Abstract：
OBJECTIVE: 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 HbA1c.
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], I2 = 94%), and 2 years (P = 0.0003, MD 0.20, 95% CI [0.09, 0.30], I2 = 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], I2 = 90%), and 2 years (P < 0.00001, MD -0.18, 95% CI [-0.25, -0.12], I2 = 86%). But there was no statistically significant effect on HbA1c 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.
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 HbA1c.
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], I2 = 94%), and 2 years (P = 0.0003, MD 0.20, 95% CI [0.09, 0.30], I2 = 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], I2 = 90%), and 2 years (P < 0.00001, MD -0.18, 95% CI [-0.25, -0.12], I2 = 86%). But there was no statistically significant effect on HbA1c 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.
摘要：
目的：本荟萃分析旨在评估抗CD3单克隆抗体（mAb）治疗1型糖尿病的疗效和安全性。
方法：我们搜索了PubMed，Embase和Cochrane直到2023年2月23日，用于比较抗CD3mAb与安慰剂在1型糖尿病中的随机对照试验。主要结果是C肽的曲线下面积（AUC），每日胰岛素剂量或HbA1c。
结果：共有12项包含1870名参与者的试验符合纳入审查的条件。与对照组相比,抗CD3单克隆抗体在1年时增加了C肽的AUC（P=0.0005，MD0.14，95％CI[0.06，0.22]，I2=94%)，和2年(P=0.0003，MD0.20，95%CI[0.09，0.30]，I2=88%)。使用抗CD3mAb减少了1年时的胰岛素使用（P=0.001，MD-0.09，95％CI[-0.15，-0.04]，I2=90%)，和2年(P<0.00001，MD-0.18，95%CI[-0.25，-0.12]，I2=86%)。但对HbA1c水平无统计学意义。呕吐,恶心,皮疹,与安慰剂相比，抗CD3mAb的发热和头痛发生率更高。然而,在比较抗CD3mAb和安慰剂时,总不良事件和严重不良事件的发生率相似.
结论：我们的结果表明，抗CD3mAb是改善1型糖尿病患者C肽AUC和胰岛素使用的潜在疗法。
方法：我们搜索了PubMed，Embase和Cochrane直到2023年2月23日，用于比较抗CD3mAb与安慰剂在1型糖尿病中的随机对照试验。主要结果是C肽的曲线下面积（AUC），每日胰岛素剂量或HbA1c。
结果：共有12项包含1870名参与者的试验符合纳入审查的条件。与对照组相比,抗CD3单克隆抗体在1年时增加了C肽的AUC（P=0.0005，MD0.14，95％CI[0.06，0.22]，I2=94%)，和2年(P=0.0003，MD0.20，95%CI[0.09，0.30]，I2=88%)。使用抗CD3mAb减少了1年时的胰岛素使用（P=0.001，MD-0.09，95％CI[-0.15，-0.04]，I2=90%)，和2年(P<0.00001，MD-0.18，95%CI[-0.25，-0.12]，I2=86%)。但对HbA1c水平无统计学意义。呕吐,恶心,皮疹,与安慰剂相比，抗CD3mAb的发热和头痛发生率更高。然而,在比较抗CD3mAb和安慰剂时,总不良事件和严重不良事件的发生率相似.
结论：我们的结果表明，抗CD3mAb是改善1型糖尿病患者C肽AUC和胰岛素使用的潜在疗法。
