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17 results on '"Roshanisefat, Homayoun"'

1. Effect of natalizumab on disease progression in secondary progressive multiple sclerosis (ASCEND): a phase 3, randomised, double-blind, placebo-controlled trial with an open-label extension

Author

Bartholomé, Emmanuel, D'Hooghe, Marie, Pandolfo, Massimo, Van Wijmeersch, Bart, Bhan, Virender, Blevins, Gregg, Brunet, Donald, Devonshire, Virginia, Duquette, Pierre, Freedman, Mark, Grand'Maison, François, Jacques, François, Lapierre, Yves, Lee, Liesly, Morrow, Sarah, Yeung, Michael, Dufek, Michal, Havrdová, Eva Kubala, Kanovsky, Petr, Stetkarova, Ivana, Talabova, Marika, Frederiksen, Jette, Kant, Matthias, Petersen, Thor, Ravnborg, Mads, Sellebjerg, Finn, Airas, Laura, Elovaara, Irina, Eralinna, Juha-Pekka, Sarasoja, Taneli, Al Khedr, Abdullatif, Brassat, David, Brochet, Bruno, Camu, William, Debouverie, Marc, Laplaud, David, Lebrun Frenay, Christine, Pelletier, Jean, Vermersch, Patrick, Vukusi, Sandra, Baum, Karl, Berthele, Achim, Faiss, Juergen, Flachenecker, Peter, Hohlfeld, Reinhard, Krumbholz, Markus, Lassek, Christoph, Maeurer, Mathias, Meuth, Sven, Ziemssen, Tjalf, Hardiman, Orla, McGuigan, Christopher, Achiron, Anat, Karussis, Dimitrios, Bergamaschi, Roberto, Morra, Vincenzo Brescia, Comi, Giancarlo, Cottone, Salvatore, Grimaldi, Luigi, Mancardi, Giovanni Luigi, Massacesi, Luca, Nocentini, Ugo, Salvetti, Marco, Scarpini, Elio, Sola, Patrizia, Tedeschi, Gioacchino, Trojano, Maria, Zaffaroni, Mauro, Frequin, Stephan, Hupperts, Raymond, Killestein, Joep, Schrijver, Hans, Van Dijl, Ronald, van Munster, Erik, Czarnecki, Maciej, Drozdowski, Wieslaw, Fryze, Waldemar, Hertmanowska, Hanka, Ilkowski, Jan, Kaminska, Anna, Klodowska-Duda, Gabriela, Maciejowski, Maciej, Motta, Ewa, Podemski, Ryszard, Potemkowski, Andrzej, Rog, Teresa, Selmaj, Krzysztof, Stelmasiak, Zbigniew, Stepien, Adam, Tutaj, Andrzej, Zaborski, Jacek, Boyko, Alexey, Chefranova, Zanna, Evdoshenko, Evgeny, Khabirov, Farit, Sivertseva, Stella, Yakupov, Eduard, Alvarez Cermeño, Jose Carlos, Escartin, Antonio, Fernandez, Oscar Fernandez, Garcia-Merino, Antonio, Hernandez Perez, Miguel Angel, Ayuso, Guillermo Izquierdo, Lallana, José Meca, Gairin, Xavier Montalban, Oreja-Guevara, Celia, Saiz Hinarejos, Albert, Gunnarsson, Martin, Lycke, Jan, Martin, Claes, Piehl, Fredrik, Roshanisefat, Homayoun, Sundstrom, Peter, Duddy, Martin, Gran, Bruno, Harrower, Timothy, Hobart, Jeremy, Kapoor, Raju, Lee, Martin, Mattison, Paul, Nicholas, Richard, Pearson, Owen, Rashid, Waqar, Rog, David, Sharrack, Basil, Silber, Eli, Turner, Ben, Williams, Anna, Woolmore, John, Young, Carolyn, Bandari, Daniel, Berger, Joseph, Camac, Ann, Cohan, Stanley, Conway, Jill, Edwards, Keith, Fabian, Michelle, Florin, Jack, Freedman, Steven, Garwacki, Dennis, Goldman, Myla, Harrison, Daniel, Herrman, Craig, Huang, Deren, Javed, Adil, Jeffery, Douglas, Kamin, Stephen, Katsamakis, George, Khatri, Bhupendra, Langer-Gould, Annette, Lynch, Sharon, Mattson, David, Miller, Tamara, Miravalle, Augusto, Moses, Harold, Muley, Suraj, Napier, James, Nielsen, Allen, Pachner, Andrew, Pardo, Gabriel, Picone, MaryAnn, Robertson, Derrick, Royal, Walter, Sheppard, Christopher, Thrower, Ben, Twyman, Cary, Waubant, Emmanuelle, Wendt, Jeanette, Yadav, Vijayshree, Zabad, Rana, Zarelli, Greg, Ho, Pei-Ran, Campbell, Nolan, Chang, Ih, Deykin, Aaron, Forrestal, Fiona, Lucas, Nisha, Yu, Bei, Arnold, Douglas L, Freedman, Mark S, Goldman, Myla D, Hartung, Hans-Peter, Miller, Aaron, Cadavid, Diego, Mikol, Dan, and Steiner, Deborah

Published
2018
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2. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study

Author

Achiron, Anat, Achtnichts, Lutz, Agan, Kadriye, Akman-Demir, Gulsen, Allen, Alison B, Antel, Jack P, Antiguedad, Alfredo Rodriguez, Apperson, Michelle, Applebee, Angela M, Ayuso, Guillermo Izquierdo, Baba, Masayuki, Bajenaru, Ovidiu, Balasa, Rodica, Balci, Belgin Petek, Barnett, Michael, Bass, Ann, Becker, Veit U, Bejinariu, Mihaela, Bergh, Florian Then, Bergmann, Arnfin, Bernitsas, Evanthia, Berthele, Achim, Bhan, Virender, Bischof, Felix, Bjork, Randall John, Blevins, Gregg, Boehringer, Matthias, Boerner, Thomas, Bonek, Robert, Bowen, James D, Bowling, Allen, Boyko, Alexey N, Boz, Cavit, Bracknies, Vera, Braune, Stefan, Brescia Morra, Vincenzo, Brochet, Bruno, Brola, Waldemar, Brownstone, Paul Kenneth, Brozman, Miroslav, Brunet, Donald, Buraga, Ioan, Burnett, Margaret, Buttmann, Mathias, Butzkueven, Helmut, Cahill, Jonathan, Calkwood, Jonathan C, Camu, William, Cascione, Mark, Castelnovo, Giovani, Centonze, Diego, Cerqueira, Joao, Chan, Andrew, Cimprichova, Andrea, Cohan, Stanley, Comi, Giancarlo, Conway, Jill, Cooper, Joanna A, Corboy, John, Correale, Jorge, Costell, Brian, Cottrell, David A, Coyle, Patricia K, Craner, Matthew, Cui, Liying, Cunha, Luis, Czlonkowska, Anna, da Silva, Ana Martins, de Sa, Joao, de Seze, Jérôme, Debouverie, Marc, Debruyne, Jan, Decoo, Danny, Defer, Gilles, Derfuss, Tobias, Deri, Norma H, Dihenia, Bhupesh, Dioszeghy, Peter, Donath, Vladimir, Dubois, Benedicte, Duddy, Martin, Duquette, Pierre, Edan, Gilles, Efendi, Husnu, Elias, Stanton, Emrich, Peter J, Estruch, Bonaventura Casanova, Evdoshenko, Evgeniy P, Faiss, Juergen, Fedyanin, Alexander S, Feneberg, Wolfgang, Fermont, Jiske, Fernandez, Oscar Fernandez, Ferrer, Francisco Coret, Fink, Katharina, Ford, Helen, Ford, Corey, Francia, Ada, Freedman, Mark, Frishberg, Benjamin, Galgani, Simonetta, Garmany, George P, Gehring, Klaus, Gitt, Jeffrey, Gobbi, Claudio, Goldstick, Lawrence P, Gonzalez, Rafael Arroyo, Grandmaison, Francois, Grigoriadis, Nikolaos, Grigorova, Olga, Grimaldi, Luigi Maria Edoardo, Gross, Jeffrey, Gross-Paju, Katrin, Gudesblatt, Mark, Guillaume, Daniel, Haas, Judith, Hancinova, Viera, Hancu, Anca, Hardiman, Orla, Harmjanz, Arndt, Heidenreich, Fedor R, Hengstman, G J D, Herbert, Joseph, Herring, Mark, Hodgkinson, Suzanne, Hoffmann, Olaf M, Hofmann, Werner E, Honeycutt, William D, Hua, Le Hanh, Huang, Dehui, Huang, Yining, Huang, DeRen, Hupperts, Raymond, Imre, Piroska, Jacobs, Alan Keith, Jakab, Gabor, Jasinska, Elzbieta, Kaida, Kenichi, Kalnina, Jolanta, Kaprelyan, Ara, Karelis, Guntis, Karussis, Dimitrios, Katz, Amos, Khabirov, Farit A, Khatri, Bhupendra, Kimura, Takashi, Kister, Ilya, Kizlaitiene, Rasa, Klimova, Eleonora, Koehler, Juergen, Komatineni, Aparna, Kornhuber, Anselm, Kovacs, Krisztina, Koves, Agnes, Kozubski, Wojciech, Krastev, Georgi, Krupp, Lauren B, Kurca, Egon, Lassek, Christoph, Laureys, Guy, Lee, Liesly, Lensch, Eckart, Leutmezer, Fritz, Li, Hongzeng, Linker, Ralf A, Linnebank, Michael, Liskova, Petra, Llanera, Cristina, Lu, Jiahong, Lutterotti, Andreas, Lycke, Jan, Macdonell, Richard, Maciejowski, Maciej, Maeurer, Mathias, Magzhanov, Rim V, Maida, Eva-Maria, Malciene, Lina, Mao-Draayer, Yang, Marfia, Girolama Alessandra, Markowitz, Clyde, Mastorodimos, Vasileios, Matyas, Klotild, Meca-Lallana, Jose, Merino, Juan Antonio Garcia, Mihetiu, Ioan Gheorghe, Milanov, Ivan, Miller, Aaron E, Millers, Andrejs, Mirabella, Massimiliano, Mizuno, Masanori, Montalban, Xavier, Montoya, Lilina, Mori, Masahiro, Mueller, Stefanie, Nakahara, Jin, Nakatsuji, Yuji, Newsome, Scott, Nicholas, Richard, Nielsen, A Scott, Nikfekr, Esmaeil, Nocentini, Ugo, Nohara, Chiyoko, Nomura, Kyoichi, Odinak, Miroslav M, Olsson, Tomas, van Oosten, B W, Oreja-Guevara, Celia, Oschmann, Patrick, Overell, James, Pachner, Andrew, Panczel, Gyula, Pandolfo, Massimo, Papeix, Caroline, Patrucco, Liliana, Pelletier, Jean, Piedrabuena, Raul, Pless, Misha, Polzer, Udo, Pozsegovits, Krisztian, Rastenyte, Daiva, Rauer, Sebastian, Reifschneider, Gerd, Rey, Roberto, Rizvi, Syed A, Robertson, Derrick, Rodriguez, Jose Martinez, Rog, David, Roshanisefat, Homayoun, Rowe, Vernon, Rozsa, Csilla, Rubin, Susan, Rusek, Stanislaw, Saccà, Francesco, Saida, Takahiko, Salgado, Antonio Vasco, Sanchez, Victoria Eugenia Fernandez, Sanders, Kalina, Satori, Maria, Sazonov, Denis V, Scarpini, Elio Angelo, Schlegel, Eugen, Schluep, Myriam, Schmidt, Stephan, Scholz, Erich, Schrijver, H M, Schwab, Matthias, Schwartz, Raymond, Scott, James, Selmaj, Krzysztof, Shafer, Stuart, Sharrack, Basil, Shchukin, Ivan A, Shimizu, Yuko, Shotekov, Penko, Siever, Arno, Sigel, Karl-Otto, Silliman, Scott, Simo, Magdolna, Simu, Mihaela, Sinay, Vladimiro, Siquier, Antonio Escartin, Siva, Aksel, Skoda, Ondrej, Solomon, Andrew, Stangel, Martin, Stefoski, Dusan, Steingo, Brian, Stolyarov, Igor D, Stourac, Pavel, Strassburger-Krogias, Katrin, Strauss, Erik, Stuve, Olaf, Tarnev, Ivaylo, Tavernarakis, Antonios, Tello, Cristina Ramo, Terzi, Murat, Ticha, Veronika, Ticmeanu, Marina, Tiel-Wilck, Klaus, Toomsoo, Toomas, Tubridy, Niall, Tullman, Mark J, Tumani, Hayrettin, Turcani, Peter, Turner, Ben, Uccelli, Antonio, Urtaza, Francisco Javier Olascoaga, Vachova, Marta, Valikovics, Attila, Walter, Silke, Van Wijmeersch, Bart, Vanopdenbosch, Ludo, Weber, Joerg R, Weiss, Sara, Weissert, Robert, Vermersch, Patrick, West, Timothy, Wiendl, Heinz, Wiertlewski, Sandrine, Wildemann, Brigitte, Willekens, Barbara, Visser, L H, Vorobeychik, Galina, Xu, Xianhao, Yamamura, Takashi, Yang, Yi N, Yelamos, Sergio Martinez, Yeung, Michael, Zacharias, Alan, Zelkowitz, Marvin, Zettl, Uwe, Zhang, Meini, Zhou, Hongyu, Zieman, Ulf, Ziemssen, Tjalf, Kappos, Ludwig, Bar-Or, Amit, Cree, Bruce A C, Fox, Robert J, Giovannoni, Gavin, Gold, Ralf, Arnold, Douglas L, Arnould, Sophie, Scherz, Tatiana, Wolf, Christian, Wallström, Erik, and Dahlke, Frank

Published
2018
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3. Cannabis-Based Medicine for Neuropathic Pain and Spasticity—A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial

Author

Hansen, Julie Schjødtz, primary, Gustavsen, Stefan, additional, Roshanisefat, Homayoun, additional, Kant, Matthias, additional, Biering-Sørensen, Fin, additional, Andersen, Claus, additional, Olsson, Anna, additional, Chow, Helene Højsgaard, additional, Asgari, Nasrin, additional, Hansen, Julie Richter, additional, Nielsen, Helle Hvilsted, additional, Hansen, Rikke Middelhede, additional, Petersen, Thor, additional, Oturai, Annette Bang, additional, Sellebjerg, Finn, additional, Sædder, Eva Aggerholm, additional, Kasch, Helge, additional, Rasmussen, Peter Vestergaard, additional, Finnerup, Nanna Brix, additional, and Svendsen, Kristina Bacher, additional

Published
2023
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6. Real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in The Danish Multiple Sclerosis Registry

Author

Papp, Viktoria, Buron, Mathias Due, Siersma, Volkert, Rasmussen, Peter Vestergaard, Illes, Zsolt, Kant, Matthias, Hilt, Claudia, Mezei, Zsolt, Roshanisefat, Homayoun, Sejbaek, Tobias, Weglewski, Arkadiusz, van Wingerden, Janneke, Geertsen, Svend Sparre, Bramow, Stephan, Sellebjerg, Finn, Magyari, Melinda, Papp, Viktoria, Buron, Mathias Due, Siersma, Volkert, Rasmussen, Peter Vestergaard, Illes, Zsolt, Kant, Matthias, Hilt, Claudia, Mezei, Zsolt, Roshanisefat, Homayoun, Sejbaek, Tobias, Weglewski, Arkadiusz, van Wingerden, Janneke, Geertsen, Svend Sparre, Bramow, Stephan, Sellebjerg, Finn, and Magyari, Melinda

Abstract

Objective Teriflunomide is a once-daily, oral disease-modifying therapy (DMT) for relapsing forms of multiple sclerosis (MS). We studied clinical outcomes in a real-world setting involving a population-based large cohort of unselected patients enrolled in The Danish Multiple Sclerosis Registry (DMSR) who started teriflunomide treatment between 2013-2019.Methods This was a complete nationwide population-based cohort study with prospectively enrolled unselected cases. Demographic and disease-specific patient parameters related to treatment history, efficacy outcomes, and discontinuation and switching rates among other clinical variables were assessed at baseline and during follow-up visits.Results A total of 3239 patients (65.4% female) started treatment with teriflunomide during the study period, 56% of whom were treatment-naive. Compared to previously treated patients, treatment-naive patients were older on average at disease onset, had a shorter disease duration, a lower Expanded Disability Status Scale score at teriflunomide treatment start and more frequently experienced a relapse in the 12 months prior to teriflunomide initiation. In the 3001 patients initiating teriflunomide treatment at least 12 months before the cut-off date, 72.7% were still on treatment one year after treatment start. Discontinuations in the first year were due mainly to adverse events (15.6%). Over the full follow-up period, 47.5% of patients discontinued teriflunomide treatment. Sixty-three percent of the patients treated with teriflunomide for 5 years were relapse-free, while significantly more treatment-naive versus previously treated patients experienced a relapse during the follow-up (pConclusions Solid efficacy and treatment persistence data consistent with other real-world studies were obtained over the treatment period. Treatment outcomes in this real-world scenario of the population-based cohort support previous findings that teriflunomide is an effective a

Published
2021

7. Real-world outcomes for a complete nationwide cohort of more than 3200 teriflunomide-treated multiple sclerosis patients in The Danish Multiple Sclerosis Registry

Author

Papp, Viktoria, primary, Buron, Mathias Due, additional, Siersma, Volkert, additional, Rasmussen, Peter Vestergaard, additional, Illes, Zsolt, additional, Kant, Matthias, additional, Hilt, Claudia, additional, Mezei, Zsolt, additional, Roshanisefat, Homayoun, additional, Sejbæk, Tobias, additional, Weglewski, Arkadiusz, additional, van Wingerden, Janneke, additional, Geertsen, Svend Sparre, additional, Bramow, Stephan, additional, Sellebjerg, Finn, additional, and Magyari, Melinda, additional

Published
2021
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10. Comparative effectiveness of teriflunomide and dimethyl fumarate:A nationwide cohort study

Author

Buron, Mathias Due, Chalmer, Thor Ameri, Sellebjerg, Finn, Frederiksen, Jette, Góra, Monika Katarzyna, Illes, Zsolt, Kant, Matthias, Mezei, Zsolt, Petersen, Thor, Rasmussen, Peter Vestergaard, Roshanisefat, Homayoun, Hassanpour-Kalam-Roudy, Houry, Sejbæk, Tobias, Tsakiri, Anna, Weglewski, Arkadiusz, Sorensen, Per Soelberg, Magyari, Melinda, Buron, Mathias Due, Chalmer, Thor Ameri, Sellebjerg, Finn, Frederiksen, Jette, Góra, Monika Katarzyna, Illes, Zsolt, Kant, Matthias, Mezei, Zsolt, Petersen, Thor, Rasmussen, Peter Vestergaard, Roshanisefat, Homayoun, Hassanpour-Kalam-Roudy, Houry, Sejbæk, Tobias, Tsakiri, Anna, Weglewski, Arkadiusz, Sorensen, Per Soelberg, and Magyari, Melinda

Abstract

OBJECTIVE: To compare on-treatment efficacy and discontinuation outcomes in teriflunomide (TFL) and dimethyl fumarate (DMF) in the treatment of relapsing-remitting multiple sclerosis (RRMS) in a real-world setting.METHODS: We identified all patients starting TFL or DMF from the Danish Multiple Sclerosis Registry and compared on-treatment efficacy outcomes between DMF using TFL, adjusted for clinical baseline variables and propensity score-based methods.RESULTS: We included 2,236 patients in the study: 1,469 patients on TFL and 767 on DMF. Annualized relapse rates (ARRs) in TFL and DMF were 0.16 (95% confidence interval [CI] 0.13-0.20) and 0.09 (95% CI 0.07-0.12), respectively. Relapse rate ratio for DMF/TFL was 0.58 (95% CI 0.46-0.73, p < 0.001). DMF had a higher relapse-free survival proportion at 48 months of follow-up (p < 0.05). We observed no difference in Expanded Disability Status Scale score worsening. Discontinuations due to disease breakthrough were 10.2% (95% CI 7.6%-12.8%) and 22.1% (95% CI 19.2%-25.0%) for DMF and TFL, respectively. A subgroup analysis of ARRs in 708 patients with available baseline MRI T2 lesion amount reported similar results after adjustment.CONCLUSION: We found lower ARR, higher relapse-free survival, and lower incidence of discontinuation due to disease breakthrough on treatment with DMF compared with TFL.CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with RRMS, DMF is more effective in preventing relapses and has lower discontinuation due to disease breakthrough compared with TFL.

Published
2019

11. 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

12. Effect of natalizumab on disease progression in secondary progressive multiple sclerosis (ASCEND): a phase 3, randomised, double-blind, placebo-controlled trial with an open-label extension

Author

Kapoor, Raju, primary, Ho, Pei-Ran, additional, Campbell, Nolan, additional, Chang, Ih, additional, Deykin, Aaron, additional, Forrestal, Fiona, additional, Lucas, Nisha, additional, Yu, Bei, additional, Arnold, Douglas L, additional, Freedman, Mark S, additional, Goldman, Myla D, additional, Hartung, Hans-Peter, additional, Havrdová, Eva Kubala, additional, Jeffery, Douglas, additional, Miller, Aaron, additional, Sellebjerg, Finn, additional, Cadavid, Diego, additional, Mikol, Dan, additional, Steiner, Deborah, additional, Bartholomé, Emmanuel, additional, D'Hooghe, Marie, additional, Pandolfo, Massimo, additional, Van Wijmeersch, Bart, additional, Bhan, Virender, additional, Blevins, Gregg, additional, Brunet, Donald, additional, Devonshire, Virginia, additional, Duquette, Pierre, additional, Freedman, Mark, additional, Grand'Maison, François, additional, Jacques, François, additional, Lapierre, Yves, additional, Lee, Liesly, additional, Morrow, Sarah, additional, Yeung, Michael, additional, Dufek, Michal, additional, Kanovsky, Petr, additional, Stetkarova, Ivana, additional, Talabova, Marika, additional, Frederiksen, Jette, additional, Kant, Matthias, additional, Petersen, Thor, additional, Ravnborg, Mads, additional, Airas, Laura, additional, Elovaara, Irina, additional, Eralinna, Juha-Pekka, additional, Sarasoja, Taneli, additional, Al Khedr, Abdullatif, additional, Brassat, David, additional, Brochet, Bruno, additional, Camu, William, additional, Debouverie, Marc, additional, Laplaud, David, additional, Lebrun Frenay, Christine, additional, Pelletier, Jean, additional, Vermersch, Patrick, additional, Vukusi, Sandra, additional, Baum, Karl, additional, Berthele, Achim, additional, Faiss, Juergen, additional, Flachenecker, Peter, additional, Hohlfeld, Reinhard, additional, Krumbholz, Markus, additional, Lassek, Christoph, additional, Maeurer, Mathias, additional, Meuth, Sven, additional, Ziemssen, Tjalf, additional, Hardiman, Orla, additional, McGuigan, Christopher, additional, Achiron, Anat, additional, Karussis, Dimitrios, additional, Bergamaschi, Roberto, additional, Morra, Vincenzo Brescia, additional, Comi, Giancarlo, additional, Cottone, Salvatore, additional, Grimaldi, Luigi, additional, Mancardi, Giovanni Luigi, additional, Massacesi, Luca, additional, Nocentini, Ugo, additional, Salvetti, Marco, additional, Scarpini, Elio, additional, Sola, Patrizia, additional, Tedeschi, Gioacchino, additional, Trojano, Maria, additional, Zaffaroni, Mauro, additional, Frequin, Stephan, additional, Hupperts, Raymond, additional, Killestein, Joep, additional, Schrijver, Hans, additional, Van Dijl, Ronald, additional, van Munster, Erik, additional, Czarnecki, Maciej, additional, Drozdowski, Wieslaw, additional, Fryze, Waldemar, additional, Hertmanowska, Hanka, additional, Ilkowski, Jan, additional, Kaminska, Anna, additional, Klodowska-Duda, Gabriela, additional, Maciejowski, Maciej, additional, Motta, Ewa, additional, Podemski, Ryszard, additional, Potemkowski, Andrzej, additional, Rog, Teresa, additional, Selmaj, Krzysztof, additional, Stelmasiak, Zbigniew, additional, Stepien, Adam, additional, Tutaj, Andrzej, additional, Zaborski, Jacek, additional, Boyko, Alexey, additional, Chefranova, Zanna, additional, Evdoshenko, Evgeny, additional, Khabirov, Farit, additional, Sivertseva, Stella, additional, Yakupov, Eduard, additional, Alvarez Cermeño, Jose Carlos, additional, Escartin, Antonio, additional, Fernandez, Oscar Fernandez, additional, Garcia-Merino, Antonio, additional, Hernandez Perez, Miguel Angel, additional, Ayuso, Guillermo Izquierdo, additional, Lallana, José Meca, additional, Gairin, Xavier Montalban, additional, Oreja-Guevara, Celia, additional, Saiz Hinarejos, Albert, additional, Gunnarsson, Martin, additional, Lycke, Jan, additional, Martin, Claes, additional, Piehl, Fredrik, additional, Roshanisefat, Homayoun, additional, Sundstrom, Peter, additional, Duddy, Martin, additional, Gran, Bruno, additional, Harrower, Timothy, additional, Hobart, Jeremy, additional, Kapoor, Raju, additional, Lee, Martin, additional, Mattison, Paul, additional, Nicholas, Richard, additional, Pearson, Owen, additional, Rashid, Waqar, additional, Rog, David, additional, Sharrack, Basil, additional, Silber, Eli, additional, Turner, Ben, additional, Williams, Anna, additional, Woolmore, John, additional, Young, Carolyn, additional, Bandari, Daniel, additional, Berger, Joseph, additional, Camac, Ann, additional, Cohan, Stanley, additional, Conway, Jill, additional, Edwards, Keith, additional, Fabian, Michelle, additional, Florin, Jack, additional, Freedman, Steven, additional, Garwacki, Dennis, additional, Goldman, Myla, additional, Harrison, Daniel, additional, Herrman, Craig, additional, Huang, Deren, additional, Javed, Adil, additional, Kamin, Stephen, additional, Katsamakis, George, additional, Khatri, Bhupendra, additional, Langer-Gould, Annette, additional, Lynch, Sharon, additional, Mattson, David, additional, Miller, Tamara, additional, Miravalle, Augusto, additional, Moses, Harold, additional, Muley, Suraj, additional, Napier, James, additional, Nielsen, Allen, additional, Pachner, Andrew, additional, Pardo, Gabriel, additional, Picone, MaryAnn, additional, Robertson, Derrick, additional, Royal, Walter, additional, Sheppard, Christopher, additional, Thrower, Ben, additional, Twyman, Cary, additional, Waubant, Emmanuelle, additional, Wendt, Jeanette, additional, Yadav, Vijayshree, additional, Zabad, Rana, additional, and Zarelli, Greg, additional

Published
2018
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13. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study

Author

Kappos, Ludwig, primary, Bar-Or, Amit, additional, Cree, Bruce A C, additional, Fox, Robert J, additional, Giovannoni, Gavin, additional, Gold, Ralf, additional, Vermersch, Patrick, additional, Arnold, Douglas L, additional, Arnould, Sophie, additional, Scherz, Tatiana, additional, Wolf, Christian, additional, Wallström, Erik, additional, Dahlke, Frank, additional, Achiron, Anat, additional, Achtnichts, Lutz, additional, Agan, Kadriye, additional, Akman-Demir, Gulsen, additional, Allen, Alison B, additional, Antel, Jack P, additional, Antiguedad, Alfredo Rodriguez, additional, Apperson, Michelle, additional, Applebee, Angela M, additional, Ayuso, Guillermo Izquierdo, additional, Baba, Masayuki, additional, Bajenaru, Ovidiu, additional, Balasa, Rodica, additional, Balci, Belgin Petek, additional, Barnett, Michael, additional, Bass, Ann, additional, Becker, Veit U, additional, Bejinariu, Mihaela, additional, Bergh, Florian Then, additional, Bergmann, Arnfin, additional, Bernitsas, Evanthia, additional, Berthele, Achim, additional, Bhan, Virender, additional, Bischof, Felix, additional, Bjork, Randall John, additional, Blevins, Gregg, additional, Boehringer, Matthias, additional, Boerner, Thomas, additional, Bonek, Robert, additional, Bowen, James D, additional, Bowling, Allen, additional, Boyko, Alexey N, additional, Boz, Cavit, additional, Bracknies, Vera, additional, Braune, Stefan, additional, Brescia Morra, Vincenzo, additional, Brochet, Bruno, additional, Brola, Waldemar, additional, Brownstone, Paul Kenneth, additional, Brozman, Miroslav, additional, Brunet, Donald, additional, Buraga, Ioan, additional, Burnett, Margaret, additional, Buttmann, Mathias, additional, Butzkueven, Helmut, additional, Cahill, Jonathan, additional, Calkwood, Jonathan C, additional, Camu, William, additional, Cascione, Mark, additional, Castelnovo, Giovani, additional, Centonze, Diego, additional, Cerqueira, Joao, additional, Chan, Andrew, additional, Cimprichova, Andrea, additional, Cohan, Stanley, additional, Comi, Giancarlo, additional, Conway, Jill, additional, Cooper, Joanna A, additional, Corboy, John, additional, Correale, Jorge, additional, Costell, Brian, additional, Cottrell, David A, additional, Coyle, Patricia K, additional, Craner, Matthew, additional, Cui, Liying, additional, Cunha, Luis, additional, Czlonkowska, Anna, additional, da Silva, Ana Martins, additional, de Sa, Joao, additional, de Seze, Jérôme, additional, Debouverie, Marc, additional, Debruyne, Jan, additional, Decoo, Danny, additional, Defer, Gilles, additional, Derfuss, Tobias, additional, Deri, Norma H, additional, Dihenia, Bhupesh, additional, Dioszeghy, Peter, additional, Donath, Vladimir, additional, Dubois, Benedicte, additional, Duddy, Martin, additional, Duquette, Pierre, additional, Edan, Gilles, additional, Efendi, Husnu, additional, Elias, Stanton, additional, Emrich, Peter J, additional, Estruch, Bonaventura Casanova, additional, Evdoshenko, Evgeniy P, additional, Faiss, Juergen, additional, Fedyanin, Alexander S, additional, Feneberg, Wolfgang, additional, Fermont, Jiske, additional, Fernandez, Oscar Fernandez, additional, Ferrer, Francisco Coret, additional, Fink, Katharina, additional, Ford, Helen, additional, Ford, Corey, additional, Francia, Ada, additional, Freedman, Mark, additional, Frishberg, Benjamin, additional, Galgani, Simonetta, additional, Garmany, George P, additional, Gehring, Klaus, additional, Gitt, Jeffrey, additional, Gobbi, Claudio, additional, Goldstick, Lawrence P, additional, Gonzalez, Rafael Arroyo, additional, Grandmaison, Francois, additional, Grigoriadis, Nikolaos, additional, Grigorova, Olga, additional, Grimaldi, Luigi Maria Edoardo, additional, Gross, Jeffrey, additional, Gross-Paju, Katrin, additional, Gudesblatt, Mark, additional, Guillaume, Daniel, additional, Haas, Judith, additional, Hancinova, Viera, additional, Hancu, Anca, additional, Hardiman, Orla, additional, Harmjanz, Arndt, additional, Heidenreich, Fedor R, additional, Hengstman, G J D, additional, Herbert, Joseph, additional, Herring, Mark, additional, Hodgkinson, Suzanne, additional, Hoffmann, Olaf M, additional, Hofmann, Werner E, additional, Honeycutt, William D, additional, Hua, Le Hanh, additional, Huang, Dehui, additional, Huang, Yining, additional, Huang, DeRen, additional, Hupperts, Raymond, additional, Imre, Piroska, additional, Jacobs, Alan Keith, additional, Jakab, Gabor, additional, Jasinska, Elzbieta, additional, Kaida, Kenichi, additional, Kalnina, Jolanta, additional, Kaprelyan, Ara, additional, Karelis, Guntis, additional, Karussis, Dimitrios, additional, Katz, Amos, additional, Khabirov, Farit A, additional, Khatri, Bhupendra, additional, Kimura, Takashi, additional, Kister, Ilya, additional, Kizlaitiene, Rasa, additional, Klimova, Eleonora, additional, Koehler, Juergen, additional, Komatineni, Aparna, additional, Kornhuber, Anselm, additional, Kovacs, Krisztina, additional, Koves, Agnes, additional, Kozubski, Wojciech, additional, Krastev, Georgi, additional, Krupp, Lauren B, additional, Kurca, Egon, additional, Lassek, Christoph, additional, Laureys, Guy, additional, Lee, Liesly, additional, Lensch, Eckart, additional, Leutmezer, Fritz, additional, Li, Hongzeng, additional, Linker, Ralf A, additional, Linnebank, Michael, additional, Liskova, Petra, additional, Llanera, Cristina, additional, Lu, Jiahong, additional, Lutterotti, Andreas, additional, Lycke, Jan, additional, Macdonell, Richard, additional, Maciejowski, Maciej, additional, Maeurer, Mathias, additional, Magzhanov, Rim V, additional, Maida, Eva-Maria, additional, Malciene, Lina, additional, Mao-Draayer, Yang, additional, Marfia, Girolama Alessandra, additional, Markowitz, Clyde, additional, Mastorodimos, Vasileios, additional, Matyas, Klotild, additional, Meca-Lallana, Jose, additional, Merino, Juan Antonio Garcia, additional, Mihetiu, Ioan Gheorghe, additional, Milanov, Ivan, additional, Miller, Aaron E, additional, Millers, Andrejs, additional, Mirabella, Massimiliano, additional, Mizuno, Masanori, additional, Montalban, Xavier, additional, Montoya, Lilina, additional, Mori, Masahiro, additional, Mueller, Stefanie, additional, Nakahara, Jin, additional, Nakatsuji, Yuji, additional, Newsome, Scott, additional, Nicholas, Richard, additional, Nielsen, A Scott, additional, Nikfekr, Esmaeil, additional, Nocentini, Ugo, additional, Nohara, Chiyoko, additional, Nomura, Kyoichi, additional, Odinak, Miroslav M, additional, Olsson, Tomas, additional, van Oosten, B W, additional, Oreja-Guevara, Celia, additional, Oschmann, Patrick, additional, Overell, James, additional, Pachner, Andrew, additional, Panczel, Gyula, additional, Pandolfo, Massimo, additional, Papeix, Caroline, additional, Patrucco, Liliana, additional, Pelletier, Jean, additional, Piedrabuena, Raul, additional, Pless, Misha, additional, Polzer, Udo, additional, Pozsegovits, Krisztian, additional, Rastenyte, Daiva, additional, Rauer, Sebastian, additional, Reifschneider, Gerd, additional, Rey, Roberto, additional, Rizvi, Syed A, additional, Robertson, Derrick, additional, Rodriguez, Jose Martinez, additional, Rog, David, additional, Roshanisefat, Homayoun, additional, Rowe, Vernon, additional, Rozsa, Csilla, additional, Rubin, Susan, additional, Rusek, Stanislaw, additional, Saccà, Francesco, additional, Saida, Takahiko, additional, Salgado, Antonio Vasco, additional, Sanchez, Victoria Eugenia Fernandez, additional, Sanders, Kalina, additional, Satori, Maria, additional, Sazonov, Denis V, additional, Scarpini, Elio Angelo, additional, Schlegel, Eugen, additional, Schluep, Myriam, additional, Schmidt, Stephan, additional, Scholz, Erich, additional, Schrijver, H M, additional, Schwab, Matthias, additional, Schwartz, Raymond, additional, Scott, James, additional, Selmaj, Krzysztof, additional, Shafer, Stuart, additional, Sharrack, Basil, additional, Shchukin, Ivan A, additional, Shimizu, Yuko, additional, Shotekov, Penko, additional, Siever, Arno, additional, Sigel, Karl-Otto, additional, Silliman, Scott, additional, Simo, Magdolna, additional, Simu, Mihaela, additional, Sinay, Vladimiro, additional, Siquier, Antonio Escartin, additional, Siva, Aksel, additional, Skoda, Ondrej, additional, Solomon, Andrew, additional, Stangel, Martin, additional, Stefoski, Dusan, additional, Steingo, Brian, additional, Stolyarov, Igor D, additional, Stourac, Pavel, additional, Strassburger-Krogias, Katrin, additional, Strauss, Erik, additional, Stuve, Olaf, additional, Tarnev, Ivaylo, additional, Tavernarakis, Antonios, additional, Tello, Cristina Ramo, additional, Terzi, Murat, additional, Ticha, Veronika, additional, Ticmeanu, Marina, additional, Tiel-Wilck, Klaus, additional, Toomsoo, Toomas, additional, Tubridy, Niall, additional, Tullman, Mark J, additional, Tumani, Hayrettin, additional, Turcani, Peter, additional, Turner, Ben, additional, Uccelli, Antonio, additional, Urtaza, Francisco Javier Olascoaga, additional, Vachova, Marta, additional, Valikovics, Attila, additional, Walter, Silke, additional, Van Wijmeersch, Bart, additional, Vanopdenbosch, Ludo, additional, Weber, Joerg R, additional, Weiss, Sara, additional, Weissert, Robert, additional, West, Timothy, additional, Wiendl, Heinz, additional, Wiertlewski, Sandrine, additional, Wildemann, Brigitte, additional, Willekens, Barbara, additional, Visser, L H, additional, Vorobeychik, Galina, additional, Xu, Xianhao, additional, Yamamura, Takashi, additional, Yang, Yi N, additional, Yelamos, Sergio Martinez, additional, Yeung, Michael, additional, Zacharias, Alan, additional, Zelkowitz, Marvin, additional, Zettl, Uwe, additional, Zhang, Meini, additional, Zhou, Hongyu, additional, Zieman, Ulf, additional, and Ziemssen, Tjalf, additional

Published
2018
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15. Insights from comorbidity into multiple sclerosis aetiology and outcomes

Author

Roshanisefat, Homayoun and Roshanisefat, Homayoun

Abstract

Aim: The overall aim of this research was to investigate the nature of the comorbidities in multiple sclerosis (MS) in four large population-based studies. The first study assessed whether the diagnosis underlying appendicectomy is a useful marker of MS risk. The second study identified whether an inherited risk of other immune-mediated diseases (IMD) contributes to the likelihood of developing MS. In the third study, we investigated if MS is associated with a raised risk of cardiovascular disease (CVD) and whether this varies by MS disease course, while in the final study we determined if cancer is under-diagnosed in MS patients by assessing mortality following cancer as a marker of delayed cancer diagnosis. Methods: This thesis uses Swedish register data to identify patterns of comorbid disease among subjects with a diagnosis of MS compared with subjects without MS. We have identified subjects with MS through the Patient Register (PR) and the MS Register (SMSreg) and subjects without MS through the Total Population Register (TPR). By using personal identity numbers and ICD codes, comorbidities among MS patients and diseases in those without MS were identified. These included appendicectomy, other immune-mediated disease, cardiovascular disease and all-cause mortality following cancer diagnosis. The study designs included in this thesis are a nested case-control study and three cohort studies. Results: There was a lower risk of MS in the group with perforated appendicitis but it was not statistically significant. Patients with MS had an elevated higher risk of other immune-mediated diseases while their parents had no increased risk. MS patients were more at risk of CVD and in particular, more likely to suffer from deep venous thrombosis than subjects without MS. This finding was observed in all MS courses. There was a lower magnitude raised risk of all-cause mortality after a cancer diagnosis in MS patients compared with the risk following cancer in the general pop

Published
2014

16. Multiple sclerosis course and clinical outcomes in patients with comorbid asthma: a survey study.

Author

Manouchehrinia, Ali, Edwards, Laura J., Roshanisefat, Homayoun, Tench, Christopher R., and Constantinescu, Cris S.

Abstract

Objective: To determine if comorbid asthma is associated with accumulation of multiple sclerosis (MS)-related impairment and disability. Method: We sent a comprehensive questionnaire to a cohort of patients with MS and examined the association between comorbid asthma and reaching Expanded Disability Status Scale (EDSS) scores 4.0 and 6.0. Multiple Sclerosis Impact Scale (MSIS-29) scores were compared between patients with MS with and without comorbid asthma. Results: 680 patients participated in our study of whom 88 (12.9%) had comorbid asthma. There was no difference in the prevalence of asthma between our MS cohort and the England general population (OR: 0.89, 95% CI 0.68 to 1.17). We did not observe a significant association between having asthma and the risk of reaching EDSS scores 4.0 and 6.0 (HR: 1.29, 95% CI 0.93 to 1.77, and HR: 1.33, 95% CI 0.93 to 1.89, respectively) after controlling for confounders. Patients with MS with asthma reported higher level of psychological impairments (coefficient: 2.29, 95% CI 0.1 to 4.49). Conclusions: Asthma is a prevalent condition among patients with MS and it may contribute to the psychological impairment in MS. Although we did not observe significant association between comorbid asthma and physical disability in MS, it seems that the two conditions influence one another. [ABSTRACT FROM AUTHOR]

Published
2015
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17. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study

Author

Ludwig Kappos, Amit Bar-Or, Bruce A C Cree, Robert J Fox, Gavin Giovannoni, Ralf Gold, Patrick Vermersch, Douglas L Arnold, Sophie Arnould, Tatiana Scherz, Christian Wolf, Erik Wallström, Frank Dahlke, Anat Achiron, Lutz Achtnichts, Kadriye Agan, Gulsen Akman-Demir, Alison B Allen, Jack P Antel, Alfredo Rodriguez Antiguedad, Michelle Apperson, Angela M Applebee, Guillermo Izquierdo Ayuso, Masayuki Baba, Ovidiu Bajenaru, Rodica Balasa, Belgin Petek Balci, Michael Barnett, Ann Bass, Veit U Becker, Mihaela Bejinariu, Florian Then Bergh, Arnfin Bergmann, Evanthia Bernitsas, Achim Berthele, Virender Bhan, Felix Bischof, Randall John Bjork, Gregg Blevins, Matthias Boehringer, Thomas Boerner, Robert Bonek, James D Bowen, Allen Bowling, Alexey N Boyko, Cavit Boz, Vera Bracknies, Stefan Braune, Vincenzo Brescia Morra, Bruno Brochet, Waldemar Brola, Paul Kenneth Brownstone, Miroslav Brozman, Donald Brunet, Ioan Buraga, Margaret Burnett, Mathias Buttmann, Helmut Butzkueven, Jonathan Cahill, Jonathan C Calkwood, William Camu, Mark Cascione, Giovani Castelnovo, Diego Centonze, Joao Cerqueira, Andrew Chan, Andrea Cimprichova, Stanley Cohan, Giancarlo Comi, Jill Conway, Joanna A Cooper, John Corboy, Jorge Correale, Brian Costell, David A Cottrell, Patricia K Coyle, Matthew Craner, Liying Cui, Luis Cunha, Anna Czlonkowska, Ana Martins da Silva, Joao de Sa, Jérôme de Seze, Marc Debouverie, Jan Debruyne, Danny Decoo, Gilles Defer, Tobias Derfuss, Norma H Deri, Bhupesh Dihenia, Peter Dioszeghy, Vladimir Donath, Benedicte Dubois, Martin Duddy, Pierre Duquette, Gilles Edan, Husnu Efendi, Stanton Elias, Peter J Emrich, Bonaventura Casanova Estruch, Evgeniy P Evdoshenko, Juergen Faiss, Alexander S Fedyanin, Wolfgang Feneberg, Jiske Fermont, Oscar Fernandez Fernandez, Francisco Coret Ferrer, Katharina Fink, Helen Ford, Corey Ford, Ada Francia, Mark Freedman, Benjamin Frishberg, Simonetta Galgani, George P Garmany, Klaus Gehring, Jeffrey Gitt, Claudio Gobbi, Lawrence P Goldstick, Rafael Arroyo Gonzalez, Francois Grandmaison, Nikolaos Grigoriadis, Olga Grigorova, Luigi Maria Edoardo Grimaldi, Jeffrey Gross, Katrin Gross-Paju, Mark Gudesblatt, Daniel Guillaume, Judith Haas, Viera Hancinova, Anca Hancu, Orla Hardiman, Arndt Harmjanz, Fedor R Heidenreich, G J D Hengstman, Joseph Herbert, Mark Herring, Suzanne Hodgkinson, Olaf M Hoffmann, Werner E Hofmann, William D Honeycutt, Le Hanh Hua, Dehui Huang, Yining Huang, DeRen Huang, Raymond Hupperts, Piroska Imre, Alan Keith Jacobs, Gabor Jakab, Elzbieta Jasinska, Kenichi Kaida, Jolanta Kalnina, Ara Kaprelyan, Guntis Karelis, Dimitrios Karussis, Amos Katz, Farit A Khabirov, Bhupendra Khatri, Takashi Kimura, Ilya Kister, Rasa Kizlaitiene, Eleonora Klimova, Juergen Koehler, Aparna Komatineni, Anselm Kornhuber, Krisztina Kovacs, Agnes Koves, Wojciech Kozubski, Georgi Krastev, Lauren B Krupp, Egon Kurca, Christoph Lassek, Guy Laureys, Liesly Lee, Eckart Lensch, Fritz Leutmezer, Hongzeng Li, Ralf A Linker, Michael Linnebank, Petra Liskova, Cristina Llanera, Jiahong Lu, Andreas Lutterotti, Jan Lycke, Richard Macdonell, Maciej Maciejowski, Mathias Maeurer, Rim V Magzhanov, Eva-Maria Maida, Lina Malciene, Yang Mao-Draayer, Girolama Alessandra Marfia, Clyde Markowitz, Vasileios Mastorodimos, Klotild Matyas, Jose Meca-Lallana, Juan Antonio Garcia Merino, Ioan Gheorghe Mihetiu, Ivan Milanov, Aaron E Miller, Andrejs Millers, Massimiliano Mirabella, Masanori Mizuno, Xavier Montalban, Lilina Montoya, Masahiro Mori, Stefanie Mueller, Jin Nakahara, Yuji Nakatsuji, Scott Newsome, Richard Nicholas, A Scott Nielsen, Esmaeil Nikfekr, Ugo Nocentini, Chiyoko Nohara, Kyoichi Nomura, Miroslav M Odinak, Tomas Olsson, B W van Oosten, Celia Oreja-Guevara, Patrick Oschmann, James Overell, Andrew Pachner, Gyula Panczel, Massimo Pandolfo, Caroline Papeix, Liliana Patrucco, Jean Pelletier, Raul Piedrabuena, Misha Pless, Udo Polzer, Krisztian Pozsegovits, Daiva Rastenyte, Sebastian Rauer, Gerd Reifschneider, Roberto Rey, Syed A Rizvi, Derrick Robertson, Jose Martinez Rodriguez, David Rog, Homayoun Roshanisefat, Vernon Rowe, Csilla Rozsa, Susan Rubin, Stanislaw Rusek, Francesco Saccà, Takahiko Saida, Antonio Vasco Salgado, Victoria Eugenia Fernandez Sanchez, Kalina Sanders, Maria Satori, Denis V Sazonov, Elio Angelo Scarpini, Eugen Schlegel, Myriam Schluep, Stephan Schmidt, Erich Scholz, H M Schrijver, Matthias Schwab, Raymond Schwartz, James Scott, Krzysztof Selmaj, Stuart Shafer, Basil Sharrack, Ivan A Shchukin, Yuko Shimizu, Penko Shotekov, Arno Siever, Karl-Otto Sigel, Scott Silliman, Magdolna Simo, Mihaela Simu, Vladimiro Sinay, Antonio Escartin Siquier, Aksel Siva, Ondrej Skoda, Andrew Solomon, Martin Stangel, Dusan Stefoski, Brian Steingo, Igor D Stolyarov, Pavel Stourac, Katrin Strassburger-Krogias, Erik Strauss, Olaf Stuve, Ivaylo Tarnev, Antonios Tavernarakis, Cristina Ramo Tello, Murat Terzi, Veronika Ticha, Marina Ticmeanu, Klaus Tiel-Wilck, Toomas Toomsoo, Niall Tubridy, Mark J Tullman, Hayrettin Tumani, Peter Turcani, Ben Turner, Antonio Uccelli, Francisco Javier Olascoaga Urtaza, Marta Vachova, Attila Valikovics, Silke Walter, Bart Van Wijmeersch, Ludo Vanopdenbosch, Joerg R Weber, Sara Weiss, Robert Weissert, Timothy West, Heinz Wiendl, Sandrine Wiertlewski, Brigitte Wildemann, Barbara Willekens, L H Visser, Galina Vorobeychik, Xianhao Xu, Takashi Yamamura, Yi N Yang, Sergio Martinez Yelamos, Michael Yeung, Alan Zacharias, Marvin Zelkowitz, Uwe Zettl, Meini Zhang, Hongyu Zhou, Ulf Zieman, Tjalf Ziemssen, Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital, University of Basel, Basel, Center for Neuroinflammation and Neurotherapeutics, and Multiple Sclerosis Division, Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, Neuroimmunology Unit, Montreal Neurological Institute and Hospital, McGill University, Montreal, QC, UCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, Mellen Centre for Multiple Sclerosis Treatment and Research, Neurological Institute, Cleveland Clinic, Cleveland, OH, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, Department of Neurology St. Josef-Hospital, Ruhr University Bochum, Germany, Institute for Translational Research in Inflammation - U 1286 (INFINITE (Ex-Liric)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Montreal Neurological Institute, McGill University, Montreal, QC, Canada, NeuroRx Research, Montreal, QC, Novartis Pharma AG, Lycalis, Brussels, AP-HM, CHU Timone, Pole de Neurosciences Cliniques, Department of Neurology, Marseille, France., Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), Centre d'Exploration Métabolique par Résonance Magnétique [Hôpital de la Timone - APHM] (CEMEREM), Hôpital de la Timone [CHU - APHM] (TIMONE)-Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), Kappos, Ludwig, Bar-Or, Amit, Cree, Bruce A C, Fox, Robert J, Giovannoni, Gavin, Gold, Ralf, Vermersch, Patrick, Arnold, Douglas L, Arnould, Sophie, Scherz, Tatiana, Wolf, Christian, Wallström, Erik, Dahlke, Frank, Achiron, Anat, Achtnichts, Lutz, Agan, Kadriye, Akman-Demir, Gulsen, Allen, Alison B, Antel, Jack P, Antiguedad, Alfredo Rodriguez, Apperson, Michelle, Applebee, Angela M, Ayuso, Guillermo Izquierdo, Baba, Masayuki, Bajenaru, Ovidiu, Balasa, Rodica, Balci, Belgin Petek, Barnett, Michael, Bass, Ann, Becker, Veit U, Bejinariu, Mihaela, Bergh, Florian Then, Bergmann, Arnfin, Bernitsas, Evanthia, Berthele, Achim, Bhan, Virender, Bischof, Felix, Bjork, Randall John, Blevins, Gregg, Boehringer, Matthia, Boerner, Thoma, Bonek, Robert, Bowen, James D, Bowling, Allen, Boyko, Alexey N, Boz, Cavit, Bracknies, Vera, Braune, Stefan, Brescia Morra, Vincenzo, Brochet, Bruno, Brola, Waldemar, Brownstone, Paul Kenneth, Brozman, Miroslav, Brunet, Donald, Buraga, Ioan, Burnett, Margaret, Buttmann, Mathia, Butzkueven, Helmut, Cahill, Jonathan, Calkwood, Jonathan C, Camu, William, Cascione, Mark, Castelnovo, Giovani, Centonze, Diego, Cerqueira, Joao, Chan, Andrew, Cimprichova, Andrea, Cohan, Stanley, Comi, Giancarlo, Conway, Jill, Cooper, Joanna A, Corboy, John, Correale, Jorge, Costell, Brian, Cottrell, David A, Coyle, Patricia K, Craner, Matthew, Cui, Liying, Cunha, Lui, Czlonkowska, Anna, da Silva, Ana Martin, de Sa, Joao, de Seze, Jérôme, Debouverie, Marc, Debruyne, Jan, Decoo, Danny, Defer, Gille, Derfuss, Tobia, Deri, Norma H, Dihenia, Bhupesh, Dioszeghy, Peter, Donath, Vladimir, Dubois, Benedicte, Duddy, Martin, Duquette, Pierre, Edan, Gille, Efendi, Husnu, Elias, Stanton, Emrich, Peter J, Estruch, Bonaventura Casanova, Evdoshenko, Evgeniy P, Faiss, Juergen, Fedyanin, Alexander S, Feneberg, Wolfgang, Fermont, Jiske, Fernandez, Oscar Fernandez, Ferrer, Francisco Coret, Fink, Katharina, Ford, Helen, Ford, Corey, Francia, Ada, Freedman, Mark, Frishberg, Benjamin, Galgani, Simonetta, Garmany, George P, Gehring, Klau, Gitt, Jeffrey, Gobbi, Claudio, Goldstick, Lawrence P, Gonzalez, Rafael Arroyo, Grandmaison, Francoi, Grigoriadis, Nikolao, Grigorova, Olga, Grimaldi, Luigi Maria Edoardo, Gross, Jeffrey, Gross-Paju, Katrin, Gudesblatt, Mark, Guillaume, Daniel, Haas, Judith, Hancinova, Viera, Hancu, Anca, Hardiman, Orla, Harmjanz, Arndt, Heidenreich, Fedor R, Hengstman, G J D, Herbert, Joseph, Herring, Mark, Hodgkinson, Suzanne, Hoffmann, Olaf M, Hofmann, Werner E, Honeycutt, William D, Hua, Le Hanh, Huang, Dehui, Huang, Yining, Huang, Deren, Hupperts, Raymond, Imre, Piroska, Jacobs, Alan Keith, Jakab, Gabor, Jasinska, Elzbieta, Kaida, Kenichi, Kalnina, Jolanta, Kaprelyan, Ara, Karelis, Gunti, Karussis, Dimitrio, Katz, Amo, Khabirov, Farit A, Khatri, Bhupendra, Kimura, Takashi, Kister, Ilya, Kizlaitiene, Rasa, Klimova, Eleonora, Koehler, Juergen, Komatineni, Aparna, Kornhuber, Anselm, Kovacs, Krisztina, Koves, Agne, Kozubski, Wojciech, Krastev, Georgi, Krupp, Lauren B, Kurca, Egon, Lassek, Christoph, Laureys, Guy, Lee, Liesly, Lensch, Eckart, Leutmezer, Fritz, Li, Hongzeng, Linker, Ralf A, Linnebank, Michael, Liskova, Petra, Llanera, Cristina, Lu, Jiahong, Lutterotti, Andrea, Lycke, Jan, Macdonell, Richard, Maciejowski, Maciej, Maeurer, Mathia, Magzhanov, Rim V, Maida, Eva-Maria, Malciene, Lina, Mao-Draayer, Yang, Marfia, Girolama Alessandra, Markowitz, Clyde, Mastorodimos, Vasileio, Matyas, Klotild, Meca-Lallana, Jose, Merino, Juan Antonio Garcia, Mihetiu, Ioan Gheorghe, Milanov, Ivan, Miller, Aaron E, Millers, Andrej, Mirabella, Massimiliano, Mizuno, Masanori, Montalban, Xavier, Montoya, Lilina, Mori, Masahiro, Mueller, Stefanie, Nakahara, Jin, Nakatsuji, Yuji, Newsome, Scott, Nicholas, Richard, Nielsen, A Scott, Nikfekr, Esmaeil, Nocentini, Ugo, Nohara, Chiyoko, Nomura, Kyoichi, Odinak, Miroslav M, Olsson, Toma, van Oosten, B W, Oreja-Guevara, Celia, Oschmann, Patrick, Overell, Jame, Pachner, Andrew, Panczel, Gyula, Pandolfo, Massimo, Papeix, Caroline, Patrucco, Liliana, Pelletier, Jean, Piedrabuena, Raul, Pless, Misha, Polzer, Udo, Pozsegovits, Krisztian, Rastenyte, Daiva, Rauer, Sebastian, Reifschneider, Gerd, Rey, Roberto, Rizvi, Syed A, Robertson, Derrick, Rodriguez, Jose Martinez, Rog, David, Roshanisefat, Homayoun, Rowe, Vernon, Rozsa, Csilla, Rubin, Susan, Rusek, Stanislaw, Saccà, Francesco, Saida, Takahiko, Salgado, Antonio Vasco, Sanchez, Victoria Eugenia Fernandez, Sanders, Kalina, Satori, Maria, Sazonov, Denis V, Scarpini, Elio Angelo, Schlegel, Eugen, Schluep, Myriam, Schmidt, Stephan, Scholz, Erich, Schrijver, H M, Schwab, Matthia, Schwartz, Raymond, Scott, Jame, Selmaj, Krzysztof, Shafer, Stuart, Sharrack, Basil, Shchukin, Ivan A, Shimizu, Yuko, Shotekov, Penko, Siever, Arno, Sigel, Karl-Otto, Silliman, Scott, Simo, Magdolna, Simu, Mihaela, Sinay, Vladimiro, Siquier, Antonio Escartin, Siva, Aksel, Skoda, Ondrej, Solomon, Andrew, Stangel, Martin, Stefoski, Dusan, Steingo, Brian, Stolyarov, Igor D, Stourac, Pavel, Strassburger-Krogias, Katrin, Strauss, Erik, Stuve, Olaf, Tarnev, Ivaylo, Tavernarakis, Antonio, Tello, Cristina Ramo, Terzi, Murat, Ticha, Veronika, Ticmeanu, Marina, Tiel-Wilck, Klau, Toomsoo, Tooma, Tubridy, Niall, Tullman, Mark J, Tumani, Hayrettin, Turcani, Peter, Turner, Ben, Uccelli, Antonio, Urtaza, Francisco Javier Olascoaga, Vachova, Marta, Valikovics, Attila, Walter, Silke, Van Wijmeersch, Bart, Vanopdenbosch, Ludo, Weber, Joerg R, Weiss, Sara, Weissert, Robert, West, Timothy, Wiendl, Heinz, Wiertlewski, Sandrine, Wildemann, Brigitte, Willekens, Barbara, Visser, L H, Vorobeychik, Galina, Xu, Xianhao, Yamamura, Takashi, Yang, Yi N, Yelamos, Sergio Martinez, Yeung, Michael, Zacharias, Alan, Zelkowitz, Marvin, Zettl, Uwe, Zhang, Meini, Zhou, Hongyu, Zieman, Ulf, Ziemssen, Tjalf, and EXPAND Clinical Investigators

Subjects
Adult, Male, 0301 basic medicine, Relative risk reduction, medicine.medical_specialty, Adolescent, Placebo, law.invention, Cohort Studies, Young Adult, 03 medical and health sciences, chemistry.chemical_compound, Multiple Sclerosis, Chronic Progressive / drug therapy, 0302 clinical medicine, Double-Blind Method, Randomized controlled trial, law, Internal medicine, Benzyl Compounds, Clinical endpoint, Humans, Medicine, ComputingMilieux_MISCELLANEOUS, Settore MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA, Expanded Disability Status Scale, Dose-Response Relationship, Drug, business.industry, Hazard ratio, General Medicine, Middle Aged, Multiple Sclerosis, Chronic Progressive, Fingolimod, Treatment Outcome, Settore M-EDF/01 - METODI E DIDATTICHE DELLE ATTIVITÀ MOTORIE, 030104 developmental biology, Siponimod, chemistry, Disease Progression, Azetidines, Female, Settore MED/26 - Neurologia, Human medicine, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, 030217 neurology & neurosurgery, medicine.drug
Abstract

Summary Background No treatment has consistently shown efficacy in slowing disability progression in patients with secondary progressive multiple sclerosis (SPMS). We assessed the effect of siponimod, a selective sphingosine 1-phosphate (S1P) receptor 1,5 modulator, on disability progression in patients with SPMS. Methods This event-driven and exposure-driven, double-blind, phase 3 trial was done at 292 hospital clinics and specialised multiple sclerosis centres in 31 countries. Using interactive response technology to assign numbers linked to treatment arms, patients (age 18–60 years) with SPMS and an Expanded Disability Status Scale score of 3·0–6·5 were randomly assigned (2:1) to once daily oral siponimod 2 mg or placebo for up to 3 years or until the occurrence of a prespecified number of confirmed disability progression (CDP) events. The primary endpoint was time to 3-month CDP. Efficacy was assessed for the full analysis set (ie, all randomly assigned and treated patients); safety was assessed for the safety set. This trial is registered with ClinicalTrials.gov, number NCT01665144. Findings 1651 patients were randomly assigned between Feb 5, 2013, and June 2, 2015 (1105 to the siponimod group, and 546 to the placebo group). One patient did not sign the consent form, and five patients did not receive study drug, all of whom were in the siponimod group. 1645 patients were included in the analyses (1099 in the siponimod group and 546 in the placebo). At baseline, the mean time since first multiple sclerosis symptoms was 16·8 years (SD 8·3), and the mean time since conversion to SPMS was 3·8 years (SD 3·5); 1055 (64%) patients had not relapsed in the previous 2 years, and 918 (56%) of 1651 needed walking assistance. 903 (82%) patients receiving siponimod and 424 (78%) patients receiving placebo completed the study. 288 (26%) of 1096 patients receiving siponimod and 173 (32%) of 545 patients receiving placebo had 3-month CDP (hazard ratio 0·79, 95% CI 0·65–0·95; relative risk reduction 21%; p=0·013). Adverse events occurred in 975 (89%) of 1099 patients receiving siponimod versus 445 (82%) of 546 patients receiving placebo; serious adverse events were reported for 197 (18%) patients in the siponimod group versus 83 (15%) patients in the placebo group. Lymphopenia, increased liver transaminase concentration, bradycardia and bradyarrhythmia at treatment initiation, macular oedema, hypertension, varicella zoster reactivation, and convulsions occurred more frequently with siponimod than with placebo. Initial dose titration mitigated cardiac first-dose effects. Frequencies of infections, malignancies, and fatalities did not differ between groups. Interpretation Siponimod reduced the risk of disability progression with a safety profile similar to that of other S1P modulators and is likely to be a useful treatment for SPMS. Funding Novartis Pharma AG.

Published
2018
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