{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T13:54:20Z","timestamp":1782222860706,"version":"3.54.5"},"reference-count":43,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,8,14]],"date-time":"2023-08-14T00:00:00Z","timestamp":1691971200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>Type 1 diabetes mellitus is widely recognized as a chronic autoimmune disease characterized by the pathogenic destruction of beta cells, resulting in the loss of endogenous insulin production. Insulin administration remains the primary therapy for symptomatic treatment. Recent studies showed that disease\u2010modifying agents, such as anti\u2010CD3 monoclonal antibodies, have shown promising outcomes in improving the management of the disease. In late 2022, teplizumab received approval from the US Food and Drug Administration (FDA) as the first disease\u2010modifying agent for the treatment of type 1 diabetes. This review aims to evaluate the clinical evidence regarding the efficacy of anti\u2010CD3 monoclonal antibodies in the prevention and treatment of type 1 diabetes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A comprehensive search of PubMed, Google Scholar, Scopus and Cochrane Central Register of Controlled Trials (CENTRAL) was conducted up to December 2022 to identify relevant randomized controlled trials. Meta\u2010analysis was performed using a random\u2010effects model, and odds ratios with 95% confidence intervals (CIs) were calculated to quantify the effects. The Cochrane risk of bias tool was employed for quality assessment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In total, 11 randomized controlled trials involving 1397 participants (908 participants in the intervention arm, 489 participants in the control arm) were included in this review. The mean age of participants was 15\u2009years, and the mean follow\u2010up time was 2.04\u2009years. Teplizumab was the most commonly studied intervention. Compared with placebo, anti\u2010CD3 monoclonal antibody treatment significantly increased the C\u2010peptide concentration in the area under the curve at shorter timeframes (mean difference\u2009=\u20090.114, 95% CI: 0.069 to 0.159,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u2009.000). Furthermore, anti\u2010CD3 monoclonal antibodies significantly reduced the patients' insulin intake across all timeframes (mean difference\u2009=\u2009\u22120.123, 95% CI: \u22120.151 to \u22120.094,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u2009.001). However, no significant effect on glycated haemoglobin concentration was observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The findings of this review suggest that anti\u2010CD3 monoclonal antibody treatment increases endogenous insulin production and improves the lifestyle of patients by reducing insulin dosage. Future studies should consider the limitations, including sample size, heterogeneity and duration of follow\u2010up, to validate the generalizability of these findings further.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.15237","type":"journal-article","created":{"date-parts":[[2023,8,15]],"date-time":"2023-08-15T02:59:56Z","timestamp":1692068396000},"page":"3377-3389","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Efficacy of\n                    <scp>anti\u2010CD3<\/scp>\n                    monoclonal antibodies in delaying the progression of recent\u2010onset type 1 diabetes mellitus: A systematic review,\n                    <scp>meta\u2010analyses<\/scp>\n                    and\n                    <scp>meta\u2010regression<\/scp>"],"prefix":"10.1111","volume":"25","author":[{"given":"Muhammad Talal","family":"Ashraf","sequence":"first","affiliation":[{"name":"Department of Internal Medicine Dow University of Health Sciences  Karachi Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syed Hassan","family":"Ahmed Rizvi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Dow University of Health Sciences  Karachi Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muhammad Arham Bin","family":"Kashif","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Dow University of Health Sciences  Karachi Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muhammad Khuzzaim","family":"Shakeel Khan","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Dow University of Health Sciences  Karachi Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Syed Hassan","family":"Ahmed","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Dow University of Health Sciences  Karachi Pakistan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6705-2030","authenticated-orcid":false,"given":"Muhammad Sohaib","family":"Asghar","sequence":"additional","affiliation":[{"name":"Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,8,14]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198605223142106"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(01)05415\u20100"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199609193351205"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0006\u20102952(97)00492\u20109"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198803173181103"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198809083191002"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/1056\u20108727(92)90016\u2010e"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.6367043"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.22.3.478"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.2337\/diab.41.3.385"},{"issue":"6","key":"e_1_2_10_12_1","first-page":"2947","article-title":"CD3 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