treated and 26 placebo-treated patients in the anakinra trial, researchers wrote.

Researchers reported a difference in C-peptide area under curve (AUC) between the canakinumab and placebo groups at 12 months (0.01 nmol/L; 95% CI, –0.11 to 0.14) and between the anakinra and the placebo groups at 9 months (0.02 nmol/L; 95% CI, –0.09 to 0.15).

However, they wrote that the number and severity of adverse events did not differ between groups in the canakinumab trial. Conversely, data indicate patients in the anakinra trial (anakinra group) had significantly greater adverse events than the placebo group (P=.018), predominantly due to a higher number of injection site reactions in the anakinra group.

Although canakinumab and anakinra were deemed safe, the agents were not efficacious as a single immunomodulatory drug in recent-onset type 1 diabetes, researchers wrote. Additionally, IL-1 beta could be more effective combined with treatments that target adaptive immunity in organ-specific autoimmune disorders.

For more information:

Bonifacio E. Lancet. 2013;doi:10.1016/S0140-6736(13)60257-3.

Moran A. Lancet. 2013;doi:10.1016/S0140-6736(13)60023-9.

Disclosure: See the study for a full list of disclosures.