This Commonly-Prescribed Drug Could Delay Progression of Type 1 Diabetes

Barcinitib, a medication commonly prescribed to treat rheumatoid arthritis, may also be effective in fighting another immune disorder, including type 1 diabetes.

In a phase 2 clinical trial published in the New England Journal of Medicine, researchers found that baricitinib helped patients who were newly diagnosed with type 1 diabetes maintain their natural ability to produce insulin, slowing the progression of the disease.

"We showed that a tablet that we use to treat conditions like rheumatoid arthritis and inflammatory bowel disease can dampen the immune attack that causes type 1 diabetes and preserve the ability to make insulin soon after diagnosis,” John Wentworth, MD, PhD, clinical trial lead of the Australasian Type 1 Diabetes Immunotherapy Collaborative, told Verywell in an email.

Baricitinib, sold under the name Olumiant, belongs to a class of drugs called Janus kinase (JAK) inhibitor, Vani Thiyagarajan, PharmD, BCPS, Assistant Director, Clinical Pharmacy & Educational Services at South Shore University Hospital, told Verywell. 

Thiyagarajan said the drug works by blocking specific enzymes, namely Janus kinases, which are involved in the inflammatory process. This makes it effective in the treatment of certain autoimmune conditions, like rheumatoid arthritis.

Here’s how baricitinib may be able to slow the progression of type 1 diabetes and other conditions it can be used for, according to experts. 

Baricitinib Can Help Improve Insulin Levels In Patients With Type 1 Diabetes

Wentworth and his colleagues recruited 91 patients with type 1 diabetes, all of whom had been diagnosed within 100 days of starting the clinical trial. Participants were between the ages of 10 to 30. Among them, 60 patients received baricitinib, while the remaining 31 participants received a placebo.

The researchers wanted to see how the participant’s C-peptide levels (which can serve as an indicator of how much insulin the pancreas is producing) changed at the end of the trial. Individuals with type 1 diabetes typically have lower C-peptide levels, therefore, elevated levels indicate higher insulin production.

They found after 48 weeks, people who took baricitinib (a once-daily tablet) had a 51% higher median C-peptide level after a meal compared to those who took a placebo. Those who took baricitinib also required smaller doses of insulin compared to the group that took a placebo, however, none of the participants were able to get off insulin completely. 

According to Wentworth, baricitinib specifically blocks the ability of the immune system to destroy the cells in the pancreas that make insulin (so-called beta cells of the pancreas). In doing so, it addresses the root cause of the disease, he said.

“We are hopeful our study will ultimately lead to the widespread use of baricitinib or other similar medications to treat type 1 diabetes,” Wentworth said. “Its advantages over other treatments is its oral bioavailability (daily tablet compared to injections or IV infusions) and the fact that it is simple to manufacture, unlike other antibody-based treatments.” 

However, Wentworth said regulators such as the Food and Drug Administration (FDA) will likely require a larger trial conducted across multiple locations to be sure that this method is truly effective and safe.

“We are actively seeking support to run such a trail with a view to getting this treatment into the clinic,” Wentworth said. “This is still about five years away.”

Michael Hughes, MD, an instructor of medicine and a member of the Diabetes Research Center at Stanford University, who was not involved in the research, said although the findings are promising and “offer a new avenue of hope,” it’s important to recognize the study’s limitations—including the fact that the findings are based on a relatively short study duration of 48 weeks.

“While the initial results are indeed promising, continued research and longer-term data will be essential to fully understand the long-term impact of these treatments for individuals with recent-onset type 1 diabetes,” Hughes added.

What Else Can Baricitinib Be Used For?  

Baricitinib is considered a multipurpose drug because of its ability to regulate the immune system by repressing Janus kinase enzymes or proteins, which play an important role in the inflammatory process, Thiyagarajan said.

Baricitinib disrupts the JAK pathways, allowing it to be effective in treating various autoimmune and inflammatory conditions, Thiyagarajan added. It may be used off-label for conditions like inflammatory bowel disease and various dermatological conditions. Right now, it’s FDA-approved for the following conditions:

Rheumatoid Arthritis

Rheumatoid arthritis is an autoimmune and inflammatory condition in which the body mistakenly attacks its own joints, causing pain, swelling, and loss of function, Thiyagarajan said. Baricitinib works by blocking these JAK enzymes, changing how cells in the immune system communicate with each other. In patients with rheumatoid arthritis, it lowers the immune system’s ability to attack the joints, reducing pain, swelling, and inflammation.

“It is a treatment option for patients when other medications such as tumor necrosis factor (TNF) blockers have been used and have not worked or haven’t been well-tolerated,” she said.

In a research study, certain patients who used baricitinib observed a 20% improvement in the signs and symptoms of their rheumatoid arthritis within just seven days, while others witnessed improvements within 12 weeks.

Additional research showed that patients receiving baricitinib experienced a much higher rate (49%) of ACR20 (or an improvement of 20% in the number of tender and swollen joints) compared to patients in a placebo group (27%).

Baricitinib was approved by the FDA in June 2018 for the treatment of rheumatoid arthritis, and it is still authorized to treat the condition.

Alopecia Areata

Alopecia areata, commonly known as alopecia, is an autoimmune disorder in which the body attacks its own hair follicles, leading to hair loss, often in clumps or patches, said Thiyagarajan. Just like in rheumatoid arthritis, baricitinib can treat the condition by blocking one or more enzymes, disrupting the pathway that leads to inflammation and preventing the immune system from attacking hair follicles.
 

Based on clinical studies, adults with severe alopecia areata who were treated with baricitinib achieved 80% scalp hair coverage at 36 weeks. Those who took 4 milligrams of baricitinib once a day experienced substantial scalp hair regrowth, with certain patients achieving 90% or more coverage at 36 weeks, and some observing 80% or more coverage as early as 24 weeks.

Baricitinib received FDA approval in June 2022 to treat alopeBaricitinib received FDA approval in June 2022 to treat alopecia areata and it is presently authorized to continue treating this condition. 

COVID-19 

Baricitinib is currently FDA-approved for the treatment of coronavirus disease (COVID-19) in hospitalized adults who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO), Thiyagarajan said.

“It alters how cells in the immune system communicate with each other, but the exact mechanism is not currently known,” she added.

According to a 2022 study, patients with severe COVID-19 who received baricitinib therapy had improved clinical outcomes and avoided mechanical ventilation compared to a placebo group.

The medication was initially utilized under emergency use authorization (EUA) during COVID-19 and then received FDA approval in May 2022. It is still authorized for use in hospitalized COVID-19 patients.