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10 p, 683.9 KB |
Ozanimod in relapsing multiple sclerosis : Pooled safety results from the clinical development program
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Selmaj, Krzysztof W. (University of Warmia and Mazury) ;
Cohen, Jeffrey A. (Neurological Institute) ;
Comi, Giancarlo (Vita-Salute San Raffaele University) ;
Bar-Or, Amit (University of Pennsylvania) ;
Arnold, Douglas Lorne (McGill University) ;
Steinman, Lawrence (Stanford University Medical Center) ;
Hartung, Hans-Peter (Medical University Vienna) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Kubala Havrdova, Eva (Charles University) ;
Cree, Bruce A. C (UCSF University of California San Francisco) ;
Minton, Neil (Bristol Myers Squibb) ;
Sheffield, James K. (Bristol Myers Squibb) ;
Ding, Ning (Bristol Myers Squibb) ;
Kappos, Ludwig (University of Basel) ;
Universitat Autònoma de Barcelona
Background: Ozanimod, an oral sphingosine 1-phosphate receptor 1 and 5 modulator, is approved in multiple countries for the treatment of relapsing multiple sclerosis (RMS). In phase 3 trials, ozanimod was well tolerated and superior to interferon beta-1a 30 µg once-weekly in reducing clinical and radiologic disease activity. [...]
2021 -  10.1016/j.msard.2021.102844
Multiple Sclerosis and Related Disorders, Vol. 51 (june 2021) , p. 102844
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2.
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15 p, 1.2 MB |
Five years of ocrelizumab in relapsing multiple sclerosis : OPERA studies open-label extension
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Hauser, Stephen L. (University of California) ;
Kappos, Ludwing (University of Basel) ;
Arnold, Douglas Lorne (McGill University) ;
Bar-Or, Amit (University of Pennsylvania) ;
Brochet, Bruno (Department of Neurology. CHU de Bordeaux) ;
Naismith, Robert (Washington University School of Medicine) ;
Traboulsee, Anthony (University of British Columbia) ;
Wolinsky, Jerry (University of Texas Health Science Center at Houston (UTHealth)) ;
Belachew, Shibeshih (F. Hoffmann-La Roche Ltd) ;
Koendgen, Harold (F. Hoffmann-La Roche Ltd) ;
Levesque, Victoria (Genentech. Inc.) ;
Manfrini, Marianna (F. Hoffmann-La Roche Ltd) ;
Model, Fabian (F. Hoffmann-La Roche Ltd) ;
Hubeaux, Stanislas (F. Hoffmann-La Roche Ltd) ;
Mehta, Lahar (Genentech. Inc.) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Universitat Autònoma de Barcelona.
Departament de Medicina
Objective: To assess over 3 years of follow-up the effects of maintaining or switching to ocrelizumab (OCR) therapy on clinical and MRI outcomes and safety measures in the open-label extension (OLE) phase of the pooled OPERA: I/II studies in relapsing multiple sclerosis. [...]
2020 - 10.1212/WNL.0000000000010376
Neurology, Vol. 95 Núm. 13 (september 2020) , p. E1854-E1867
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14 p, 762.0 KB |
Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis : Results from ASCLEPIOS I and II
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Gärtner, Jutta (University Medical Centre Göttingen) ;
Hauser, Stephen L. (University of California, San Francisco) ;
Bar-Or, Amit (University of Pennsylvania) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron. Institut de Recerca) ;
Cohen, Jeffrey A. (Cleveland Clinic Foundation) ;
Cross, Anne H. (Washington University School of Medicine) ;
Deiva, Kumaran (University Hospitals Paris Saclay) ;
Ganjgahi, Habib (University of Oxford) ;
Häring, Dieter A. (Novartis) ;
Li, Bingbing (Novartis) ;
Pingili, Ratnakar (Novartis) ;
Ramanathan, Krishnan (Novartis) ;
Su, Wendy (Novartis) ;
Willi, Roman (Novartis) ;
Kieseier, Bernd (Novartis) ;
Kappos, Ludwig (University of Basel) ;
Universitat Autònoma de Barcelona
Background: In the phase III ASCLEPIOS I and II trials, participants with relapsing multiple sclerosis receiving ofatumumab had significantly better clinical and magnetic resonance imaging (MRI) outcomes than those receiving teriflunomide. [...]
2022 - 10.1177/13524585221078825
Multiple sclerosis, Vol. 28 Núm. 10 (2022) , p. 1562-1575
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15 p, 1.4 MB |
Serum Neurofilament Light Trajectories and Their Relation to Subclinical Radiological Disease Activity in Relapsing Multiple Sclerosis Patients in the APLIOS Trial
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Bar-Or, Amit (University of Pennsylvania) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Hu, Xixi (Novartis) ;
Kropshofer, Harald (Novartis) ;
Kukkaro, Petra (Novartis) ;
Coello, Neva (Novartis) ;
Ludwig, Inga (Novartis) ;
Willi, Roman (Novartis) ;
Zalesak, Martin (Novartis) ;
Ramanathan, Krishnan (Novartis) ;
Kieseier, Bernd C. (Novartis) ;
Häring, Dieter A. (Novartis) ;
Bagger, Morten (Novartis) ;
Fox, Edward (University of Texas) ;
Universitat Autònoma de Barcelona
Introduction: Several studies have described prognostic value of serum neurofilament light chain (sNfL) at the group level in relapsing multiple sclerosis (RMS) patients. Here, we aimed to explore the temporal association between sNfL and development of subclinical disease activity as assessed by magnetic resonance imaging (MRI) at the group level and evaluate the potential of sNfL as a biomarker for capturing subclinical disease activity in individual RMS patients. [...]
2023 - 10.1007/s40120-022-00427-8
Neurology and Therapy, Vol. 12 Núm. 1 (2023) , p. 303-317
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19 p, 537.2 KB |
Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis : Up to 5 years of follow-up in the DAYBREAK open-label extension trial
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Cree, Bruce A. C (University of California) ;
Selmaj, Krzysztof W. (University of Warmia and Mazury in Olsztyn) ;
Steinman, Lawrence (Stanford University) ;
Comi, Giancarlo (Vita-Salute San Raffaele University) ;
Bar-Or, Amit (University of Pennsylvania) ;
Arnold, Douglas Lorne (McGill University) ;
Hartung, Hans-Peter (Medical University of Vienna) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Kubala Havrdova, Eva (Charles University) ;
Sheffield, James K. (Bristol-Myers Squibb Company) ;
Minton, Neil (Bristol-Myers Squibb Company) ;
Cheng, Chun Yen (Bristol-Myers Squibb Company) ;
Silva, Diego (Bristol-Myers Squibb Company) ;
Kappos, Ludwig (University of Basel) ;
Cohen, Jeffrey A. (Cleveland Clinic) ;
Universitat Autònoma de Barcelona
Background: Ozanimod, an oral sphingosine 1-phosphate receptor 1 and 5 modulator, is approved in multiple countries for treatment of relapsing forms of MS. Objective: To characterize long-term safety and efficacy of ozanimod. [...]
2022 - 10.1177/13524585221102584
Multiple sclerosis, Vol. 28 Núm. 12 (2022) , p. 1944-1962
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15 p, 877.1 KB |
Rapid and sustained B-cell depletion with subcutaneous ofatumumab in relapsing multiple sclerosis : APLIOS, a randomized phase-2 study
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Bar-Or, Amit (University of Pennsylvania) ;
Wiendl, Heinz (University of Münster) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Alvarez, Enrique (University of Colorado) ;
Davydovskaya, Maria (Pirogov Russian National Research Medical University) ;
Delgado, Silvia (University of Miami) ;
Evdoshenko, Evgeniy P. (St Petersburg Center for Multiple Sclerosis and Other Autoimmune Diseases) ;
Giedraitiene, Natasa (Vilnius University) ;
Gross-Paju, Katrin (Institute of Health Care Technology) ;
Haldre, Sulev (University of Tartu) ;
Herrman, Craig E. (JWM Neurology) ;
Izquierdo, Guillermo (Hospital Vithas Sevilla) ;
Karelis, Guntis (Riga East University Hospital) ;
Leutmezer, Fritz (Medical University of Vienna) ;
Mares, Miroslav (Pardubice Regional Hospital) ;
Meca-Lallana, Jose Eustasio (Hospital Universitario Virgen de la Arrixaca (Múrcia)) ;
Mickeviciene, Dalia (Lithuanian University of Health Sciences) ;
Nicholas, Jacqueline (Riverside Methodist Hospital) ;
Robertson, Derrick S. (University of South Florida) ;
Sazonov, Denis V. (Department of Clinical Trials FSBIH SDMC of FMBA of Russia) ;
Sharlin, Kenneth (Sharlin Health and Neurology) ;
Sundaram, Bharathy (Texas Institute for Neurological Disorders) ;
Totolyan, Natalia (Pavlov First State Medical University of St. Petersburg) ;
Vachova, Marta (Teplice Hospital) ;
Valis, Martin (Charles University) ;
Bagger, Morten (Novartis) ;
Häring, Dieter A. (Novartis) ;
Ludwig, Inga (Novartis) ;
Willi, Roman (Novartis) ;
Zalesak, Martin (Novartis) ;
Su, Wendy (Novartis) ;
Merschhemke, Martin (Novartis) ;
Fox, Edward J. (Central Texas Neurology Consultants PA) ;
Universitat Autònoma de Barcelona
Background: Ofatumumab, the first fully human anti-CD20 monoclonal antibody, is approved in several countries for relapsing multiple sclerosis (RMS). Objective: To demonstrate the bioequivalence of ofatumumab administered by an autoinjector versus a pre-filled syringe (PFS) and to explore the effect of ofatumumab on B-cell depletion. [...]
2022 - 10.1177/13524585211044479
Multiple sclerosis, Vol. 28 Núm. 6 (2022) , p. 910-924
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8 p, 976.6 KB |
Efficacy and safety of ozanimod in multiple sclerosis : Dose-blinded extension of a randomized phase II study
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Cohen, Jeffrey A. (Mellen Center for MS Treatment and Research, Cleveland Clin) ;
Comi, Giancarlo (Vita-Salute San Raffaele University) ;
Arnold, Douglas Lorne (McGill University, Montreal) ;
Bar-Or, Amit (University of Pennsylvania. Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology) ;
Selmaj, Krzysztof W. (Center for Neurology, Łódź, Poland) ;
Steinman, Lawrence (Stanford University Medical Center) ;
Havrdová, Eva K. (Charles University. Department of Neurology and Center for Clinical Neuroscience) ;
Cree, Bruce A. C. (University of California. UCSF Weill Institute for Neurosciences) ;
Montalbán, Xavier (Universitat Autònoma de Barcelona. Departament de Medicina) ;
Hartung, Hans-Peter (Heinrich Heine University. Department of Neurology) ;
Huang, Vivian (Celgene Corporation, San Diego, CA) ;
Frohna, Paul (Celgene Corporation, San Diego, CA) ;
Skolnick, Brett E. (Celgene Corporation, San Diego, CA) ;
Kappos, Ludwig (University Hospital Basel (Basilea, Suïssa))
Ozanimod, an oral immunomodulator, selectively targets sphingosine 1-phosphate receptors 1 and 5. Evaluate efficacy, safety, and tolerability of ozanimod in relapsing multiple sclerosis. In the RADIANCE Part A phase II study (NCT01628393), participants with relapsing multiple sclerosis were randomized (1:1:1) to once-daily ozanimod hydrochloride (0. [...]
2018 - 10.1177/1352458518789884
Multiple sclerosis, Vol. 25 (july 2018) , p. 1255-1262
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