medicalnewstoday.com
- A commonly prescribed medication for rheumatoid arthritis might help prevent the progression of type 1 diabetes, according to new research.
- Researchers said a few participants in the clinical trial did not need any insulin by the end of the study. The rest of the participants decreased the amount of insulin they needed daily.
- Researchers reported that although the drug reduced the need for insulin, it did not cure the disease.
Researchers at St Vincent’s Institute of Medical Research in Melbourne, Australia, are reporting that a commonly prescribed rheumatoid arthritis drug can help suppress the progression of type 1 diabetes.
Their findings were revealed in a study published in the New England Journal of Medicine.
The medication, baricitinib (Olumiant), is an immunosuppressant used in the treatment of rheumatoid arthritis.
Baricitinib has also been approved by the Federal Drug Administration (FDA) for use in treating alopecia areata. Additionally, the results of clinical trials of baricitinib in combination with topical corticosteroids for treating atopic dermatitis have also been promising.
Like type 1 diabetes, rheumatoid arthritis, atopic dermatitis, and alopecia areata are autoimmune disorders.
In addition, the FDA granted emergency use authorization in 2020 to baricitinib to treat COVID-19 when combined with remdesivir for people needing a respirator.
In the new clinical trial, researchers said that baricitinib can effectively preserve the body’s insulin production and suppress the progression of type 1 diabetes when treatment begins within 100 days of diagnosis.
“When type 1 diabetes is first diagnosed there is a substantial number of insulin-producing cells still present. We wanted to see whether we could protect the further destruction of these cells by the immune system. We showed that baricitinib is safe and effective at slowing the progression of type 1 diabetes in people who have been recently diagnosed,” said Tom Kay, PhD, a professor at St. Vincent’s Institute and an author of the study, in a press release.
During the study, children and young adults who received a diagnosis of type 1 diagnosis within the previous 100 days received either baricitinib or a placebo for 48 weeks.
The researchers reported that insulin production continued when the participants remained on the medication.
Additional findings for those taking baricitinib included:
- The variability in glucose level was lower.
- The percentage of time the glucose level stayed in the target range with higher.
- There was a decreased need for insulin therapy,.
Three participants did not need insulin therapy by the end of the trial. The remainder did but with lower levels, the researchers said.
The researchers noted that there was too much irreversible damage by the time of diagnosis to allow for the complete cessation of insulin therapy in participants.
“These are exciting findings since the only medication approved by the FDA to delay the onset of clinical type 1 diabetes is an infusion,” said Dr. Eliud Sifonte, an endocrinologist at NYU Langone Medical Associates — West Palm Beach in Florida who was not involved in the research. “I would like to see further studies showing similar or better efficacy.”
“It remains to be seen whether treating patients earlier in their process may lead to delaying the need for insulin. In this study, we saw decreased dosages, but patients had to continue using insulin nevertheless,” Sifonte told Medical News Today. “The study showed decreased needs for insulin but not resolution or ‘cure’ of diabetes. Patients treated with this agent should continue to monitor their blood glucose as indicated and as required based on their treatment regime.”
Dr. Caroline Messer, an endocrinologist at Northwell Lenox Hill Hospital in New York who also was not involved in the research, agreed.
“The class of JAK inhibitors, in general, shows promise for the preservation of beta cell function (the cells in the pancreas that produce insulin) in patients with type one diabetes,” she told Medical News Today. “There are similarities between this drug and teplizumab (TZIELD), which is already on the market for a similar indication.”
“The study clearly proves that baricitinib can decrease the amount of insulin required by patients with early type one diabetes and decrease the variability of blood sugars,” Messer added. “However, the Hemoglobin A1C (a measure of 3 months of average blood sugars) did not improve. As the authors noted, this trial may have been more successful if baricitinib had been initiated at an earlier stage in the disease process when there was less damage to the beta cells. One of the major advantages to this new medication is that it is administered in pill rather than IV form.”
“There is a higher risk of diabetic ketoacidosis (high acid in the bloodstream seen when insulin levels are low) in patients who are skipping insulin while taking this medication,” Messer noted.
The researchers indicate the following limitations:
- Most of the patients were white, making it difficult to generalize the findings to other races.
- The sample size was small.
- The short duration of the trial limited the ability to identify rare adverse events.
- None of the participants were under 10 years of age.
“The trial was only a phase two trial, which simply looks to see if a medication actually works,” Messer said. “I would need to see a phase three trial, which is a longer trial that compares a medication to the current standard of care. I would also need a larger sample size to make sure that the risks do not outweigh the benefits. Finally, I would want to see how this medication works when administered at an earlier phase of type one diabetes. Also, since the benefits appear to quickly decline once the medication is stopped, I would want to see data on long-term use of this medication.”
Type 1 diabetes is an autoimmune disorder where the immune system attacks cells in the pancreas that make insulin by the immune system.
According to the Centers for Disease Control and Prevention (CDC), symptoms include:
- Frequent urination
- Being very thristy
- Weight loss without trying
- Blurry vision
- Numbness or tingling in hands and feet
- Dry skin
- Sores that take a long time to heal
- More infections than normal
In addition, individuals might experience nausea, vomiting, or stomach pains.