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We report an interim analysis of the ongoing open-label extension (OLE) designed to evaluate long-term treatment effects.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Following completion of the 26-week RCP, patients could enter the OLE; patients who received ravulizumab in the RCP continued the drug; patients who previously received placebo switched to ravulizumab. Patients receive body-weight-based maintenance dosing of ravulizumab every 8\u00a0weeks. Efficacy endpoints up to 60\u00a0weeks included Myasthenia Gravis\u2013Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores, with least-squares (LS) mean change and 95% confidence intervals (95% CI) reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Long-term efficacy and safety in the OLE were analyzed in 161 and 169 patients, respectively. Improvements in all scores were maintained through 60\u00a0weeks in patients who received ravulizumab during the RCP; LS mean change from RCP baseline in MG-ADL score was \u2212\u20094.0 (95% CI: \u2212\u20094.8, \u2212\u20093.1; p\u2009&lt;\u20090.0001). Rapid (within 2\u00a0weeks) and sustained improvements occurred in patients previously receiving placebo; LS mean change in MG-ADL score from OLE baseline to Week 60 was \u2212\u20091.7 (95% CI: \u2212\u20092.7, \u2212\u20090.8; p\u2009=\u20090.0007). Similar trends were seen in QMG scores. Ravulizumab treatment was associated with a decreased rate of clinical deterioration events compared with placebo. Ravulizumab was well tolerated; no meningococcal infections were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Findings support the sustained efficacy and long-term safety of ravulizumab, administered every 8\u00a0weeks, in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis.<\/jats:p>\n                    <jats:p>ClinicalTrials.gov identifier: NCT03920293; EudraCT: 2018-003243-39.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00415-023-11699-x","type":"journal-article","created":{"date-parts":[[2023,4,27]],"date-time":"2023-04-27T06:02:06Z","timestamp":1682575326000},"page":"3862-3875","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":120,"title":["Long-term efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis: results from the phase\u00a03 CHAMPION MG open-label extension"],"prefix":"10.1007","volume":"270","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7233-5342","authenticated-orcid":false,"given":"Andreas","family":"Meisel","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6805-8944","authenticated-orcid":false,"given":"Djillali","family":"Annane","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0724-0210","authenticated-orcid":false,"given":"Tuan","family":"Vu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9810-5737","authenticated-orcid":false,"given":"Renato","family":"Mantegazza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9453-9311","authenticated-orcid":false,"given":"Masahisa","family":"Katsuno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8587-7105","authenticated-orcid":false,"given":"Rasha","family":"Aguzzi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Glen","family":"Frick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Gault","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7136-8617","authenticated-orcid":false,"suffix":"Jr.","given":"James F.","family":"Howard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the CHAMPION MG Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,4,27]]},"reference":[{"key":"11699_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 J (2019) Myasthenia gravis. 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He serves as chairman of the medical advisory board of the German Myasthenia Gravis Society. Djillali Annane has received consultancy fees from Alexion, AstraZeneca Rare Disease. 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\/or consultant honoraria from Alexion, AstraZeneca Rare Disease, UCB, and argenx. 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. 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. Rasha Aguzzi and Glen Frick are employees of and own stock in Alexion, AstraZeneca Rare Disease. Laura Gault was an employee of Alexion, AstraZeneca Rare Disease at the time the study and analysis were conducted. James F Howard Jr has received research support (paid to institution) from Alexion, AstraZeneca Rare Disease, 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 Pharma), and Takeda Pharmaceuticals; honoraria from Alexion, AstraZeneca Rare Disease, argenx, Immunovant Inc., Ra Pharmaceuticals (now UCB Pharma), 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 Pharma), and Toleranzia AB.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict 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":"Ethics 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"}}]}}