{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T02:33:23Z","timestamp":1793846003403,"version":"4.6.1"},"reference-count":40,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2023,3,9]],"date-time":"2023-03-09T00:00:00Z","timestamp":1678320000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,3,9]],"date-time":"2023-03-09T00:00:00Z","timestamp":1678320000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Alexion, AstraZeneca Rare Disease"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Neurol"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Introduction<\/jats:title>\n                <jats:p>The terminal complement C5 inhibitor ravulizumab has a long elimination half-life, allowing maintenance dosing every 8\u00a0weeks. In the 26-week, double-blind, randomized, placebo-controlled period (RCP) of the CHAMPION MG study, ravulizumab provided rapid and sustained efficacy and was well tolerated in adults with anti-acetylcholine receptor antibody-positive (AChR Ab+) generalized myasthenia gravis (gMG). This analysis evaluated the pharmacokinetics (PK), pharmacodynamics (PD), and potential immunogenicity of ravulizumab in adults with AChR Ab+\u2009gMG.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Data were analyzed from 86 patients who received ravulizumab in the CHAMPION MG RCP. Ravulizumab dosing was weight-based: initial loading dose of 2400\/2700\/3000\u00a0mg on Day 1 and maintenance doses of 3000\/3300\/3600\u00a0mg on Day 15 and then every 8\u00a0weeks. PK parameters were estimated from serum ravulizumab concentrations determined pre- and post-dose; PD effects of ravulizumab on serum free C5 concentrations were measured; and immunogenicity was assessed using anti-drug antibody and neutralizing-antibody assays.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Target serum ravulizumab concentrations (&gt;\u2009175\u00a0\u00b5g\/mL) were achieved immediately after the first ravulizumab dose (within 30\u00a0min of infusion completion) and maintained throughout the 26-week treatment period irrespective of patient body weight. Following the final maintenance dose, mean <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> was 1548\u00a0\u00b5g\/mL and <jats:italic>C<\/jats:italic><jats:sub>trough<\/jats:sub> 587\u00a0\u00b5g\/mL; no meaningful differences were noted among body-weight categories. Inhibition of serum free C5 was immediate, complete (&lt;\u20090.5\u00a0\u03bcg\/mL), and sustained throughout treatment in all patients. No treatment-emergent anti-drug antibodies were observed.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>PK\/PD evidence supports the use of ravulizumab every 8\u00a0weeks for immediate, complete, and sustained inhibition of terminal complement C5 in adults with AChR Ab+\u2009gMG.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov ID: NCT03920293 (April 18, 2019).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00415-023-11617-1","type":"journal-article","created":{"date-parts":[[2023,3,9]],"date-time":"2023-03-09T04:33:17Z","timestamp":1678336397000},"page":"3129-3137","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":49,"title":["Ravulizumab pharmacokinetics and pharmacodynamics in patients with generalized myasthenia gravis"],"prefix":"10.1007","volume":"270","clinical-trial-number":[{"clinical-trial-number":"nct03920293","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Tuan","family":"Vu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Ortiz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahisa","family":"Katsuno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Djillali","family":"Annane","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renato","family":"Mantegazza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen N.","family":"Beasley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rasha","family":"Aguzzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"James F.","family":"Howard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,3,9]]},"reference":[{"key":"11617_CR1","doi-asserted-by":"publisher","first-page":"30","DOI":"10.1038\/s41572-019-0079-y","volume":"5","author":"NE Gilhus","year":"2019","unstructured":"Gilhus NE, Tzartos S, Evoli A, Palace J, Burns TM, Verschuuren JJGM (2019) Myasthenia gravis. 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Front Neurol 11:538. https:\/\/doi.org\/10.3389\/fneur.2020.00538","journal-title":"Front Neurol"}],"container-title":["Journal of Neurology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00415-023-11617-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00415-023-11617-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00415-023-11617-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,5,16]],"date-time":"2023-05-16T04:12:45Z","timestamp":1684210365000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00415-023-11617-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3,9]]},"references-count":40,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2023,6]]}},"alternative-id":["11617"],"URL":"https:\/\/doi.org\/10.1007\/s00415-023-11617-1","relation":{},"ISSN":["0340-5354","1432-1459"],"issn-type":[{"value":"0340-5354","type":"print"},{"value":"1432-1459","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3,9]]},"assertion":[{"value":"23 November 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 February 2023","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 February 2023","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 March 2023","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Tuan Vu is the USF Site Principal Investigator for MG clinical trials sponsored by Alexion, AstraZeneca Rare Disease, argenx, Ra\/UCB Pharma, Horizon\/Viela Bio, Janssen\/Momenta, Sanofi, Regeneron, and Cartesian Therapeutics; he receives speaker and consultant honoraria from Alexion, AstraZeneca Rare Disease, UCB, and argenx. Stephan Ortiz, Kathleen N Beasley, and Rasha Aguzzi are employees of Alexion, AstraZeneca Rare Disease and own stock in AstraZeneca. Masahisa Katsuno has received speaker honoraria from Biogen Japan, Chugai, and Eisai, and financial research support from Alexion, AstraZeneca Rare Disease, argenx, Eisai, and Mitsubishi-Tanabe. Djillali Annane has received consultancy fees from Alexion, AstraZeneca Rare Disease. Renato Mantegazza serves on advisory boards for Alexion, AstraZeneca Rare Disease, UCB, argenx, Catalyst, and Sanofi. He has received speaker\u2019s honoraria from Alexion, AstraZeneca Rare Disease, UCB, and argenx, and consultancy fees from Catalyst. James F Howard Jr has received research support (paid to his institution) from argenx, Cartesian Therapeutics, the Centers for Disease Control and Prevention (Atlanta, GA, USA), the Myasthenia Gravis Foundation of America, the Muscular Dystrophy Association, the National Institutes of Health (including the National Institute of Neurological Disorders and Stroke and the National Institute of Arthritis and Musculoskeletal and Skin Diseases), PCORI, Ra Pharmaceuticals (now UCB), and Takeda Pharmaceuticals; honoraria from Alexion, AstraZeneca Rare Disease, argenx, Immunovant Inc., Ra Pharmaceuticals (now UCB), Regeneron Pharmaceuticals, Sanofi US, and Viela Bio Inc. (now Horizon Therapeutics); and non-financial support from Alexion, AstraZeneca Rare Disease, argenx, Ra Pharmaceuticals (now UCB), and Toleranzia AB.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"The trial protocol was approved by the independent ethics committee or institutional review board at each participating institution. The trial was conducted in accordance with the provisions of the World Medical Association Declaration of Helsinki, the International Conference on Harmonisation E6 Guidelines for Good Clinical Practice, and all applicable regulatory requirements.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}}]}}