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Effect of Previous Disease-Modifying Therapy on Treatment Effectiveness for Patients Treated With Ocrelizumab.
Pfeuffer, Steffen; Rolfes, Leoni; Ingwersen, Jens; Pul, Refik; Kleinschnitz, Konstanze; Korsen, Melanie; Räuber, Saskia; Ruck, Tobias; Schieferdecker, Simon; Willison, Alice Grizzel; Aktas, Orhan; Kleinschnitz, Christoph; Hartung, Hans-Peter; Kappos, Ludwig; Meuth, Sven G.
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  • Pfeuffer S; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Rolfes L; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Ingwersen J; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Pul R; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Kleinschnitz K; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Korsen M; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Räuber S; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Ruck T; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Schieferdecker S; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Willison AG; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Aktas O; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Kleinschnitz C; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Hartung HP; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Kappos L; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
  • Meuth SG; From the Department of Neurology (S.P.), University Hospital Giessen and Marburg, Justus-Liebig-University Giessen; Department of Neurology (L.R., J.I., M.K., S.R., T.R., S.S., A.G.W., O.A., H.-P.H., S.G.M.), University Hospital Duesseldorf, Germany; Brain and Mind Center (H.-P.H.), University of Sy
Neurol Neuroimmunol Neuroinflamm ; 10(3)2023 05.
Article en En | MEDLINE | ID: mdl-37041077
BACKGROUND AND OBJECTIVES: B cell-depleting antibodies were proven as effective strategy for the treatment of relapsing multiple sclerosis (RMS). The monoclonal antibody ocrelizumab was approved in 2017 in the United States and in 2018 in the European Union, but despite proven efficacy in randomized, controlled clinical trials, its effectiveness in the real-world setting remains to be fully elucidated. In particular, most study patients were treatment naive or switched from injectable therapies, whereas oral substances or monoclonal antibodies made up >1% of previous treatments. METHODS: We evaluated ocrelizumab-treated patients with RMS enrolled in the prospective cohorts at the University Hospitals Duesseldorf and Essen, Germany. Epidemiologic data at baseline were compared, and Cox proportional hazard models were applied to evaluate outcomes. RESULTS: Two hundred eighty patients were included (median age: 37 years, 35% male patients). Compared with using ocrelizumab as a first-line treatment, its use as a third-line therapy increased hazard ratios (HRs) for relapse and disability progression, whereas differences between first- vs second-line and second- vs third-line remained smaller. We stratified patients according to their last previous disease-modifying treatment and here identified fingolimod (FTY) (45 patients, median age 40 years, 33% male patients) as a relevant risk factor for ongoing relapse activity despite 2nd-line (HR: 3.417 [1.007-11.600]) or 3rd-line (HR: 5.903 [2.489-13.999]) ocrelizumab treatment, disability worsening (2nd line: HR: 3.571 [1.013-12.589]; 3rd line: HR: 4.502 [1.728-11.729]), and occurrence of new/enlarging MRI lesions (2nd line: HR: 1.939 [0.604-6.228]; 3rd line: HR: 4.627 [1.982-10.802]). Effects were persistent throughout the whole follow-up. Neither peripheral B-cell repopulation nor immunoglobulin G levels were associated with rekindling disease activity. DISCUSSION: Our prospectively collected observational data suggest suboptimal effectiveness of ocrelizumab in patients switching from FTY compared with those switching from other substances or having been treatment naive. These findings support previous studies indicating abated effectiveness of immune cell-depleting therapies following FTY treatment in patients with RMS. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with RMS, previous treatment with FTY compared with previous treatment with other immunomodulating therapies decreases the effectiveness of ocrelizumab.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Esclerosis Múltiple Recurrente-Remitente / Esclerosis Múltiple Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: Neurol Neuroimmunol Neuroinflamm Año: 2023 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Esclerosis Múltiple Recurrente-Remitente / Esclerosis Múltiple Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: Neurol Neuroimmunol Neuroinflamm Año: 2023 Tipo del documento: Article