- Researchers have published the results of the first human clinical trial on the effectiveness of the rheumatoid arthritis drug baricitinib for treating new-onset type 1 diabetes.
- Baricitinib is a disease-modifying drug that works by preserving the functioning of insulin-producing beta cells in the pancreas.
- The data from the clinical trial is still limited by a small number of participants and observation period.
A new treatment for type 1 diabetes could be on the horizon, according to a new study.
Researchers have completed the first human clinical trial of the rheumatoid arthritis (RA) and alopecia drug baricitinib, sold under the trade name Olumiant, for the treatment of new-onset type 1 diabetes.
The drug offers a novel approach to treating type 1 diabetes that aims to try and preserve the body’s ability to produce insulin, rather than simply replacing it through injections.
Baricitininb belongs to a class of drugs known as Janus kinase inhibitors or JAK inhibitors. The drugs work on the body by modulating signaling to the immune system. For individuals with rheumatoid or autoimmune conditions, JAK inhibitors help prevent the immune system from becoming overactive and attacking the body itself.
Now researchers are demonstrating that this same mechanism can be utilized for type 1 diabetes, which is caused by the destruction of the body’s natural insulin producing beta cells in the pancreas. But there’s a catch: the drug needs to be used as soon after diagnosis as possible to help preserve insulin function before those cells are totally destroyed.
“They [JAKs] target immune system pathways that cause type 1 diabetes and prevent the loss of the body’s natural ability to produce insulin rather than administering insulin by injection which has been the treatment for type 1 diabetes for 100 years,” Professor Thomas Kay, MD, PhD, Director of St Vincent’s Institute of Medical Research, and leading the clinical trials, told Healthline.
The first human trial of its kind
The results of the “Baricitinib in New-onset Type 1 Diabetes” (BANDIT) trial were published today in the New England Journal of Medicine.
For this Phase 2, double-blind, randomized, placebo-controlled trial, Kay and his team recruited 91 patients with type 1 diabetes, all of whom had been diagnosed within 100 days of starting the trial. 60 of those patients received baricitinib, while the remaining 31 got a placebo. The average age of participants was 18, and there was a good mix of men and women.
Researchers wanted to see how the participant’s C-peptide levels were affected at the end of the 48-week trial. C-peptide levels are indicators of natural insulin (made by the body) and indicate that the pancreas is still producing the hormone. As you might expect, type 1 diabetes patients have low C-peptide levels, so higher levels indicate higher insulin production.
After 48 weeks, participants in the group that took baricitinib had a 48% increase in the median of their C-peptide levels after a meal, compared to the placebo group.
“Our results show that baricitinib and potentially other members of the JAK inhibitor class of drugs are active in type 1 diabetes and preserve insulin production,” said Kay.
Dr. Michael Hughes, an instructor of medicine and a member of the Diabetes Research Center at Stanford University, called the findings “promising.” Hughes wasn’t affiliated with the research.
“Baricitinib is already commercially available, orally administered once daily, and has a known profile of being relatively well-tolerated, attributes that make it an accessible and potentially attractive option toward future integration into real-world clinical settings,” he said.
Researchers also looked at additional outcomes to further confirm their findings. Those included insulin dose and glycated hemoglobin level, commonly known as an A1C test.
After 48 weeks, participants who took baricitinib had an average A1C level of 7%, compared to 7.5% in the placebo group. They also saw improvements to insulin dose: at the end of the trial, they required smaller doses of insulin compared to the placebo group.
The trial also demonstrated “acceptable safety.” Among those that took baricitinib, 152 adverse events were reported, including two serious incidences of ketoacidosis in one participant that required hospitalization.
During the trial, 22 of the patients receiving baricitinib and 16 of those taking the placebo contracted COVID-19; however, the illness wasn’t deemed to have had a meaningful impact on the results of the trial.
Could treatment last indefinitely?
Despite the findings, some serious questions still remain about the potential for baricitinib as a type 1 diabetes treatment.
“It’s important to note that the observed effects have been documented for a limited duration of only 48 weeks,” said Hughes.
“These initial results are certainly exciting, but ongoing research and extended observations will be key in understanding longer-term potential on the preservation of insulin secretion as well as the resulting impacts on other clinical outcomes associated with type 1 diabetes,” he said.
The trial was also limited in terms of its size (under 100 participants) and population. Although generally diverse in terms of men and women, the participants were overwhelmingly white, which makes the findings difficult to generalize to other groups of people.
Dr. Robert Gabbay, MD, PhD, Chief Scientific and Medical Officer at the American Diabetes Association told Healthline, “The study adds to the number of potential candidates for further testing to be utilized to slow down the destruction of insulin producing beta cells in type I diabetes…This is a promising early study and will need to be followed up in larger studies before any recommendations on its use can be made.”
The bottom line
Researchers have completed the first ever human trial of baricitinib, a JAK inhibitor drug used for the treatment of alopecia and rheumatoid arthritis, as a treatment for type 1 diabetes.
Baricitinib works by modulating how certain cells in the immune system communicate with each other, helping to slow and prevent autoimmune conditions.
The results of the trial are promising, but experts caution that larger trials will be needed to measure both safety and effectiveness.
This RA and Alopecia Drug May Help Treat Type 1 Diabetes
Source: Pinoy Lang Sakalam
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