Teplizumab Studies Lead to Important Update in ADA Living Standards of Care

Recent studies involving teplizumab, which is currently being evaluated by FDA to delay clinical type 1 diabetes (T1D), have yielded evidence that led to an update in the American Diabetes Association (ADA) Living Standards of Care, which were released last week ahead of the 81st Scientific Sessions.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recently voted 10-7 in favor of recommending approval of the therapy. And, according to Robert A. Gabbay, the ADA’s chief scientific and medical officer, the update based on 2019 and 2021 results for teplizumab were important to include, due to their significance to families who know they have an elevated risk of T1D.

A few years ago, the ADA shifted from annual updates to the Standards of Medical Care in Diabetes to the Living Standards model, including a number that appear on the eve of each year’s Scientific Sessions.

“The field is moving so rapidly that we can't wait a whole year to publish a new set of guidelines,” Gabbay said in an interview with The American Journal of Managed Care® ahead of this week’s meeting. Among the studies that merited recognition were those involving teplizumab, he said, which suggest that the therapy can delay the onset of diabetes by an average of 2 years.

“If you speak to any parent of a child with type 1 diabetes, or an individual type 1 diabetes, not having diabetes for 2 years matters,” Gabbay said. “And so the guidelines reflect that new data and the opportunity to consider screening for type 1 diabetes, for when the time comes when this drug will be available on the market, which we anticipate will be not too far away, based on recent FDA advisory group recommendations.

The section on Classification and Diagnosis of Diabetes has been updated to include evidence from a trial on the anti-CD3 antibody teplizumab that showed a delay in the onset of T1D for at-risk relatives of those who were already diagnosed with the disease.

Results from a 2019 and a 2021 extension by the TrialNet Study Group, which calls screening for T1D risk with a glutamic acid decarboxylase autoantibody in a research setting, were expanded; the full paragraph of the article mentions teplizumab’s submission to FDA “for the indication or delay or prevention of clinical type 1 diabetes in at-risk individuals,” although the article notes the therapy is not yet available.

Reference

American Diabetes Association. American Diabetes Association Diabetes Care 2021 Jan; 44(Supplement 1): S15-S33.https://doi.org/10.2337/dc21-S002