Background::
Type one diabetes mellitus (T1DM) is an autoimmune disease characterized by gradual destruction
of beta cells in islets of Langerhans. Teplizumab is a humanized anti-CD3 monoclonal antibody, which may have beneficial
effects for T1DM patients.
Objective::
To assess the safety and efficacy of teplizumab in T1DM patients.
Methods::
We searched electronic databases using related keywords for randomized clinical trials that assessing the safety
and efficacy of teplizumab. We evaluated the retrieved citations for eligibility, and we extracted the data then analyzed it using
Review Manager Software.
Results::
We included eight randomized clinical trials with 866 patients. Teplizumab was associated with lower insulin use
than placebo at 6 months (MD = -0.17, 95% CI [-0.24, -0.09], P < 0.001), 12 months (MD = -0.12, 95% CI [-0.18, -0.06], P
< 0.001), 18 months (MD = -0.22, 95% CI [-0.32, -0.11], P < 0.001) and 24 months (MD = -0.17, 95% CI [-0.28, -0.06], P =
0.003). The area under the curve of C-peptide was significantly increased in teplizumab group at 12 months (MD = 0.08,
95% CI [0.01, 0.15], P = 0.03), 18 months (MD = 0.13, 95% CI [0.01, 0.25], P = 0.03) and 24 months (MD = 0.13, 95% CI
[0.01, 0.24], P = 0.03). No significant effect of teplizumab on HbA1c levels at any time point. Teplizumab was associated
with some side effects such as lymphopenia, skin and subcutaneous tissue disorders.
Conclusions::
Teplizumab is associated with lower insulin use and higher AUC of C-peptide in type 1 diabetic patients with
no significant effect on Hb1c levels. Besides, teplizumab showed some adverse effects.