Teplizumab Use in Practice
Panelists discuss clinical use of teplizumab including patient selection, navigating approval processes, and managing the 14-day infusion regimen to optimize outcomes and delay the progression of type 1 diabetes.
The following transcript has been edited for clarity and length.
Javier Morales, MD: Setting up infusion services for patients is no small task, and it’s critical to discuss the challenges and successes in establishing these facilities. Let’s ask the audience: are you aware of any facilities offering infusion services for teplizumab?
We’ll give everyone a moment to respond. Abha, I know setting this up in your clinic must have been quite an undertaking. Similarly, our other expert panelists have been instrumental in setting up their own services.
One important point you mentioned, Abha, is that even though patients are coming to an infusion center, this is not chemotherapy, which is reassuring for them. Now, let’s hear from the audience.
It seems many of you are aware that such facilities exist, which is excellent. But let’s ask another critical question: how many patients have you referred for teplizumab treatment?
Before treatment begins, early identification is key. As clinicians, we need to remain vigilant and avoid clinical inertia, ensuring earlier diagnoses. Let’s see the audience’s responses.
It appears that a large portion of the audience has not yet referred patients for treatment. That’s understandable—teplizumab is relatively new and offers significant promise. Natalie, could you walk us through the patient selection criteria in the time we have left?
Natalie Bellini, DNP, FNP-BC, BC-ADM, CDCES: Absolutely. It’s not surprising that primary care hasn’t widely adopted teplizumab infusion yet, but we aim to reduce that burden.
So, who qualifies for this treatment? Teplizumab is FDA-approved for patients aged 8 and older diagnosed with stage 2 type 1 diabetes. This includes individuals with dysglycemia and two or more positive autoantibodies.
Insurance companies typically require repeat antibody testing to confirm the diagnosis. Dysglycemia is confirmed without overt hyperglycemia, often using an oral glucose tolerance test (OGTT). While OGTTs are not popular with patients, they remain the standard for most insurers. Continuous glucose monitoring (CGM) data can sometimes be used as supportive evidence, but insurers still favor OGTT results.
Additionally, it’s critical to differentiate between type 1 and type 2 diabetes. The presence of antibodies—two or more—is definitive for type 1 diabetes, which aligns with teplizumab’s FDA label.
Aubrey Molgaard, DNP, ARNP, FNP-BC, CDCES: Teplizumab dosing is based on body surface area and administered over 14 days with a titration schedule. Pre-treatment includes antihistamines, antipyretics, and antiemetics to minimize side effects. During and after infusion, monitoring is essential for adverse reactions, such as liver dysfunction, infections, or cytopenias.
Post-treatment follow-up with endocrinology is crucial to monitor potential side effects and blood glucose levels.
Regarding infusion sites, options include doctor’s offices, infusion centers, at-home services, or hybrid models. Each has its pros and cons:
- Doctor’s office: Supervised by providers but less flexible due to the 14-day continuous infusion schedule.
- Infusion centers: Offer specialized staff and equipment but may require patient travel.
- At-home infusion: Convenient but poses challenges with scheduling and lacks immediate medical assistance if needed.
Morales: Despite the logistical challenges of a 14-day infusion schedule, teplizumab significantly impacts the progression of type 1 diabetes, curtailing its advancement.
To the audience, as we wrap up, what key insight did you gain from today’s discussion on type 1 diabetes staging and management? Please share your thoughts. And now, panelists, would you share your final thoughts?
Molgaard: The most important takeaway is collaboration. Primary care providers should involve endocrinology early in the process. Screening is vital—what we can do to work together is going to change the lives and future of type 1 diabetes.
Bellini: Primary care clinicians, if you identify a positive patient, reach out to your endocrinology colleagues. Most screened patients won’t have antibodies, but when they do, it’s critical to act. We are here to help and accommodate these patients.
Abha Choudhary, MD: My advice: screen it like you mean it. Patients in stage 1 type 1 diabetes, with two or more antibodies, will inevitably progress to stage 3 in their lifetime. Screening and timely referral can make all the difference.
Javier Morales: Thank you all for joining today’s program. We hope you found it both informative and engaging. Remember: screen, screen, screen! See you soon.
