Efficacy and Safety of T Cell-Targeted Immunotherapy in Newly Diagnosed Type 1 Diabetes: A Systematic Review and Meta-Analysis.
To assess the efficacy and safety of T cell-targeted immunotherapy in patients with newly diagnosed type 1 diabetes (T1D).
A comprehensive search of PubMed, Embase, CENTRAL, Web of Science, Scopus and ClinicalTrials.gov up to 6 March 2026 was performed. Randomised controlled trials comparing T cell-targeted immunotherapeutic agents with placebo in patients with newly diagnosed T1D were included. The primary outcome was change in the area under the curve (AUC) of C-peptide, whereas the secondary outcomes included change in glycated haemoglobin (HbA1c) levels, change in daily insulin dose, and adverse events.
Twenty-one trials involving 1970 participants were included in this study. Compared with the control treatment, T cell-targeted immunotherapy significantly increased the C-peptide AUC, with SMDs of 0.38 (95% CI: 0.19-0.57; p < 0.001) at 6 months, 0.41 (95% CI: 0.12-0.69; p = 0.005) at 12 months, 0.48 (95% CI: 0.32-0.65; p < 0.001) at 18 months, and 0.49 (95% CI: 0.32-0.65; p < 0.001) at 24 months. Consistently, this therapy also reduced HbA1c levels and daily insulin dose at all time points (all p < 0.05). Subgroups with younger age (< 18 years), worse baseline metabolic status, and single-blind or open-label design showed greater efficacy in the early phase of therapy. The risks of total and serious adverse events were comparable between the intervention and control groups.
T cell-targeted immunotherapy provides sustained preservation of β-cell function and improvements in HbA1c levels and insulin requirements for at least 24 months in patients with newly diagnosed T1D.
A comprehensive search of PubMed, Embase, CENTRAL, Web of Science, Scopus and ClinicalTrials.gov up to 6 March 2026 was performed. Randomised controlled trials comparing T cell-targeted immunotherapeutic agents with placebo in patients with newly diagnosed T1D were included. The primary outcome was change in the area under the curve (AUC) of C-peptide, whereas the secondary outcomes included change in glycated haemoglobin (HbA1c) levels, change in daily insulin dose, and adverse events.
Twenty-one trials involving 1970 participants were included in this study. Compared with the control treatment, T cell-targeted immunotherapy significantly increased the C-peptide AUC, with SMDs of 0.38 (95% CI: 0.19-0.57; p < 0.001) at 6 months, 0.41 (95% CI: 0.12-0.69; p = 0.005) at 12 months, 0.48 (95% CI: 0.32-0.65; p < 0.001) at 18 months, and 0.49 (95% CI: 0.32-0.65; p < 0.001) at 24 months. Consistently, this therapy also reduced HbA1c levels and daily insulin dose at all time points (all p < 0.05). Subgroups with younger age (< 18 years), worse baseline metabolic status, and single-blind or open-label design showed greater efficacy in the early phase of therapy. The risks of total and serious adverse events were comparable between the intervention and control groups.
T cell-targeted immunotherapy provides sustained preservation of β-cell function and improvements in HbA1c levels and insulin requirements for at least 24 months in patients with newly diagnosed T1D.
Authors
Wang Wang, Zhou Zhou, Zhu Zhu, Wang Wang, Shi Shi, Li Li, Huang Huang, Li Li, Xie Xie, Zhou Zhou
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