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Res. Pract."],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Myasthenia gravis has a variable disease course. Early identification of patients with a highly active disease is crucial to prevent myasthenic exacerbations and crisis, necessitating more aggressive immunotherapy. However, no biomarkers currently exist to identify patients at risk for highly active disease course.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>\n                      The PROGNO-MG study aims to identify blood-based biomarker signatures associated with a highly active disease course in immunotherapy-na\u00efve patients with acetylcholine-receptor-antibody positive (AChR\n                      <jats:sup>+<\/jats:sup>\n                      ) generalized Myasthenia gravis (gMG).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This is an investigator-initiated prospective, multicentric, observational study. Seventy newly diagnosed immunotherapy-na\u00efve AChR\n                      <jats:sup>+<\/jats:sup>\n                      gMG patients will be enrolled and followed up for 24 months. Blood samples and clinical data will be collected biannually. Biomarkers (calprotectin, neurofilament light chain, ITIH3, complement activation, kappa free light chains, and exploratory proteome-analyses and immune cell phenotyping) will be measured and their association with clinical outcomes will be evaluated.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Perspective<\/jats:title>\n                    <jats:p>\n                      The results will provide evidence for prognostic biomarkers, supporting risk stratification and early individualized treatment for AChR\n                      <jats:sup>+<\/jats:sup>\n                      gMG patients.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>The study is registered in the German clinical trial register (DRKS00035457).<\/jats:p>\n                  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The study is registered in the German clinical trial register (DRKS00035457, retrospectively registered on the 20.01.2025).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Version 1.0 of the study protocol. Any changes to the study protocol will be communicated immediately to all investigators and participants. Next to an update of the study registry, the investigators will publish an updated version of this manuscript.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Protocol amendments"}},{"value":"Study results will be published in aggregated form without identifying information.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"F.K. received honoraria for lectures from argenx and travel compensation from Alexion. F.F.K. received honoraria for lectures and travel compensation from Alexion, argenx, Merck, Novartis, and Takeda. He received research support as fellow of the German Research Foundation (DFG)- and Hannover Medical School (MHH)-funded Clinician Scientist Program (PRACTIS) at MHH and from Merck, Siemens, and Erwin-R\u00f6ver-Foundation. S.G. received travel\/accommodation\/meeting expenses from Alexion Pharmaceuticals, argenx, Bayer, Grifols, Octapharma, and UCB pharma and received speaker honoraria from Alexion Pharmaceuticals, argenx, and UCB pharma. P.T. received travel\/accommodation\/meeting expenses and honoraria for a lecture by Astra Zeneca Rare Disease. C.S. received speaker honoraria from Alexion, argenx, Desitin, and TAD and received personal fees for advisory boards and grants for congress travel and participation from Alexion and argenx. J.Z. received travel\/accommodation\/meeting expenses from Alexion Astra Zeneca Rare Disease, argenx, Johnsson&Johnsson, Kedrion, Sanofi and UCB. She also received speaking honoria and honoria for attendance at advisory boards from Alexion Astra Zeneca Rare Disease, Amicus, argenx, Kedrion, Roche, Sanofi, StreamedUp, and UCB. She received financial research support (paid to her institution) from argenx and UCB. J.Z. is board member of the German Myasthenia Association and member of the German Muscle Society. J.P.S. received lecture and consulting fees from Alexion, argenx, Axunio, Hormosan, Janssen-Cilag, Roche, SERB Specialty Pharmaceuticals, Temmler, and UCB over the past three years. S.L. received travel\/accommodation\/meeting expenses from Alexion Astra Zeneca Rare Disease, argenx, Johnsson&Johnsson, and UCB received speaking honoria and honoria for attendance at advisory boards from Alexion Astra Zeneca Rare Disease, argenx, Biogen, Hormosan, Huma, Johnsson&Johnsson, Merck, Roche, StreamedUp and UCB. She received financial research support (paid to her institution) from Ad Scientiam, Alexion Pharmaceuticals, argenx, Hormosan and UCB. S.L. is shareholder of RareLink digital health GmbH and mamahealth GmbH. F.S. received travel\/accommodation\/meeting expenses from Alexion Pharmaceuticals and argnx and received speaking honoria and honoria for attendance at advisory boards from Alexion Pharmaceuticals, argnx, and UCB pharma. She receives financial research support (paid to her institution) from Alexion Pharmaceuticals and argenx. She serves as a member of the medical advisory of the German Myasthenia Gravis Society e.V.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"38"}}