Patient Selection for Teplizumab in T1D

EP: 1.Overview of Type 1 Diabetes (T1D)

EP: 2.Screening and Diagnosis of T1D

EP: 3.ADA Guidelines for Managing T1D

EP: 4.Using Type 2 Diabetes Medications to Treat T1D

EP: 5.Delaying Onset of T1D

EP: 6.New Therapies to Delay T1D Progression

EP: 7.Safety and Efficacy of Teplizumab in T1D

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EP: 8.Patient Selection for Teplizumab in T1D

EP: 9.Patient Monitoring After Teplizumab Therapy in T1D

EP: 10.Investigational Therapies for the Management of T1D

EP: 11.Managing T1D Comorbidities

EP: 12.Strategies to Improve Screening and Diagnosis of T1D

Robert Busch, MD: Assuming our audience is following what we’ve discussed and checking the antibodies in patients, finding the patient who has 2 antibodies present, they do the glucose tolerance test, and if the patient has some dysglycemia, which patients would you treat? Assuming, that 1, it’s covered by managed care, and 2, you have an infusion site with staff who can look for any potential adverse effects and are geared up for doing this, because we know access isn’t available to everyone. Who would you be treating with this tool? I guess everyone could start on this, so we can start with Dr Goland, and then we’ll go around. How do we plan on doing this screening and getting our patients on this product?

Robin S. Goland, MD: I would present this and the other options to everybody.

Robert Busch, MD: Good, presenting it as another option to patients.

Robin S. Goland, MD: Yes.

Robert Busch, MD: I think what you all highlighted is even a day without diabetes is so important with what you must go through, and putting it off 2 years or more is quite something. It’s certainly a game changer in a field that hasn’t had much new, other than some better insulins, pumps, and monitoring, which is great, but avoiding ketoacidosis and putting off the burden of diabetes would be great for the patient and their family as well. Everyone agree?

Kimberly Simmons, MD, MPH/MSPH: Yes. One thing that’s interesting to think about is that the family members who have someone with type 1 diabetes is a very different population than the group that doesn’t know anybody with type 1 diabetes. I think all of us can probably agree that most relatives would be excited to have the opportunity to do something that would delay diabetes and are willing to do an IV [intravenous] infusion, for example. It’s a bit trickier in our general population families because they don’t have the context of what it means to live each day with type 1 diabetes. There is a challenge there in being able to have people understand what the value of the medication is. That’s why starting with families is going to probably where we’ll have the most success.

Robert Busch, MD: Dr Quattrin, with the 2-year delay, some of our colleagues think, well, it’s only 2 years. But highlighting what you’ve all been saying, it’s an effect for the patient and everyone.

Teresa Quattrin, MD: The initial paper from Kevan Herold, MD, and many others, including Dr Goland, talked about a median delay of 2 years, but follow-up data showed a median delay of actually 3 years. I could not agree more with Drs Simmons and Goland that, in my mind, a delay of 1 year is still something that makes sense and is important. Moreover, it’s not only the delay; we don’t have enough data on that. It’s not only the delay of how you get to this diagnosis of stage 3, but what reservoir you have at that point. Additionally, and we don’t have any data in this field, we’re talking a lot about teplizumab, and rightly so. But here are other modalities of therapy. That’s why Dr Goland said it’s important to offer and increase the awareness about potential other therapies that have a slightly different way of addressing the abnormalities that are happening in type 1 diabetes. For example, patting down inflammation all together with anti-TNF [tumor necrosis factor] therapy. There is an array of potential. I’m not one for saying we practice polypharmacy, but there is potential for increasing the delay.

I also want to say for the audience, we’re not a side in the study that is likely to gain approval, but we of course referred patients where we could. Unfortunately, the patient who made it through the screening was assigned to placebo, and I can tell you, this man is still crying. This is important because people who say it’s just 1 year, just 2 years, they are not in the rooms when we tell patients they have type 1 diabetes; it is like Dr Goland said, a bomb. It’s hugely important to do all we can and ensure that our health system supports these efforts.

Transcript Edited for Clarity