{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T06:16:13Z","timestamp":1789193773685,"version":"build-2803163510"},"reference-count":22,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2022,9,25]],"date-time":"2022-09-25T00:00:00Z","timestamp":1664064000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Euro J of Neurology"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and purpose<\/jats:title><jats:p>Neuromyelitis optica spectrum disorder (NMOSD) is a severe neurological inflammatory disease mainly caused by pathogenic aquaporin\u20104 antibodies (AQP4\u2010IgG). The safety and efficacy of the neonatal Fc receptor antagonist batoclimab addition to conventional intravenous methylprednisolone pulse (IVMP) therapy in patients with NMOSD acute attacks was assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In an open\u2010label, dose\u2010escalation phase 1b study, NMOSD patients with acute myelitis and\/or optic neuritis received four doses of weekly subcutaneous injections of either 340\u2009mg or 680\u2009mg batoclimab with concurrent IVMP and were followed up for 27\u2009weeks. The primary end\u2010points were safety and tolerability. Secondary end\u2010points included pharmacodynamics and efficacy, with key efficacy assessment at week 4.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In total nine NMOSD patients were enrolled, including two and seven in the 340 and 680\u2009mg groups. Five patients had acute myelitis, while the remaining four had unilateral optic neuritis. Batoclimab add\u2010on therapy had an overall good safety profile without serious adverse events. In the 680\u2009mg group, mean immunoglobulin G (IgG) reached its maximum reduction at the last dose (day 22). In the meantime, AQP4\u2010IgG was undetectable in six of seven subjects whose baseline AQP4\u2010IgG titers ranged from 1:32 to 1:320. Expanded Disability Status Scale score was reduced by 1.3\u2009\u00b1\u20090.4 at week 4 (2.7\u2009\u00b1\u20091.3) compared with baseline (4.0\u2009\u00b1\u20091.0).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Batoclimab add\u2010on therapy to IVMP is safe and tolerated in patients with NMOSD. Preliminary evidence suggests a beneficial neurological effect. A randomized controlled trial would be needed to prove the efficacy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ene.15561","type":"journal-article","created":{"date-parts":[[2022,9,10]],"date-time":"2022-09-10T10:14:22Z","timestamp":1662804862000},"page":"195-203","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Batoclimab as an add\u2010on therapy in neuromyelitis optica spectrum disorder patients with acute attacks"],"prefix":"10.1111","volume":"30","author":[{"given":"Yuge","family":"Wang","sequence":"first","affiliation":[{"name":"Department of Neurology Third Affiliated Hospital of Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaonan","family":"Zhong","sequence":"additional","affiliation":[{"name":"Department of Neurology Third Affiliated Hospital of Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1215-6219","authenticated-orcid":false,"given":"Honghao","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Neurology, Nanfang Hospital Southern Medical University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Peng","sequence":"additional","affiliation":[{"name":"Department of Neurology, Nanfang Hospital Southern Medical University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fudong","family":"Shi","sequence":"additional","affiliation":[{"name":"Department of Neurology Tianjin Medical University General Hospital  Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dongmei","family":"Jia","sequence":"additional","affiliation":[{"name":"Department of Neurology Tianjin Medical University General Hospital  Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1523-0338","authenticated-orcid":false,"given":"Huan","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Neurology, Xiangya Hospital Central South University  Changsha China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2021-1484","authenticated-orcid":false,"given":"Qiuming","family":"Zeng","sequence":"additional","affiliation":[{"name":"Department of Neurology, Xiangya Hospital Central South University  Changsha China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chao","family":"Quan","sequence":"additional","affiliation":[{"name":"Department of Neurology, Huashan Hospital Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jingzi","family":"ZhangBao","sequence":"additional","affiliation":[{"name":"Department of Neurology, Huashan Hospital Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Lee","sequence":"additional","affiliation":[{"name":"Harbour BioMed  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Qi","sequence":"additional","affiliation":[{"name":"Harbour BioMed  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoxiang","family":"Chen","sequence":"additional","affiliation":[{"name":"Harbour BioMed  Shanghai 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"}]},{"name":"Batoclimab NMOSD Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,9,25]]},"reference":[{"key":"e_1_2_10_2_1","first-page":"815","article-title":"Neuromyelitis optica spectrum disorder and other non\u2010multiple sclerosis central nervous system inflammatory diseases","volume":"25","author":"Flanagan EP","year":"2019","journal-title":"Continuum (Minneap Minn)"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jneuroim.2020.577387"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/ana.24554"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/1352458508100837"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-021-00568-8"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2021.720907"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1212\/NXI.0000000000000504"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/jca.21965"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jneuroim.2021.577604"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2019.10.017"},{"key":"e_1_2_10_12_1","unstructured":"CollinsJ JonesL SnyderM et al.A novel anti\u2010FcRn monoclonal antibody is well tolerated in healthy subjects and reduces plasma IgG following subcutaneous or intravenous administration. In: 2019 American Academy of Neurology Annual Meeting. Philadelphia PA;2019."},{"key":"e_1_2_10_13_1","unstructured":"Immunovant Inc. (Annual Report on Form 10\u2010K Received: 06\/29\/2020 08:31:45) (edgar\u2010online.com)."},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13019"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1212\/NXI.0000000000000005"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/cen3.12239"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000015944"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1080\/08916934.2016.1214823"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/1744-9987.12465"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2018-11-833996"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1177\/1352458515617248"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1177\/1352458515581438"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.msard.2020.102325"}],"container-title":["European Journal of Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ene.15561","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/ene.15561","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ene.15561","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,20]],"date-time":"2023-08-20T13:18:59Z","timestamp":1692537539000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ene.15561"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9,25]]},"references-count":22,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2023,1]]}},"alternative-id":["10.1111\/ene.15561"],"URL":"https:\/\/doi.org\/10.1111\/ene.15561","archive":["Portico"],"relation":{},"ISSN":["1351-5101","1468-1331"],"issn-type":[{"value":"1351-5101","type":"print"},{"value":"1468-1331","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9,25]]},"assertion":[{"value":"2022-04-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-09-04","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-09-25","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}