Safety and Efficacy of Teplizumab for Treatment of Type One Diabetes Mellitus: A Systematic Review and Meta-Analysis

Title:Safety and Efficacy of Teplizumab for Treatment of Type One Diabetes Mellitus: A Systematic Review and Meta-Analysis

Volume: 21 Issue: 10

Author(s): Anas Zakarya Nourelden, Alaa Ahmed Elshanbary, Loalo'a El-Sherif, Amira Yasmine Benmelouka, Hagar Ismail Rohim, Sara Kamel Helmy, Merhan Kamal Sayed, Ammar Ismail, Ahmed Said Ali, Khaled Mohamed Ragab and Mohamed Sayed Zaazouee*

Affiliation:

• Faculty of Medicine, Al-Azhar University, Assiut,Egypt

Keywords: Teplizumab, anti-CD3 monoclonal antibody, insulin, T1DM, systematic review, meta-analysis.

Abstract:

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: The aim of the study was to assess the safety and efficacy of teplizumab in T1DM patients.

Methods: We searched electronic databases using related keywords for randomized clinical trials assessing the safety and efficacy of teplizumab. We evaluated the retrieved citations for eligibility, and we extracted the data and 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 was observed at any time point. Teplizumab was found to be associated with some side effects such as lymphopenia, skin and subcutaneous tissue disorders.

Conclusion: 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 has shown some adverse effects.

Cite this article as:

Nourelden Zakarya Anas , Elshanbary Ahmed Alaa , El-Sherif Loalo'a , Benmelouka Yasmine Amira , Rohim Ismail Hagar, Helmy Kamel Sara , Sayed Kamal Merhan , Ismail Ammar , Ali Said Ahmed , Ragab Mohamed Khaled and Zaazouee Sayed Mohamed *, Safety and Efficacy of Teplizumab for Treatment of Type One Diabetes Mellitus: A Systematic Review and Meta-Analysis, Endocrine, Metabolic & Immune Disorders - Drug Targets 2021; 21 (10) . https://dx.doi.org/10.2174/1871530320999201209222921