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1.
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12 p, 888.5 KB |
Ocrelizumab efficacy in subgroups of patients with relapsing multiple sclerosis
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Turner, Benjamin (The Royal London Hospital) ;
Cree, Bruce A. C (University of California) ;
Kappos, Ludwig (University Hospital Basel (Basilea, Suïssa)) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Papeix, Caroline (Pitié-Salpêtrière Hospital) ;
Wolinsky, Jerry S. (The University of Texas Health Science Center at Houston (UTHealth)) ;
Buffels, Regine (F. Hoffmann-La Roche Ltd) ;
Fiore, Damian (Genentech. Inc) ;
Garren, Hideki (Genentech. Inc) ;
Han, Jian (Genentech. Inc) ;
Hauser, Stephen L. (University of California) ;
Universitat Autònoma de Barcelona.
Departament de Medicina
Objective: The efficacy and safety of ocrelizumab, versus interferon (IFN) β-1a, for the treatment of relapsing multiple sclerosis (RMS) from the identically designed OPERA I (NCT01247324) and OPERA II (NCT01412333) phase III studies has been reported; here we present subgroup analyses of efficacy endpoints from the pooled OPERA I and OPERA II populations. [...]
2019 -  10.1007/s00415-019-09248-6
Journal of Neurology, Vol. 266 Núm. 5 (may 2019) , p. 1182-1193
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2.
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14 p, 1.2 MB |
Safety of Ocrelizumab in Patients with Relapsing and Primary Progressive Multiple Sclerosis
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Hauser, Stephen L. (University of California) ;
Kappos, Ludwig (University of Basel) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Craveiro, Licinio (F. Hoffmann-La Roche Ltd.) ;
Chognot, Cathy (F. Hoffmann-La Roche Ltd.) ;
Hughes, Richard (F. Hoffmann-La Roche Ltd.) ;
Koendgen, Harold (F. Hoffmann-La Roche Ltd.) ;
Pasquarelli, Noemi (F. Hoffmann-La Roche Ltd.) ;
Pradhan, Ashish (Genentech Inc.) ;
Prajapati, Kalpesh (IQVIA Solutions Inc.) ;
Wolinsky, Jerry S. (Health Science Center at Houston) ;
Universitat Autònoma de Barcelona
Background and Objectives To report safety of ocrelizumab (OCR) up to 7 years in patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) enrolled in clinical trials or treated in real-world postmarketing settings. [...]
2021 - 10.1212/WNL.0000000000012700
Neurology, Vol. 97 Núm. 16 (october 2021) , p. E1546-E1559
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3.
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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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4.
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10 p, 391.9 KB |
Ponesimod Compared with Teriflunomide in Patients with Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study : A Randomized Clinical Trial
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Kappos, Ludwig (University of Basel) ;
Fox, Robert J. (Cleveland Clinic) ;
Burcklen, Michel (Actelion Pharmaceuticals) ;
Freedman, Mark S. (University of Ottawa) ;
Kubala Havrdova, Eva (Charles University) ;
Hennessy, Brian (Actelion Pharmaceuticals) ;
Hohlfeld, Reinhard (Ludwig Maximilians University Munich) ;
Lublin, Fred (Icahn School of Medicine at Mount Sinai) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Pozzilli, Carlo (Sapienza University of Rome) ;
Scherz, Tatiana (Actelion Pharmaceuticals) ;
D'Ambrosio, Daniele (Galapagos GmbH) ;
Linscheid, Philippe (Actelion Pharmaceuticals) ;
Vaclavkova, Andrea (Actelion Pharmaceuticals) ;
Pirozek-Lawniczek, Magdalena (Actelion Pharmaceuticals) ;
Kracker, Hilke (Actelion Pharmaceuticals) ;
Sprenger, Till (University of Basel) ;
Universitat Autònoma de Barcelona
Importance: To our knowledge, the Oral Ponesimod Versus Teriflunomide In Relapsing Multiple Sclerosis (OPTIMUM) trial is the first phase 3 study comparing 2 oral disease-modifying therapies for relapsing multiple sclerosis (RMS). [...]
2021 - 10.1001/jamaneurol.2021.0405
JAMA Neurology, Vol. 78 Núm. 5 (may 2021) , p. 558-567
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5.
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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, Ludwig (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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6.
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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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9 p, 341.7 KB |
Risk of requiring a wheelchair in primary progressive multiple sclerosis : Data from the ORATORIO trial and the MSBase registry
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Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Butzkueven, Helmut (Monash University) ;
Spelman, Tim (University of Melbourne) ;
Horakova, Dana (Charles University. Faculty of Medicine in Hradec Králové) ;
Hughes, Stella (Craigavon Area Hospital) ;
Solaro, Claudio Marcello (CRRF "Mons. Luigi Novarese") ;
Izquierdo, Guillermo (Hospital Vithas Nisa) ;
Kubala Havrdova, Eva (Charles University) ;
Grand'Maison, Francois (Neuro Rive-Sud) ;
Prat, Alexandre (Universite de Montreal) ;
Girard, Marc (Universite de Montreal) ;
Hupperts, Raymond (Zuyderland Ziekenhuis) ;
Onofrj, Marco (University G. d'Annunzio) ;
Lugaresi, Alessandra (UOSI Riabilitazione Sclerosi Multipla) ;
Taylor, Bruce (Royal Hobart Hospital) ;
Giovannoni, Gavin (Queen Mary University of London) ;
Kappos, Ludwig (University of Basel) ;
Hauser, Stephen L. (University of California) ;
Craveiro, Licinio (F. Hoffmann-La Roche Ltd) ;
Freitas, Rita (F. Hoffmann-La Roche Ltd) ;
Model, Fabian (F. Hoffmann-La Roche Ltd) ;
Overell, James (F. Hoffmann-La Roche Ltd) ;
Muros-Le Rouzic, Erwan (F. Hoffmann-La Roche Ltd) ;
Sauter, Annette (F. Hoffmann-La Roche Ltd) ;
Wang, Qing (F. Hoffmann-La Roche Ltd) ;
Wormser, David (F. Hoffmann-La Roche Ltd) ;
Wolinsky, Jerry S. (McGovern Medical School) ;
MSBase Study Group ;
Universitat Autònoma de Barcelona
Background and purpose: Reaching Expanded Disability Status Scale (EDSS) ≥7. 0 represents the requirement for a wheelchair. Here we (i) assess the effect of ocrelizumab on time to EDSS ≥7. 0 over the ORATORIO (NCT01194570) double-blind and extended controlled periods (DBP+ECP), (ii) quantify likely long-term benefits by extrapolating results, and (iii) assess the plausibility of extrapolations using an independent real-world cohort (MSBase registry; ACTRN12605000455662). [...]
2022 - 10.1111/ene.14824
European Journal of Neurology, Vol. 29 Núm. 4 (2022) , p. 1082-1090
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8.
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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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9.
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9 p, 2.2 MB |
Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS
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DeLuca, John (Rutgers - The State University of New Jersey, Newark) ;
Schippling, Sven (University of Zurich) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Kappos, Ludwig (University of Basel) ;
Cree, Bruce A. C (University of California, San Francisco) ;
Comi, Giancarlo (Vita-Salute San Raffaele University) ;
Arnold, Douglas Lorne (McGill University, Montreal) ;
Hartung, Hans Peter (Heinrich Heine University Düsseldorf) ;
Sheffield, James K. (Bristol-Myers Squibb Company) ;
Liu, Hongjuan (Bristol-Myers Squibb Company) ;
Silva, Diego (Bristol-Myers Squibb Company) ;
Cohen, Jeffrey A. (Neurological Institute, Cleveland Clinic) ;
Universitat Autònoma de Barcelona.
Departament de Medicina
Background: Cognitive dysfunction, including slowed cognitive processing speed (CPS), is one of the most disabling symptoms of multiple sclerosis (MS). The Symbol Digit Modalities Test (SDMT) is a preferred measure of CPS for MS trials and routine screening. [...]
2021 - 10.1016/j.msard.2020.102673
Multiple Sclerosis and Related Disorders, Vol. 48 (2021) , p. 102673
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10.
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9 p, 1.1 MB |
Paramagnetic rims are a promising diagnostic imaging biomarker in multiple sclerosis
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Meaton, Isobel (University of Nottingham) ;
Altokhis, Amjad (University of Nottingham) ;
Allen, Christopher Martin (University of Nottingham) ;
Clarke, Margareta A. (Vanderbilt University) ;
Sinnecker, Timm (University Basel) ;
Meier, Dominik (University Basel) ;
Enzinger, Christian (Medical University of Graz) ;
Calabrese, Massimiliano (University of Verona) ;
De Stefano, Nicola (University of Siena) ;
Pitiot, Alain (Laboratory of Image and Data Analysis (Regne Unit)) ;
Giorgio, Antonio (University of Siena) ;
Schoonheim, Menno M. (Universiteit Amsterdam) ;
Paul, Friedemann (Charité - Universitätsmedizin Berlin) ;
Pawlak, Mikolaj A. (Poznan University of Medical Sciences) ;
Schmidt, Reinhold (Medical University of Graz) ;
Granziera, Cristina (University of Basel) ;
Kappos, Ludwig (University of Basel) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Rovira, Alex (Hospital Universitari Vall d'Hebron) ;
Wuerfel, Jens (Charité - Universitätsmedizin Berlin) ;
Evangelou, Nikos (University of Nottingham) ;
Universitat Autònoma de Barcelona
White matter lesions (WMLs) on brain magnetic resonance imaging (MRI) in multiple sclerosis (MS) may contribute to misdiagnosis. In chronic active lesions, peripheral iron-laden macrophages appear as paramagnetic rim lesions (PRLs). [...]
2022 - 10.1177/13524585221118677
Multiple sclerosis, Vol. 28 (august 2022) , p. 2212-2220
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