Teplizumab for Delaying Onset and Progression of T1D

The following Frontline Insights transcript has been edited for clarity and length.

Javier Morales, MD: Let’s pose a question to the audience: Are you aware of any medical facilities in your area that offer teplizumab infusions? Please choose the most accurate response.

Abha, teplizumab is a relatively new treatment, and setting up infusion facilities and protocols must be challenging. While some infrastructure likely exists, building and expanding these networks must require significant effort. From our audience responses, it seems that about three-quarters are unaware of such facilities, while a smaller portion has some familiarity.

Dr. Molgaard, can you describe how your facility has implemented protocols for teplizumab infusions?

Aubrey Molgaard, DNP, ARNP, FNP-BC, CDCES: Developing our protocol took about a year. We now have an outpatient infusion center accessible across the United States through our healthcare system. We also offer hybrid models, including home infusions, which expand patient options. These protocols are in place for both adult and pediatric patients, ensuring a safe and well-managed process.

Morales: That’s impressive. Audience, have you ever referred a patient for teplizumab therapy? Please provide your answer.

Among us presenters, it’s clear that screening and therapy implementation are top priorities. Aubrey, you’ve likely referred over 10 patients. My numbers are more modest as I’m starting to screen more now that I’ve learned so much about this therapy. Abha, how do you select appropriate patients for teplizumab therapy?

Abha Choudhary, MD: Teplizumab is approved for individuals aged eight years or older with stage 2 type 1 diabetes. Stage 2 is defined by the presence of two or more positive islet autoantibodies alongside evidence of dysglycemia, which can be established through several methods:

• Oral glucose tolerance test (OGTT): Fasting glucose >100 mg/dL or a 2-hour glucose between 140–199 mg/dL
• Continuous glucose monitoring (CGM): Evidence of dysglycemia
• Hemoglobin A1c: Levels in the prediabetic range (5.7–6.4%)

Remember that it is crucial to rule out type 2 diabetes through clinical history. In my pediatric patients, even those presenting with characteristics of type 2 diabetes (eg, obesity), we routinely test for pancreatic autoantibodies to confirm the diagnosis.

Morales: Can you walk us through the teplizumab infusion process?

Molgaard: Teplizumab is administered as a body surface area (BSA)-based infusion over 14 days: Day 1: 65 mcg/m² Day 2: 125 mcg/m² Day 3: 250 mcg/m² Day 4: 500 mcg/m² Days 5–14: 1,030 mcg/m²

Pre-medications, such as antipyretics, antihistamines, and antiemetics, help mitigate common side effects like fever, headache, muscle and joint pain, and nausea. We also recommend saline boluses during the initial infusion days. Monitoring for adverse effects, including liver function, infections, and persistent cytopenias, is critical throughout and for up to 28 days post-treatment.

Collaboration between primary care physicians, endocrinologists, and infusion centers is essential to ensure optimal patient outcomes. The infusion can be delivered via IV, midline, or PICC, depending on patient preferences. Some patients choose daily peripheral IV placement to maintain work schedules, while others opt for midlines to facilitate lab draws.

There are a few options for infusion sites and each has pros and cons:

• Doctor’s office or outpatient settings: Supervised by a provider; however, scheduling may be less flexible given the 14-day infusion schedule.
• Infusion centers: Provide specialized equipment and staff but may require patient travel.
• Home infusions: Offer convenience but lack immediate medical supervision.

A hybrid model can address these limitations, such as starting treatment in an outpatient setting for days 1 to 5 and and completing it at home.

Morales: The home infusion option is particularly beneficial in areas lacking infusion centers. I know personally, when we're looking at some of the patients that are in the hospital that are coming in with some sort of systemic infection that requires prolonged antimicrobial therapies. And some of these antimicrobial therapies are associated with some side effects, yet it's still pretty tolerable provided that these protocols are put in place with the infusion to minimize some of these side effects like Abha had described so eloquently during her portion of the presentation.