{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T11:43:53Z","timestamp":1778154233974,"version":"3.51.4"},"reference-count":43,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2021,2,18]],"date-time":"2021-02-18T00:00:00Z","timestamp":1613606400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Metabolism Res"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>We aimed to study the feasibility and tolerability of a combination therapy consisting of glutamic acid decarboxylase (GAD\u2010alum), Etanercept and vitamin D in children and adolescents with newly diagnosed with type 1 diabetes (T1D), and evaluate preservation of beta cell function.<\/jats:p><\/jats:sec><jats:sec><jats:title>Material and Methods<\/jats:title><jats:p>Etanercept Diamyd Combination Regimen is an open\u2010labelled multi\u2010centre study pilot trial which enrolled 20 GAD antibodies positive T1D patients (7 girls and 13 boys), aged (mean\u00a0\u00b1SD): 12.4\u00a0\u00b1\u00a02.3\u00a0(8.3\u201316.1)\u00a0years, with a diabetes duration of 81.4\u00a0\u00b1\u00a022.1\u00a0days. Baseline fasting C\u2010peptide was 0.24\u00a0\u00b1\u00a00.1\u00a0(0.10\u20130.35)\u00a0nmol\/l. The patients received Day 1\u2010450 Vitamin D (Calciferol) 2000 U\/d per os, Etanercept sc Day 1\u201090 0.8\u00a0mg\/kg once a week and GAD\u2010alum sc injections (20\u00a0\u03bcg, Diamyd\u2122) Day 30 and 60. They were followed for 30\u00a0months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>No treatment related serious adverse events were observed. After 6\u00a0months 90\u2010min stimulated C\u2010peptide had improved in 8\/20 patients and C\u2010peptide area under the curve (AUC) after Mixed Meal Tolerance Test in 5 patients, but declined thereafter, while HbA1c and insulin requirement remained close to baseline. Administration of Etanercept did not reduce tumour necrosis factor (TNF) spontaneous secretion from peripheral blood mononuclear cells, but rather GAD65\u2010induced TNF\u2010\u03b1 increased. Spontaneous interleukin\u201017a secretion increased after the administration of Etanercept, and GAD65\u2010induced cytokines and chemokines were also enhanced following 1\u00a0month of Etanercept administration.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Combination therapy with parallel treatment with GAD\u2010alum, Etanercept and vitamin D in children and adolescents with type 1 diabetes was feasible and tolerable but had no beneficial effects on the autoimmune process or beta cell function.<\/jats:p><\/jats:sec>","DOI":"10.1002\/dmrr.3440","type":"journal-article","created":{"date-parts":[[2021,1,24]],"date-time":"2021-01-24T10:59:38Z","timestamp":1611485978000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Combined Etanercept, GAD\u2010alum and vitamin D treatment: an open pilot trial to preserve beta cell function in recent onset type 1 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