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2. Improvements in no evidence of disease activity with ublituximab vs. teriflunomide in the ULTIMATE phase 3 studies in relapsing multiple sclerosis.

Author

Alvarez, Enrique, Steinman, Lawrence, Fox, Edward, Hartung, Hans-Peter, Qian, Peiqing, Wray, Sibyl, Robertson, Derrick, Selmaj, Krzysztof, Wynn, Daniel, Mok, Koby, Xu, Yihuan, Bodhinathan, Karthik, Miskin, Hari, and Cree, Bruce

Subjects
BRIUMVI, anti-CD20, disability, disease activity, disease-modifying therapy, multiple sclerosis, no evidence of disease activity, relapse
Abstract

BACKGROUND: Ublituximab is a novel anti-CD20 monoclonal antibody glycoengineered for enhanced antibody-dependent cellular cytotoxicity. The phase 3 ULTIMATE I and II studies showed significant improvements in annualized relapse rate, total number of gadolinium-enhancing (Gd+) T1 lesions, and total number of new or enlarging T2 at Week 96, as well as improvement in the proportion of participants with no evidence of disease activity (NEDA) from Weeks 24-96 with ublituximab vs. teriflunomide. METHODS: In ULTIMATE I (NCT03277261; www.clinicaltrials.gov) (N = 549) and II (NCT03277248; www.clinicaltrials.gov) (N = 545), participants with relapsing multiple sclerosis received ublituximab 450 mg intravenous infusion every 24 weeks (following Day 1 infusion of 150 mg and Day 15 infusion of 450 mg) or teriflunomide 14 mg oral once daily for 96 weeks. Pooled post hoc analyses evaluated NEDA by treatment epoch and participant subtype: age ( ≤ 38 or >38 years), early or later disease (3.5 at baseline. NEDA was defined as no confirmed relapses, no Gd+ T1 lesions, no new or enlarging T2 lesions, and no disability progression confirmed for ≥12 weeks. RESULTS: NEDA rates in the ublituximab vs. teriflunomide cohorts by treatment epoch were: Weeks 0-96, 44.6% vs. 12.4% (3.6 × improvement); Weeks 24-96 (re-baselined), 82.1% vs. 22.5% (3.6 × improvement); and Weeks 48-96 (re-baselined), 88.2% vs. 30.4% (2.9 × improvement) (all p < 0.0001). The primary driver of disease activity in ublituximab-treated participants was new or enlarging T2 lesions during Weeks 0-24. 41.8% of ublituximab-treated participants who had evidence of disease activity in the first year (Weeks 0-48) experienced NEDA in the second year of treatment (Weeks 48-96) compared with 17.3% of teriflunomide-treated participants. At Weeks 24-96 (re-baselined), rates of NEDA were significantly higher with ublituximab than teriflunomide in all participant subtypes (all p < 0.0001). CONCLUSIONS: ULTIMATE I and II pooled post hoc analyses demonstrated a consistent NEDA benefit among ublituximab-treated participants across treatment epochs and key participant subpopulations.

Published
2024

3. Safety and efficacy of evobrutinib in relapsing multiple sclerosis (evolutionRMS1 and evolutionRMS2): two multicentre, randomised, double-blind, active-controlled, phase 3 trials

Author

Carra, Adriana Josefa, Deri, Norma Haydee, Jose, Jorge Gustavo, del Valle Liwacki, Susana, Mainella, Carolina Natalia, Pagani, Fatima, Povedano, Guillermo, Alfici, Alberto Rodriguez, Tavolini, Dario Raul, Buonanotte, Carlos Federico, Burgos, Marcos, Giugni, Juan Carlos, Artesi, Juan Jose Martin, Rojas, Juan Ignacio, Zuin, Daniel Raul, Videla, Hugo Osvaldo, Correale, Jorge Daniel, Luetic, Geraldine G., Hodgkinson, Suzanne, Lechner-Scott, Jeannette, Parratt, John, Saines, Noel, Reddel, Stephen, Wijeratne, Tissa, Taylor, Bruce, Deisenhammer, Florian, Traxler, Gerhard, Leutmezer, Fritz, Wipfler, Peter, Weber, Joerg R., Lampl, Christian, Bartholome, Emmanuel, Dive, Dominique, Glibert, Nele, Perrotta, Gaetano, Pesch, Vincent, Buyle, Maarten, Wijmeersch, Bart, Willekens, Barbara, Basagic, Edin, Mehmedika Suljic, Enra, Klupka-Sarić, Inge, Danovska, Maya, Dimitrova, Maria, Genov, Krasimir, Izmaylov, Alim, Mavrov, Radoslav, Milanov, Ivan, Naydenov, Valcho, Shotekov, Penko, Tarnev, Ivaylo, Traykov, Latchezar, Emond, Francois, Selchen, Daniel, Rivest, Donald, Sabella, Lisa, Witkowski, Ludivine, Saveriano, Alexander, Bolano Solano, Addinson Rene, Ruiz, Cesar Augusto Franco, Nassar Tobon, Andrea Catalina, Cardozo, Carlos Alberto Navas, Schlesenger, Antonio, Triana, Javier Dario, Sarabia, Osvaldo Elias Lara, Montero, Luis Alfonso Zarco, Arango, Jorge Andres Jimenez, Basic, Silvio, Pasic, Marija Bosnjak, Soldo, Silva Butkovic, Habek, Mario, Kidjemet-Piskac, Spomenka, Matijaca, Meri, Vuletic, Vladimira, Ampapa, Radek, Dufek, Michal, Grunermelova, Marketa, Mares, Jan, Martinkova, Alena, Peterka, Marek, Stetkarova, Ivana, Stourac, Pavel, Talab, Radomir, Tyblova, Michaela, Marta, Vachova, Valis, Martin, Hradilek, Pavel, Rockova, Petra, Gross-Paju, Katrin, Haldre, Sulev, Airas, Laura, Karppa, Mikko, Bourre, Bertrand, Casez, Olivier, Ciron, Jonathan, Kwitakowski, Arnaud, Labauge, Pierre, Lebrun Frenay, Christine, Michel, Laure, Derache, Nathalie, Vukusic, Sandra, Laplaud, David-Axel, Beridze, Maia, Chakhava, George, Gauarashvili, Ann, Giorgadze, Gvantsa, Guldedava, Nana, Janelidze, Marina, Kiziria, Marina, Shakarishvili, Roman, Tsiskaridze, Alexander, Chkhikvishvili, Shalva, Albert, Christian, Berthele, Achim, Yalachkov, Yavor, Pitarokoili, Kalliopi, Kallmann, Boris-Alexander, Klotz, Luisa, Oschmann, Patrick, Pul, Refik, Rau, Daniela, Skripuletz, Thomas, Chan, Koon Ho, Lau, Alexander Yuk Lun, Li, Jessica Tsz Ching, Wong, Wa Tai, Maria, Biro Zita, Bokor, Magdolna, Dobos, Eniko, Janszky, Jozsef, Kovacs, Krisztina, Lazarcsik, Ildiko, Piros, Palma, Rozsa, Csilla, Satori, Maria, Simo, Magdolna, Nagy, Ferenc, Behari, Madhuri, Kulkarni, Rahul, Kumar, Radhakrishanan Suresh, Dwivedee, Shamsher, Iype, Thomas, Baviskar, Rahul, Mathukumalli, Neeharika L., Gilad, Ronit, Karussis, Dimitrios, Milo, Ron, Shahien, Radi, Vaknin, Adi, Weller, Boaz, Wilf-Yarkoni, Adi, Achiron, Anat, Aguglia, Umberto, Di Gregorio, Maria, Calabrese, Massimiliano, Cordioli, Cinzia, Sessa, Edoardo, Tomassini, Valentina, Inglese, Matilde, Castro Farfan, Freddy Guillermo, Roldan, Giovana Femat, Gonzalez Guardado, Antonio, Lopez Meza, Elmer, Maldonado, Jair Fernando, Boschetti, Laura Ordonez, Partida Medina, Luis Roberto, Frequin, Stephan, Hupperts, Raymond, Schrijver, Hans, Smolders, Joost, Diaz, Cesar Abel Castaneda, Pretell, Edwin, Boczarska-Jedynak, Magdalena, Bonek, Robert, Brola, Waldemar, Darda-Ledzion, Lidia, Fryze, Waldemar, Maciejowski, Maciej, Rejdak, Konrad, Rosciszewska-Zukowska, Iwona, Selmaj, Krzysztof, Szymanska, Malgorzata, Zajda, Małgorzata, Zielinski, Tomasz, Beata, Zakrzewska-Pniewska, Adam, Stepien, Swiat, Maciej, Kim, Byoung Joon, Kim, Ho-Jin, Kim, Kwang-Kuk, Shin, Ha Young, Kim, Sung Min, Kim, Woojun, Oh, Jeeyoung, Bakhtiyarova, Klara Z., Belova, Anna N., Davydovskaya, Maria V., Dudin, Viacheslav A., Erina, Olesya V., Evdoshenko, Evgeny P., Greshnova, Irina V., Khabirov, Farit A., Kotov, Sergey V., Makarov, Nikolay S., Maslova, Natalia, Mishin, Gennadiy N., Pokhabov, Dmitry V., Smagina, Inna V., Spirin, Nikolay N., Trushnikova, Tatiana N., Volkova, Larisa I., Zaslavskiy, Leonid G., Zhukova, Natalia G., Ceranic, Mirjana, Cvijanovic, Vera, Drulovic, Jelena, Gavric Kezic, Mira, Jovanovic, Dragoslava, Milicevic, Svetlana K., Raicevic, Ranko, Suknjaja, Vesna, Boskovic Matic, Tatjana, Vojinovic, Slobodan, Ruiz, Luis Brieva, Castillo Trivino, Tamara, Costa-Frossard Franca, Lucienne, Eichau Madueno, Sara, Forero Diaz, Lucia, Martinez, Jose Enrique, Martinez Yelamos, Sergio, Meca Lallana, Virginia, Oreja Guevara, Celia, Ramio i Torrenta, Lluis, Arroyo Gonzalez, Rafael, Guo, Yuh-Cherng, Ro, Long-Sun, Tsai, Nai-Wen, Wang, Kai-Chen, Yang, Fu-Chi, Cherkez, Alla, Deineka, Natalia, Delva, Mykhaylo, Goloborodko, Alla, Hovbakh, Iryna, Khavunka, Marta, Kmyta, Oleksii, Kozyolkin, Olexandr, Lekomtseva, Yevgeniya, Litovchenko, Tetyana, Moskovko, Sergii, Pashkovskyy, Valeriy, Riabichenko, Tetiana, Tovazhnyanska, Olena, Voloshyna, Nataliya, Hrebeniuk, Hanna, Sokolova, Larysa, Arun, Tarunya, Constantinescu, Cris, Harrower, Timothy, Mattoscio, Miriam, Paling, David, Pearson, Owen, Robertson, Neil, Webb, Stewart, Cottrell, David, Nicholas, Richard, Duddy, Martin, Anadani, Nidhiben, Belkin, Martin, Bernitsas, Evanthia, Borazanci, Aimee, Clark, David, Costell, Brian, Delgado, Silvia, Fox, Edward, Gudesblatt, Mark, Gupta, Vipan, Harel, Asaff, Harrison, Daniel, Herrman, Craig, Honeycutt, William David, Hua, Le, Hunter, Samuel, Katsamakis, George, Kilgo, William, Koffman, Boyd, Lindsey, William, Lynch, Sharon G., Mateen, Farrah J., McAllister, Peter, Farahmand, Arya, Morales, Idanis Berrios, Rahmlow, Megan, Naismith, Robert, Napoli, Salvatore, Newman, Stephen, Pardo, Gabriel, Patel, Nirav, Scott, James, Purino, Lorraine, Vasquez, Alberto B., Weisman, David, Wray, Sibyl, Wynn, Daniel, Dihenia, Bhupesh, Obeidat, Ahmed, Ayala, Ricardo, Erwin, April, Betz, Michelle, DeAngelis, Teresa, Osborne Dusan Stefoski, Benjamin, Giang, Daniel, Hendin, Barry, Nagaraj, Arun, Saltis, Lawrence, Singer, Barry, Balabanov, Roumen, Bromley, Steven Michael, Puente, John, Tran, Duc, Kojan, Suleiman, Graves, Jennifer, Fishman, Simon, Maher, Leo, Londono, Diana, Sadiq, Mohamed, Alekseenko, Yuri, Fedulau, Aliaksandr, Kulesh, Sergey, Mikhailova, Elena, Navumava, Halina, Aragon deVecino, Maria Cecilia, Callegaro, Dagoberto, Daccach Marques, Vanessa, Finkelsztejn, Alessandro, Guerreiro, Alexandre, Kleinpaul, Rodrigo, Koiti Sato, Henry, Luiz Longo, Alexandre, Papais Alvarenga, Regina Maria, Pereira Damasceno, Benito, Pereira Gomes Neto, Antonio, Diniz Carneiro, Denise S., Tauil, Carlos Bernardo, Maciel Dias, Ronaldo, Olival, Guilherme, Zago Melo Dias, Paula, de Jesus Carvalho, Margarete, Sato, Douglas Kazutoshi, Forcelini, Cassiano Mateus, Pelov, Plamen, Haralanov, Lyubomir, Ikonomov, Rosen, Ivanov, Ivan, Kastrev, Sasho, Kirilov, Krasimir, Lilovski, Hristo, Maslarov, Dimitar, Staikov, Ivan, Zhelyazkov, Petko, Freedman, Mark, MacLean, Gregg, Marriott, James, McKelvey, John Roger, Girard, Jean-Marc, Vorobeychik, Galina, Morrow, Sarah, Clavelou, Pierre, de Seze, Jerome, Louapre, Celine, Maurousset, Aude, Ruet, Aurelie, Thouvenot, Eric, Morel, Nathalie, Montcuquet, Alexis, Rouhart, Francois, Angstwurm, Klemens, Bayas, Antonios, Bittner, Stefan, Heesen, Christoph, Kowarik, Markus, Marckmann-Boenke, Silke, Muller, Thomas, Zimmermann, Julian, Nelles, Gereon, Paul, Friedemann, Then Bergh, Florian, Wildemann, Brigitte, Zettl, Uwe Klaus, Ziemssen, Tjalf, Doerr, Jan-Marcus, Chroni, Elisabeth, Dardiotis, Efthymios, Doskas, Triantafyllos, Gatzonis, Stylianos, Grigoriadis, Nikolaos, Karageorgiou, Klimentini, Kouremenos, Evangelos, Mitsias, Panayiotis, Spengos, Konstantinos, Kimiskidis, Vasilios, Evangelopoulos, Maria E., Fakas, Nikolaos, Karanasios, Panagiotis, Kyritsis, Athanasios, Maltezou, Maria, Sotirli, Stefania, Tsolaki, Magda, Rohtagi, Anshu, Mukherjee, Joy, Nellikunja, Shankara, Srinivasa, Rangashetty, Sharma, Arvind, Chowdhury, Debashish, Kalita, Jayantee, Brescia Morra, Vincenzo, Centonze, Diego, Gasperini, Claudio, Grimaldi, Luigi, Maniscalco, Giorgia Teresa, Patti, Francesco, Salemi, Giuseppe, Trojano, Maria, Amato, Maria Pia, Malucchi, Simona, Brambilla, Laura, Pozzilli, Carlo, Al Roughani, Raed, Karelis, Guntis, Kalnina, Jolanta, Millers, Andrejs, Mickeviciene, Dalia, Giedraitiene, Natasa, Kazlauskas, Andrius, Malciene, Lina, Joseph, Joyce Pauline, Chung, Law Wan, Looi, Irene, Remli, Rabani, Binti Sapuan, Sapiah, Abdullah, Suhailah, Carbajal Ramirez, Angelica, Espino Ojeda, Alba, Silvestre Bejar Medina, Jesus, Quinones Aguilar, Sandra, Rivas Alonso, Veronica, de la Rosa, Rogelio Francisco, San Juan Orta, Daniel, Misic, Octavian, Odainic, Olesea, Torkildsen, Oivind, Schuler, Stephan, Broch, Line, Canete, Ma. Teresa, Hiyadan, John Harold, Hormillosa, Mary Pauline, Rosales, Raymond L., Adamczyk Sowa, Monika, Bartosik-Psujek, Halina, Berkowicz, Tomasz, Czarnecki, Maciej, Kłodowska, Gabriela, Klosek, Agata, Koscielniak, Jozef, Lisewski, Pawel, Mielcarek, Bartlomiej, Piasecka-Stryczynska, Karolina, Potemkowski, Andrzej, Stasiołek, Mariusz, Krzystanek, Ewa, Lasek-Bal, Anetta, Sikorska, Swietlana, Szczudlik, Andrzej, Gospodarczyk-Szot, Krystyna, Wierzchowska-Cioch, Ewa, K. Jastrzebska, Iwona, Capela, Carlos, Cerqueira, Joao, Correia, Ana Sofia, Correia, Filipe, Ferreira, Joaquim J., Gouveia, Raquel, Mendes, Irene, Nunes, Carla Cecilia, Timoteo, Angela, Veira, Carlos, Martins da Silva, Ana, Domingues, Joana, Chinea, Angel R, Tiu, Cristina, Balasa, Rodica, Chiru, Mirela, Dulamea, Adriana Octaviana, Silviu Manescu, Emilian, Mitrea, Dan, Mitu, Cristina, Nicolae, Silvia Maria, Filip, Carmen Corina Roman, Sabau, Monica, Vanghelie, Doinita, Varga, Ioana, Nunkoo, Vharoon, Agafina, Alina S., Gennadevna, Arefeva Elena, Alexeeva, Tatiana M., Bogdanov, Enver, Dorogov, Nikolay, Doronina, Olga, Goncharova, Zoya, Khasanova, Dina, Korobko, Denis, Pankratov, Evgeny V., Parshina, Elena, Poverennova, Irina, Prokopenko, Semyion V., Sazonov, Denis V., Shkilnyuk, Galina, Sivertseva, Stella, Stolyarov, Igor, Totolyan, Natalia A., Tsukurova, Larisa A., Vorobyeva, Olga V., Voznyuk, Igor A., Zakharova, Maria, Ardashev, Igor V., Boyko, Alexey, Alshehri, Ebtesam, Alkhawajah, Nuha M, Alfugham, Nora, Quek, Amy, Kevin, Tan, Dupejova, Beata, Feketova, Sona, Hancinova, Viera, Jurcaga, Frantisek, Turcani, Peter, Krastev, Georgi, Cimprichova, Andrea, Perichtova, Magdalena, Hojs-Fabjan, Tanja, Horvat Ledinek, Alenka, Savsek, Lina, Bateman, Kathleen, Frost, Andrew Charles, Henning, Franclo, Retief, Chris Francois, Aguado Valcarcel, Marta, Morales, Eduardo Aguera, Alonso Torres, Ana Maria, Borrega Canelo, Laura, Casanova Estruch, Bonaventura, Gascon Gimenez, Francisco, Ayuso, Guillermo I, Martinez Gines, Maria Luisa, Eustasio Meca Lallana, Jose, Rodriguez Antiguedad, Alfredo, Blasco Quilez, Rosario, Brieva Ruiz, Luis, Piehl, Fredrik, Lycke, Jan, Katsarogiannis, Evangelos, Nilsson, Christer, Hoepner, Robert, Zecca, Chiara, Findling, Oliver, Asawavichienjinda, Thanin, Kasemsap, Narongrit, Prayoonwiwat, Naraporn, Mhiri, Chokri, Ağan Yıldırım, Kadriye, Boz, Cavit, Efendi, Husnu, Soysal, Aysun, Terzi, Murat, Uygunoglu, Ugur, Gümüş, Haluk, Mungan, Semra, Ozakbas, Serkan, Serhan Sevim, Mustafa, Tamam, Yusuf, Kale, Nilufer, Karabudak, Rana, Bachinskaya, Natalia, Buchakchyiska, Nataliia, Chmyr, Galyna, Dzyak, Ludmyla, Ivashchenko, Svitlana, Kalbus, Oleksandr, Kareta, Serhiy, Korolova, Oksana, Kostiuchenko, Andrii, Kruchkevych, Zhanna, Larysa, Kadina, Mishchenko, Tamara, Moroz, Olena, Neryanova, Yuliya, Pasiura, Ihor, Pohrebnyak, Oleksandr, Pryshchepa, Volodymyr, Sanotskyy, Yanosh, Shkrobot, Svitlana, Shulga, Olga, Smolanka, Volodymyr, Tomakh, Nataliya, Zhuravlyova, Natalia, Allen, Alison B., Armstrong, Robert, Antezana, Ariel, Baker, Matthew, Bass, Ann, Benenati, Diana, Benson, Dalton, Beretich, Biljana, Burke, Deborah, Calkwood, Jonathan, Carpenter, Adam, Drake, Ryan, Dujmovic Basuroski, Irena, Gupta, Ajay, Hentati, Afif, Kaplan, Jeffrey, Katsafanas, Constance, Keegan, Andrew, Khatri, Bhupendra, Luzzio, Christopher, Malik, Maheen, Bennette, Myers, Miravalle, Augusto, Montoya, Liliana, Nash, Marshall, Poole Pharr, Emily, Sater, Richard A., Scagnelli, John, Schulman, Alan, Shafer, Stuart, Stein, Lee, Vandersluis, Joel, Williams, Armistead, Winkley, James, Berkovich, Regina, Cerghet, Mirela, Horton, Lindsay, Jacobs, Daniel H., Laurin, Nida, Liow, Kore, Robertson, Derrick, Mattson, David, Cabrera, Alicia V., Leist, Thomas, Negroski, Donald, Royter, Vladimir, LaGanke, Christopher, Winner, Paul, Sweeney, Michael, Weinberg, Lawrence A., Smith, Andrew, Rivas-Rodriguez, Erica, Wagner, Kimberly, Montalban, Xavier, Vermersch, Patrick, Arnold, Douglas L, Bar-Or, Amit, Cree, Bruce A C, Cross, Anne H, Kubala Havrdova, Eva, Kappos, Ludwig, Stuve, Olaf, Wiendl, Heinz, Wolinsky, Jerry S, Dahlke, Frank, Le Bolay, Claire, Shen Loo, Li, Gopalakrishnan, Sathej, Hyvert, Yann, Javor, Andrija, Guehring, Hans, Tenenbaum, Nadia, and Tomic, Davorka

Published
2024
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5. Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial

Author

van der Walt, Anneke, Dwyer, Christopher, Buzzard, Katherine, Spies, Judith, Parratt, John, van Pesch, Vincent, Willekens, Barbara, Perrotta, Gaetano, Bartholomé, Emmanuel, Grand'Maison, Francois, Jacques, Francois, Giacomini, Paul, Vosoughi, Reza, Girard, Jean-Marc, de Seze, Jerome, Lebrun Frenay, Christine, Ruet, Aurelie, Laplaud, David-Axel, Reifschneider, Gerd, Wagner, Bert, Rauer, Sebastian, Pul, Refik, Seipelt, Maria, Berthele, Achim, Klotz, Luisa, Kallmann, Boris-Alexander, Paul, Friedemann, Achiron, Anat, Lus, Giacomo, Centonze, Diego, Patti, Francesco, Grimaldi, Luigi, Hupperts, Raymond, Frequin, Stephan, Fermont, Jiske, Madueno, Sara Eichau, Alonso Torres, Ana Maria, Costa-Frossard França, Lucienne, Meca-Lallana, Jose Eustasio, Ruiz, Luis Brieva, Pearson, Owen, Rog, David, Evangelou, Nikolaos, Ismail, Azza, Lathi, Ellen, Fox, Edward, Leist, Thomas, Sloane, Jacob, Wu, Gregory, Khatri, Bhupendra, Steingo, Brian, Thrower, Ben, Gudesblatt, Mark, Calkwood, Jonathan, Bandari, Daniel, Scagnelli, John, Laganke, Christopher, Robertson, Derrick, Kipp, Lucas, Belkin, Martin, Cohan, Stanley, Goldstick, Lawrence, Courtney, Ardith, Vargas, Wendy, Sylvester, Andrew, Srinivasan, Jayshri, Kannan, Meena, Picone, Maryann, English, Jeffrey, Napoli, Salvatore, Balabanov, Roumen, Zaydan, Islam, Nicholas, Jacqueline, Kaplan, Jeffrey, Lublin, Fred, Riser, Emily, Miller, Tamara, Alvarez, Enrique, Wray, Sibyl, Gross, Jeffrey, Pawate, Siddharama, Hersh, Carrie, McCarthy, Lucas, Crayton, Heidi, Graves, Jennifer, Foley, John F, Defer, Gilles, Ryerson, Lana Zhovtis, Cohen, Jeffrey A, Arnold, Douglas L, Butzkueven, Helmut, Cutter, Gary, Giovannoni, Gavin, Killestein, Joep, Wiendl, Heinz, Smirnakis, Karen, Xiao, Shan, Kong, George, Kuhelj, Robert, and Campbell, Nolan

Published
2022
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6. Efficacy and Safety Outcomes with Diroximel Fumarate After Switching from Prior Therapies or Continuing on DRF: Results from the Phase 3 EVOLVE-MS-1 Study

Author

Wray, Sibyl, Then Bergh, Florian, Wundes, Annette, Arnold, Douglas L., Drulovic, Jelena, Jasinska, Elzbieta, Bowen, James D., Negroski, Donald, Naismith, Robert T., Hunter, Samuel F., Gudesblatt, Mark, Chen, Hailu, Lyons, Jennifer, Shankar, Sai L., Kapadia, Shivani, Mendoza, Jason P., and Singer, Barry A.

Published
2022
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10. Safety and efficacy of tolebrutinib, an oral brain-penetrant BTK inhibitor, in relapsing multiple sclerosis: a phase 2b, randomised, double-blind, placebo-controlled trial

Author

Grand'Maison, Francois, Jacques, Francois, Traboulsee, Anthony, Tyblova, Michaela, Meluzinova, Eva, Ampapa, Radek, Valis, Martin, Hradilke, Pavel, Mareš, Miroslav, Stourac, Pavel, Gross-Paju, Katrin, Laplaud, David, Mathey, Guillaume, Uitdehaag, Bernard, Evdoshenkoo, Evgeny, Popova, Ekaterina, Zakharova, Maria, Totolyan, Natalia, Litvinenko, Igor, Khabirov, Farit, Sivertseva, Stella, Hancinova, Viera, Kantorova, Ema, Gines, Maria Luisa Martinez, Montalban, Xavier, Maduano, Sara Eichau, Meca-Lallana, Jose, Ramió-Torrentà, Lluís, Nehrych, Tetyanna, Pashkovskyy, Valeriy, Moskovko, Sergii, Kalbus, Oleksandr, Khavunka, Marta, Pryshchepa, Volodymyr, Goloborodko, Alla, Wynn, Daniel, Honeycutt, William, Wray, Sibyl, Steingo, Brian, LaGanke, Christopher, Huang, Deren, Hemphill, John Michael, Goldstick, Lawrence, Robertson, Derrick, Reich, Daniel S, Arnold, Douglas L, Vermersch, Patrick, Bar-Or, Amit, Fox, Robert J, Matta, Andre, Turner, Timothy, Wallström, Erik, Zhang, Xinyan, and Khabirov, Farit A

Published
2021
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11. Brain Volume Changes Over 1 Year in Ozanimod-treated Patients with Early-relapsing Multiple Sclerosis: An Interim Analysis of the ENLIGHTEN Study (P11-6.017)

Author

Zivadinov, Robert, primary, Naismith, Robert, additional, Morrow, Sarah, additional, Bass, Ann, additional, Obeidat, Ahmed, additional, Riser, Emily, additional, Wray, Sibyl, additional, Riolo, Jon, additional, Chaudhry, Burhan, additional, Thorpe, Andrew, additional, Cheng, Chun-Yen, additional, and DeLuca, John, additional

Published
2024
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12. Safety and Efficacy of Ozanimod in Patients with Early Relapsing Multiple Sclerosis: 1-year Analysis of the ENLIGHTEN Study (P10-6.014)

Author

Naismith, Robert, primary, Zivadinov, Robert, additional, Morrow, Sarah, additional, Bass, Ann, additional, Obeidat, Ahmed, additional, Riser, Emily, additional, Wray, Sibyl, additional, Cristofanilli, Massimiliano, additional, Riolo, Jon, additional, Thorpe, Andrew, additional, Chaudhry, Burhan, additional, Mohiuddin, Kamran, additional, Cheng, Chun-Yen, additional, and DeLuca, John, additional

Published
2024
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14. Longer-term Safety and Efficacy of Ofatumumab in People with Relapsing Multiple Sclerosis for Up to 6 Years (P9-6.010)

Author

Wiendl, Heinz, primary, Hauser, Stephen, additional, Nicholas, Jacqueline, additional, De Seze, Jerome, additional, Meuth, Sven, additional, Giacomini, Paul, additional, Robertson, Derrick, additional, Wray, Sibyl, additional, Bhatt, Alit, additional, Hu, Xixi, additional, Fu, Haoyi, additional, Jehl, Valentine, additional, Sullivan, Roseanne, additional, Boer, Ibolya, additional, Cohen, Jeffrey, additional, and Kappos, Ludwig, additional

Published
2024
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16. Diroximel fumarate in patients with relapsing–remitting multiple sclerosis: Final safety and efficacy results from the phase 3 EVOLVE-MS-1 study

Author

Singer, Barry A, primary, Arnold, Douglas L, additional, Drulovic, Jelena, additional, Freedman, Mark S, additional, Gold, Ralf, additional, Gudesblatt, Mark, additional, Jasinska, Elzbieta, additional, LaGanke, Christopher C, additional, Naismith, Robert T, additional, Negroski, Donald, additional, Oh, Jiwon, additional, Hernandez Perez, Miguel Angel, additional, Selmaj, Krzysztof, additional, Then Bergh, Florian, additional, Wundes, Annette, additional, Ziemssen, Tjalf, additional, Castro-Borrero, Wanda, additional, Chen, Hailu, additional, Levin, Seth, additional, Scaramozza, Matthew, additional, Shankar, Sai L, additional, Wang, Ting, additional, and Wray, Sibyl, additional

Published
2023
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17. Efficacy of Early Ofatumumab vs Late Switch From Teriflunomide: Subgroup Analysis of the ALITHIOS Open-label Extension Study by Previous Disease-Modifying Therapy Exposure and Age (P6-3.016)

Author

Wiendl, Heinz, primary, Cohen, Jeffrey, additional, Gold, Ralf, additional, De Seze, Jerome, additional, Robertson, Derrick, additional, Wray, Sibyl, additional, Sacca, Francesco, additional, Zielman, Ronald, additional, Azmon, Amin, additional, King, Miriam, additional, Fantaccini, Simone, additional, and Kappos, Ludwig, additional

Published
2023
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18. Ublituximab Efficacy in Treatment-Naive Participants With Relapsing Multiple Sclerosis in the Phase 3 ULTIMATE I and II Studies (P6-3.015)

Author

Steinman, Lawrence, primary, Fox, Edward, additional, Hartung, Hans-Peter, additional, Alvarez, Enrique, additional, Qian, Peiqing, additional, Wray, Sibyl, additional, Robertson, Derrick, additional, Huang, Deren, additional, Selmaj, Krzysztof, additional, Wynn, Daniel, additional, Bosco, Jenna, additional, Mok, Koby, additional, Garner, Christopher A., additional, and Cree, Bruce, additional

Published
2023
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19. Disease Outcomes With Ublituximab in Participants With Highly Active Disease: Subpopulation Analyses of the Phase 3 ULTIMATE I and II Studies in Participants With Relapsing Multiple Sclerosis (P6-3.002)

Author

Alvarez, Enrique, primary, Steinman, Lawrence, additional, Hartung, Hans-Peter, additional, Fox, Edward, additional, Qian, Peiqing, additional, Wray, Sibyl, additional, Robertson, Derrick, additional, Mok, Koby, additional, Garner, Christopher A., additional, and Cree, Bruce, additional

Published
2023
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20. Satisfaction with alemtuzumab in relapsing multiple sclerosis patients: Results from the real-world PRO-ACT study

Author

Wray, Sibyl, primary, Jacques, Francois, additional, Miller, Tamara A, additional, Nicholas, Jacqueline A, additional, Arroyo, Rafael, additional, Travis, Lori, additional, Khatri, Bhupendra, additional, Chirieac, Magdalena, additional, Gandhi, Roopali, additional, Roesch, Nora, additional, Rodrigues, Amelie, additional, Melas-Melt, Lydie, additional, Rawlings, Andreea M, additional, and Hunter, Samuel F, additional

Published
2022
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21. Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis

Author

Steinman, Lawrence, primary, Fox, Edward, additional, Hartung, Hans-Peter, additional, Alvarez, Enrique, additional, Qian, Peiqing, additional, Wray, Sibyl, additional, Robertson, Derrick, additional, Huang, DeRen, additional, Selmaj, Krzysztof, additional, Wynn, Daniel, additional, Cutter, Gary, additional, Mok, Koby, additional, Hsu, Yanzhi, additional, Xu, Yihuan, additional, Weiss, Michael S., additional, Bosco, Jenna A., additional, Power, Sean A., additional, Lee, Lily, additional, Miskin, Hari P., additional, and Cree, Bruce A.C., additional

Published
2022
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22. Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial

Author

Foley, John F, primary, Defer, Gilles, additional, Ryerson, Lana Zhovtis, additional, Cohen, Jeffrey A, additional, Arnold, Douglas L, additional, Butzkueven, Helmut, additional, Cutter, Gary, additional, Giovannoni, Gavin, additional, Killestein, Joep, additional, Wiendl, Heinz, additional, Smirnakis, Karen, additional, Xiao, Shan, additional, Kong, George, additional, Kuhelj, Robert, additional, Campbell, Nolan, additional, van der Walt, Anneke, additional, Dwyer, Christopher, additional, Buzzard, Katherine, additional, Spies, Judith, additional, Parratt, John, additional, van Pesch, Vincent, additional, Willekens, Barbara, additional, Perrotta, Gaetano, additional, Bartholomé, Emmanuel, additional, Grand'Maison, Francois, additional, Jacques, Francois, additional, Giacomini, Paul, additional, Vosoughi, Reza, additional, Girard, Jean-Marc, additional, de Seze, Jerome, additional, Lebrun Frenay, Christine, additional, Ruet, Aurelie, additional, Laplaud, David-Axel, additional, Reifschneider, Gerd, additional, Wagner, Bert, additional, Rauer, Sebastian, additional, Pul, Refik, additional, Seipelt, Maria, additional, Berthele, Achim, additional, Klotz, Luisa, additional, Kallmann, Boris-Alexander, additional, Paul, Friedemann, additional, Achiron, Anat, additional, Lus, Giacomo, additional, Centonze, Diego, additional, Patti, Francesco, additional, Grimaldi, Luigi, additional, Hupperts, Raymond, additional, Frequin, Stephan, additional, Fermont, Jiske, additional, Madueno, Sara Eichau, additional, Alonso Torres, Ana Maria, additional, Costa-Frossard França, Lucienne, additional, Meca-Lallana, Jose Eustasio, additional, Ruiz, Luis Brieva, additional, Pearson, Owen, additional, Rog, David, additional, Evangelou, Nikolaos, additional, Ismail, Azza, additional, Lathi, Ellen, additional, Fox, Edward, additional, Leist, Thomas, additional, Sloane, Jacob, additional, Wu, Gregory, additional, Khatri, Bhupendra, additional, Steingo, Brian, additional, Thrower, Ben, additional, Gudesblatt, Mark, additional, Calkwood, Jonathan, additional, Bandari, Daniel, additional, Scagnelli, John, additional, Laganke, Christopher, additional, Robertson, Derrick, additional, Kipp, Lucas, additional, Belkin, Martin, additional, Cohan, Stanley, additional, Goldstick, Lawrence, additional, Courtney, Ardith, additional, Vargas, Wendy, additional, Sylvester, Andrew, additional, Srinivasan, Jayshri, additional, Kannan, Meena, additional, Picone, Maryann, additional, English, Jeffrey, additional, Napoli, Salvatore, additional, Balabanov, Roumen, additional, Zaydan, Islam, additional, Nicholas, Jacqueline, additional, Kaplan, Jeffrey, additional, Lublin, Fred, additional, Riser, Emily, additional, Miller, Tamara, additional, Alvarez, Enrique, additional, Wray, Sibyl, additional, Gross, Jeffrey, additional, Pawate, Siddharama, additional, Hersh, Carrie, additional, McCarthy, Lucas, additional, Crayton, Heidi, additional, and Graves, Jennifer, additional

Published
2022
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24. Relapse Rate and Time to First Relapse Were Improved With Ublituximab vs Teriflunomide in the Phase 3 ULTIMATE I and ULTIMATE II Studies in Patients With Relapsing Multiple Sclerosis (RMS) (P1-1.Virtual)

Author

Steinman, Lawrence, primary, Fox, Edward, additional, Hartung, Hans-Peter, additional, Alvarez, Enrique, additional, Qian, Peiqing, additional, Wray, Sibyl, additional, Robertson, Derrick, additional, Huang, DeRen, additional, Selmaj, Krzysztof, additional, Wynn, Daniel, additional, Weiss, Michael S., additional, Bosco, Jenna A., additional, Power, Sean A., additional, Mok, Koby, additional, Lee, Lily, additional, and Cree, Bruce, additional

Published
2022
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25. Infusion-Related Reactions (IRRs) With Ublituximab in Patients With Relapsing Multiple Sclerosis (RMS): Post Hoc Analyses From the Phase 3 ULTIMATE I and II Studies (P6-4.010)

Author

Fox, Edward, primary, Steinman, Lawrence, additional, Hartung, Hans-Peter, additional, Alvarez, Enrique, additional, Qian, Peiqing, additional, Wray, Sibyl, additional, Robertson, Derrick, additional, Huang, DeRen, additional, Selmaj, Krzysztof, additional, Wynn, Daniel, additional, Weiss, Michael S., additional, Bosco, Jenna A., additional, Power, Sean A., additional, Mok, Koby, additional, Lee, Lily, additional, and Cree, Bruce, additional

Published
2022
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27. Ublituximab Treatment Is Associated With a Significant Proportion of Patients Achieving No Evidence of Disease Activity (NEDA): Results From the Ultimate I and Ultimate II Phase 3 Studies of Ublituximab vs Teriflunomide in Relapsing Multiple Sclerosis (RMS) (P6-4.005)

Author

Alvarez, Enrique, primary, Steinman, Lawrence, additional, Fox, Edward, additional, Hartung, Hans-Peter, additional, Qian, Peiqing, additional, Wray, Sibyl, additional, Robertson, Derrick, additional, Huang, DeRen, additional, Selmaj, Krzysztof, additional, Wynn, Daniel, additional, Weiss, Michael S., additional, Bosco, Jenna A., additional, Power, Sean A., additional, Mok, Koby, additional, Lee, Lily, additional, and Cree, Bruce, additional

Published
2022
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28. Disability Improvements With Ublituximab in Relapsing Multiple Sclerosis (RMS): Expanded Disability Status Scale (EDSS), 9-Hole Peg Test (9-HPT), and Timed 25-Foot Walk (T25FW) Evaluations From the Phase 3 ULTIMATE I and II Studies (P5-4.009)

Author

Cree, Bruce, primary, Fox, Edward, additional, Hartung, Hans-Peter, additional, Alvarez, Enrique, additional, Qian, Peiqing, additional, Wray, Sibyl, additional, Robertson, Derrick, additional, Huang, DeRen, additional, Selmaj, Krzysztof, additional, Wynn, Daniel, additional, Weiss, Michael S., additional, Bosco, Jenna A., additional, Power, Sean A., additional, Mok, Koby, additional, Lee, Lily, additional, and Steinman, Lawrence, additional

Published
2022
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29. sj-docx-1-mso-10.1177_20552173221135888 - Supplemental material for Satisfaction with alemtuzumab in relapsing multiple sclerosis patients: Results from the real-world PRO-ACT study

Author

Wray, Sibyl, Jacques, Francois, Miller, Tamara A, Nicholas, Jacqueline A, Arroyo, Rafael, Travis, Lori, Khatri, Bhupendra, Chirieac, Magdalena, Gandhi, Roopali, Roesch, Nora, Rodrigues, Amelie, Melas-Melt, Lydie, Rawlings, Andreea M, and Hunter, Samuel F

Subjects
FOS: Clinical medicine, 110904 Neurology and Neuromuscular Diseases, Neuroscience
Abstract

Supplemental material, sj-docx-1-mso-10.1177_20552173221135888 for Satisfaction with alemtuzumab in relapsing multiple sclerosis patients: Results from the real-world PRO-ACT study by Sibyl Wray, Francois Jacques, Tamara A Miller, Jacqueline A Nicholas, Rafael Arroyo, Lori Travis, Bhupendra Khatri, Magdalena Chirieac, Roopali Gandhi, Nora Roesch, Amelie Rodrigues, Lydie Melas-Melt, Andreea M Rawlings and Samuel F Hunter in Multiple Sclerosis Journal – Experimental, Translational and Clinical

Published
2022
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30. Safety and efficacy of tolebrutinib, an oral brain-penetrant BTK inhibitor, in relapsing multiple sclerosis: a phase 2b, randomised, double-blind, placebo-controlled trial

Author

Reich, Daniel S, primary, Arnold, Douglas L, additional, Vermersch, Patrick, additional, Bar-Or, Amit, additional, Fox, Robert J, additional, Matta, Andre, additional, Turner, Timothy, additional, Wallström, Erik, additional, Zhang, Xinyan, additional, Mareš, Miroslav, additional, Khabirov, Farit A, additional, Traboulsee, Anthony, additional, Grand'Maison, Francois, additional, Jacques, Francois, additional, Tyblova, Michaela, additional, Meluzinova, Eva, additional, Ampapa, Radek, additional, Valis, Martin, additional, Hradilke, Pavel, additional, Stourac, Pavel, additional, Gross-Paju, Katrin, additional, Laplaud, David, additional, Mathey, Guillaume, additional, Uitdehaag, Bernard, additional, Evdoshenkoo, Evgeny, additional, Popova, Ekaterina, additional, Zakharova, Maria, additional, Totolyan, Natalia, additional, Litvinenko, Igor, additional, Khabirov, Farit, additional, Sivertseva, Stella, additional, Hancinova, Viera, additional, Kantorova, Ema, additional, Gines, Maria Luisa Martinez, additional, Montalban, Xavier, additional, Maduano, Sara Eichau, additional, Meca-Lallana, Jose, additional, Ramió-Torrentà, Lluís, additional, Nehrych, Tetyanna, additional, Pashkovskyy, Valeriy, additional, Moskovko, Sergii, additional, Kalbus, Oleksandr, additional, Khavunka, Marta, additional, Pryshchepa, Volodymyr, additional, Goloborodko, Alla, additional, Wynn, Daniel, additional, Honeycutt, William, additional, Wray, Sibyl, additional, Steingo, Brian, additional, LaGanke, Christopher, additional, Huang, Deren, additional, Hemphill, John Michael, additional, Goldstick, Lawrence, additional, and Robertson, Derrick, additional

Published
2021
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31. (DMT47) Stable Medulla Oblongata Volume, Lateral Ventricular Volume, and Physical Disability During 1 Year of Ozanimod Use for Early Relapsing Multiple Sclerosis.

Author

Zivadinov, Robert, Bergsland, Niels, Naismith, Robert T., Morrow, Sarah A., Bass, Ann D., Obeidat, Ahmed Z., Riser, Emily, Wray, Sibyl, Dwyer, Michael G., Riolo, Jon V., Thorpe, Andrew, Chahin Pachai, Chun-Yen Cheng, and DeLuca, John

Subjects
BRAIN stem anatomy, IMMUNOSUPPRESSIVE agents, MULTIPLE sclerosis, CEREBRAL ventricles, CLINICAL trials, TREATMENT effectiveness, CONFERENCES & conventions, PEOPLE with disabilities, PHYSICAL activity
Abstract

BACKGROUND: Spinal cord atrophy and whole brain volume (WBV) loss are associated with physical disability in patients with multiple sclerosis (MS). Medulla oblongata volume (MOV) as a surrogate for spinal cord volume and lateral ventricular volume (LVV) as a surrogate for WBV are easy-to-measure, validated biomarkers. LVV expansion of > 3.5% per year, which corresponds to WBV loss of > 0.4% per year, has been proposed to represent a pathological change in MS. A cutoff has not yet been identified for MOV. OBJECTIVES: To evaluate change at 1 year in MOV, LVV, and measures of physical disability among patients with early relapsing MS (RMS) treated with ozanimod in the ongoing ENLIGHTEN trial. METHODS: ENLIGHTEN (NCT04140305) is a prospective, multicenter, open-label study of ozanimod 0.92 mg in patients with early RMS. Participants are aged 18 to 65 years; are taking ≤ 1 MS disease-modifying therapy (DMT); have received a diagnosis of RMS within ≤ 5 years; and have an Expanded Disability Status Scale (EDSS) score of ≤ 3.5, no relapses within 30 days of screening, and ≤ 10 gadolinium-enhancing lesions on baseline brain MRI. For this analysis, MOV, LVV, Nine-Hole Peg Test (9-HPT), Timed 25-Foot Walk test (T25W), and EDSS scores at baseline and year 1 were evaluated (data cutoff: February 14, 2023). Change at 1 year was analyzed descriptively in the subset of patients with assessments at both time points. RESULTS: ENLIGHTEN participants (N = 185) were mostly women (78.4%), White (85. 9%), and DMT naive (72.4%), with a mean (SD) age of 39.5 (10.7) years at baseline, 4.1 (5.5) years since MS symptom onset, 1.1 (1.3) years since MS diagnosis, and a mean (SD) 0.8 (0.8) relapses in the year before the study. At baseline, the median MOV (n = 99) was 6.0 cm3, and LVV (n = 100) was 35.7 cm3. After 1 year of ozanimod, the change from baseline in these measures was small (median % change: MOV, --0.11%; LVV, 0.14% [n = 98 for both]). Patients' median time for completion of the 9-HPT (n = 106) was 22.0 seconds at baseline, and they completed it a median of 0.5 seconds faster after 1 year of ozanimod. For the T25W, (n = 105), median time at baseline was 5.2 seconds, with little change at year 1 (median change: 0.05 seconds). The median EDSS score (n = 122) was 2.0 at baseline and remained so at year 1 (median change: 0.0). CONCLUSIONS: During treatment with ozanimod, patients with early RMS had relatively stable MOV, LVV, and levels of physical disability over 1 year and improved their speed on the 9-HPT. The median percent change in LVV (0.14%) remained well below the 3.5% cutoff that is suggestive of pathologic change. FUNDING: Bristol Myers Squibb. Writing and editorial assistance was provided by Noud van Helmond of Peloton Advantage, LLC, an OPEN Health company, and was funded by Bristol Myers Squibb. [ABSTRACT FROM AUTHOR]

Published
2024

32. (DMT26) Longer-Term Safety and Efficacy of Ofatumumab in People With Relapsing Multiple Sclerosis Up to 6 Years.

Author

Wiendl, Heinz, Hauser, Stephen L., Nicholas, Jacqueline A., de Sèze, Jérôme, Meuth, Sven G., Giacomini, Paul S., Robertson, Derrick S., Wray, Sibyl, Bhatt, Alit, Xixi Hu, Haoyi Fu, Jehl, Valentine, Sullivan, Roseanne, Boer, Ibolya, Cohen, Jeffrey A., and Kappos, Ludwig

Subjects
THERAPEUTIC use of monoclonal antibodies, MULTIPLE sclerosis, PATIENT safety, CONFERENCES & conventions, DRUG efficacy, DISEASE relapse
Abstract

BACKGROUND: Ofatumumab, a fully human anti-CD20 monoclonal antibody, demonstrated superior efficacy vs teriflunomide in the phase 3 ASCLEPIOS I/II (NCT02792218/ NCT02792231) trials in people with relapsing multiple sclerosis (PwRMS). Previously reported data for up to 5 years demonstrated sustained efficacy and a favorable safety profile in PwRMS. OBJECTIVES: To assess ofatumumab's longer-term safety and efficacy for up to 6 years in PwRMS. METHODS: Efficacy analyses will include all participants randomly assigned to cohorts in ASCLEPIOS I/II and their data from the first dose in ASCLEPIOS I/ II, whereas safety analyses will include all participants who received at least 1 dose of ofatumumab in ASCLEPIOS I/II, APOLITOS (NCT03249714), APLIOS (NCT03560739), or ALITHIOS (NCT03650114; cutoff: September 25, 2023). Efficacy will be analyzed by the randomized treatment in the core study, with those randomly assigned to ofatumumab being referred to as the continuous group and those randomly assigned to teriflunomide as the switch group. RESULTS: Mean baseline age in ASCLEPIOS I/II (N = 1882) was 38 years, 67.6% were female, and mean Expanded Disability Status Scale score was 2.9 in both groups. Previously reported 5-year data (cutoff: September 25, 2022) for ofatumumab showed a sustained, low annualized relapse rate (ARR) and sustained and almost complete suppression of MRI lesion activity in the continuous group. In the switch group, ARR was markedly reduced from years 2-3 (0.16- 0.06) and remained low through years 3-5 (0.05). MRI lesion activity was almost completely suppressed through years 3-5. At year 5, 9 of 10 patients reached no evidence of disease activity in both groups. Exposure-adjusted incidence rate of adverse events (AEs), serious AEs, serious infections, and malignancies remained consistent, with no increased risk over 5 years. Mean immunoglobulin (Ig) G levels remained stable (above the lower limit of normal [LLN]: 5.65 g/L), whereas mean IgM levels decreased but remained above the LLN (0.4 g/L). Updated 6-year efficacy and safety results will be presented at the annual meeting. CONCLUSIONS: These analyses will help inform physicians on the longer-term safety and efficacy profile of ofatumumab in PwRMS. [ABSTRACT FROM AUTHOR]

Published
2024

33. sj-pdf-1-tan-10.1177_1756286421993999 – Supplemental material for Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study

Author

Wundes, Annette, Wray, Sibyl, Gold, Ralf, Singer, Barry A., Elzbieta Jasinska, Tjalf Ziemssen, Seze, Jerome De, Repovic, Pavle, Hailu Chen, Hanna, Jerome, Messer, Jordan, Miller, Catherine, and Naismith, Robert T.

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

Supplemental material, sj-pdf-1-tan-10.1177_1756286421993999 for Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study by Annette Wundes, Sibyl Wray, Ralf Gold, Barry A. Singer, Elzbieta Jasinska, Tjalf Ziemssen, Jerome de Seze, Pavle Repovic, Hailu Chen, Jerome Hanna, Jordan Messer, Catherine Miller and Robert T. Naismith in Therapeutic Advances in Neurological Disorders

Published
2021
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34. sj-pdf-2-tan-10.1177_1756286421993999 – Supplemental material for Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study

Author

Wundes, Annette, Wray, Sibyl, Gold, Ralf, Singer, Barry A., Elzbieta Jasinska, Tjalf Ziemssen, Seze, Jerome De, Repovic, Pavle, Hailu Chen, Hanna, Jerome, Messer, Jordan, Miller, Catherine, and Naismith, Robert T.

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

Supplemental material, sj-pdf-2-tan-10.1177_1756286421993999 for Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study by Annette Wundes, Sibyl Wray, Ralf Gold, Barry A. Singer, Elzbieta Jasinska, Tjalf Ziemssen, Jerome de Seze, Pavle Repovic, Hailu Chen, Jerome Hanna, Jordan Messer, Catherine Miller and Robert T. Naismith in Therapeutic Advances in Neurological Disorders

Published
2021
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35. Efficacy and safety of ublituximab versus teriflunomide in relapsing multiple sclerosis: Results of the Phase 3 ULTIMATE I and II trials (4494)

Author

Steinman, Lawrence, primary, Fox, Edward, additional, Hartung, Hans-Peter, additional, Alvarez, Enrique, additional, Qian, Peiqing, additional, Wray, Sibyl, additional, Robertson, Derrick, additional, Huang, Deren, additional, Selmaj, Krzysztof, additional, Wynn, Daniel, additional, Weiss, Michael, additional, Bosco, Jenna, additional, Power, Sean, additional, Mok, Koby, additional, and Cree, Bruce, additional

Published
2021
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38. Le diroximel fumarate (DRF) chez les patients atteints de sclérose en plaques récurrente-rémittente : résultats intermédiaires de sécurité et d’efficacité de l’étude de phase 3 EVOLVE-MS-1

Author

Wray, Sibyl, primary, Singer, Barry A., additional, Drulovic, Jelena, additional, Chen, Hailu, additional, Hanna, Jerome, additional, Lyons, Jennifer, additional, Bergh, Florian Puis Then, additional, Negroski, Donald, additional, and Kapadia, Shivani, additional

Published
2021
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40. Improved gastrointestinal profile with diroximel fumarate is associated with a positive impact on quality of life compared with dimethyl fumarate: results from the randomized, double-blind, phase III EVOLVE-MS-2 study

Author

Wundes, Annette, primary, Wray, Sibyl, additional, Gold, Ralf, additional, Singer, Barry A., additional, Jasinska, Elzbieta, additional, Ziemssen, Tjalf, additional, de Seze, Jerome, additional, Repovic, Pavle, additional, Chen, Hailu, additional, Hanna, Jerome, additional, Messer, Jordan, additional, Miller, Catherine, additional, and Naismith, Robert T., additional

Published
2021
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42. A phase 2 multicenter study of ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis

Author

Fox, Edward, primary, Lovett-Racke, Amy E, additional, Gormley, Matthew, additional, Liu, Yue, additional, Petracca, Maria, additional, Cocozza, Sirio, additional, Shubin, Richard, additional, Wray, Sibyl, additional, Weiss, Michael S, additional, Bosco, Jenna A, additional, Power, Sean A, additional, Mok, Koby, additional, and Inglese, Matilde, additional

Published
2020
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44. Baseline Demographics and Disease Characteristics from the ULTIMATE Phase III Trials Evaluating Ublituximab, a Novel Glycoengineered Anti-CD20 Monoclonal Antibody, in Patients with Relapsing Multiple Sclerosis (4845)

Author

Steinman, Lawrence, primary, Fox, Edward, additional, Hartung, Hans-Peter, additional, Cree, Bruce, additional, Alvarez, Enrique, additional, Qian, Peiqing, additional, Wray, Sibyl, additional, Robertson, Derrick, additional, Huang, Deren, additional, Selmaj, Krzystof, additional, Wynn, Daniel, additional, Weiss, Michael, additional, Bosco, Jenna, additional, Power, Sean, additional, and Mok, Koby, additional

Published
2020
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46. Improved Gastrointestinal Tolerability Profile with Diroximel Fumarate Compared to Dimethyl Fumarate in Relapsing MS Patients (994)

Author

Wundes, Annette, primary, Wolinsky, Jerry S., additional, Wray, Sibyl, additional, Ziemssen, Tjalf, additional, Jasinska, Elzbieta, additional, Freedman, Mark S., additional, Bidollari, Ilda, additional, Chen, Hailu, additional, Hanna, Jerome, additional, Leigh-Pemberton, Richard, additional, Lyons, Jennifer, additional, Messer, Jordan, additional, and Naismith, Robert T., additional

Published
2020
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47. Alemtuzumab Maintains Efficacy on Clinical and MRI Disease Activity Outcomes, Including Slowing of Brain Volume Loss, Over 9 Years in RRMS Patients: CARE-MS II Follow-up (TOPAZ Study) (151)

Author

Bass, Ann D., primary, Alroughani, Raed, additional, Broadley, Simon, additional, Comi, Giancarlo, additional, Mao-Draayer, Yang, additional, Hartung, Hans-Peter, additional, Havrdova, Eva Kubala, additional, Kim, Ho Jin, additional, Nakamura, Kunio, additional, Navas, Carlos, additional, Rovira, Alex, additional, Selmaj, Krzysztof W., additional, Vermersch, Patrick, additional, Wray, Sibyl, additional, Choudhry, Zia, additional, Daizadeh, Nadia, additional, Afsar, Salman, additional, and Singer, Barry A., additional

Published
2020
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48. Supplemental material for Patients transitioning from non-pegylated to pegylated interferon beta-1a have a low risk of new flu-like symptoms: ALLOW phase 3b trial results

Author

Naismith, Robert T, Hendin, Barry, Wray, Sibyl, Huang, DeRen, Gaudenzi, Fiorenza, Qunming Dong, Sperling, Bjørn, Mann, Monica, and Werneburg, Brian

Subjects
FOS: Clinical medicine, 110904 Neurology and Neuromuscular Diseases, Neuroscience
Abstract

Supplemental Material for Patients transitioning from non-pegylated to pegylated interferon beta-1a have a low risk of new flu-like symptoms: ALLOW phase 3b trial results by Robert T Naismith, Barry Hendin, Sibyl Wray, DeRen Huang, Fiorenza Gaudenzi, Qunming Dong, Bjørn Sperling, Monica Mann and Brian Werneburg in Multiple Sclerosis Journal—Experimental, Translational and Clinical

Published
2019
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49. MSJ881759_supplemental_material – Supplemental material for Efficacy of alemtuzumab over 6 years in relapsing–remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies

Author

Wijmeersch, Bart Van, Singer, Barry A, Boster, Aaron, Broadley, Simon, Fernández, Óscar, Freedman, Mark S, Izquierdo, Guillermo, Lycke, Jan, Pozzilli, Carlo, Sharrack, Basil, Steingo, Brian, Wiendl, Heinz, Wray, Sibyl, Tjalf Ziemssen, Chung, Luke, Margolin, David H, Karthinathan Thangavelu, and Vermersch, Patrick

Subjects
FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 110904 Neurology and Neuromuscular Diseases
Abstract

Supplemental material, MSJ881759_supplemental_material for Efficacy of alemtuzumab over 6 years in relapsing–remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies by Bart Van Wijmeersch, Barry A Singer, Aaron Boster, Simon Broadley, Óscar Fernández, Mark S Freedman, Guillermo Izquierdo, Jan Lycke, Carlo Pozzilli, Basil Sharrack, Brian Steingo, Heinz Wiendl, Sibyl Wray, Tjalf Ziemssen, Luke Chung, David H Margolin, Karthinathan Thangavelu and Patrick Vermersch in Multiple Sclerosis Journal

Published
2019
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50. Efficacy of alemtuzumab over 6 years in relapsing–remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies

Author

Van Wijmeersch, Bart, primary, Singer, Barry A, additional, Boster, Aaron, additional, Broadley, Simon, additional, Fernández, Óscar, additional, Freedman, Mark S, additional, Izquierdo, Guillermo, additional, Lycke, Jan, additional, Pozzilli, Carlo, additional, Sharrack, Basil, additional, Steingo, Brian, additional, Wiendl, Heinz, additional, Wray, Sibyl, additional, Ziemssen, Tjalf, additional, Chung, Luke, additional, Margolin, David H, additional, Thangavelu, Karthinathan, additional, and Vermersch, Patrick, additional

Published
2019
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