Anti-CD3 monoclonal antibody in treating patients with type 1 diabetes: an updated systematic review and meta-analysis
Authors' conclusion
Anti-CD3 mAb effectively preserves C-peptide secretion and reduces insulin requirement in patients with T1D. Younger age (≤ 18 years), earlier treatment initiation (≤ 6 weeks post-diagnosis), higher cumulative doses (≥ 25 mg) may present better therapeutic effect.
Study context
- Population
- Participants with T1D in RCTs; PubMed, Embase and Cochrane searched until 31 May 2024
- Participants
- 1,573 participants11 RCTs
- Comparison
- Anti-CD3 monoclonal antibody (mAb) vs placebo or standard care
- Outcome
- Changes in AUC of C-peptide, HbA1c and daily insulin requirement (main outcomes)
Methodological detailsmeta-regression, subgroup analyses
- Meta-regression
- Subgroup analyses
Pooled result
As reported in the abstract
AUC of C-peptide; daily insulin requirement
SMD (AUC of C-peptide)
0.337
95% CI 0.105–0.569P = 0.004
increased with anti-CD3 mAb
SMD (daily insulin requirement)
- 0.598
95% CI - 0.927 to - 0.269P < 0.001
AUC of C-peptide; daily insulin requirement
Further pooled results
| Outcome | Estimate | P value | |
|---|---|---|---|
| AUC of C-peptide by subgroupAnti-CD3 mAbvs Control | SMD (average age ≤ 18 years) 0.546 (95% CI 0.203–0.889) | P < 0.001 | |
| AUC of C-peptide by subgroupAnti-CD3 mAbvs Control | SMD (cumulative dose ≥ 25 mg) 0.588 (95% CI 0.424–0.752) | P < 0.001 | |
| −0.500.51Difference (linear scale) |
| Outcome | SMD (T1D duration ≤ 6 weeks) (95% CI) | P value |
|---|---|---|
| AUC of C-peptide by subgroupAnti-CD3 mAb vs Control | 0.609 (0.405–0.814) | P < 0.001 |
AUC of C-peptide by subgroup
- Meta-regression: cumulative dose was the most critical factor, masking the effect of average age and T1D diagnosis duration
Safety
- Most adverse events were transient and could be medically treated
Original publication
Anti-CD3 monoclonal antibody in treating patients with type 1 diabetes: an updated systematic review and meta-analysis. Cardiovasc Diabetol. Published 29 March 2025. doi:10.
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