Once-daily JAK inhibitor helps preserve beta-cell function in type 1 diabetes
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Key takeaways:
- Children and adults with type 1 diabetes receiving baricitinib had higher mean C-peptide at 48 weeks than those receiving placebo.
- Those receiving baricitinib had more time in range compared with placebo.
A Janus kinase inhibitor may preserve beta-cell function for children and young adults recently diagnosed with type 1 diabetes, according to findings published in The New England Journal of Medicine.
In a randomized controlled trial enrolling children and adults aged 10 to 30 years with type 1 diabetes, once-daily treatment with the Janus kinase (JAK) inhibitor baricitinib (Olumiant, Eli Lilly/Incyte) conferred a higher mean C-peptide level at 48 weeks compared with placebo. Participants receiving baricitinib also required lower insulin doses and had better continuous glucose monitoring metrics at 48 weeks.
“Type 1 diabetes may be treated as an autoimmune disease with treatment to prevent loss of natural production of insulin rather than as a hormone deficiency disease with insulin by injection as has been the treatment for more than 100 years,” Thomas W.H. Kay, MBBS, PhD, professor and director of St Vincent’s Institute in Melbourne, Australia, told Healio.
Kay and colleagues enrolled 91 children and adults diagnosed with type 1 diabetes within 100 days of starting the trial who had the presence of at least one islet autoantibody and a random C-peptide level of more than 0.3 nmol/L or a C-peptide level of more than 0.2 nmol/L on a 2-hour mixed-meal tolerance test. Participants were randomly assigned, 2:1, to 4 mg baricitinib (n = 61) or matching placebo (n = 30) once daily for 48 weeks. Mean C-peptide level measured during a 2-hour mixed-meal tolerance test at 48 weeks was the primary outcome. Secondary measures included HbA1c, total daily insulin dose and CGM metrics.
At 48 weeks, people receiving baricitinib had a higher mean C-peptide level than those receiving placebo (0.65 nmol/L per minute vs. 0.43 nmol/L per minute; P = .001). Mean daily insulin dose decreased at 12 and 24 weeks in the baricitinib group and increased at those same time points in the placebo group. Mean daily insulin dose was 0.41 U/kg in the baricitinib group and 0.52 U/kg in the placebo group at 48 weeks.
At 48 weeks, mean HbA1c was 7% for adults receiving baricitinib and 7.5% for the placebo group. Time in range with a glucose level of 70 mg/dL to 180 mg/dL was higher for people receiving baricitinib vs. placebo. The baricitinib group also had a lower time above range with a glucose level of more than 180 mg/dL than the placebo group. Both groups had very low time below range with glucose of less than 70 mg/dL.
There were seven serious adverse events recorded in the study, with none attributed to baricitinib or placebo. The median number of adverse events per participant was similar between the two groups.
Kay said more studies are needed to further analyze the impact of baricitinib on people with type 1 diabetes.
“A larger phase 3 [study is needed] to meet the requirements of the FDA to license the drug for type 1 diabetes,” Kay said. “Also, other studies of longer duration of administration to see how long the beneficial effects last. Also, treating people earlier in the course of type 1 diabetes when they have a larger mass of insulin-producing beta cells.”
For more information:
Thomas W.H. Kay, MBBS, PhD, can be reached at tkay@svi.edu.au.
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