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2. Post-natalizumab disease reactivation in multiple sclerosis: systematic review and meta-analysis.

Author

Prosperini, Luca, Kinkel, Revere, Miravalle, Augusto, Iaffaldano, Pietro, and Fantaccini, Simone

Subjects
discontinuation, meta-analysis, natalizumab, relapsing–remitting multiple sclerosis
Abstract

BACKGROUND: Natalizumab (NTZ) is sometimes discontinued in patients with multiple sclerosis, mainly due to concerns about the risk of progressive multifocal leukoencephalopathy. However, NTZ interruption may result in recrudescence of disease activity. OBJECTIVE: The objective of this study was to summarize the available evidence about NTZ discontinuation and to identify which patients will experience post-NTZ disease reactivation through meta-analysis of existing literature data. METHODS: PubMed was searched for articles reporting the effects of NTZ withdrawal in adult patients (⩾18 years) with relapsing-remitting multiple sclerosis (RRMS). Definition of disease activity following NTZ discontinuation, proportion of patients who experienced post-NTZ disease reactivation, and timing to NTZ discontinuation to disease reactivation were systematically reviewed. A generic inverse variance with random effect was used to calculate the weighted effect of patients clinical characteristics on the risk of post-NTZ disease reactivation, defined as the occurrence of at least one relapse. RESULTS: The original search identified 205 publications. Thirty-five articles were included in the systematic review. We found a high level of heterogeneity across studies in terms of sample size (10 to 1866 patients), baseline patient characteristics, follow up (1-24 months), outcome measures (clinical and/or radiological), and definition of post-NTZ disease reactivation or rebound. Clinical relapses were observed in 9-80% of patients and peaked at 4-7 months, whereas radiological disease activity was observed in 7-87% of patients starting at 6 weeks following NTZ discontinuation. The meta-analysis of six articles, yielding a total of 1183 patients, revealed that younger age, higher number of relapses and gadolinium-enhanced lesions before treatment start, and fewer NTZ infusions were associated with increased risk for post-NTZ disease reactivation (p ⩽ 0.05). CONCLUSIONS: Results from the present review and meta-analysis can help to profile patients who are at greater risk of post-NTZ disease reactivation. However, potential reporting bias and variability in selected studies should be taken into account when interpreting our data.

Published
2019

5. Contributors

Author

Abrams, Gary M., primary, Albers, Gregory W., additional, Amans, Matthew R., additional, Aminoff, Michael J., additional, Batla, Amit, additional, Betjemann, John P., additional, Camilleri, Michael, additional, Chen, Robert, additional, Christine, Chadwick W., additional, Coleman, Kyle J., additional, Davies-Jones, G.A.B., additional, DeAngelis, Lisa M., additional, Dhand, Amar, additional, Dillon, William P., additional, Douglas, Vanja C., additional, Fox, Christine, additional, Furman, Joseph M., additional, Gelb, Douglas J., additional, Gladstone, David J., additional, Glynn, Simon M., additional, Goodin, Douglas S., additional, Goodman, Brent P., additional, Greenlee, John E., additional, Guterman, Elan, additional, Halabi, Cathra, additional, Hallett, Mark, additional, Halperin, John J., additional, Harris, Shelby, additional, Hemphill, J. Claude, additional, Hurko, Orest, additional, Irani, Sarosh R., additional, Jo, Jasmin, additional, Josephson, S. Andrew, additional, Kaley, Thomas J., additional, Kim, Anthony S., additional, Ko, Nerissa U., additional, Koshy, Anita A., additional, Kraler, Lironn, additional, Krumholz, Allan, additional, Leonard, John M., additional, Levin, Morris, additional, Manno, Edward M., additional, Mastaglia, Frank L., additional, Maurer, Carine W., additional, McCall, Andrew A., additional, Messing, Robert O., additional, Miravalle, Augusto, additional, Monderer, Renee, additional, Morren, John A., additional, Muccilli, Alexandra D., additional, Muir, Ryan T., additional, Murphy, Olwen C., additional, Nash, Kendall, additional, Ooi, Winnie W., additional, Pal, Pramod K., additional, Panicker, Jalesh N., additional, Parent, Jack M., additional, Peluso, Michael J., additional, Perfect, John R., additional, Peyvandi, Shabnam, additional, Pfeiffer, Ronald F., additional, Phillips, Steven M., additional, Poncelet, Ann Noelle, additional, Prasad, Sashank, additional, Prasad, Shweta, additional, Probasco, John C., additional, Purdy, Kaylynn, additional, Rabinstein, Alejandro A., additional, Ralph, Jeffrey W., additional, Ramachandran, Prashanth S., additional, Roos, Karen L., additional, Rose-Innes, Andrew P., additional, Safarpour, Delaram, additional, Schiff, David, additional, Schipper, Hyman M., additional, Shah, Maulik P., additional, Sharzehi, Kaveh, additional, Shaw, Pamela J., additional, Spudich, Serena, additional, Srinivasan, Jayashri, additional, Stern, Barney J., additional, Sun, Chung-Huan Johnny, additional, Sussman, Jon D., additional, Thorpy, Michael, additional, Verber, Nick S., additional, VoduŠek, David B., additional, Weissenborn, Karin, additional, Williams, Linda S., additional, Wilson, Michael R., additional, and Zochodne, Douglas W., additional

Published
2021
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7. 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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8. Effects of Ibudilast on MRI Measures in the Phase 2 SPRINT-MS Study

Author

Naismith, Robert T., Bermel, Robert A., Coffey, Christopher S., Goodman, Andrew D., Fedler, Janel, Kearney, Marianne, Klawiter, Eric C., Nakamura, Kunio, Narayanan, Sridar, Goebel, Christopher, Yankey, Jon, Klingner, Elizabeth, Fox, Robert J., Shinnar, Shlomo, Ontaneda, Daniel, Riley, Claire S., Perumal, Jai, Lava, Neil, Klawiter, Eric, Cohen, Bruce, Racke, Michael, Yadav, Vijayshree, Jubelt, Burk, WeinstockGutman, Bianca, Coyle, Patricia, Repovic, Pavle, Bashir, Khurram, Apperson, Michelle, Giesser, Barbara, Zabeti, Aram, Miravalle, Augusto, Lynch, Sharon, Delgado, Silvia, Suski, Valerie, Goodman, Andrew, Flores, Angela, DeWitt, Dana, Goldman, Myla, Moses, Harold, Naismith, Robert, Peng, Qi, Sakaie, Ken, Jambawalikar, Sachin, Dyke, Jonathan P., Kitajima, Hiroumi, Panych, Lawrence, Witzel, Thomas, Parrish, Todd, Layman, Rick, Yang, Xiangyu, Yee, Seonghwan, Shah, Dhaval, Button, Terry, Williams, Tony, Buonocore, Mike, Tanase, Costin, Ellingson, Ben, GaskillShipley, Mary, Morton, Ray, Brown, Mark, Lee, Phil, Pattany, Pradip, Hetherington, Hoby, Zhang, Jianhui, Varghese, Shijn, Lee, James, Mugler, John P., Price, Ron, Thomas, Betsy, Welch, Mary, Liff, Jeremy, Smith, Andrew, Ian, Rossman, Vargas, Wendy, Cioroiu, Comana, Nealon, Nancy, Vargas, Diana, Cook, Calli, Baharnoori, Moogeh, Reda, Haatem, Mateen, Farrah, Patel, Kevin, Kay-Stacey, Margaret, Kisanuki, Yasushi, Brett, Alldredge, Bogda, Christine, Mass, Michele, Kim, Edward, Duleep, Anuradha, Grosso, Megan, Bucello, Meg, McLinkskey, Nancy, Mayadev, Angeli, Peiqing, Qian, Meador, William, Richman, David, Dorsch, Andrew, Nygren, Kristin, Obeidat, Ahmed, Wall, Anastacia, Hammond, Nancy, Andersen, Heather, Mittal, Manoj, Tornes, Leticia, Lizarraga, Alexis, Zaydan, Islam, Hyland, Megan, Munoz, Shanan, Wright, Katy, Smith, Gordon, Bruen, Denise, Brenton, James Nicholas, Pawate, Siddharama, Sriram, Subramaniam, Oddis, Kerry, Scheid, Eileen, Thayer, William, Duodova, Mariana, Keller, Margaret, Scott, Jennifer, and Teshome, Mengesha

Published
2021
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11. Design, rationale, and baseline characteristics of the randomized double-blind phase II clinical trial of ibudilast in progressive multiple sclerosis

Author

Fox, Robert J., Coffey, Christopher S., Cudkowicz, Merit E., Gleason, Trevis, Goodman, Andrew, Klawiter, Eric C., Matsuda, Kazuko, McGovern, Michelle, Conwit, Robin, Naismith, Robert, Ashokkumar, Akshata, Bermel, Robert, Ecklund, Dixie, Koepp, Maxine, Long, Jeffrey, Natarajan, Sneha, Ramachandran, Srividya, Skaramagas, Thomai, Thornell, Brenda, Yankey, Jon, Agius, Mark, Bashir, Khurram, Cohen, Bruce, Coyle, Patricia, Delgado, Silvia, Dewitt, Dana, Flores, Angela, Giesser, Barbara, Goldman, Myla, Jubelt, Burk, Lava, Neil, Lynch, Sharon, Miravalle, Augusto, Moses, Harold, Ontaneda, Daniel, Perumal, Jai, Racke, Michael, Repovic, Pavle, Riley, Claire, Severson, Christopher, Shinnar, Shlomo, Suski, Valerie, Weinstock-Gutman, Bianca, Yadav, Vijayshree, and Zabeti, Aram

Published
2016
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14. Cladribine Tablets in Patients With Relapsing-Remitting Multiple Sclerosis or Active Secondary Progressive Multiple Sclerosis After Suboptimal Response to a Disease-Modifying Therapy (CLICK-MS and MASTER-2): Interim Baseline and Safety Review (P1-1.Virtual)

Author

Miravalle, Augusto A., primary, Katz, Joshua, additional, Robertson, Derrick, additional, Aldridge, Julie, additional, Evans, Emily, additional, Harlow, Danielle E., additional, Lebson, Lori A., additional, Sloane, Jacob A., additional, Bass, Ann D., additional, and Fox, Edward J., additional

Published
2022
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19. Development and Usability Testing of a Patient-based Digital Tool to Understand Early Signs of Changes in Multiple Sclerosis Symptoms and Progression: Your MS Questionnaire (2118)

Author

Ziemssen, Tjalf, primary, Alvarez, Enrique, additional, Bhan, Virender, additional, Burton, Jason, additional, Hoffmann, Olaf, additional, Oreja-Guevara, Celia, additional, Robles-Cedeño, René, additional, Trojano, Maria, additional, Vermersch, Patrick, additional, Napoli, Salvatore, additional, Miravalle, Augusto, additional, Xu, Yan, additional, Vandercappellen, Jo, additional, Khwaja, Mudeer, additional, Marchaterre, Mark, additional, Stadler, Bianca, additional, Hach, Thomas, additional, and Giovannoni, Gavin, additional

Published
2021
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26. Supplementary_File_2 – Supplemental material for Post-natalizumab disease reactivation in multiple sclerosis: systematic review and meta-analysis

Author

Prosperini, Luca, Revere P. Kinkel, Miravalle, Augusto A., Iaffaldano, Pietro, and Fantaccini, Simone

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 110904 Neurology and Neuromuscular Diseases
Abstract

Supplemental material, Supplementary_File_2 for Post-natalizumab disease reactivation in multiple sclerosis: systematic review and meta-analysis by Luca Prosperini, Revere P. Kinkel, Augusto A. Miravalle, Pietro Iaffaldano and Simone Fantaccini in Therapeutic Advances in Neurological Disorders

Published
2019
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31. 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

32. 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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33. Comparison of Baseline Characteristics of Natalizumab versus Healthy Controls in Multiple Sclerosis Patients on Brain Volume, Cognition and Neuro-QOL outcomes: Preliminary Analysis of a Longitudinal Observational Study (P3.335)

Author

Alvarez, Enrique, primary, Nair, Kavita, additional, Hoyt, Brian, additional, Sillau, Stefan, additional, Wedeman, Brittany, additional, Engebretson, Eric, additional, Miravalle, Augusto, additional, Corboy, John, additional, Vollmer, Timothy, additional, and Honce, Justin, additional

Published
2017
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42. Comparison of Baseline Characteristics of Glatiramer Acetate Versus Fingolimod in Multiple Sclerosis Patients on Brain Volume, Cognition and Neuro-QOL Outcomes: Preliminary Analysis of a Longitudinal Observational Study (P6.170)

Author

Honce, Justin, primary, Nair, Kavita, additional, Hoyt, Brian, additional, Sillau, Stefan, additional, Wedeman, Brittany, additional, Engebretson, Eric, additional, Vollmer, Brandi, additional, Johnson, Kristen, additional, Tenenbaum, Nadia, additional, Herrera, Vivian, additional, Siconolfi, Lisa, additional, Miravalle, Augusto, additional, Bennett, Jeffrey, additional, Corboy, John, additional, Vollmer, Timothy, additional, and Alvarez, Enrique, additional

Published
2016
Full Text
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43. Recent advances in the treatment of multiple sclerosis

Author

Miravalle, Augusto

Subjects
Journal of Experimental Pharmacology
Abstract

Jeffrey L Bennett, Augusto A MiravalleUniversity of Colorado, Aurora, CO, USAAbstract: Multiple sclerosis (MS) is a chronic inflammatory, immune-mediated, demyelinating, neurodegenerative disorder of the central nervous system. Despite the lack of an etiologic factor, it has been consistently demonstrated that the immune system plays a crucial role in the pathogenesis of MS. The traditional description of immunopathogenesis of MS suggests a preferential CD4+ TH1 cell activity causing tissue damage by the release of pro-inflammatory cytokines and subsequent demyelination and axonal loss. Recent evidence, however, suggests that other immune cells including TH17 cells, CD8+ effector T cells, CD4+ CD25+ regulatory T cells, and B cells may play a prominent role in MS immunopathology. A better understanding of the molecular and cellular components of the immunopathogenesis of MS is allowing the development of novel therapies.Keywords: multiple sclerosis, immunopathology, oral medication, clinical trial

Published
2010

46. Profile of oral laquinimod and its potential in the treatment of multiple sclerosis

Author

West,Matthew, Miravalle,Augusto, West,Matthew, and Miravalle,Augusto

Abstract

Matthew S West, Augusto MiravalleDepartment of Neurology, University of Colorado, Denver, CO, USAAbstract: The medications available to treat relapsing-remitting multiple sclerosis (RRMS) are expanding as newer, and more potent, disease-modifying treatments become available. In particular, there is an impetus for safe and effective oral options. Laquinimod is a novel oral immunomodulator currently under investigation for the treatment of RRMS. Although the exact mechanism of action is not known, laquinimod is not an immunosuppressant. Rather, it appears to have multiple effects on the immune system, including a shift to an anti-inflammatory cytokine state, reduction in antigen presentation, and effect on migration of T cells. In addition, laquinimod may have a neuroprotective effect. Phase II trials of RRMS patients showed a statistically significant reduction in magnetic resonance imaging (MRI) outcomes, such as decrease in gadolinium-enhancing lesions, and initial Phase III data have now shown a reduction in relapse rate, reduction in sustained disability, and a decrease in atrophy on brain MRI. In all trials, laquinimod has shown a favorable tolerability and safety profile. Laquinimod has been granted fast-track status by the US Food and Drug Administration, and may become an approved treatment for RRMS.Keywords: laquinimod, multiple sclerosis, mechanism of action, efficacy

Published
2011

47. Emerging therapies for treatment of multiple sclerosis

Author

Corboy,John, Miravalle,Augusto A, Corboy,John, and Miravalle,Augusto A

Abstract

John R Corboy, Augusto A MiravalleRocky Mountain Multiple Sclerosis Center, Anschutz Medical Campus, University of Colorado Denver, Aurora, Colorado, USAAbstract: In the last decade, a new armamentarium of immune-based therapies have been developed and tested in patients with multiple sclerosis. Some of these therapies are showing a high level of efficacy, with an acceptable adverse effect profile. Because present therapies have significant limitations in slowing disease progression, require injections, are sometimes associated with significant side effects of immunosuppression, and do little to reverse disability, identifying more effective treatments is an important goal for clinical research in multiple sclerosis. However, in order to improve our current approach to disease-modifying therapies, it is imperative to promote the development of individualized therapy strategies.Keywords: multiple sclerosis, lymphocyte-targeted therapy, immune sequestration, non-specific immune modulation

Published
2010

48. Recent advances in the treatment of multiple sclerosis

Author

Bennett,Jeffrey L, Miravalle,Augusto, Bennett,Jeffrey L, and Miravalle,Augusto

Abstract

Jeffrey L Bennett, Augusto A MiravalleUniversity of Colorado, Aurora, CO, USAAbstract: Multiple sclerosis (MS) is a chronic inflammatory, immune-mediated, demyelinating, neurodegenerative disorder of the central nervous system. Despite the lack of an etiologic factor, it has been consistently demonstrated that the immune system plays a crucial role in the pathogenesis of MS. The traditional description of immunopathogenesis of MS suggests a preferential CD4+ TH1 cell activity causing tissue damage by the release of pro-inflammatory cytokines and subsequent demyelination and axonal loss. Recent evidence, however, suggests that other immune cells including TH17 cells, CD8+ effector T cells, CD4+ CD25+ regulatory T cells, and B cells may play a prominent role in MS immunopathology. A better understanding of the molecular and cellular components of the immunopathogenesis of MS is allowing the development of novel therapies.Keywords: multiple sclerosis, immunopathology, oral medication, clinical trial

Published
2010

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