How new drug delays onset of insulin shot stage in Type 1 diabetes

WHAT THE NEW DRUG DOES

This is where Provention Bio’s new drug Tzeild (teplizumab-mzwv) steps in. It blocks the CD3 immune cells to prevent them from attacking and damaging the insulin-producing cells of the body. In a clinical trial, the drug delayed the onset of stage 3 Type 1 diabetes by a median of two years as compared to a placebo. This, the company said, can prevent up to 2,920 finger pricks to check blood glucose levels and 2,200 insulin injections for persons living with the condition.

More importantly, it can prevent nearly 254 episodes of hypoglycaemia – sudden drop in blood glucose levels after taking insulin – that people with type 1 diabetes experience on average in two years.

“The progression of T1D can be particularly onerous; patients who progress from Stage 2 to Stage 3 T1D can develop diabetic ketoacidosis, which can be life-threatening and is experienced by up to 50 per cent of Stage 3 patients at the time of presentation. The onset of Stage 3 T1D is a life-changing moment as once insulin-producing cells are no longer capable of maintaining normal glycaemic control,” said Dr Eleanor Ramos, Chief Medical Officer at Provention Bio in a release.

The study of 76 persons in stage 2 of type 1 diabetes – characterised by the presence of two or more antibodies that attack the insulin-producing cells and abnormal blood glucose levels – showed that 45 per cent of those given the medicine progressed on to stage 3 as compared to 72 per cent of those who were given the placebo during the trial period. The median time of onset of stage 3 was found to be 50 months in the group given the medicine as compared to 25 months in those given the placebo.

CAN YOU GET THE NEW DRUG NOW? WILL IT WORK IN INDIA?

Dr Anoop Misra, Chairman of Fortis-CDOC Centre of Excellence for Diabetes, says that the drug has very limited applicability in India. “First of all, it is very difficult to diagnose the disease in stage 2. Tests have to be done to look for the presence of antibodies and then repeated tests to see the trends in blood glucose levels. This is not something the general population will do. It may be recommended only in those with a family history of type 1 diabetes.”

At present, not everyone, even families where type 1 diabetes has been detected, undergo such screening, with most people getting their diagnosis only when they are already in stage 3. “Other than that, it is terribly expensive, making its applicability close to nil as far as India is concerned,” said Dr Misra.

However, when it comes to the science of it, he says it is exciting. “The news is exciting as it is the first time there is hope that an approved drug can delay the onset of type 1 diabetes. The concept has been floating around for years, but this is the first time we have seen an indication that it works. And, the medicine has received FDA approval too,” he said.

DRUG USE MUST BE PRECEDED BY SCREENING

The FDA-approved medicine can be given to those in stage 2 of Type 1 diabetes and are eight years or older. However, ensuring timely administration of the drug would require screening with blood tests as most cases are diagnosed only when children reach doctors with lethargy, extreme thirst, frequent urination, extreme hunger, and weight loss.

As per the company, Type 1 diabetes typically takes away more than a decade off from a person’s life – life expectancy is reduced by 16 years in those diagnosed before the age of 10 years. The only treatment currently is monitoring the level of blood glucose and administering insulin without which they cannot live.

“This is a historic occasion for the T1D community and a paradigm-shifting breakthrough for individuals aged eight years and older with Stage 2 T1D who now have a therapy approved by the FDA to delay the onset of Stage 3 disease. It cannot be emphasised enough how precious a delay in the onset of Stage 3 T1D can be from a patient and family perspective; more time to live without and, when necessary, prepare for the burdens, complications and risks associated with Stage 3 disease,” said Ashleigh Palmer, co-founder and CEO of Provention Bio, in a release.

The medicine, which will be available in single-dose vials, has to be administered as an intravenous infusion over 30 minutes every day for 14 days. It will cost $13,850 (or nearly INR 11.3 lakh) per dose. The company has partnered with Sanofi for marketing the drug in the US.

WHAT ARE SIDE EFFECTS? DOS AND DON’Ts

The most common side effects of Tzield include decreased levels of certain white blood cells, rash and headache. It can also result in hypersensitivity reactions. Those who are given the drug have to be monitored for cytokine release syndrome or an excessive response of the immune system to the medicine for a period of 28 days after the administration of the last dose. The drug shouldn’t be given to those with a current serious infection.

The company also recommends that all age-appropriate vaccines be taken before starting the course of treatment – live vaccines (using live, weakened pathogens) should not be used eight weeks prior and 52 weeks post the treatment, inactivated or mRNA vaccines should not be given two weeks prior to the treatment, and inactivated vaccine shouldn’t be administered for six weeks after the completion of treatment.