Research Shows Efficacy of Teplizumab in Newly Diagnosed T1D: Dr Kevan Herold

Kevan Herold, MD, Yale Medicine

Recently published results from the PROTECT trial of teplizumab suggest that the agent slows disease progression in children and adolescents newly diagnosed with type 1 diabetes (T1D).

In an interview with The American Journal of Managed Care^® (AJMC^®), Kevan Herold, MD, primary PROTECT investigator and professor of immunobiology and medicine at Yale School of Medicine, discussed the latest findings and what they mean for the use of teplizumab in T1D.

AJMC: How do the new results add to previous findings in trials of teplizumab?

Herold: I would say they look pretty close to all of the other trials of teplizumab. What's different about this one is it's phase 3, it's randomized, placebo controlled. It's a little different because this is children—only children and adolescents. So, that's different than the other trials. The C-peptide data looks very similar to other trials. But I think the general trend here, like in the other trials, is no matter when you give this drug, it reduces the rate of loss of beta cell function. There are a couple other measures in the trial that I didn't mention earlier, which includes the timing range from continuous glucose monitors. When we did a protocol analysis, that was significantly better. And then the portion of people who had hemoglobin A_1C of less than 6.5—which, by the way, is the diagnostic criteria for diabetes—and were using less than a quarter of a unit per kilo per day of insulin, which was used as a criteria for remission in the past, and an insulin dose that was given to people without diabetes in a prevention trial that was done earlier, the proportion of people who met that criteria was also greater in in this trial. So, it looks really similar in that it reinforces what we've seen repeatedly, and what I think led to the approval of the drug for stage II diabetes a year ago.

AJMC: How does teplizumab differ from other treatments tested in T1D previously?

Herold: One of the things that's important about this drug is that it is not continuously given. It's given for, in this case, 12 days. It was repeated here—and we can have a whole discussion as to whether you need 2 doses or 3 doses—but it's given for 12 days, and then that's it. It is not continuous immune therapy, and I frankly would say it is not continuous immune suppression. It causes some changes in immune cells that we've described over the years, but patients are well, and there's not an increased risk of infections after the drug has been given. I think that's very different than a number of other drugs that have been used.

AJMC: Is there anything else you'd like to add?

Herold: The only other thing is, with my experience as an endocrinologist, is that the unfortunate thing right now is that teplizumab has been approved for people at risk for type 1 diabetes, and most people at risk for type 1 diabetes don't know they're at risk. So, there's a big effort now to expand screening. That's something we do in TrialNet. I know Sanofi is interested in that, but TrialNet, the consortium that I chair, is very interested in expanding that. But the point I want to make is the data that led to the approval of teplizumab in the at-risk population came from people with diabetes, just as this trial was done for people with diabetes, and I frankly feel that we're at the point where if the drug is effective enough in people with diabetes to warrant approval for the people at risk, and if we show it again, why aren't we approving it for people with diabetes?

Reference

Jeremias S. Phase 3 data show teplizumab slows T1D progression in children, adolescents. AJMC. October 21, 2023. Accessed December 22, 2023. https://www.ajmc.com/view/phase-3-data-shows-teplizumab-slows-t1d-progression-in-children-adolescents