Meta-Analysis
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Jul 15, 2024; 15(7): 1615-1626
Published online Jul 15, 2024. doi: 10.4239/wjd.v15.i7.1615
Evaluation of teplizumab's efficacy and safety in treatment of type 1 diabetes mellitus: A systematic review and meta-analysis
Xiao-Lan Ma, Dan Ge, Xue-Jian Hu
Xiao-Lan Ma, Dan Ge, Xue-Jian Hu, Department of Endocrinology and Metabolism, The Second Hospital of Lanzhou University, Lanzhou 730030, Gansu Province, China
Author contributions: Ma XL contributed to concept and designed the study; Ge D contributed to analyzed data and drafting of the manuscript; Hu XJ contributed to collect the data and helped in data analysis.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
PRISMA 2009 Checklist statement: The authors have read the PRISMA 2009 Checklist, and the manuscript was prepared and revised according to the PRISMA 2009 Checklist.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Xue-Jian Hu, MM, Doctor, Department of Endocrinology and Metabolism, The Second Hospital of Lanzhou University, Lanzhou 730030, Gansu Province, China. xuejian2023@sina.com
Received: January 24, 2024
Revised: March 5, 2024
Accepted: April 30, 2024
Published online: July 15, 2024
Processing time: 166 Days and 0.5 Hours
Abstract
BACKGROUND

Islets of Langerhans beta cells diminish in autoimmune type 1 diabetes mellitus (T1DM). Teplizumab, a humanized anti-CD3 monoclonal antibody, may help T1DM. Its long-term implications on clinical T1DM development, safety, and efficacy are unknown.

AIM

To assess the effectiveness and safety of teplizumab as a therapeutic intervention for individuals with T1DM.

METHODS

A systematic search was conducted using four electronic databases (PubMed, Embase, Scopus, and Cochrane Library) to select publications published in peer-reviewed journals written in English. The odds ratio (OR) and risk ratio (RR) were calculated, along with their 95%CI. We assessed heterogeneity using Cochrane Q and I2 statistics and the appropriate P value.

RESULTS

There were 8 randomized controlled trials (RCTs) in the current meta-analysis with a total of 1908 T1DM patients from diverse age cohorts, with 1361 patients receiving Teplizumab and 547 patients receiving a placebo. Teplizumab was found to have a substantial link with a decrease in insulin consumption, with an OR of 4.13 (95%CI: 1.72 to 9.90). Teplizumab is associated with an improved C-peptide response (OR 2.49; 95%CI: 1.62 to 3.81) and a significant change in Glycated haemoglobin A1c (HbA1c) levels in people with type 1 diabetes [OR 1.75 (95%CI: 1.03 to 2.98)], and it has a RR of 0.71 (95%CI: 0.53 to 0.95).

CONCLUSION

In type 1 diabetics, teplizumab decreased insulin consumption, improved C-peptide response, and significantly changed HbA1c levels with negligible side effects. Teplizumab appears to improve glycaemic control and diabetes management with good safety and efficacy.

Keywords: Type-1 diabetes mellitus; Teplizumab; Anti-CD3 monoclonal antibody; Insulin; Glycated haemoglobin A1c; C-peptide

Core Tip: Type 1 diabetes mellitus (T1DM) may benefit from teplizumab. However, there is limited data on its long-term effects on clinical T1DM development, safety, and efficacy. Given its perceived use, this research evaluated the effectiveness and safety of teplizumab for T1DM patients through a systematic review and meta-analysis of 8 randomized controlled trials, including 1908 patients from various age groups. It was found that teplizumab treatment results in reduced insulin use, improved C-peptide response, significant glycated haemoglobin A1c changes in T1DM patients with minimal side effects and improved glycaemic management.