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

Autor:	Nourelden AZ; Faculty of Medicine, Al-Azhar University, Cairo, Egypt., Elshanbary AA; Faculty of Medicine, Alexandria University, Alexandria, Egypt., El-Sherif L; Faculty of Medicine, Minia University, Minia, Egypt., Benmelouka AY; Faculty of Medicine, University of Algiers, Algiers, Algeria., Rohim HI; High Institute of Public Health, Alexandria University, Alexandria, Egypt., Helmy SK; Faculty of Pharmacy, Al-Azhar University, Cairo, Egypt., Sayed MK; Faculty of Medicine, Minia University, Minia, Egypt., Ismail A; Faculty of Medicine, Al-Azhar University, Cairo, Egypt., Ali AS; Faculty of Medicine, Al-Azhar University, Cairo, Egypt., Ragab KM; Faculty of Medicine, Minia University, Minia, Egypt., Zaazouee MS; Faculty of Medicine, Al-Azhar University, Assiut, Egypt.
Jazyk:	angličtina
Zdroj:	Endocrine, metabolic & immune disorders drug targets [Endocr Metab Immune Disord Drug Targets] 2021; Vol. 21 (10), pp. 1895-1904.
DOI:	10.2174/1871530320999201209222921
Abstrakt:	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. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)
Databáze:	MEDLINE
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