Imagine the possibilities of delaying Stage 3 T1D
TZIELD delayed the median time to the diagnosis of Stage 3 type 1 diabetes (T1D) in the TN-10 trial.1
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FOR US HEALTHCARE PROFESSIONALS ONLY
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CLINICAL EFFICACY
TZIELD significantly delayed the development of Stage 3 T1D1
Kaplan-Meier curve: time to diagnosis of Stage 3 T1D by treatment group1*
(HR 0.41; 95% CI, 0.22-0.78; p=0.0066 by adjusted Cox proportional-hazards model)
*Adapted from the TZIELD Prescribing Information.
Median follow-up time was 51 months.
Kaplan-Meier curve: time to diagnosis of Stage 3 T1D by treatment group1*
(HR 0.41; 95% CI, 0.22-0.78; p=0.0066 by adjusted Cox proportional-hazards model)
*Adapted from the TZIELD Prescribing Information.
Median follow-up time was 51 months.
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DATA ANALYSES
In patients with Stage 2 T1D, TZIELD significantly delayed the median time to Stage 3 T1D onset compared with placebo.1
MEDIAN TIME TO STAGE 3 T1D
(HR 0.41; 95% CI, 0.22-0.78; p=0.0066 by adjusted Cox proportional-hazards model)
TZIELD delayed median time to onset of Stage 3 T1D by 25 months longer than placebo in Stage 2 patients. Median follow-up time was 51 months (range: 74 days to 2683 days).1,3
In the TN-10 trial extended follow-up, participants’ median time to Stage 3 T1D diagnosis was4:
MEDIAN TIME TO STAGE 3 T1D
(HR 0.457; p=0.01 by adjusted Cox proportional-hazards model)
In the extended follow-up of TZIELD- and placebo-treated patients of the TN-10 trial, the median follow-up time was 923 days (range, 74 days to 3119 days).4‡
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. Patient results may vary.1,4
‡The median follow-up time from Sims et al was calculated using time to T1D diagnosis, end-of-study participation, or administration cutoff (end of study). The median follow-up time from the TZIELD Prescribing Information was calculated using the reverse Kaplan-Meier method.
Download the TZIELD Clinical Information
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.
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.
1. TZIELD Prescribing Information. Provention Bio, Inc.2. Data on file. Provention Bio, Inc. 3. 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):603-613.4. Sims EK, Bundy BN, Stier K, et al. Sci Transl Med. 2021;13(583):eabc8980.
Provention Bio, TZIELD, and the TZIELD logo are the registered trademarks of Provention Bio, a Sanofi Company.
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