medwireNews: Treatment with the interleukin (IL)-1 inhibitor anakinra improves both glycemic and inflammatory endpoints among patients with rheumatoid arthritis (RA) and type 2 diabetes, suggest findings from the TRACK trial.
“The inflammatory contribution to type 2 diabetes has suggested new therapeutic targets using biologic drugs designed for rheumatoid arthritis,” and the present findings “suggest that inhibition of IL-1 by anakinra may enable therapeutic targeting of both disorders,” write the investigators in PLOS Medicine.
The phase IV open-label trial included 39 individuals who had moderate-to-severe RA and an inadequate response to methotrexate, as well as type 2 diabetes with glycated hemoglobin (HbA1c) levels above 7% but below 10%. All participants were undergoing treatment with antidiabetic medications, with 74.4% taking oral drugs (primarily metformin), and 25.6% given insulin.
Roberto Giacomelli (University of L’Aquila, Italy) and fellow researchers found that average HbA1c levels at the 3-month follow-up visit were significantly lower among the 22 participants who were randomly assigned to receive anakinra 100 mg/day compared with the 17 patients who were instead given a tumor necrosis factor (TNF) inhibitor (adalimumab, certolizumab pegol, etanercept, infliximab, or golimumab), at 6.95% versus 7.63%.
Similar results were observed at 6 months, with average HbA1c levels of 6.70% versus 7.64%. The average levels at baseline were 7.73% in the anakinra group and 7.83% in the TNF inhibitor arm.
Using linear mixed models adjusted for various potential confounders, the study authors demonstrated a significant effect of anakinra treatment on overall HbA1c reduction at 3 and 6 months, but this was not observed in the TNF inhibitor group.
The TRACK (Treatment of Rheumatoid Arthritis and Comorbidities with Kineret [anakinra]) investigators note that the trial was stopped early due to the clear benefits of anakinra demonstrated when all participants reached the 6-month follow up, and data were not analyzed beyond this time point.
Participants in both the anakinra and TNF inhibitor groups experienced progressive reduction in disease activity, with no significant differences between the groups. For instance, mean DAS28 score in the anakinra group decreased from 5.42 at baseline to 2.95 at 3 months and 2.70 at 6 months. The corresponding values in the TNF inhibitor arm were 5.70, 3.94, and 3.58.
These findings confirm the efficacy of both anakinra and TNF inhibitors in RA, “as already reported by meta-analytic data,” write Giacomelli and team.
They caution that their pilot study had “some limitations, mainly due to open-label design, and future studies are necessary to fully clarify this topic.”
And they conclude: “Future studies might include the possible use of these drugs in monotherapy and as disease-modifying drugs and of the timing of the therapy.”
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