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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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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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3.
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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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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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8 p, 1.1 MB |
Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis : Benefit/risk following review of trial and post-marketing data
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Coles, Alasdair J. (University of Cambridge) ;
Jones, Joanne L. (University of Cambridge) ;
Vermersch, Patrick (Université de Lille) ;
Traboulsee, Anthony (University of British Columbia) ;
Bass, Ann D. (Neurology Center of San Antonio) ;
Boster, Aaron (Boster Center for Multiple Sclerosis) ;
Chan, Andrew (University of Bern) ;
Comi, Giancarlo (Vita-Salute San Raffaele University) ;
Fernández, Óscar (Hospital Regional Universitario Carlos Haya (Málaga)) ;
Giovannoni, Gavin (Queen Mary University of London) ;
Kubala Havrdova, Eva (Charles University) ;
LaGanke, Christopher (North Central Neurology Associates) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Oreja-Guevara, Celia (Universidad Complutense de Madrid) ;
Piehl, Fredrik (Karolinska Institutet (Estocolm, Suècia)) ;
Wiendl, Heinz (University of Münster) ;
Ziemssen, Tjalf (Dresden University of Technology) ;
Universitat Autònoma de Barcelona
Does preexisting or treatment-emergent autoimmunity increase the risk of subsequent autoimmune disease in individuals with relapsing-remitting multiple sclerosis (MS) after alemtuzumab? In the extended phase 2/3 trials, 34/96 (35. [...]
2022 - 10.1177/13524585211061335
Multiple sclerosis, Vol. 28 Núm. 5 (2022) , p. 842-846
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6.
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27 p, 1.5 MB |
Clinicogenomic factors of biotherapy immunogenicity in autoimmune disease : A prospective multicohort study of the ABIRISK consortium
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Hässler, Signe (Hôpital Pitié-Salpêtrière) ;
Bachelet, Delphine (Hôpital Bichat) ;
Duhaze, Julianne (CHU Ste-Justine Research Center) ;
Szely, Natacha (Paris-Sud University) ;
Gleizes, Aude (Le Kremlin-Bicêtre Hospital) ;
Hacein-Bey Abina, Salima (Paris-Descartes-Sorbonne-Cite University) ;
Aktas, Orhan (University of Düsseldorf) ;
Auer, Michael (Innsbruck Medical University) ;
Avouac, Jerôme (Cochin Hospital) ;
Birchler, Mary (GlaxoSmithKline (Estats Units d'Amèrica)) ;
Bouhnik, Yoram (GETAID (França)) ;
Brocq, Olivier (Princess Grace Hospital) ;
Buck-Martin, Dorothea (Technische Universität München) ;
Cadiot, Guillaume (University Hospital of Reims) ;
Carbonnel, Franck (Hôpital Kremlin-Bicêtre) ;
Chowers, Yehuda (Rambam Health Care Campus) ;
Comabella, Manuel (Hospital Universitari Vall d'Hebron. Institut de Recerca) ;
Derfuss, Tobias (University Hospital Basel (Basilea, Suïssa)) ;
Sikkema, Dan (University of Amsterdam) ;
Donnellan, Naoimh (Ipsen Biopharm (Regne Unit)) ;
Doukani, Abiba (Sorbonne Université) ;
Guger, Michael (Kepler University Hospital) ;
Hartung, Hans-Peter (University of Düsseldorf) ;
Kubala Havrdova, Eva (Charles University and General University Hospital, Prague, Czech Republic) ;
Hemmer, Bernhard (Munich Cluster for Systems Neurology) ;
Huizinga, Tom (Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands) ;
Ingenhoven, Kathleen (University of Düsseldorf, Medical Faculty, Department of Neurology, Düsseldorf, Germany) ;
Hyldgaard-Jensen, Poul Erik (Copenhagen University Hospital Rigshospitalet) ;
Jury, Elizabeth C. (University College London) ;
Khalil, Michael (Medical University of Graz) ;
Kieseier, Bernd (University of Düsseldorf) ;
Lindberg, Raija (University Hospital Basel (Basilea, Suïssa)) ;
Loercher, Amy (GlaxoSmithKline (Estats Units d'Amèrica)) ;
Maggi, Enrico (Bambino Gesù Children's Hospital) ;
Manson, Jessica (University College London Hospital) ;
Mauri, Claudia (University College London) ;
Mohand Oumoussa, Badreddine (Sorbonne Université) ;
Montalban, Xavier (St. Michael's Hospital) ;
Nachury, Maria (University Hospital of Lille (França)) ;
Nytrova, Petra (Charles University. Faculty of Medicine in Hradec Králové) ;
Richez, Christophe (Bordeaux University) ;
Ryner, Malin (Karolinska Institutet (Estocolm, Suècia)) ;
Sellebjerg, Finn (Copenhagen University Hospital Rigshospitalet) ;
Sievers, Claudia (University Hospital Basel (Basilea, Suïssa)) ;
Sikkema, Dan (Quanterix Corporation (Estats Units d'Amèrica)) ;
Soubrier, Martin (University Hospital of Clermont Ferrand) ;
Tourdot, Sophie (Paris-Sud University) ;
Trang, Caroline (CHU de Nantes) ;
Vultaggio, Alessandra (Università di Firenze) ;
Warnke, Clemens (University Hospital Köln) ;
Spindeldreher, Sebastian (Integrated Biologix GmbH (Suïssa)) ;
Dönnes, Pierre (SciCross AB (Suècia)) ;
Hickling, Timothy P. (Pfizer (Estats Units d'Amèrica)) ;
Hincelin Mery, Agnès (Sanofi, Chilly-Mazarin, France) ;
Allez, Matthieu (Hôpital Saint-Louis, AP-HP) ;
Deisenhammer, Florian (Innsbruck Medical University) ;
Fogdell-Hahn, Anna (Karolinska Institutet (Estocolm, Suècia)) ;
Mariette, Xavier (Université Paris-Saclay) ;
Pallardy, Marc (Paris-Sud University) ;
Broët, Philippe (Paris-Sud University Hospitals) ;
Universitat Autònoma de Barcelona
Biopharmaceutical products (BPs) are widely used to treat autoimmune diseases, but immunogenicity limits their efficacy for an important proportion of patients. Our knowledge of patient-related factors influencing the occurrence of antidrug antibodies (ADAs) is still limited. [...]
2020 - 10.1371/journal.pmed.1003348
PLoS Medicine, Vol. 17 (october 2020)
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