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11.
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9 p, 570.9 KB |
Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis : An Integrated Analysis of Safety
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Giovannoni, Gavin (Queen Mary University of London) ;
Galazka, Andrew (Merck. Aubonne. Switzerland. a division of Merck KGaA) ;
Schick, Regina (Merck KGaA) ;
Leist, Thomas (Jefferson University) ;
Comi, Giancarlo (Università Vita-Salute San Raffaele. Ospedale San Raffaele) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Damian, Doris (EMD Serono Research and Development Institute. Inc) ;
Dangond, Fernando (EMD Serono Research and Development Institute. Inc) ;
Cook, Stuart (The State University of New Jersey) ;
Universitat Autònoma de Barcelona.
Departament de Medicina
Introduction: Although use of contraception was pre-specified during cladribine clinical trials for multiple sclerosis, some pregnancies did occur. Objective: This analysis reports on pregnancy outcomes in the cladribine clinical development program. [...]
2020 -  10.1007/s40264-020-00948-x
Drug Safety, Vol. 43 Núm. 7 (july 2020) , p. 635-643
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12.
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14 p, 1.0 MB |
Long-term safety and efficacy of daclizumab beta in relapsing-remitting multiple sclerosis : 6-year results from the SELECTED open-label extension study
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Gold, Ralf (Ruhr-University Bochum) ;
Radue, Ernst-Wilhem (University Hospital Basel (Basilea, Suïssa)) ;
Giovannoni, Gavin (Queen Mary University of London) ;
Selmaj, Krzysztof. (University of Warmia and Mazury) ;
Havrdova, Eva Kubala (Charles University) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Stefoski, Dusan (Rush University Medical Center) ;
Sprenger, Till (DKD Helios Klinik Wiesbaden) ;
Robinson, Randy R. (AbbVie Inc.) ;
Fam, Sami (Biogen) ;
Smith, Jonathan (Biogen) ;
Chalkias, Spyros (Biogen) ;
Giannattasio, Giorgio (Biogen) ;
Lima, Gabriel (Biogen) ;
Castro-Borrero, Wanda (Biogen) ;
Universitat Autònoma de Barcelona
Objective: SELECTED, an open-label extension study, evaluated daclizumab beta treatment for up to 6 years in participants with relapsing multiple sclerosis who completed the randomized SELECT/SELECTION studies. [...]
2020 - 10.1007/s00415-020-09835-y
Journal of Neurology, Vol. 267 Núm. 10 (january 2020) , p. 2851-2864
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13.
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11 p, 473.7 KB |
Effectiveness of delayed-release dimethyl fumarate on patient-reported outcomes and clinical measures in patients with relapsing-remitting multiple sclerosis in a real-world clinical setting : PROTEC
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Berger, Thomas (Universitätsklinik für Neurologie) ;
Brochet, B. (Groupe Hospitalier Pellegrin Hôpital Pellegrin) ;
Brambilla, L. (IRCCS Foundation Neurological Institute Carlo Besta) ;
Giacomini, P.S. (Montreal Neurological Institute Hospital) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Vasco Salgado, A (Hospital Professor Doutor Fernando Fonseca) ;
Su, R (Biogen, USA) ;
Bretagne, A (Biogen International GmbH) ;
Universitat Autònoma de Barcelona.
Departament de Medicina
Background: Patient-reported outcomes (PRO) and clinical outcomes give a broad assessment of relapsing-remitting multiple sclerosis (RRMS) disease. Objective: The aim is to evaluate the effectiveness of delayed-release dimethyl fumarate (DMF) on disease activity and PROs in patients with RRMS in the clinic. [...]
2019 - 10.1177/2055217319887191
Multiple Sclerosis Journal - Experimental, Translational and Clinical, Vol. 5 Núm. 4 (2019)
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14.
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11 p, 1.1 MB |
Safety of cladribine tablets in the treatment of patients with multiple sclerosis : An integrated analysis
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Cook, Stuart (Rutgers. The State University of New Jersey) ;
Leist, Thomas (Jefferson University) ;
Comi, Giancarlo (Università Vita-Salute San Raffaele) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Giovannoni, Gavin (Queen Mary University of London) ;
Nolting, Axel (Merck KGaA) ;
Hicking, Christine (Merck KGaA) ;
Galazka, Andrew (Merck. Zone Industrielle de L'Ouriettaz) ;
Sylvester, Elke (Merck KGaA) ;
Universitat Autònoma de Barcelona.
Departament de Medicina
Background: Treating patients with relapsing multiple sclerosis (MS) with cladribine tablets (two times 4 or 5 days of treatment each year for 2 years) results in long-lasting efficacy, with continued stability in many patients for 4 or more years. [...]
2019 - 10.1016/j.msard.2018.11.021
Multiple Sclerosis and Related Disorders, Vol. 29 (april 2019) , p. 157-167
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15.
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17 p, 300.8 KB |
Expert opinion on the use of cladribine tablets in clinical practice
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Sørensen, Per Soelberg (University of Copenhagen) ;
Centonze, Diego (Unit of Neurology and Neurorehabilitation) ;
Giovannoni, Gavin (Queen Mary University of London) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Selchen, Daniel (St. Michael's Hospital, Toronto) ;
Vermersch, Patrick (Univ. Lille) ;
Wiendl, Heinz (University of Münster) ;
Yamout, Bassem (American University of Beirut) ;
Salloukh, Hashem (Ares Trading S.A. Merck Serono S.A) ;
Rieckmann, Peter (University of Erlangen) ;
Universitat Autònoma de Barcelona.
Departament de Medicina
Background: Gaps in current product labels and a lack of detailed clinical guidelines leaves clinicians' questions on the practical management of patients receiving cladribine tablets for the treatment of relapsing multiple sclerosis (MS) unanswered. [...]
2020 - 10.1177/1756286420935019
Therapeutic Advances in Neurological Disorders, Vol. 13 (2020)
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16.
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15 p, 1.4 MB |
Critical role of interleukin (IL)-17 in inflammatory and immune disorders : An updated review of the evidence focusing in controversies
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Ruiz de Morales, José María G. (Universidad de León) ;
Puig, Lluís (Universitat Autònoma de Barcelona. Departament de Medicina) ;
Daudén, Esteban (Hospital Universitario de la Princesa (Madrid)) ;
Cañete, Juan D. (Hospital Clínic i Provincial de Barcelona) ;
Pablos, José Luis (Hospital Universitario 12 de Octubre (Madrid)) ;
Martín, Antonio Oliveira (Hospital Universitario La Paz (Madrid)) ;
Juanatey, Carlos González (Hospital Universitario Lucus Augusti (Lugo)) ;
Adan Civera, Alfredo (Hospital Clínic i Provincial de Barcelona) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Borruel, Natalia (Hospital Universitari Vall d'Hebron) ;
Ortí, Guillermo (Vall d'Hebron Institut d'Oncologia) ;
Holgado-Martín, Esther (Ruber Internacional) ;
Garcia-Vidal, Carolina (Hospital Clínic i Provincial de Barcelona) ;
Vizcaya-Morales, Cynthia (Novartis Pharma) ;
Martín-Vázquez, Víctor (Novartis Farmacéutica) ;
González-Gay, Miguel Ángel (Universidad de Cantabria)
Interleukin 17 (IL-17) is a proinflammatory cytokine that has been the focus of intensive research because of its crucial role in the pathogenesis of different diseases across many medical specialties. [...]
2020 - 10.1016/j.autrev.2019.102429
Autoimmunity Reviews, Vol. 19 Núm. 1 (january 2020) , p. 102429
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17.
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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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18.
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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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19.
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8 p, 915.8 KB |
Long-term safety data from the cladribine tablets clinical development program in multiple sclerosis
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Leist, Thomas (Jefferson University) ;
Cook, S. (New Jersey Medical School) ;
Comi, Giancarlo (Università Vita-Salute San Raffaele) ;
Montalban, Xavier (Hospital Universitari Vall d'Hebron) ;
Giovannoni, Gavin (Queen Mary University of London) ;
Nolting, A. (Merck KGaA) ;
Damian, D. (Merck KGaA) ;
Syed, S. (Merck KGaA) ;
Galazka, Andrew (Merck KGaA) ;
Universitat Autònoma de Barcelona
Background: Long-term safety data are of particular interest for any newly approved treatment in multiple sclerosis such as cladribine tablets 10 mg (MAVENCLAD®; 3. 5 mg/kg cumulative dose over 2 years, referred to as cladribine tablets 3. [...]
2020 - 10.1016/j.msard.2020.102572
Multiple Sclerosis and Related Disorders, Vol. 46 (november 2020) , p. 102572
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20.
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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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