Safety of teplizumab in stage 2 and stage 3 type 1 diabetes: Integrated analysis of clinical trials

Dayan, C. M. ORCID: https://orcid.org/0000-0002-6557-3462, Herold, K. C., Simmons, K. M., Šumník, Z., Knecht, L. A., Popescu, L., Tian, W., Gonzalez, O., Kordonouri, O., Niemoeller, E. and Gitelman, S. E. 2025. Safety of teplizumab in stage 2 and stage 3 type 1 diabetes: Integrated analysis of clinical trials. Diabetologie und Stoffwechsel 20 (S 01) , S55. 10.1055/s-0045-1807462

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Abstract

Objective : Teplizumab is the first FDA-approved disease-modifying therapy to delay the onset of type 1 diabetes (T1D) stage 3 in adults and children 8 years of age and older with T1D stage 2. Teplizumab has also been studied in recently diagnosed T1D stage 3. This study evaluates the safety of teplizumab in an integrated analysis of 7 clinical trials in T1D stages 2 and 3. Methods : The analysis included patients treated with teplizumab in the PROTECT (NCT03875729), Protégé (NCT00385697), Protégé Extension (NCT00870818), Protégé Encore (NCT00920582), AbATE (NCT00129259), Delay (NCT00378508), and TN10 (NCT01030861) studies. Patients received teplizumab IV infusions over a 6-, 12-, or 14-day dosing schedule in one or two cycles, separated by 6 to 12 months, in either a placebo- or standard-of-care-controlled setting. Results : A total of 1,346 patients were included in the analysis, with 1,008 patients receiving teplizumab and 356 controls (18 patients from the open-label Delay study counted for both cohorts). Demographic data were analyzed based on randomization (n=990 teplizumab; n=356 control). The mean age±standard deviation (SD) was 16.3±7.0 years (teplizumab group) and 15.4±7.0 years (control group). The mean±SD study duration was 688±261 days (teplizumab group) and 648±247 days (control group). Treatment-emergent adverse events (TEAEs) were reported for 99.5% (teplizumab) vs. 95.8% (controls). Lymphopenia was reported more frequently in the teplizumab (74.5%) than in the control group (12.9%). However, infection rates were similar between groups (teplizumab: 55.3%; controls: 55.1%). Cytokine release syndrome (CRS) was reported in 6.4% (teplizumab group) vs. 1.1% (control group). TEAEs leading to treatment discontinuation (teplizumab: 12.7%; controls: 3.4%), the majority of which included protocol-defined discontinuation criteria, were primarily due to laboratory abnormalities, including elevated alanine aminotransferase (teplizumab: 4.5%; controls: 0.3%) and elevated aspartate aminotransferase (teplizumab: 2.2%; controls: 0.3%). Treatment-emergent serious adverse events (TESAEs) were reported for 11.8% vs. 7.3%. The most common TESAEs in the teplizumab group were diabetic ketoacidosis (teplizumab: 2.1%; controls: 0.3%), CRS (teplizumab: 0.9%; controls: 0.0%), and hypoglycemic seizures (teplizumab: 0.7%; controls: 0.0%).

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Schools > Medicine
Publisher:	Thieme Gruppe
ISSN:	1861-9002
Last Modified:	17 Jun 2025 10:45
URI:	https://orca.cardiff.ac.uk/id/eprint/179111

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