{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T17:27:53Z","timestamp":1791912473472,"version":"4.3.4"},"reference-count":42,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,5,10]],"date-time":"2024-05-10T00:00:00Z","timestamp":1715299200000},"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":["Euro J of Neurology"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and purpose<\/jats:title><jats:p>This study aimed to investigate the clinical efficacy and safety of telitacicept in patients with generalized myasthenia gravis (gMG) who tested positive for acetylcholine receptor antibodies or muscle\u2010specific kinase antibodies and were receiving standard\u2010of\u2010care therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients meeting the eligibility criteria were randomly assigned to receive telitacicept subcutaneously once a week for 24\u2009weeks in addition to standard\u2010of\u2010care treatment. The primary efficacy endpoint was the mean change in the quantitative myasthenia gravis (QMG) score from baseline to week 24. Secondary efficacy endpoints included mean change in QMG score from baseline to week 12 and gMG clinical absolute score from baseline to week 24. Additionally, safety, tolerability and pharmacodynamics were assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twenty\u2010nine of the 41 patients screened were randomly selected and enrolled. The mean (\u00b1 standard deviation [SD]) reduction in QMG score from baseline to week 24 was 7.7 (\u00b1\u20095.34) and 9.6 (\u00b1\u20094.29) in the 160\u2009mg and 240\u2009mg groups, respectively. At week 12, mean reductions in QMG scores for these two groups were 5.8 (\u00b1\u20095.85) and 9.5 (\u00b1\u20095.03), respectively, indicating rapid clinical improvement. Safety analysis revealed no adverse events leading to discontinuation or mortalities. All patients showed consistent reductions in serum immunoglobulin (Ig) A, IgG and IgM levels throughout the study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Telitacicept demonstrated safety, good tolerability and reduced clinical severity throughout the study period. Further validation of the clinical efficacy of telitacicept in gMG will be conducted in an upcoming phase 3 clinical trial.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ene.16322","type":"journal-article","created":{"date-parts":[[2024,5,10]],"date-time":"2024-05-10T08:48:29Z","timestamp":1715330909000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":46,"title":["A multicenter, randomized, open\u2010label, phase 2 clinical study of telitacicept in adult patients with generalized myasthenia gravis"],"prefix":"10.1111","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0009-0003-2054-7281","authenticated-orcid":false,"given":"Jian","family":"Yin","sequence":"first","affiliation":[{"name":"Department of Neurology Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mingming","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Neurology Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xianhao","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Neurology Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meini","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Neurology First Hospital of Shanxi Medical University  Taiyuan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zucai","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Neurology Affiliated Hospital of Zunyi Medical University  Zunyi China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zunbo","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Neurology Xi'an Gaoxin Hospital  Xi'an China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinyue","family":"Qin","sequence":"additional","affiliation":[{"name":"Department of Neurology First Affiliated Hospital of Chongqing Medical University  Chongqing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhuyi","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Neurology Tangdu Hospital, Air Force Medical University of PLA (formerly known as the Fourth Military Medical University)  Xi'an China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9481-1418","authenticated-orcid":false,"given":"Chongbo","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Neurology Huashan Hospital, Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongyu","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Neurology West China Hospital, Sichuan University  Chengdu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Ma","sequence":"additional","affiliation":[{"name":"Department of Neurology Affiliated Hospital of North Sichuan Medical College  Nanchong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenfeng","family":"Cao","sequence":"additional","affiliation":[{"name":"Department of Neurology Jiangxi Provincial People's Hospital  Nanchang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guoping","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Neurology Anhui Provincial Hospital  Hefei China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongzhong","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Neurology Second Affiliated Hospital of Dalian Medical University  Dalian China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jizhong","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Neurology Nanyang First People's Hospital  Nanyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xu","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Neurology First Affiliated Hospital of Wenzhou Medical University  Wenzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongbin","family":"Cai","sequence":"additional","affiliation":[{"name":"Department of Neurology Lanzhou University Second Hospital  Lanzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weidong","family":"Qian","sequence":"additional","affiliation":[{"name":"Department of Neurology First Affiliated Hospital of Bengbu Medical College  Bengbu China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yiqi","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Neurology Zhejiang Provincial People's Hospital  Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xinghu","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Neurology Beijing Tiantan Hospital, Capital Medical University  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guangzhi","family":"Liu","sequence":"additional","affiliation":[{"name":"Department of Neurology Beijing Anzhen Hospital, Capital Medical University  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiawei","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Neurology Beijing Tongren Hospital, Capital Medical University  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0880-958X","authenticated-orcid":false,"given":"Wei","family":"Qiu","sequence":"additional","affiliation":[{"name":"Department of Neurology Third Affiliated Hospital of Sun Yat\u2010sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lianqiu","family":"Min","sequence":"additional","affiliation":[{"name":"Department of Neurology First Affiliated Hospital of Jinzhou Medical University  Jinzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Neurology Xiangya Hospital, Central South University  Changsha China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Deng","sequence":"additional","affiliation":[{"name":"Department of Neurology First Hospital of Jilin University  Changchun China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lan","family":"Chu","sequence":"additional","affiliation":[{"name":"Department of Neurology Affiliated Hospital of Guizhou Medical University  Guiyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yifan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Neurology Affiliated Hospital of Guizhou Medical University  Guiyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianmin","family":"Fang","sequence":"additional","affiliation":[{"name":"School of Life Science and Technology Tongji University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,5,10]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI29894"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.25122\/jml-2020-0145"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1080\/14728214.2021.1952982"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-019-00742-8"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/13543784.2021.1897567"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00415-023-11699-x"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(21)00159-9"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.3389\/fneur.2020.00538"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/mus.25973"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000007600"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00415-022-11517-w"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2022.2887"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000005323"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/08830185.2016.1276903"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2019.00721"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2017040367"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.04370418"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms21239064"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10157-019-01700-1"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2016060640"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaut.2018.10.016"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clim.2012.11.010"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.285.5425.260"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2018.02285"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1084\/jem.20032000"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcp.28445"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.smim.2006.04.006"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2011-05-353961"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1177\/0961203315608254"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1080\/08923973.2021.1973493"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2011.09.014"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejphar.2011.01.002"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1358\/dot.2022.58.1.3352743"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-021-01591-1"},{"key":"e_1_2_10_36_1","doi-asserted-by":"publisher","DOI":"10.1212\/wnl.55.1.16"},{"key":"e_1_2_10_37_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ctim.2014.08.003"},{"key":"e_1_2_10_38_1","doi-asserted-by":"publisher","DOI":"10.3969\/j.issn.1672\u20436731.2020.01.007"},{"key":"e_1_2_10_39_1","doi-asserted-by":"publisher","DOI":"10.1097\/CND.0b013e31824619d5"},{"key":"e_1_2_10_40_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12908"},{"key":"e_1_2_10_41_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.686"},{"key":"e_1_2_10_42_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2018-214502"},{"key":"e_1_2_10_43_1","doi-asserted-by":"publisher","DOI":"10.4161\/mabs.21338"}],"container-title":["European Journal of Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ene.16322","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,6]],"date-time":"2024-07-06T06:56:45Z","timestamp":1720249005000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ene.16322"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5,10]]},"references-count":42,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2024,8]]}},"alternative-id":["10.1111\/ene.16322"],"URL":"https:\/\/doi.org\/10.1111\/ene.16322","archive":["Portico"],"relation":{},"ISSN":["1351-5101","1468-1331"],"issn-type":[{"value":"1351-5101","type":"print"},{"value":"1468-1331","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5,10]]},"assertion":[{"value":"2023-09-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-14","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-05-10","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e16322"}}