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Phase 2 trial on baricitinib shows promise for high-risk patients with diabetic kidney disease
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In a phase 2, double-blind, dose-ranging study, baricitinib showed potential as a Janus kinases 1 and 2 inhibitor, reducing albuminuria in patients with type 2 diabetes and kidney disease, according to a report published in Nephrology Dialysis Transplantation.
“We haven't had a new drug approved, at least for diabetes or hypertensive kidney disease, since the Angiotensin receptor blockers. We have an epidemic of kidney disease from these two causes leading to deaths and end stage renal disease,” said study co-author Katherine R. Tuttle, MD, FASN, FACP, FNKF. “And so, to find new targets that we could use to keep people healthy and prevent those outcomes, is an amazing opportunity and this study, I think, is a great use case for how that could happen as we discover more pathways such as the JAK2 pathway.”
In the phase 2 study, 124 patients were given one of the four doses of the JAK1/JAK2 inhibitor. Participants in the study were at least 18 years old, had type 2 diabetes and had been treated with one or more antihyperglycemic agents. Researchers randomized patients 1:1:1:1:1 to receive either baricitinib or placebo for 24 weeks followed by 4 weeks to 8 weeks of washout. Albuminuria had been used as the inflammatory marker, according to the report.
“We found that over a 6-month period, there were substantial reductions in albuminuria, which was the primary endpoint and they occurred in a dose-related fashion, with the greatest dose reduction at the highest dose,” Tuttle said. “Then, along with that, we measured a number of biomarkers of JAK2 activation in order to determine whether we hit the target or not, and we did.”
At the conclusion of the phase 2 trial, Tuttle and colleagues found baricitinib could significantly reduce albuminuria. According to the study, inhibition of JAK1/JAK2 through baricitinib has the potential to improve outcomes and treat diabetic kidney disease in patients who, despite standard therapy, remain at high risk.
“[It’s] a promising phase 2 study which looks like yes, we had the pathway, the pathway was involved in the human disease and the patients responded well to the drug. It was also an opportunity to take a medication that had been developed for another purpose and re-purpose it for another condition,” Tuttle said. “But of course, [at] this point it’s just phase 2 data, so there's no FDA label change in regard to that, but we're hoping that there might be future studies that would lead to a proper phase 3 trial.” - by Scott Buzby
Disclosure: Tuttle reports that this study was funded by Eli Lilly and Company and Incyte Corporation.
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