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Following completion of MycarinG, patients could enroll in the open-label extension MG0004 study (NCT04124965) to receive chronic weekly rozanolixizumab.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>Patients were re-randomized 1:1 to once-weekly rozanolixizumab 7 or 10\u00a0mg\/kg for up to 52 infusions. The primary endpoints were the occurrence of treatment-emergent adverse events (TEAEs) and TEAEs leading to rozanolixizumab discontinuation. After \u22656 visits\/infusions patients could switch to the MG0007 study (NCT04650854) to receive cyclic rozanolixizumab treatment.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>In MG0004, 70 patients received rozanolixizumab 7\u00a0mg\/kg (<jats:italic>n<\/jats:italic>\u2009=\u200935) or 10\u00a0mg\/kg (<jats:italic>n<\/jats:italic>\u2009=\u200935). Mean treatment duration was 22.9 and 23.7\u00a0weeks, respectively, due to rollover into MG0007. TEAEs were reported in 60\/70 (85.7%) patients; most were mild\/moderate. The most frequently reported TEAEs were headache (25\/70 [35.7%]), diarrhea (13\/70 [18.6%]) and decreased blood immunoglobulin G (11\/70 [15.7%]). There were no opportunistic, serious or severe infections, serious or severe hypersensitivity or injection-site reactions, any anaphylactic reactions or albumin or lipid abnormalities. Maximum mean reduction from baseline in MG Activities of Daily Living score was 3.1 in the 7\u00a0mg\/kg group and 4.1 in the 10\u00a0mg\/kg group.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>Chronic weekly rozanolixizumab for up to 52 infusions was generally well tolerated, and clinically relevant improvements across MG-specific outcomes were maintained, supporting the long-term use of rozanolixizumab in patients with gMG.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Trial registration<\/jats:title>\n            <jats:p>NCT04124965 (registered October 11, 2019).<\/jats:p>\n          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All patients provided written informed consent. The study was conducted in accordance with local regulations, the International Conference on Harmonization Good Clinical Practice requirements, and the principles of the Declaration of Helsinki.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"V. Bril is a Consultant for Akcea, Alexion Pharmaceuticals, Alnylam, argenx, CSL, Grifols, Immunovant, Ionis, Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine), Momenta (now Johnson & Johnson), Novo Nordisk, Octapharma, Pfizer, Powell Mansfield, Roche, Sanofi, Takeda Pharmaceuticals and UCB. She has received research support from Akcea, Alexion Pharmaceuticals, argenx, CSL, Grifols, Immunovant, Ionis, Momenta (now Johnson & Johnson), Octapharma, Takeda Pharmaceuticals, UCB and Viela Bio (now Amgen). A. Dru\u017cd\u017c has nothing to disclose. J. Grosskreutz has served as a Consultant for Alexion Pharmaceuticals, Biogen and UCB, and his institution has received research support from the Boris Canessa Foundation. A.A. Habib has received research support from Alexion Pharmaceuticals, argenx, Cabaletta Bio, Genentech\/Roche, Immunovant, Regeneron Pharmaceuticals, UCB and Viela Bio (now Amgen). He has received honoraria from Alexion Pharmaceuticals, Alpine Immune Sciences, argenx, Genentech\/Roche, Immunovant, Inhibrx, NMD Pharma, Regeneron Pharmaceuticals and UCB. H.J. Kaminski is a Consultant for Cabaletta Bio, Lincoln Therapeutics, Roche, Takeda Pharmaceuticals and UCB, and is CEO and CMO of ARC Biotechnology, LLC based on US Patent 8,961,98. He is Principal Investigator of the Rare Disease Network for Myasthenia Gravis (MGNet) National Institute of Neurological Disorders & Stroke, U54 NS115054, and Targeted Therapy for Myasthenia Gravis. He has received R41 NS110331-01 to ARC Biotechnology. R. Mantegazza has received funding for travel and meeting attendance or advisory board participation from Alexion Pharmaceuticals, argenx, BioMarin, Catalyst, Sanofi, Regeneron Pharmaceuticals Sanofi and UCB. S. Sacconi has nothing to disclose. K. Utsugisawa has served as a paid Consultant for argenx, Chugai Pharmaceutical, HanAll Biopharma, Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine), Merck, Mitsubishi Tanabe Pharma, UCB and Viela Bio (now Amgen); he has received speaker honoraria from Alexion Pharmaceuticals, argenx, the Japan Blood Products Organization and UCB. T. Vu is the USF Site Principal Investigator for MG clinical trials sponsored by Alexion\/AstraZeneca Rare Disease, Amgen, argenx, Cartesian Therapeutics, COUR Pharmaceuticals, Dianthus Therapeutics, Immunovant, Johnson & Johnson, NMD Pharma, Regeneron Pharmaceuticals and UCB, and has served as a speaker for Alexion\/AstraZeneca Rare Disease, argenx and CSL Behring. He performed consulting work for Alexion\/AstraZeneca Rare Disease, argenx, Dianthus Therapeutics, ImmunAbs and UCB. M. Boehnlein is an employee and shareholder of UCB. M. Gayfieva is a former employee and shareholder of UCB. B. Greve is an employee and shareholder of UCB. F. Woltering is an employee and shareholder of UCB. J. Vissing has been a Consultant on advisory boards for Amicus Therapeutics, Biogen, Edgewise Therapeutics, Fulcrum Therapeutics, Genethon, Horizon Therapeutics (now Amgen), Lupin, ML Biopharma, Novartis, Regeneron Pharmaceuticals, Roche, Sanofi Genzyme (now Sanofi), Sarepta Therapeutics and UCB. He has received research, travel support and\/or speaker honoraria from Alexion Pharmaceuticals, argenx, Biogen, Edgewise Therapeutics, Fulcrum Therapeutics, Lupin, Sanofi Genzyme (now Sanofi) and UCB. He is a Principal Investigator in clinical trials for Alexion Pharmaceuticals, argenx, Atamyo Therapeutics, Genethon, Horizon Therapeutics (now Amgen), Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine), ML Biopharma, Novartis, Regeneron Pharmaceuticals, Roche, Sanofi Genzyme (now Sanofi) and UCB.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}}],"article-number":"275"}}