Empowering Early Intervention: Navigating Treatments for Delaying T1D Progression, Insights from AM Diabetes and Endocrinology Center - Episode 7
Navigating Teplizumab: Dosing, Infusion Process, and Patient Experience in Delaying Late Onset Diabetes
Kent Stoneking Pharm D, CDECS and Marianne Briggs, DNP, FNP-C share their experiences with the dosing regimen and infusion process for teplizumab. This segment offers an in-depth look at the 14-day course of treatment, providing insights into the patient experience and what individuals can expect during this crucial intervention period.
The following transcript has been lightly edited for style and clarity.
Dr. Jennifer Goldman: Let's push this question out. Are you aware of any medical facilities in your area that offer teplizumab screening and evaluation services to individuals at risk of progression through type one stages? So 58% are not aware and 17% have facilities that do. So that's interesting. Have you treated any patients with teplizumab?
Marianne Briggs: Yes. So we have treated one, she was 57. So I think that's really important for everyone to understand that it's not just the kids that can develop type one diabetes.
Dr. Jennifer Goldman: How does she do?
Dr. Marianne Briggs: She's doing great now. So we're seeing that it's working. And for her, she has a family history of type one diabetes, but she came in to see me for her thyroid. That wasn't even on the thoughts and they had misdiagnosed her maybe some pre-diabetes. And you look at her, she's super thin and I was like, that just doesn't make sense.
Dr. Jennifer Goldman: That was a good picture.
Dr. Kent Stoneking: It's a great catch, Marianne.
Marianne Briggs: But that's something we need to look out for in primary care.
Dr. Jennifer Goldman: Do I have answer to this question? There we go. None. So maybe if you find someone now, we'll be able to make an intervention. That's Kent, you're going to talk about the dosing briefly, 14 days?
Dr. Kent Stoneking: Absolutely. So we do start with a low dose and then we ramp up sequentially, essentially doubling the dose per day up until day five. And we do that because of the risk of lymphopenia and the other adverse events that you mentioned, lymphopenia being the primary. And quite frankly, if you see a reduction in lymphocytes, that's proof positive that your biologic therapy is working. So we gauge that very carefully. And again, that's the primary reason we start with the low-dose and then ramp up sequentially, but days. If you get through day five and you have a reasonable reduction in lymphocytes and our patient had a rash, developed around day three and day four. But it was visible but not bothersome and several days later it resolved on its own.
Dr. Jennifer Goldman: What about premedication?
Dr. Kent Stoneking: Premedication is vitally important. We had that conversation with her. The recommendation is to [00:51:00] pretreat with acetaminophen. We gave our patient 500 milligrams acetaminophen, 25 milligrams of diphenhydramine, and four milligrams of ondansetron ODT for nausea. By day three, she said, "Please don't gimme that on ondansetron anymore. That plus the diphenhydramine, I'm sorbed, I can't function the rest of my day. I'm not having nausea." So we bypassed that. But we pretreated her and that certainly had its impact, but we did see good outcomes. And once we got past day five, day six through 14 were very smooth.
Dr. Jennifer Goldman: Excellent. Good to know. And so initial management, you talked about this and it's maybe you use it or maybe you don't once people are in.
How are you monitoring for serious side effects? Is it daily? What are you checking every day?
Dr. Kent Stoneking: We stay in close contact with the patient. In this case, we let her describe her experience. What is she feeling, what is she feeling after she leaves the clinic and before she returns the next day, what kind of symptoms and so forth? So case in point, she said, "I'm having no nausea whatsoever, I'd like to decline any additional ondansetron." And having that dialogue with her, we felt was very important. Then she was a part of that conversation and a part of the process. We explained what was available and why we felt like it was important. And then she provided her feedback and we went with what we knew was safe, but also in keeping with her wishes along that line.
Dr. Jennifer Goldman: Are you getting CBCs, LFTs and stuff on a daily basis?
Dr. Kent Stoneking: Absolutely. We did full lab panel including hepatic function and CBC, baseline on day one and ran stat. Could we even treat this patient based on those criteria? And indeed we could. And then we repeated on days four, day seven, day 10, and then we did a close out on day 14.
Dr. Jennifer Goldman: And how often, what's a follow up recommendation? When they finish their 14 days, then what happens?
Marianne Briggs: In our clinic, we're privileged that we have access to putting a continuous glucose monitor on the patient. So we put, she was wearing a sensor for two weeks checking to see how her sugars were doing. And her blood sugars were doing great and we're like, we can push out further. We can maybe wait three months to see her. So it's pretty amazing.
