{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T20:56:31Z","timestamp":1790283391360,"version":"4.1.0"},"reference-count":37,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,4,11]],"date-time":"2024-04-11T00:00:00Z","timestamp":1712793600000},"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":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To provide updated efficacy and safety information for teplizumab in the treatment of Stage 3 type 1 diabetes mellitus (T1DM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      The PubMed, Embase and Cochrane databases were searched for randomized controlled trials (RCTs) comparing teplizumab to placebo for T1DM that reported any of the following outcomes: (1) C\u2010peptide area under the curve (AUC); (2) glycated haemoglobin (HbA1c) levels; (3) insulin requirements; and (4) adverse events. Heterogeneity was examined with\n                      <jats:italic>I<\/jats:italic>\n                      <jats:sup>2<\/jats:sup>\n                      statistics.\n                      <jats:italic>p<\/jats:italic>\n                      values &lt;0.05 were taken to indicate statistical significance. The continuous endpoints were compared through the pooled mean difference (MD) and binary endpoints were assessed using risk ratios, both with 95% confidence intervals (CIs). Statistical analyses were performed using Review Manager Web software.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Eight RCTs with 1052 patients (754 receiving teplizumab) were included. Teplizumab significantly increased the AUC of C\u2010peptide levels at 6 (MD 0.10\u2009nmol\/L, 95% CI 0.05, 0.16), 12 (MD 0.13\u2009nmol\/L, 95% CI 0.06, 0.20), 18 (MD 0.18\u2009nmol\/L, 95% CI 0.09, 0.27) and 24\u2009months (MD 0.16\u2009nmol\/L, 95% CI 0.02, 0.31), significantly reduced HbA1c levels at 6 (MD \u22120.57%, 95% CI \u22121.07, \u22120.08) and 12\u2009months (MD \u22120.31%, 95% CI \u22120.59, \u22120.02), and significantly reduced insulin requirements at 6 (MD \u22120.12\u2009U\/kg, 95% CI \u22120.16, \u22120.08), 12 (MD \u22120.11\u2009U\/kg, 95% CI \u22120.15, \u22120.07), 18 (MD \u22120.17\u2009U\/kg, 95% CI \u22120.26, \u22120.09) and 24\u2009months (MD \u22120.11\u2009U\/kg, 95% CI \u22120.22, \u22120.01).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Teplizumab increases AUC of C\u2010peptide levels and decreases HbA1c levels and insulin use, without raising serious adverse event risk.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.15581","type":"journal-article","created":{"date-parts":[[2024,4,11]],"date-time":"2024-04-11T09:28:34Z","timestamp":1712827714000},"page":"2652-2661","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Safety and efficacy of teplizumab in the treatment of type 1 diabetes mellitus: An updated systematic review and meta\u2010analysis of randomized controlled trials"],"prefix":"10.1111","volume":"26","author":[{"given":"Gabriel","family":"Grando Alves","sequence":"first","affiliation":[{"name":"Department of Medicine Federal University of Santa Maria  Santa Maria Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luisa","family":"Cunha","sequence":"additional","affiliation":[{"name":"Department of Medicine Lus\u00edada University Center  S\u00e3o Paulo Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafael","family":"Henkes Machado","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Southern Santa Catarina  Palho\u00e7a Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-3854-0377","authenticated-orcid":false,"given":"Vanessa","family":"Lins de Menezes","sequence":"additional","affiliation":[{"name":"Department of Medicine Ribeir\u00e3o Preto Medical School, University of S\u00e3o Paulo  Ribeir\u00e3o Preto Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,4,11]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.abh1654"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)60971-0"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/dc23-0180"},{"key":"e_1_2_9_5_1","unstructured":"Highlights of prescribing information: TZIELD (teplizumab\u2010mzwv).Silver Spring MD: Food and Drug Administration [Internet]. 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