For US Healthcare Professionals Only
Efficacy data
Efficacy data
Treat with TZIELD in Stage 2 of T1D today to potentially delay Stage 3 T1D onset
In the TN-10 Study with patients with Stage 2 T1D
One 2-week course of TZIELD led to twice the median time to
Stage 3 onset vs placebo1,2
Stage 3 onset vs placebo1,2
Time to diagnosis of Stage 3 T1D in
patients with Stage 2 T1D by treatment group1*
patients with Stage 2 T1D by treatment group1*
HR 0.41; 95% CI, 0.22-0.78; P=0.0066 by adjusted Cox proportional-hazards model (stratified by age and OGTT status at randomization)
*Adapted from the TZIELD Prescribing Information.
Patient results may vary.1
Median follow-up time was 51 months (range: 74 days to 2683 days)
Data from extended follow-up of the TN-10 study (median 923 days)3
Extended follow-up limitations
These data are not contained in the Prescribing Information. The TN-10 study was relatively small at the start of the trial, and patient numbers decreased throughout follow-up. Therefore, definitive conclusions cannot be derived from these data. Patient results may vary.3
At the time of the TN-10 extension analysis (~8.5 years after first patient start)†
29 of the original 76 study participants with Stage 2 T1D had not
progressed to Stage 33
progressed to Stage 33
Time without progression to Stage 3 T1D (in years)
50% of TZIELD-treated patients (22/44) with Stage 2 T1D had not progressed to Stage 3 at the end of the extended follow-up analysis versus 22% of placebo-treated patients (7/32)
Extended follow-up limitations
These data are not contained in the Prescribing Information. The TN-10 study was relatively small at the start of the trial, and patient numbers decreased throughout follow-up. Therefore, definitive conclusions cannot be derived from these data. Patient results may vary.3
†Median time of 923 days (~2.5 years; range, 74 days to 3119 days; ~0.2 to ~8.6 years).
At the end of the extended follow-up analysis,
10 of 13 subjects followed for
5 years were not diagnosed with T1D. These represent 18% (8/44) of the teplizumab group and 6% (2/32) of the placebo group of the original participants.3
Important Safety Information
INDICATION
TZIELD is a CD3-directed monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
- Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. Prior to TZIELD treatment, premedicate with antipyretics, antihistamines and/or antiemetics, and treat similarly if symptoms occur during treatment. If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.
- Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor patients for signs and symptoms of infection during and after TZIELD administration. If serious infection develops, treat appropriately, and discontinue TZIELD.
- Lymphopenia: Lymphopenia occurred in most TZIELD-treated patients. For most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within two weeks after treatment completion and without dose interruption. Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), discontinue TZIELD.
- Hypersensitivity Reactions: Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in TZIELD-treated patients. If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly.
- Vaccinations: The safety of immunization with live-attenuated (live) vaccines with TZIELD-treated patients has not been studied. TZIELD may interfere with immune response to vaccination and decrease vaccine efficacy. Administer all age-appropriate vaccinations prior to starting TZIELD.
- Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
- Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment. Inactivated vaccines are not recommended during treatment or 6 weeks after completion of treatment.
ADVERSE REACTIONS
Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia, and headache.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm.
- Lactation: A lactating woman may consider pumping and discarding breast milk during and for 20 days after TZIELD administration.
Please see full Prescribing Information, including patient selection criteria, and Medication Guide. View Important Safety Information page.
References: 1. TZIELD Prescribing Information. Provention Bio, Inc; 2023. 2. Herold KC, Bundy BN, Long SA, et al. Type 1 Diabetes TrialNet Study Group. An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes. N Engl J Med. 2019;381(7):603-613. 3. Sims EK, Bundy BN, Stier K, et al. Teplizumab improves and stabilizes beta cell function in antibody-positive high-risk individuals + Supplementary Appendix. Sci Transl Med. 2021;13(583):eabc8980
