Pill for arthritis could stop type 1 diabetes in its tracks

A commonly-prescribed pill for rheumatoid arthritis may be able to stop the progression of type 1 diabetes in its tracks, according to a groundbreaking trial.

The findings have raised hopes that many patients who begin treatment soon after diagnosis will need fewer, or lower-dose, insulin injections as their capacity to produce insulin naturally “appeared to be preserved” over the 48 weeks of the trial – though it remains to be seen whether that capacity will be preserved in the longer term.

If cases are caught and treated really early, it is hoped patients may eventually be able to do without insulin injections altogether, the researchers said, while emphasising that this has yet to be demonstrated in a trial and may never be the case.

Insulin helps you manage your blood sugar levels and helps prevent short-term or long-term serious health problems known as diabetes complications.

Reducing, or eliminating, the amount of insulin needed to top up deficiencies suffered by diabetics will make their condition much easier to manage, the researchers said.

The treatment would cut the risk of long-term complications, such as kidney failure and low blood sugar, or hypoglycaemia, with symptoms such as feeling anxious and dizzy, researchers predict.

The world-first human trial showed that the drug, known as baricitinib, or Olumiant, can safely and effectively preserve the body’s own insulin production and suppress the development of type 1 diabetes in people who started their treatment within 100 days of diagnosis. 

Most people in the trial needed to have some insulin because their condition was already sufficiently advanced that their capacity to produce insulin had been reduced. But they needed to have much less of it than those who didn’t take the drug.

While there are other treatments being trialled for type 1 diabetes that appear to have a similar effect on insulin levels – such as the immunotherapy drugs teplizumab and low-dose antithymocyte globulin – the crucial difference is that these require intravenous infusion or injections, whereas this treatment is given as a daily pill, the study noted.

“We are very optimistic that this treatment will become clinically available. This would be a huge step-change in how type 1 diabetes is managed and we believe it shows promise as a fundamental improvement in the ability to control type 1 diabetes,” said Professor Helen Thomas, of St Vincent’s Institute of Medical Research (SVI) in Melbourne.

It is unclear how much the drug would cost for this application but in the UK it costs about £10,000 a year as an arthritis treatment.

Professor Thomas Kay, also of St Vincent’s, who led the trial, told i he was hopeful that the drug could become available within three to five years, given that it is already being used for arthritis with lots of safety data available.

But he said a further clinical trial would probably be needed first to confirm the benefit.

He said: “When type 1 diabetes is first diagnosed there is a substantial number of insulin-producing cells still present. This is a new way of preserving the natural way of producing insulin using a well-tolerated daily tablet – whereas type 1 diabetes treatment for the past 100 years has been about managing the loss of insulin by giving insulin as an injection.

“Retaining insulin production makes diabetes easier to manage and potentially leads to fewer long-term complications.

“When type 1 diabetes begins it is challenging to handle, especially for young children and adolescents and their families. The onset of diabetes and its management with insulin carries physical and mental burdens that can be reduced with this treatment.”

Professor Kay continued: “Up until now, people with type 1 diabetes have been reliant on insulin delivered via injection or infusion pump. Our trial showed that, if started early enough after diagnosis, and while the participants remained on the medication, their production of insulin was maintained. People with type 1 diabetes in the trial who were given the drug required significantly less insulin for treatment.”

“In our study relatively few people no longer needed insulin at all. But it is possible that if baricitinib was begun earlier – we started it within 100 days of diagnosis – or even before conventional diagnosis when people can be identified through screening [they may no longer need insulin injections]. We have not yet tested baricitinib in this latter setting.”

Experts not involved in the research welcomed the findings.

Dr Faye Riley, research communications manager at Diabetes UK, said the findings were “incredibly exciting”.

“This can give people with type 1 diabetes much steadier blood sugar levels and help to protect against serious diabetes complications down the line,” she said.

“For more than 100 years, people living with type 1 diabetes have relied solely on insulin, but these findings show by tackling the root of type 1 diabetes – an immune system attack – an existing drug can help to shield the pancreas, in people recently diagnosed with type 1, so they can continue making more insulin for longer.”

Shareen Forbes of Edinburgh University said: “There have been other clinical trials in the area of type 1 diabetes that have used immunotherapies that have been injected for example tepluzimab; where this is novel is that baricitinib is an oral agent. This has potentially major advantages for treatment of patients, particularly for young children at diagnosis of type 1 diabetes.”

“This is a well-conducted trial,” she added.

Professor Lucy Walker, of University College London, said: “The drug tested here appears to temper the ability of the immune system to damage insulin-producing cells in the pancreas, slowing the progression of type 1 diabetes. It will be really exciting to see larger follow-up trials with this drug to establish the scale and duration of the benefit.”

Johnny Ludvigsson, of Linköping University in Sweden, said it was a “promising treatment that may soon be offered to patients with type 1 diabetes at the onset of their disease. With sufficient healthcare resources, these treatments will be pragmatically feasible.”

Up until insulin’s discovery more than 100 years ago, type 1 diabetes was a fatal condition. Despite insulin’s life-saving role, the therapy itself is potentially dangerous if too much or too little is administered, and the condition still comes with long-term complications, including heart attack and stroke, vision impairment, kidney disease and nerve damage.  

Baricitinib works by blocking an enzyme which normally helps to transmit signals that regulate the immune system and inflammation.

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The drug is currently prescribed for the treatment of rheumatoid arthritis, which is another autoimmune disease. It is thought that the drug similarly dampens down the immune response that is mounted against insulin-producing cells in people with newly diagnosed type 1 diabetes. This delays the onset of full-blown symptoms of the disease, improving glucose control and reducing potential for detrimental longer-term health effects.  

The trial monitored the blood glucose and insulin production of 91 participants over the course of one year.  Of these, 60 were given baricitinib and 31 were given a placebo.

All trial participants were aged between 10 years old and 30 years old and started on the trial within 100 days of having been diagnosed with type 1 diabetes.

Participants continued with their prescribed insulin therapy throughout the duration of the study.

Researchers monitored participants’ total daily dose of insulin, the amount of insulin produced by their own pancreas, their blood glucose levels, and their HbA1C levels. HbA1c, or glycated haemoglobin, is a measure of average blood glucose (sugar) levels for the last two to three months.