Immunotherapy Shown Safe in Type 1 Diabetes Clinical Trial
WEDNESDAY, Aug. 9, 2017 -- A small clinical trial showed an immune system therapy was safe for people with type 1 diabetes, British researchers report.
The immunotherapy also showed signs of helping to keep insulin production steady in people newly diagnosed with the disease, the study authors said. However, because this was a placebo-controlled safety trial, there weren't enough people included to know for sure how well the treatment works.
The therapy is similar to an allergy shot in the way it works, the researchers explained.
"Type 1 diabetes comes about when the immune system inadvertently and irreparably damages beta cells that make insulin," said one of the study's authors, Dr. Mark Peakman. He's a professor of clinical immunology at King's College London in England.
Insulin is a naturally occurring hormone that helps usher the sugar from foods into the body's cells to be used as energy. If the immune system continues to attack the beta cells, which are found in the pancreas, a person with type 1 diabetes will no longer make enough insulin to meet the body's needs. It's at this point that they must take insulin injections or use an insulin pump to replace the lost insulin.
Peakman and his colleagues are trying to stop the attacks on the beta cells.
"We have learned that immune attacks like this can be suppressed by immune cells called T-regs (regulatory T cells)," Peakman said.
When people develop type 1 diabetes, it's likely that they don't have enough of the right type of T-regs or those T-regs aren't working very well. So, the investigators developed a type of treatment called peptide immunotherapy using disease-related autoantigens.
Autoantigens are the substances that cause an autoimmune attack, but it's not clear which ones are responsible for a person's diabetes, according to Simi Ahmed, a senior scientist at JDRF (formerly the Juvenile Diabetes Research Foundation) in New York City.
Ahmed said the immunotherapy re-educates the immune system, and teaches the cells that they shouldn't attack the beta cells.
Peakman pointed out that the researchers "used peptide immunotherapy as a way to try and induce more of these cells and/or make them work better. Our results show encouraging signs that this can be achieved. Next steps will be bigger trials to test whether the therapy can halt beta cell damage."
And, he added, "Scientists think this works by enhancing natural immune networks that control inflammation."
The study included 27 people with type 1 diabetes who had been diagnosed with the disease within 100 days. The study volunteers were randomly selected to be in one of three groups: a placebo group; a group given immunotherapy once every four weeks; and a group that received the immunotherapy injection once every two weeks.
The study team measured levels of a substance called C-peptide, which is created when insulin is produced. Stable or increasing levels of C-peptide indicate that insulin is being made. Declining levels indicate that less insulin is being made.
The volunteers given immunotherapy once every four weeks saw no decline in C-peptide, the findings showed. The group given the treatment once every two weeks saw a decrease in C-peptide at the 12-month mark. Those given a placebo had decreased C-peptide levels at 3, 6, 9 and 12 months.
Peakman said there weren't enough people in the study to know why there were slight differences in the treatment groups. That's for a larger study to figure out, he suggested.
But the researchers found that the treatment was quite safe, and there were no side effects "of note," Peakman added.
The study also looked at insulin use. Over 12 months, insulin use went up by 50 percent in the placebo group. But there was no increase in the treated groups.
And even though all the study volunteers still needed insulin, both diabetes experts said that the need for less insulin would likely improve quality of life and lessen complications.
It's not yet clear from this trial how often the treatment would need to be given to keep the immune attack at bay.
It's also not clear if it could benefit people who've had type 1 diabetes for a while. Peakman said it probably wouldn't help them because most of their beta cells would be gone. But Ahmed noted that if someone had detectable C-peptide levels, it's possible that this treatment or future ones that may contain more than one autoantigen might have an effect.
In December 2016, a study published in Diabetologia found that about one-third of people with type 1 diabetes for at least 10 years still had detectable C-peptide levels. And two-thirds of them showed signs of an ongoing immune system attack.
Findings from the new study were published Aug. 9 in Science Translational Medicine.
Learn more about type 1 diabetes from the American Diabetes Association.
Posted: August 2017