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1. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis

Author

Montalban, X., Hauser, S. L., Kappos, L., Arnold, D. L., Bar‑or, A., Comi, G., de Seze, J., Giovannoni, G., Hartung, H. -P., Hemmer, B., Lublin, F., Rammohan, K. W., Selmaj, K., Traboulsee, A., Sauter, A., Masterman, D., Fontoura, P., Belachew, S., Garren, H., Mairon, N., Chin, P., Wolinsky, J. S., Uccelli, A, for the ORATORIO Clinical Investigators, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, MUMC+: MA Med Staf Spec Neurologie (9), Klinische Neurowetenschappen, Institut Català de la Salut, [Montalban X] Hospital Universitari Vall d’Hebron, Barcelona, Spain. [Hauser SL] University of California, San Francisco, United States. [Kappos L] University Hospital Basel, Basel, Switzerland. [Arnold DL, Bar-Or A] McGill University, Montreal, Canada. [Comi G] University Vita-Salute San Raffaele, Milan, Italy., Hospital Universitari Vall d'Hebron, CIC Strasbourg (Centre d’Investigation Clinique Plurithématique (CIC - P) ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Strasbourg (UNISTRA)-Hôpital de Hautepierre [Strasbourg]-Nouvel Hôpital Civil de Strasbourg, CHU Strasbourg, Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Nouvel Hôpital Civil de Strasbourg-Hôpital de Hautepierre [Strasbourg], Montalban, X., Hauser, S. L., Kappos, L., Arnold, D. L., Bar or, A., Comi, Giancarlo, De Seze, J., Giovannoni, G., Hartung, H. . P., Hemmer, B., Lublin, F., Rammohan, K. W., Selmaj, K., Traboulsee, A., Sauter, A., Masterman, D., Fontoura, P., Belachew, S., Garren, H., Mairon, N., Chin, P., and Wolinsky, J. S.

Subjects
Male, 0301 basic medicine, Intention to Treat Analysi, T-Lymphocytes, Esclerosi múltiple, enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple::esclerosis múltiple crónica progresiva [ENFERMEDADES], Other subheadings::Other subheadings::/drug therapy [Other subheadings], DOUBLE-BLIND, chemistry.chemical_compound, 0302 clinical medicine, DEMYELINATION, Monoclonal, Clinical endpoint, aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados [COMPUESTOS QUÍMICOS Y DROGAS], Infusions, Intravenou, Other subheadings::/therapeutic use [Other subheadings], Otros calificadores::Otros calificadores::/inmunología [Otros calificadores], Humanized, Otros calificadores::Otros calificadores::/tratamiento farmacológico [Otros calificadores], MULTICENTER TRIAL, Enfermedades del Sistema Nervioso::Enfermedades Autoinmunes del Sistema Nervioso::Enfermedades Autoinmunes Desmielinizantes SNC::Esclerosis Múltiple::Esclerosis Múltiple Crónica Progresiva [ENFERMEDADES], DAMAGE, B-Lymphocytes, Medicine (all), Hazard ratio, B-Lymphocyte, Brain, General Medicine, Multiple Sclerosis, Chronic Progressive, Middle Aged, Magnetic Resonance Imaging, Intention to Treat Analysis, 3. Good health, Chronic Progressive, Disease Progression, Female, Intravenous, Human, medicine.drug, Adult, Infusions, medicine.medical_specialty, Multiple Sclerosis, Adolescent, CANCER-RISK, Antibodies, Monoclonal, Humanized, Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized [CHEMICALS AND DRUGS], Placebo, Antibodies, Young Adult, 03 medical and health sciences, Double-Blind Method, Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis::Multiple Sclerosis, Chronic Progressive [DISEASES], Other subheadings::Other subheadings::/immunology [Other subheadings], Multicenter trial, Internal medicine, medicine, Humans, CD20, Lymphocyte Count, Antigens, Intention-to-treat analysis, Otros calificadores::/uso terapéutico [Otros calificadores], business.industry, Multiple sclerosis, Antigens, CD20, medicine.disease, Infusions, Intravenous, Surgery, PATHOLOGY, 030104 developmental biology, Siponimod, T-Lymphocyte, ANTIBODY, chemistry, Ocrelizumab, Medicaments immunosupressors, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, 030217 neurology & neurosurgery
Abstract

Ocrelizumab; Placebo; Multiple sclerosis Ocrelizumab; Placebo; Esclerosi múltiple Ocrelizumab; Placebo; Esclerosis múltiple BACKGROUND: An evolving understanding of the immunopathogenesis of multiple sclerosis suggests that depleting B cells could be useful for treatment. We studied ocrelizumab, a humanized monoclonal antibody that selectively depletes CD20-expressing B cells, in the primary progressive form of the disease. METHODS: In this phase 3 trial, we randomly assigned 732 patients with primary progressive multiple sclerosis in a 2:1 ratio to receive intravenous ocrelizumab (600 mg) or placebo every 24 weeks for at least 120 weeks and until a prespecified number of confirmed disability progression events had occurred. The primary end point was the percentage of patients with disability progression confirmed at 12 weeks in a time-to-event analysis. RESULTS: The percentage of patients with 12-week confirmed disability progression was 32.9% with ocrelizumab versus 39.3% with placebo (hazard ratio, 0.76; 95% confidence interval [CI], 0.59 to 0.98; P=0.03). The percentage of patients with 24-week confirmed disability progression was 29.6% with ocrelizumab versus 35.7% with placebo (hazard ratio, 0.75; 95% CI, 0.58 to 0.98; P=0.04). By week 120, performance on the timed 25-foot walk worsened by 38.9% with ocrelizumab versus 55.1% with placebo (P=0.04); the total volume of brain lesions on T2-weighted magnetic resonance imaging (MRI) decreased by 3.4% with ocrelizumab and increased by 7.4% with placebo (P

Published
2017

3. [Therapeutic armamentarium in neurology: the birth of a new era]

Author

Belachew S, Magis D, Lievens I, Ml, Cuvelier, Rikir E, Gaëtan Garraux, Hotermans C, Salmon E, Sadzot B, Cambron L, Maquet P, Poirrier R, and Moonen G

Subjects
Sleep Wake Disorders, Epilepsy, Multiple Sclerosis, Migraine Disorders, Humans, Peripheral Nervous System Diseases, Cluster Headache, Parkinson Disease, Nervous System Diseases
Abstract

The field of neurology was long infamous for a lack of therapeutic options. How many of you have once thought: "Neurologists don't cure the disease, they admire it". But those days have passed into history, and the field is now vibrant with new treatments and hope even for patients with the worst neurodegenerative diseases. We summarized in the present review the latest major advances in therapeutic principles and practice for some of the most frequent chronic neurological disorders such as headaches, epilepsy, multiple sclerosis, dementias, Parkinson's disease, sleep/wake disturbances and peripheral neuropathies. We cannot cure or prevent, but we can now halt or control symptoms and disease progression to provide physical and psychological relief, and a better quality of life for patients who suffer from these otherwise devastating neurological conditions.

Published
2007

5. The inhibition of cyclin-dependent kinases induces differentiation of supernumerary hair cells and Deiters' cells in the developing organ of Corti

Author

Brigitte Malgrange, Knockaert, M., Belachew, S., Nguyen, L., Moonen, G., Meijer, L., Lefebvre, P. P., Molécules et cibles thérapeutiques (MCT), Station biologique de Roscoff [Roscoff] (SBR), and Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Animals Apoptosis CDC2 Protein Kinase/antagonists & inhibitors CDC2-CDC28 Kinases/antagonists & inhibitors Cell Differentiation Cell Division Cyclin-Dependent Kinase 2 Cyclin-Dependent Kinases/*antagonists & inhibitors/metabolism Enzyme Inhibitors/pharmacology Hair Cells/cytology/*embryology/enzymology Immunoblotting Immunohistochemistry Models, Biological Organ of Corti/*cytology/*embryology/enzymology/growth & development Purines/pharmacology Rats, [SDV.BBM]Life Sciences [q-bio]/Biochemistry, Molecular Biology, sense organs, biological phenomena, cell phenomena, and immunity
Abstract

In the embryonic day 19 organs of Corti, we showed that roscovitine, a chemical inhibitor of cyclin-dependent kinases (CDKs), significantly increased the number of hair cells (HCs) and corresponding supporting cells (SCs) by triggering differentiation of precursor cells without interacting with cell proliferation. The effect of roscovitine was mimicked by other CDK1, 2, 5, and 7 inhibitors but not by CDK4/6 and mitogen-activated protein kinase pathway antagonists. Immunohistochemical analysis indicated that roscovitine-specific intracellular targets, CDK1, 2, 5, and 7, were expressed in the organ of Corti and especially in Hensen's cells. Affinity chromatography studies showed a tight correlation between the protein levels of CDK1/2 and 5 and the rate of roscovitine-induced supernumerary cells in the organ of Corti. In addition, we demonstrated that basal CDK activity was higher and more roscovitine-sensitive at developmental stages that are selectively permissive for the emergence of supernumerary cells. These results suggest that CDKs are involved in the normal development of the organ of Corti and that, at least in E19 embryos, inhibition of CDKs is sufficient to trigger the differentiation of HCs and corresponding SCs, presumably from the Hensen's cell progenitors and/or from progenitors located in the greater epithelial ridge area.

7. Comparative efficacy of first-line natalizumab versus IFNb or glatiramer acetate in relapsing MS

Author

Spelman, T., Kalincik, T., Jokubaitis, V., Zhang, A., Pellegrini, F., Wiendl, H., Belachew, S., Hyde, R., Verheul, F., Lugaresi, A., Havrdova, E., Horakova, D., Grammond, P., Duquette, P., Prat, A., Iuliano, G., Terzi, M., Izquierdo, G., Hupperts, R., Boz, C., Pucci, E., Giuliani, G., Sola, P., La Spitaleri, D., Lechner-Scott, J., Bergamaschi, R., Grand Maison, F., Granella, F., Kappos, L., Trojano, M., Butzkueven, H., and MSBase Study Grp

10. Phenotypical characterization of alpha-galacatosidase A gene mutations in a large Fabry disease screening program in stroke in the young

Author

Isabelle De Brabander, Laetitia Yperzeele, Chantal Ceuteric-De Groote, Raf Brouns, Robert Baker, Belachew, S., Jean Delbecq, Gilles De Keulenaer, Sophie Dethy, Francois Eyskens, Fumal, A., Groener, J., Aerts, J., Hemelsoet, D., Hughes, D., Jeangette, S., Dirk Nuytten, Redondo, P., Bernard Sadzot, Cj. Sindic, Thijs, V., Broeckhoven, C., Peter Paul De Deyn, and Internal Medicine Specializations

Subjects
Stroke, Fabry disease, genetic screening
Abstract

OBJECTIVE: In the Belgian Fabry Study (BeFaS), the prevalence of Fabry disease was assessed in 1000 young patients presenting with stroke, unexplained white matter lesions or vertebrobasilar dolichoectasia. The results of the BeFaS suggested that Fabry disease may play a role in up to 1% of young patients presenting with cerebrovascular disease. However, the clinical relevance was unclear in all cases. We report on detailed phenotyping in subjects identified with ?-galactosidase A (?-Gal A) enzyme deficiency or GLA mutations identified in the BeFaS (n=10), and on the results of family screening in this population. METHODS: Family screening was performed to identify additional mutation carriers. Biochemical and/or clinical evaluation of all subjects (BeFaS index patients and relatives carrying a GLA mutation) was performed. RESULTS: Genetic family screening revealed 18 additional GLA mutation carriers. Bloodspot ?-Gal A enzyme activity was normal in all GLA mutation carriers, even in 2 males with the p.A143T mutation. Plasma Gb3 and lyso-Gb3 levels were normal in all subjects. Elevated Gb3 in urine was detected in 2 subjects. Some classic clinical signs of Fabry disease, like angiokeratoma or cornea verticillata, could not be detected in our population. Cardiac symptoms of Fabry disease were found in 6 out of 10 p.A143T carriers. No signs of cerebrovascular disease were found in the relatives with a GLA mutation. CONCLUSIONS: We could not identify mutations causing the classical clinical phenotype of Fabry disease in our cerebrovascular disease population. Enzyme activity analysis in bloodspots and plasma may fail to identify late-onset variants of Fabry disease. We recommend genetic testing when an atypical, late-onset variant of Fabry disease is suspected in a male cerebrovascular disease patient. However, this may lead to the identification of non-disease causing or controversial genetic variants.

12. Efficacy and Treatment Persistence of First-line Natalizumab vs. Interferon beta or Glatiramer Acetate in relapsing MS

Author

Butzkueven, H., Spelman, T., Kalincik, T., Jokubaitis, V., Zhang, A., Pellegrini, F., Wiendl, H., Belachew, S., Hyde, R., Verheul, F., Lugaresi, A., Havrdova, E., Horakova, D., Grammond, P., Duquette, P., Prat, A., Iuliano, G., Terzi, M., Izquierdo, G., Hupperts, R., Boz, C., Pucci, E., Giuliani, G., Sola, P., La Spitaleri, D., Lechner-Scott, J., Bergamaschi, R., Grand-Maison, F., Granella, F., Kappos, L., Trojano, M., MSBase Investigators, and Top, Investigators

13. Preliminary validity of the Draw a Shape Test for upper extremity assessment in multiple sclerosis

Author

Graves, Jennifer S., Ganzetti, Marco, Dondelinger, Frank, Lipsmeier, Florian, Belachew, Shibeshih, Bernasconi, Corrado, Montalban, Xavier, Beek, Johan van, Baker, Michael, Gossens, Christian, Lindemann, Michael, Universitat Autònoma de Barcelona. Departament de Medicina, Institut Català de la Salut, [Graves JS] Department of Neurosciences, University of California San Diego, San Diego, California, USA. [Ganzetti M, Dondelinger F, Lipsmeier F, Belachew S, Bernasconi C] F. Hoffmann-La Roche Ltd, Basel, Switzerland. [Montalban X] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
General Neuroscience, Body Regions::Extremities::Upper Extremity [ANATOMY], Brain, Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis [DISEASES], Otros calificadores::Otros calificadores::/diagnóstico por imagen [Otros calificadores], Magnetic Resonance Imaging, Braços, Upper Extremity, Extremitats, Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging::Tomography::Magnetic Resonance Imaging [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple [ENFERMEDADES], regiones corporales::extremidades::extremidad superior [ANATOMÍA], Humans, diagnóstico::técnicas y procedimientos diagnósticos::diagnóstico por imagen::tomografía::imagen por resonancia magnética [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Smartphone, Neurology (clinical), Multiple Sclerosis/diagnostic imaging, Esclerosi múltiple - Imatgeria per ressonància magnètica, Other subheadings::Other subheadings::/diagnostic imaging [Other subheadings]
Abstract

Multiple sclerosis Esclerosi múltiple Esclerosis múltiple Objective To validate the smartphone sensor-based Draw a Shape Test – a part of the Floodlight Proof-of-Concept app for remotely assessing multiple sclerosis-related upper extremity impairment by tracing six different shapes. Methods People with multiple sclerosis, classified functionally normal/abnormal via their Nine-Hole Peg Test time, and healthy controls participated in a 24-week, nonrandomized study. Spatial (trace accuracy), temporal (mean and variability in linear, angular, and radial drawing velocities, and dwell time ratio), and spatiotemporal features (trace celerity) were cross-sectionally analyzed for correlation with standard clinical and brain magnetic resonance imaging (normalized brain volume and total lesion volume) disease burden measures, and for capacity to differentiate people with multiple sclerosis from healthy controls. Results Data from 69 people with multiple sclerosis and 18 healthy controls were analyzed. Trace accuracy (all shapes), linear velocity variability (circle, figure-of-8, spiral shapes), and radial velocity variability (spiral shape) had a mostly fair/moderate-to-good correlation (|r| = 0.14–0.66) with all disease burden measures. Trace celerity also had mostly fair/moderate-to-good correlation (|r| = 0.18–0.41) with Nine-Hole Peg Test performance, cerebellar functional system score, and brain magnetic resonance imaging. Furthermore, partial correlation analysis related these results to motor impairment. People with multiple sclerosis showed greater drawing velocity variability, though slower mean velocity, than healthy controls. Linear velocity (spiral shape) and angular velocity (circle shape) potentially differentiate functionally normal people with multiple sclerosis from healthy controls. Interpretation The Draw a Shape Test objectively assesses upper extremity impairment and correlates with all disease burden measures, thus aiding multiple sclerosis-related upper extremity impairment characterization. This research was funded by F. Hoffmann-La Roche Ltd, Basel, Switzerland.

Published
2022

14. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis

Author

Hauser, Stephen L., Bar-Or, Amit, Comi, Giancarlo, Giovannoni, Gavin, Hartung, Hans-Peter, Hemmer, Bernhard, Lublin, Fred, Montalban, Xavier, Rammohan, Kottil W., Selmaj, Krzysztof, Traboulsee, Anthony, Wolinsky, Jerry S., Arnold, Douglas L., Klingelschmitt, Gaelle, Masterman, Donna, Fontoura, Paulo, Belachew, Shibeshih, Chin, Peter, Mairon, Nicole, Garren, Hideki, Kappos, Ludwig, And Opera Ii Clinical Investigators, Opera I., Reingold, Stephen C., Sandberg-Wollheim, Magnhild, Barkhof, Frederik, Dörmer, Thomas, Evans, Scott, Mcfarland, Henry F., Steiner, Israel, Yaldizli, Özgür, D Souza, Marcus, Andelova, Michaela, Rust, Heiko, Ballario, Carlos, Giannaula, Rolando, Reich, Edgardo Gabriel, Parratt, John, Eggers, Christian, Buyle, Maarten, Pesch, Vincent, Vanopdenbosch, Ludo, Carneiro, Denise, Friedrich, Mauricio, Longo, Alexandre Luiz, Genov, Krasimir, Ivanova, Sonya, Maslarov, Dimitar, Lilovski, Hristo, Staikov, Ivan, Cueto, German, Dufek, Michal, Havrdova, Eva, Novotna, Alena, Skoda, Ondrej, Talabova, Marika, Vachova, Marta, Gross-Paju, Katrin, Haldre, Sulev, Elovaara, Irina, Brochet, Bruno, Castelnovo, Giovanni, Clavelou, Pierre, Seze, Jerome, Debouverie, Marc, Braune, Stefan, Haas, Judith, Heidenreich, Fedor, Schwarz, Wolfgang, Siever, Arno, Urban, Peter Paul, Zettl, Uwe, Ziemann, Ulf, Ziemssen, Tjalf, Zipp, Frauke, Debreczeni, Robert, Rozsa, Csilla, Satori, Maria, Chapman, Joab, Ghezzi, Angelo, Perini, Paola, Pozzilli, Carlo, Kalnina, Jolanta, Millers, Andrejs, Budrys, Valmantas, Kizlaitiene, Rasa, Malciene, Lina, Vaitkus, Antanas, Castro Farfan, Guillermo, Gongora Rivera, Juan Fernando, Frequin, S. T. F. M., Gavidia Chucan, Jorge Martin, Perez Villegas, Julio, Pretell, Edwin Javier, Rodriguez Kadota, Liliana Elizabe, Fryze, Waldemar, Hertmanowska, Hanka, Maciejowski, Maciej, Opala, Grzegorz, Cerqueira, João, Arefieva, Elena, Maslova, Natalia, Odinak, Miroslav, Pankratov, Evgeny, Perfiliev, Semen, Poverennova, Irina, Sazonov, Denis, Shirshova, Elena, Sivertseva, Stella, Volkova, Larisa, Vorobyova, Olga, Knezevic, Zorica, Raicevic, Ranko, Vojinovic, Slobodan, Hancinova, Viera, Saffova, Patricia, Turcani, Peter, Vyletelka, Juraj, Coetzee, Christo C., Garcia-Merino, Antonio, Hernandez, Miguel A., Izquierdo Ayuso, Guillermo, Rodriguez Antigüedad, Alfredo, Gobbi, Claudio, Belal, Samir, Frih-Ayed, Mahbouba, Gouider, Riadh, Mrissa, Ridha, Sergii Moskovko, Sanotskyy, Yanosh, Sokolova, Larysa, Statinova, Olena, Voloshyna, Nataliya, Turner, Benjamin, Wilson, Martin, Applebee, Angela, Bandari, Daniel, Belkin, Martin, Birnbaum, Gary, Borresen, Thor, Boyd, James, Cascione, Mark, Cohan, Stanley, Cohen, Bruce, Conway, Jill, Cree, Bruce, Dihenia, Bhupesh, Dissin, Jonathan, Flitman, Stephen, Ford, Corey, Giancarlo, Thomas, Gold, Scott, Green, Barbara, Gwynn, Matthews, Honeycutt, David, Huddlestone, John, Klawiter, Eric, Kohrman, Bruce, Langer-Gould, Annette, Lava, Neil, Lindsey, William, Mitchell, Galen, Naismith, Robert, Nicolas, Joseph, Pardo, Gabriel, Patel, Malti, Porter, John A. H., Racke, Michael, Robertson, Derrick, Rossman, Howard, Schafer, John, Shubin, Richard, Singer, Barry, Smith, Charles, Suski, Valerie, Thrower, Ben, Wilson, Christopher, Wynn, Daniel, Zabad, Rana, Estol, Conrado J., Scarlatti, Annita, Alekseenko, Yuri, Fedulau, Aliaksandr, Kulesh, Sergey, Navumava, Halina, Willekens, Barbara, Alajbegovic, Azra, Sinanovic, Osman, Christo, Paulo, Papais Alvarenga, Regina Maria, Pereira Damasceno, Benito, Baldaranov, Dimo, Grigorova, Olga, Haralanov, Lyubomir, Milanova, Milena, Ayotte, Charles, Blevins, Gregg, Freedman, Mark, Grand Maison, François, Jacques, François, Yeung, Michael, Basic, Silvio, Hajnsek, Sanja, Janko-Labinac, Dolores, Kidjemet Piskac, Spomenka, Benesova, Yvonne, Hradilek, Pavel, Brassat, David, Edan, Gilles, Hautecoeur, Patrick, Moreau, Thibault, Papeix, Caroline, Tourbah, Ayman, Vukusic, Sandra, Aktas, Orhan, Berthele, Achim, Bodenschatz, Ralf, Foerch, Christian, Hohlfeld, Reinhard, Landefeld, Harald, Lang, Michael, Platten, Michael, Puzich, Reinhard, Schmidt, Stephan, Tubridy, Niall, Ardito, Bonaventura, Capra, Ruggero, Centonze, Diego, Crociani, Paola, Danni, Maura, Grimaldi, Luigi, Gusmaroli, Graziano, Mantegazza, Renato, Mirabella, Massimiliano, Uccelli, Antonio, Carbajal Ramirez, Angelica, Lopez Meza, Elmer Guillermo, Lopez Prieto, Juan Jose, Oropeza Alba, Jose Luis, Reyes-Morales, Sarug, San Juan Orta, Daniel, Myhr, Kjell Morten, Binek, Maciej, Czarnecki, Maciej, Klodowska-Duda, Gabriela, Stelmasiak, Zbigniew, Szczudlik, Andrzej, Tutaj, Andrzej, Belova, Anna, Dorogov, Nikolay, Fedyanin, Alexander, Khasanova, Dina, Makarov, Nikolay, Mishin, Gennadiy, Sherman, Mikhail, Skoromets, Alexander, Trushnikova, Tatiana, Donath, Vladimir, Dupejova, Beata, Gurcik, Ladislav, Arroyo, Rafael, Andres, Clara, Fernandez Fernandez, Oscar, Lainez Andrep, Jose Miguel, Martinez Gines, Maria Luisa, Martinez Rodriguez, Jose Enrique, Martinez Yelamos, Sergio, Oreja Guevara, Celia, Perez Sempere, Angel, Ramio, Luis, Ramo Tello, Cristina, Lycke, Jan, Olsson, Tomas, Roshanisefat, Homayoun, Sundström, Peter, Svenningsson, Anders, Akman Demir, Gulsen, Petek Balci, Belgin, Boz, Cavit, Efendi, Husnu, Karabudak, Rana, Siva, Aksel, Terzi, Murat, Yuceyar, Ayse Nur, Chmyr, Galyna, Goncharova, Yana, Kareta, Serhiy, Lutskiy, Igor, Harrower, Timothy, Hawkins, Clive, Pearson, Owen, Silber, Eli, Absher, John, Arnold, Thomas, Bass, Ann, Bernitsas, Evanthia, Braley, Tiffany, Calkwood, Jonathan, Carnes, Kenneth, Coyle, Patricia, Dunn, Jeffrey, Edwards, Keith, English, Jeffrey, Ferencz, Gerald, Fox, Edward, Frohman, Elliott, Gazda, Suzanne, Gitt, Jeffrey, Goodman, Andrew, Gross, Jeffrey, Hendin, Barry, Herrman, Craig, Hillen, Machteld, Huang, Deren, Hunter, Samuel, Hutton, George, Jacobs, Daniel, Keller, Bridget, Khan, Omar, Kister, Ilya, Krupp, Lauren, Lathi, Ellen, Lynch, Sharon, Miller, Tamara, Miravalle, Augusto, Omidvar, Omid, Perumal, Jai, Picone, Maryann, Rao, T. Hemanth, Repovic, Pavle, Riskind, Peter, Rowe, Vernon, Sheremata, William, Steingo, Brian, Twyman, Cary, Weisman, David, Wendt, Jeanette, Wray, Sibyl, Yapundich, Robert, Zarif, Myassar, Lääketieteen ja biotieteiden tiedekunta - Faculty of Medicine and Life Sciences, Tampere University, Hauser, S. L., Bar or, A., Comi, Giancarlo, Giovannoni, G., Hartung, H. . P., Hemmer, B., Lublin, F., Montalban, X., Rammohan, K. W., Selmaj, K., Traboulsee, A., Wolinsky, J. S., Arnold, D. L., Klingelschmitt, G., Masterman, D., Fontoura, P., Belachew, S., Chin, P., Mairon, N., Garren, H., Kappos, L., Universidade do Minho, Willekens, Barbara, and OPERA I and OPERA II Clinical Investigators

Subjects
0301 basic medicine, Male, Esclerosi múltiple, Adult, Antibodies, Monoclonal, Humanized, Antigens, CD20, B-Lymphocytes, Brain, Disease Progression, Female, Humans, Immunologic Factors, Infusions, Intravenous, Interferon-beta, Magnetic Resonance Imaging, Middle Aged, Multiple Sclerosis, Relapsing-Remitting, Recurrence, Medicine (all), Relapsing-Remitting, Gastroenterology, Medicina Clínica [Ciências Médicas], law.invention, 0302 clinical medicine, Immunologic Factor, Randomized controlled trial, law, Monoclonal, Clinical endpoint, Infusions, Intravenou, Immunologia, Humanized, Hazard ratio, B-Lymphocyte, General Medicine, Settore MED/26 - Neurologia, Intravenous, Neurotieteet - Neurosciences, medicine.drug, Human, medicine.medical_specialty, Infusions, Multiple Sclerosis, Immunology, Antibodies, Multiple sclerosis, 03 medical and health sciences, Internal medicine, medicine, CD20, Antigens, Ciências Médicas::Medicina Clínica, business.industry, Interferon beta-1a, medicine.disease, Confidence interval, Ocrelizumab, Interferon Beta-1a, Relapsing Multiple Sclerosis, 030104 developmental biology, Monoclonal antibodies, Human medicine, business, Anticossos monoclonals, 030217 neurology & neurosurgery
Abstract

BACKGROUND B cells influence the pathogenesis of multiple sclerosis. Ocrelizumab is a humanized monoclonal antibody that selectively depletes CD20+ B cells. METHODS In two identical phase 3 trials, we randomly assigned 821 and 835 patients with relapsing multiple sclerosis to receive intravenous ocrelizumab at a dose of 600 mg every 24 weeks or subcutaneous interferon beta-1a at a dose of 44 mu g three times weekly for 96 weeks. The primary end point was the annualized relapse rate. RESULTS The annualized relapse rate was lower with ocrelizumab than with interferon beta-1a in trial 1 (0.16 vs. 0.29; 46% lower rate with ocrelizumab; P, info:eu-repo/semantics/publishedVersion

Published
2017

15. Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS

Author

Spelman, Tim, Kalincik, Tomas, Jokubaitis, Vilija, Zhang, Annie, Pellegrini, Fabio, Wiendl, Heinz, Belachew, Shibeshih, Hyde, Robert, Verheul, Freek, Lugaresi, Alessandra, Havrdova, Eva, Horakova, Dana, Grammond, Pierre, Duquette, Pierre, Prat, Alexandre, Iuliano, Gerardo, Terzi, Murat, Izquierdo, Guillermo, Hupperts, Raymond M. M., Boz, Cavit, Pucci, Eugenio, Giuliani, Giorgio, Sola, Patrizia, Spitaleri, Daniele L. A., Lechner-Scott, Jeannette, Bergamaschi, Roberto, Grand'Maison, Francois, Granella, Franco, Kappos, Ludwig, Trojano, Maria, Butzkueven, Helmut, MSBase Investigators TOP Investiga, DIPARTIMENTO DI SCIENZE BIOMEDICHE E NEUROMOTORIE, OMÜ, Spelman, T, Kalincik, T, Jokubaitis, V, Zhang, A, Pellegrini, F, Wiendl, H, Belachew, S, Hyde, R, Verheul, F, Lugaresi, A, Havrdová, E, Horáková, D, Grammond, P, Duquette, P, Prat, A, Iuliano, G, Terzi, M, Izquierdo, G, Hupperts, R.M.M, Boz, C, Pucci, E, Giuliani, G, Sola, P, Spitaleri, D.L.A, Lechner-Scott, J, Bergamaschi, R, Grand'Maison, F, Granella, F, Kappos, L, Trojano, M, Butzkueven, H., RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, MUMC+: MA Med Staf Spec Neurologie (9), Klinische Neurowetenschappen, [Spelman, Tim] Univ Melbourne, Royal Melbourne Hosp, Dept Med, Melbourne, Vic 3010, Australia, [Kalincik, Tomas] Univ Melbourne, Royal Melbourne Hosp, Dept Med, Melbourne, Vic 3010, Australia, [Jokubaitis, Vilija] Univ Melbourne, Royal Melbourne Hosp, Dept Med, Melbourne, Vic 3010, Australia, [Butzkueven, Helmut] Univ Melbourne, Royal Melbourne Hosp, Dept Med, Melbourne, Vic 3010, Australia, [Spelman, Tim] Univ Melbourne, Royal Melbourne Hosp, Melbourne Brain Ctr, Melbourne, Vic 3010, Australia, [Kalincik, Tomas] Univ Melbourne, Royal Melbourne Hosp, Melbourne Brain Ctr, Melbourne, Vic 3010, Australia, [Jokubaitis, Vilija] Univ Melbourne, Royal Melbourne Hosp, Melbourne Brain Ctr, Melbourne, Vic 3010, Australia, [Butzkueven, Helmut] Univ Melbourne, Royal Melbourne Hosp, Melbourne Brain Ctr, Melbourne, Vic 3010, Australia, [Zhang, Annie] Biogen Idec Inc, Cambridge, MA USA, [Pellegrini, Fabio] Biogen Idec Inc, Cambridge, MA USA, [Belachew, Shibeshih] Biogen Idec Inc, Cambridge, MA USA, [Hyde, Robert] Biogen Idec Inc, Cambridge, MA USA, [Wiendl, Heinz] Univ Munster, Dept Neurol, Munster, Germany, [Verheul, Freek] Groene Hart Ziekenhuis, Gouda, Netherlands, [Lugaresi, Alessandra] Univ G DAnnunzio, Dept Neurosci Imaging & Clin Sci, MS Ctr, Chieti, Italy, [Havrdova, Eva] Charles Univ Prague, Dept Neurol, MS Ctr, Fac Med 1, Prague, Czech Republic, [Horakova, Dana] Charles Univ Prague, Dept Neurol, MS Ctr, Fac Med 1, Prague, Czech Republic, [Grammond, Pierre] Ctr Readaptat Deficience Phys Chaudiere Appalache, Levis, PQ, Canada, [Duquette, Pierre] Hop Notre Dame De Bon Secours, Montreal, PQ, Canada, [Prat, Alexandre] Hop Notre Dame De Bon Secours, Montreal, PQ, Canada, [Iuliano, Gerardo] Osped Riuniti Salerno, Salerno, Italy, [Terzi, Murat] 19 Mayis Univ, Fac Med, Samsun, Turkey, [Izquierdo, Guillermo] Hosp Univ Virgen Macarena, Seville, Spain, [Hupperts, Raymond M. M.] Orbis Med Ctr, Sittard Geleen, Netherlands, [Boz, Cavit] Farabi Hosp, KTU Med Fac, Trabzon, Turkey, [Pucci, Eugenio] ASUR Marche AV3, Neurol Unit, Macerata, Italy, [Giuliani, Giorgio] ASUR Marche AV3, Neurol Unit, Macerata, Italy, [Sola, Patrizia] Nuovo Osped Civile S Agostino, Modena, Italy, [Spitaleri, Daniele L. A.] AORN San Giuseppe Moscati, Avellino, Italy, [Lechner-Scott, Jeannette] John Hunter Hosp, Newcastle, NSW, Australia, [Bergamaschi, Roberto] IRCCS Mondino, Neurol Inst, Pavia, Italy, [Grand'Maison, Francois] Hop Charles LeMoyne, Neuro Rive Sud, Longueuil, PQ, Canada, [Granella, Franco] Univ Parma, I-43100 Parma, Italy, [Kappos, Ludwig] Univ Basel Hosp, Dept Neurol, Basel, Switzerland, [Trojano, Maria] Univ Bari, Dept Basic Med Sci Neurosci & Sense Organs, I-70121 Bari, Italy, [Butzkueven, Helmut] Monash Univ, Dept Neurol, Eastern Hlth, Clayton, Vic 3800, Australia, NHMRC, NHMRC Center for Research Excellence, MSBase Foundation, Merck Serono, Biogen, Novartis Pharma, Bayer-Schering, Sanofi-Aventis, BioCSL, and Czech Ministry of Education

Subjects
Risk, Oncology, medicine.medical_specialty, Outcomes, 03 medical and health sciences, 0302 clinical medicine, Natalizumab, Patient selection, Internal medicine, Disease-activity, Medicine, 030212 general & internal medicine, Long-term safety, Glatiramer acetate, Autoimmune disease, Predictors, business.industry, Progressive multifocal leukoencephalopathy, Multiple sclerosis, Research, Double-blind, Interferon-beta, medicine.disease, Remitting multiple-sclerosis, Benefits, Institutional repository, Physical therapy, Population study, Observational study, Neurology (clinical), business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Jokubaitis, Vilija G./0000-0002-3942-4340; pietrolongo, erika/0000-0002-6311-5994; Horakova, Dana/0000-0003-1915-0036; Lugaresi, Alessandra/0000-0003-2902-5589; Belachew, Shibeshih/0000-0003-3976-1950; Havrdova, Eva Kubala/0000-0002-9543-4359; Trojano, Maria/0000-0002-6329-8946; Butzkueven, Helmut/0000-0003-3940-8727; Kalincik, Tomas/0000-0003-3778-1376; pucci, eugenio/0000-0001-7606-7330 WOS: 000392602400009 Background: We compared efficacy and treatment persistence in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) initiating natalizumab compared with interferon-beta (IFN-beta)/glatiramer acetate (GA) therapies, using propensity score-matched cohorts from observational multiple sclerosis registries. Methods: The study population initiated IFN-beta/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had >= 3 months of on-treatment follow-up, and had active RRMS, defined as >= 1 gadolinium-enhancing lesion on cerebral MRI at baseline or >= 1 relapse within the 12 months prior to baseline. Baseline demographics and disease characteristics were balanced between propensity-matched groups. Annualized relapse rate (ARR), time to first relapse, treatment persistence, and disability outcomes were compared between matched treatment arms in the total population (n = 366/group) and subgroups with higher baseline disease activity. Results: First-line natalizumab was associated with a 68% relative reduction in ARR from a mean (SD) of 0.63 (0.92) on IFN-beta/GA to 0.20 (0.63) (p [signed-rank] < 0.0001), a 64% reduction in the rate of first relapse (hazard ratio [HR] 0.36, 95% confidence interval [CI] 0.28-0.47; p < 0.001), and a 27% reduction in the rate of discontinuation (HR 0.73, 95% CI 0.58-0.93; p = 0.01), compared with first-line IFN-beta/GA therapy. Confirmed disability progression and area under the Expanded Disability Status Scale-time curve analyses were not significant. Similar relapse and treatment persistence results were observed in each of the higher disease activity subgroups. Conclusions: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse and treatment persistence outcomes compared to first-line IFN-beta/GA. This needs to be balanced against the risk of progressive multifocal leukoencephalopathy in natalizumab-treated patients. Classification of evidence: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse rates and treatment persistence outcomes compared to first-line IFN-beta/GA. NHMRCNational Health and Medical Research Council of Australia [628856, 1071124, 1032484, 1083539]; NHMRC Center for Research ExcellenceNational Health and Medical Research Council of Australia [1001216]; MSBase Foundation; Merck SeronoMerck SeronoMerck & Company; BiogenBiogen; Novartis Pharma; Bayer-ScheringBayer AG; Sanofi-AventisSanofi-Aventis; BioCSL; Czech Ministry of EducationMinistry of Education, Youth & Sports - Czech Republic [PRVOUK-P26/LF1/4] Supported by the NHMRC Career Development Award (Clinical) to H.B. (ID628856), NHMRC Early Career Fellowship (1071124), NHMRC Project Grants (1032484 and 1083539), NHMRC Center for Research Excellence (Grant ID 1001216), and the MSBase Foundation. The MSBase Foundation is a not-for-profit organization that receives support from Merck Serono, Biogen, Novartis Pharma, Bayer-Schering, Sanofi-Aventis, and BioCSL. The Tysabri Observational Program is fully funded by Biogen. E. Havrdova and D. Horakova have been supported by Research Grant of Czech Ministry of Education, PRVOUK-P26/LF1/4.

Published
2016

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