Anti-CD3 monoclonal antibodies in treatment of type 1 diabetes: a systematic review and meta-analysis

Purpose This meta-analysis aimed to assess the efficacy and safety of anti-CD3 monoclonal antibodies (mAbs) for type 1 diabetes. Methods We searched PubMed, Embase and Cochrane until 23 February 2023 for randomized controlled trials that compared anti-CD3 mAbs with placebo in type 1 diabetes. The primary outcome was the area under the curve (AUC) of C-peptide, daily insulin dose or HbA 1c . Results Totally 12 trials that included 1870 participants were eligible for inclusion in the review. Compared with the control group, anti-CD3 mAbs increased AUC of C-peptide at 1 year ( P = 0.0005, MD 0.14, 95% CI [0.06, 0.22], I 2 = 94%), and 2 years ( P = 0.0003, MD 0.20, 95% CI [0.09, 0.30], I 2 = 88%). The use of anti-CD3 mAbs decreased insulin use at 1 year ( P = 0.001, MD −0.09, 95% CI [−0.15, −0.04], I 2 = 90%), and 2 years ( P < 0.00001, MD −0.18, 95% CI [−0.25, −0.12], I 2 = 86%). But there was no statistically significant effect on HbA 1c levels. Vomiting, nausea, rash, pyrexia and headache were reported more frequently with anti-CD3 mAbs than with placebo. However, incidence of total adverse events and serious adverse events was similar when comparing anti-CD3 mAbs with placebo. Conclusions Our results suggest that anti-CD3 mAbs were a potential therapy for improving AUC of C-peptide and insulin use in type 1 diabetes.