{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T23:41:30Z","timestamp":1773272490984,"version":"3.50.1"},"reference-count":39,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2008,7,7]],"date-time":"2008-07-07T00:00:00Z","timestamp":1215388800000},"content-version":"vor","delay-in-days":2744,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Endocrinology"],"published-print":{"date-parts":[[2001,1]]},"abstract":"<jats:p>First, to evaluate the performance level of a new TSH binding inhibitory antibody assay using human recombinant TSH receptors (h\u2010TBII) in comparison with a thyroid stimulating antibody (TSAb) bioassay performed before, at the end of treatment (18\u2003months) and after antithyroid drug withdrawal in Graves' disease patients; second, to assess the accuracy with which h\u2010TBII levels could predict relapse and remission.<\/jats:p><jats:p>Retrospective study on serum samples of Graves' disease patients treated by antithyroid drugs for 18\u2003months.<\/jats:p><jats:p>Serum samples from 140 patients (27 men and 113 women; median age 42\u2003years) with recent onset hyperthyroidism due to\u00a0Graves' disease were retrospectively tested for h\u2010TBII at diagnosis, at 18\u2003months and for 76 of them\u00a06,\u00a012, 24 and 36\u2003months after drug withdrawal or at relapse. TSAb were also evaluated at each time.\u00a0Thyroid blocking antibodies (TBAb) were measured in sera positive for h\u2010TBII and negative for TSAb. h\u2010TBII levels were measured with a radioreceptor assay using the human recombinant TSH receptor (DYNOtest TRAK human from B.R.A.H.M.S. Diagnostica, Berlin, Germany). TSAb and TBAb levels were assayed in thyrocyte cultures.<\/jats:p><jats:p>At diagnosis, high levels of h\u2010TBII were found in 138 of 140 patients with Graves' disease (98\u00b76%). High TSAb values were also detected in the same 138 patients. The h\u2010TBII and TSAb values were significantly correlated (<jats:italic>r<\/jats:italic>\u2003=\u20030\u00b7582, <jats:italic>p<\/jats:italic>\u2003&lt;\u20030\u00b70001).<\/jats:p><jats:p>At 18\u2003months, h\u2010TBII were found in 48 of the 140 patients (34%) and TSAb in 43 patients (31%). The h\u2010TBII and TSAb values were significantly correlated (<jats:italic>r<\/jats:italic>\u2003=\u20030\u00b7618, <jats:italic>p<\/jats:italic>\u2003&lt;\u20030\u00b70001) and fell significantly between diagnosis and 18\u2003months (<jats:italic>Z<\/jats:italic>\u2003=\u2003\u2212\u20039\u00b784, <jats:italic>p<\/jats:italic>\u2003&lt;\u20030\u00b70001 and <jats:italic>Z<\/jats:italic>\u2003=\u2003\u2212\u20039\u00b719, <jats:italic>p<\/jats:italic>\u2003&lt;\u20030\u00b70001). TBAb were found in two of the 11 sera positive for h\u2010TBII and negative for TSAb.<\/jats:p><jats:p>At diagnosis, the median levels of h\u2010TBII and TSAb were not significantly different between the patients who relapsed within the 3\u2003years after the withdrawal of treatment (<jats:italic>n<\/jats:italic>\u2003=\u200360) and those who did not (<jats:italic>n<\/jats:italic>\u2003=\u200380) (<jats:italic>Z<\/jats:italic>\u2003=\u2003\u2212\u20031\u00b71, ns; <jats:italic>Z<\/jats:italic>\u2003=\u2003\u2212\u20030\u00b7216, ns).<\/jats:p><jats:p>At 18\u2003months, the prevalences of h\u2010TBII and TSAb were significantly increased in patients who relapsed compared to those who remained in remission at 3\u2003years (60% <jats:italic>vs.<\/jats:italic> 15%, \u03c7<jats:sup>2<\/jats:sup>\u2003=\u200330\u00b78, <jats:italic>p<\/jats:italic>\u2003&lt;\u20030\u00b70001 and 55% <jats:italic>vs.<\/jats:italic> 13%, \u03c7<jats:sup>2<\/jats:sup>\u2003=\u200329\u00b71, <jats:italic>p<\/jats:italic>\u2003&lt;\u20030\u00b70001, respectively). h\u2010TBII and TSAb median levels were also significantly increased in patients who relapsed compared to the others (<jats:italic>Z<\/jats:italic>\u2003=\u2003\u2212\u20034,8, <jats:italic>p<\/jats:italic>\u2003&lt;\u20030\u00b70001; <jats:italic>Z<\/jats:italic>\u2003=\u2003\u2212\u20033,01, <jats:italic>P<\/jats:italic>\u2003&lt;\u20030\u00b7005).<\/jats:p><jats:p>Among the 60 patients who relapsed, 36 (60%) displayed h\u2010TBII and 33 (55%) TSAb at 18\u2003months. The majority of patients who relapsed during the 2\u2003years following the end of treatment, in contrast to those who relapsed later, were positive for h\u2010TBII (67% <jats:italic>vs.<\/jats:italic> 27%, \u03c7<jats:sup>2<\/jats:sup>\u2003=\u20036\u00b701, <jats:italic>p<\/jats:italic>\u2003=\u20030\u00b7035). Seventeen of the 18 tested patients who relapsed were negative for h\u2010TBII at 18\u2003months, were then positive for h\u2010TBII at the time of relapse, whereas 15 of them were still negative, 6\u201312\u2003months before the relapse.<\/jats:p><jats:p>Among the 80 patients who remained in remission at 3\u2003years, only 10 (13%) displayed TSAb and 12 (15%) h\u2010TBII at 18\u2003months. In 10 of these 12 patients who were further evaluated for h\u2010TBII positivity, h\u2010TBII fell to control levels during the 3\u2003years following the end of treatment.<\/jats:p><jats:p>The new h\u2010TBII assay is a simple and rapid method with a performance level similar to that of TSAb determination. Its sensitivity is close to 100% at diagnosis. In the whole group, TBII level analysis is relevant as a predictor for short time relapse. However, some of the patients are \u2018misclassified\u2019, due to the inter\u2010individual variability in the time course of h\u2010TBII activity. Our results confirm that, in addition to h\u2010TBII, even when measured with a highly sensitive test, the concomitant analysis of other clinical and\/or biological parameters is necessary to improve the prediction of treatment outcome.<\/jats:p>","DOI":"10.1046\/j.1365-2265.2001.01197.x","type":"journal-article","created":{"date-parts":[[2003,3,11]],"date-time":"2003-03-11T10:47:45Z","timestamp":1047379665000},"page":"89-96","source":"Crossref","is-referenced-by-count":54,"title":["Clinical value of a new TSH binding inihibitory activity assay using human TSH receptors in the follow\u2010up of antithyroid drug treated Graves' disease. 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