New Therapies to Delay T1D Progression

Video

Robin S. Goland, MD, and Kimberly Simmons, MD, MPH/MSPH, provide insight on teplizumab, which was recently approved by the FDA, to delay the progression of type 1 diabetes, and they discuss the implications of autoantibody detection in patients.

Robert Busch, MD: We’ve been very spoiled lately with the FDA approval of this miraculous drug that will delay the progression of diabetes. Dr Goland, can you talk about how it works and how you give it? Then we’ll also talk about potential adverse effects.

Robin S. Goland, MD: Teplizumab, recently FDA approved, is anti-CD3. It’s a monoclonal antibody that works by focusing on activated T cells. Multiple studies have demonstrated that in patients with impaired glucose tolerance and 2 or more antibodies, the treatment enhances the preservation of beta-cell function. We were part of this study, which follows patients who’ve had a nice prevention of diabetes. I take care of people who got anti-CD3 15 years ago. This is a landmark occasion for those of us in the field for decades. The ability to offer something that’s FDA approved in this population is extremely exciting, and we’ll discuss the logistics. It is a 14-day infusion, and it’s not marketed. It needs to be given IV [intravenously]. It can be given in a diabetes center, an infusion center, and potentially in a home-infusion situation. We’re looking forward to hearing further details about the logistics, insurance coverage, and exactly how the rollout will be accomplished.

Robert Busch, MD: I skipped 1 of the questions that I was going to ask earlier about. What if you have only 1 antibody detected? We talked about 2 antibodies and dysglycemia, but what if only 1 antibody is detected in your patient? What do you do differently?

Robin S. Goland, MD: I run the Columbia University side of TrialNet, so I encourage my patients with type 1 diabetes and their families—who are at a 15-fold increased risk of getting type 1 diabetes—to consider being in a study. This was before the FDA approval. There are now multiple ways to be screened for the antibodies if you’re interested in being in a study. I encourage the family members to be screened in TrialNet—5% to 6% will be positive, so the vast majority will be negative. Those who have 1 antibody are an increased risk of getting diabetes in 5 to 10 years. If you have 2 antibodies, if 1 of those is IA-2, your risk is substantial to get diabetes in the next 5 years—upward of 35%. If you have 2 others, it’s in the 25% range. At that point we recommend a glucose tolerance test by TrialNet protocol. We’re about to launch a new trial for people with impaired glucose tolerance and a relative with type 1 diabetes who’s been screened in TrialNet. Individuals with type 1 diabetes and their families deserve a lot of options. This is a challenging disease. The pumps and sensors have made it easier, but it’s hard. The more options, the better.

Kimberly Simmons, MD, MPH/MSPH: For the single-islet autoantibodies, in the autoimmunity for kids study—which is the general population study in Colorado—their antibodies are being measured by standard radio-binding assay and by a more high-affinity assay, electrochemiluminescence detection. We have data showing that if you have a high-affinity single antibody, your risk of progression is much higher than having a single antibody by a more standard assay method. There’s a lot to be learned about the group that has single-islet autoantibodies. We’re also seeing some differences in ethnicity, and that deserves more investigation as well.

Transcript Edited for Clarity

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