Teplizumab-mzwv, an injectable monoclonal antibody has been FDA approved as a treatment to delay the onset of stage 3 type 1 diabetes in adults and children (aged ≥8 years) with stage 2 type 1 diabetes. Teplizumab-mzwv is an anti-CD3-directed antibody.^1,2 

In stage 1 type 1 diabetes, two or more type 1 diabetes–associated islet autoantibodies are positive; however, the patient is asymptomatic and normoglycemic. In stage 2, dysglycemia develops and patients are mostly asymptomatic. Stages 1 and 2 are presymptomatic type 1 diabetes. Stage 3 is when type 1 diabetes can be clinically diagnosed. It is symptomatic type 1 diabetes and manifests with the classical symptoms of diabetes (polyuria, polydipsia, fatigue, unexplained weight loss, blurred vision) or may present with diabetic ketoacidosis.³

Dosage form: 2 mg per 2 mL (1 mg/mL) single-dose vial

Dose and administration: Teplizumab-mzwv is administered as IV infusion once daily x 14 days over a minimum duration of 30 minutes. Use an NSAID/paracetamol, antihistamine and/or antiemetic as premedication for the first five days (minimum) of administration. Dose is calculated based on the body surface area.

• Day 1: 65 mcg/m2
• Day 2: 125 mcg/m2
• Day 3: 250 mcg/m2
• Day 4: 500 mcg/m2
• Days 5 through 14: 1,030 mcg/m2

Side effects: Skin rash, headache, lymphopenia

Warning and precautions

• Two doses should not be given on the same day.
• Obtain baseline CBC and liver enzymes before starting treatment.
• A minimum of two positive pancreatic islet autoantibodies must be obtained to confirm stage 2 type 1 diabetes prior to starting treatment. Type 2 diabetes must be excluded.
• Monitor the patient for cytokine release syndrome: check liver enzymes; discontinue treatment if ALT or AST are increased more than 5 times the upper limit of normal.
• Assess for serious infections during and after treatment. Stop treatment if a serious infection develops. Avoid in patients with active serious infection or chronic active infection except for localized skin infections.
• Monitor WBC count during treatment; discontinue the drug in case of lymphopenia (<500 cells per mcL) lasting 1 week or longer.
• Hypersensitivity reactions may occur.
• Administer all age-appropriate vaccinations before starting treatment; avoid simultaneous administration of live, inactivated and mRNA vaccines. Live vaccines should be administered ≥8 weeks before treatment and inactivated/mRNA vaccines ≥2 weeks prior to treatment.

References

1. US FDA news release, November 17, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes
2. Tzield prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761183s000lbl.pdf.
3. Insel RA, et al. Staging presymptomatic type 1 diabetes: a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care. 2015 Oct;38(10):1964-74. doi: 10.2337/dc15-1419.