Teplizumab: A Disease-Modifying Therapy for Type 1 Diabetes That Preserves β-Cell Function
Authors' conclusion
These data confirm consistency in the preservation of β-cell function, as measured by C-peptide, across multiple clinical trials. This analysis showed that the most common adverse events included lymphopenia, rash, and headache, a majority of which occurred during and after the first few weeks of teplizumab administration and generally resolved without intervention, consistent with a safety profile characterized by self-limited adverse events after one or two courses of teplizumab treatment.
Study context
- Population
- Patients with stage 3 T1D from five clinical trials
- Participants
- 609 patients5 trials
- Comparison
- Teplizumab vs control
- Teplizumabn = 375
- Controln = 234reference
- Outcome
- Change from baseline in stimulated C-peptide
- Follow-up
- Years 1 and 2
Methodological detailspooled analysis
- Pooled analysis
Pooled result
As reported in the abstract
Average increase
0.08 nmol/L
P < 0.0001
year 1
Average increase
0.12 nmol/L
P < 0.0001
year 2
Further pooled results
Exogenous insulin use · years 1 and 2
- Overall reduction, year 1 (P = 0.0001)
- 0.08
- Overall reduction, year 2 (P < 0.0001)
- 0.10 units/kg/day
Safety
Integrated safety analysis (5 trials, 1,018 patients with stage 2 or 3 T1D; ∼1,500 patient-years teplizumab follow-up)
- Most common AEs: lymphopenia, rash, headache; mostly during and after first few weeks of administration, generally resolved without intervention
Original publication
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