PMID- 38519028
OWN - NLM
STAT- MEDLINE
DCOM- 20240504
LR  - 20240709
IS  - 1530-891X (Print)
IS  - 1530-891X (Linking)
VI  - 30
IP  - 5
DP  - 2024 May
TI  - Role of Teplizumab, a Humanized Anti-CD3 Monoclonal Antibody, in Managing Newly 
      Diagnosed Type 1 Diabetes: An Updated Systematic Review and Meta-Analysis.
PG  - 431-440
LID - S1530-891X(24)00084-3 [pii]
LID - 10.1016/j.eprac.2024.03.006 [doi]
AB  - OBJECTIVE: Teplizumab has emerged as a potential disease-modifying drug in type 1 
      diabetes (T1D). This meta-analysis sought to summarize the therapeutic effect of 
      teplizumab in newly diagnosed patients with T1D. METHODS: Randomized controlled 
      trials involving patients with T1D receiving teplizumab in the intervention arm 
      and placebo (or no active intervention) in the control arm were searched 
      throughout the electronic databases. The primary outcome was the change in area 
      under the curve of C-peptide levels from baseline. RESULTS: Seven reports from 6 
      studies involving 834 subjects met the inclusion criteria. Compared to 
      teplizumab, greater reductions in area under the curve of C-peptide from the 
      baseline values were observed in the control group after 6 months (mean 
      difference [MD] 0.07 nmol/L [0.01, 0.13], P = .02), after 12 months (MD 
      0.07 nmol/L [0.04, 0.11], P = .0001), after 18 months (MD 0.10 nmol/L [0.06, 
      0.14], P < .00001), and after 24 months (MD 0.07 nmol/L [0.01, 0.14], P = .03) of 
      interventions. Moreover, fewer patients treated with teplizumab had a decreased 
      C-peptide response after 6 months (odds ratio [OR] 0.21), after 12 months (OR 
      0.17), after 18 months (OR 0.30), and after 24 months (OR 0.12) of treatment. The 
      preservation of endogenous insulin production was supported by reduced use of 
      exogenous insulin with maintenance of comparable glycemic control for up to 18 
      months post-treatment. Teplizumab imparted higher risks of grade 3 or higher 
      adverse events, adverse events leading to study medication discontinuation, 
      nausea, rash, and lymphopenia. CONCLUSION: The results of the meta-analysis 
      support teplizumab as a promising disease-modifying therapy for newly diagnosed 
      T1D.
CI  - Copyright (c) 2024 AACE. Published by Elsevier Inc. All rights reserved.
FAU - Kamrul-Hasan, A B M
AU  - Kamrul-Hasan ABM
AD  - Department of Endocrinology, Mymensingh Medical College, Mymensingh, Bangladesh. 
      Electronic address: rangassmc@gmail.com.
FAU - Mondal, Sunetra
AU  - Mondal S
AD  - Department of Endocrinology, NRS Medical College, Kolkata, India.
FAU - Nagendra, Lakshmi
AU  - Nagendra L
AD  - Department of Endocrinology, JSS Medical College, JSS Academy of Higher Education 
      and Research, Mysore, India.
FAU - Yadav, Ashmita
AU  - Yadav A
AD  - Department of Neurosciences, Nobel Medical College and Teaching Hospital, 
      Biratnagar, Nepal.
FAU - Aalpona, Fatema Tuz Zahura
AU  - Aalpona FTZ
AD  - Department of Gyne & Obs, Khaliajuri Upazila Health Complex, Netrokona, 
      Bangladesh.
FAU - Dutta, Deep
AU  - Dutta D
AD  - Department of Endocrinology, CEDAR Superspeciality Healthcare, New Delhi, India.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
PT  - Systematic Review
DEP - 20240320
PL  - United States
TA  - Endocr Pract
JT  - Endocrine practice : official journal of the American College of Endocrinology 
      and the American Association of Clinical Endocrinologists
JID - 9607439
RN  - S4M959U2IJ (teplizumab)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (CD3 Complex)
RN  - 0 (C-Peptide)
SB  - IM
MH  - *Diabetes Mellitus, Type 1/drug therapy
MH  - Humans
MH  - *Antibodies, Monoclonal, Humanized/therapeutic use
MH  - CD3 Complex/immunology
MH  - Randomized Controlled Trials as Topic
MH  - C-Peptide/blood
OTO - NOTNLM
OT  - C-peptide
OT  - beta-cell function
OT  - disease-modifying therapy
OT  - safety
OT  - teplizumab
OT  - type 1 diabetes
COIS- Disclosure The authors have no conflicts of interest to disclose.
EDAT- 2024/03/23 05:42
MHDA- 2024/05/05 07:47
CRDT- 2024/03/22 20:29
PHST- 2024/01/29 00:00 [received]
PHST- 2024/02/23 00:00 [revised]
PHST- 2024/03/13 00:00 [accepted]
PHST- 2024/05/05 07:47 [medline]
PHST- 2024/03/23 05:42 [pubmed]
PHST- 2024/03/22 20:29 [entrez]
AID - S1530-891X(24)00084-3 [pii]
AID - 10.1016/j.eprac.2024.03.006 [doi]
PST - ppublish
SO  - Endocr Pract. 2024 May;30(5):431-440. doi: 10.1016/j.eprac.2024.03.006. Epub 2024 
      Mar 20.