Teplizumab Infusion Protocol: Details on the 14-Day Process and Comprehensive Monitoring Overview

The following is a summary of the video transcript and has been edited for length and clarity.

Goldman: Would you just briefly review the eligibility requirements for treatment with teplizumab?

Springfield: patients that are eligible and would be good candidates for teplizumab are any adults or pediatric patients aged 8 years and older who have stage II type 1 diabetes. They do have to have at least 2 positive pancreatic islet cell autoantibodies and dysglycemia without overt hyperglycemia. And that's why it is now so important to be watching and screening, so we can catch these patients in stage II before they progress to stage III.

Goldman: Are you doing oral glucose tolerance tests (OGTT)?

Springfield: Yes. We're having to do those more for insurance requirements. We have been monitoring a few patients with [continuous glucose monitors] to watch their blood sugars, but insurance is requiring glucose tolerance tests to confirm dysglycemia.

Burton: So we do the OGTTs to select patients for teplizumab. I don't repeat once after teplizumab has been infused most of the time unless the sugars that we check at home or in the office are starting to creep up.

Goldman: Would you tell us again the type of patient you would be screening in your office? You're not looking for patients with or at risk for type 2 diabetes. Do they have prediabetes or are they looking for weight loss?

Burton: We get referrals for kids who are a little bit overweight or obese, and they have an HbA1c of 5.8%. One young man I saw recently fit the classic pre-diabetic, pubertal profile. He is African American, slightly overweight but when I looked at his did antibodies, he was positive for all 4 of them. So now we're trying to get him covered for teplizumab. So I think it goes both ways. Make sure we're not dealing with type 2. But often we see so much type 2 and insulin resistant, make sure that we're not overlooking type 1.

Goldman: You have talked about sending your patients to infusion centers for the treatment - would you talk more specifically about the process?

Burton: The teplizumab treatment is a 2-week process with a 30-minute infusion every day including weekends. The first dose is a low one and then it is doubled each day until day 5 and that is the maximum dose and given from day 5 through 14. Any side effects typically appear within those first 5 days of dose escalation. We haven't had any situations where a patient feels so awful we have to stop infusion. We always check patients in the office after the infusion and we have an after-hours phone line. We see them after each infusion, then again right after the 2-week treatment and then then I see them in a month after the last dose.

Goldman: What type of blood tests are being done?

Burton: As far as blood tests, we check complete blood count and we do liver function tests (LFT) during the infusion. We check them again during the office visit after the 2-week treatment to make sure things are resolving, and they do. As in the TN10, lymphopenia and elevated LFTs all resolved between 2 and 6 weeks after treatment.