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3. Concurrent administration of serotonergic antidepressants and ozanimod in participants with relapsing multiple sclerosis from the open-label extension DAYBREAK trial.

Author

Naismith, Robert, Cohen, Jeffrey, Bar-Or, Amit, Comi, Giancarlo, Selmaj, Krzysztof, Hartung, Hans-Peter, Sheffield, James, Krakovich, Anthony, Tatosian, Daniel, Cheng, Chun-Yen, Reardon, Jennifer, Khaychuk, Vadim, Riolo, Jon, Silva, Diego, and Cree, Bruce

Subjects
Multiple sclerosis, selective serotonin reuptake inhibitors, serotonin–norepinephrine reuptake inhibitors, sphingosine 1-phosphate receptor modulators, Humans, Selective Serotonin Reuptake Inhibitors, Serotonin and Noradrenaline Reuptake Inhibitors, Serotonin, Multiple Sclerosis, Antidepressive Agents, Indans, Oxadiazoles
Abstract

BACKGROUND: Monoamine oxidase (MAO) inhibitors can interact with selective serotonin reuptake inhibitors (SSRIs)/serotonin-norepinephrine reuptake inhibitors (SNRIs). There is clinical interest surrounding use of ozanimod with SSRIs/SNRIs because the major metabolites of ozanimod are weak inhibitors of MAO-B in vitro. OBJECTIVE: To evaluate the incidence of treatment-emergent adverse events (TEAEs) potentially related to serotonin accumulation (SA) during concomitant ozanimod and SSRI/SNRI use by performing analyses of data from an open-label, oral ozanimod 0.92 mg trial (DAYBREAK; NCT02576717). METHODS: SA narrow (serotonin syndrome, neuroleptic malignant syndrome, and hyperthermia malignant) and broad (terms potentially associated with SA) MedDRA v24.0 searches were performed using TEAE data from participants with relapsing multiple sclerosis who entered DAYBREAK from phase 3 studies (cutoff February 1, 2022). Incidences of TEAEs matching terms from each search were stratified by SSRI/SNRI use. RESULTS: Of 2257 DAYBREAK participants, 274 (12.1%) used an SSRI/SNRI. No participants had TEAEs matching the SA narrow search terms. There was no significant difference in the percentage of participants with ⩾1 TEAE matching the SA broad search for those on versus off SSRIs/SNRIs (on: 12.4%, n = 34/274; off: 15.6%, n = 310/1982, nominal p = 0.1630). CONCLUSION: MedDRA searches showed no increase in TEAEs potentially associated with SA with concomitant SSRI/SNRI and ozanimod use.

Published
2024

4. Multiple sclerosis: time for early treatment with high-efficacy drugs.

Author

Barnett, Michael, Thompson, Alan, Hartung, Hans-Peter, Selmaj, Krzysztof, and Cree, Bruce

Subjects
Escalation therapy, High-efficacy drugs, Multiple sclerosis, Safety, Humans, Multiple Sclerosis, Pharmaceutical Preparations, Treatment Outcome, Multiple Sclerosis, Relapsing-Remitting, Randomized Controlled Trials as Topic
Abstract

This review addresses current changes in the approach to treating patients with multiple sclerosis (MS). The widely practiced approach of utilizing agents with lower treatment efficacy (LETA) at onset with subsequent escalation has been challenged by new data suggesting that MS patients derive greater benefit when therapy is initiated with high-efficacy treatment agents (HETA). Several recent studies compared treatment efficacy and safety of early administration of HETA versus LETA. The results of randomized, double blind, phase III studies with LETA as a control arm and population-based larger and longer studies using propensity scoring, marginal structural modeling and weighted cumulative exposure analysis support the benefit of early treatment with HETA. Patients initiating their treatment with HETA, regardless of prognostic factors and MRI burden at baseline, showed significantly lower annualized relapse rate (ARR) and reduced disability progression in follow-up periods of up to 10-15 years. Moreover, the safety profile of recently approved HETA ameliorates concerns about off-target effects associated with a number of earlier high-efficacy drugs. Patient perception has also changed with an increasing preference for medication profiles that both improve symptoms and prevent disease progression. Accumulating data from randomized studies and the results of large population-based studies demonstrating short-term and longer-term patient benefits support the view that HETA should be more widely used. The adoption of early treatment with HETA capitalizes on a window of opportunity for anti-inflammatory drugs to maximally impact disease pathology and heralds a sea change in clinical practice toward pro-active management and away from a philosophy routed in generating clinical benefit as a consequence of treatment failure.

Published
2024

6. Safety, tolerability, and efficacy of subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ADHERE): a multicentre, randomised-withdrawal, double-blind, placebo-controlled, phase 2 trial

Author

Grinzinger, Susanne, Wanschitz, Julia, Seifert-Held, Thomas, Claeys, Kristl G., Baets, Jonathan, Remiche, Gauthier, Bissay, Véronique, Dubuisson, Nicolas, Delstanche, Stephanie, Tarnev, Ivaylo, Genov, Krasimir, Tsvetanov, Plamen, Milanov, Ivan, Zhao, Chongbo, Bu, Bitao, Yu, Xuefan, Li, Wei, Jiang, Haishan, Da, Yuwei, Lu, Zuneng, Liang, Hui, Guo, Fuqiang, Li, Zunbo, Zou, Zhangyu, Hong, Daojun, Yang, Huan, Guo, Junhong, Shi, Jianquan, Tu, Jianglong, He, Dian, Wang, Yiqi, Ding, Jing, Zhang, Yali, Zhao, Yuanqi, Xu, Renxi, Yue, Yunhua, Guo, Aihong, Wang, Yuzhong, Talab, Radomir, Harbo, Thomas, Sindrup, Soeren, De Seze, Jérôme, Sacconi, Sabrina, Péréon, Yann, Echaniz-Laguna, Andoni, Magy, Laurent, Nicolas, Guillaume, Taithe, Frédéric, Cassereau, Julien, Debs, Rabab, Shakarishvili, Roman, Tsiskaridze, Alexander, Mania, Maka, Janelidze, Marina, Janelidze, Tamar, Schroeter, Michael, Skripuletz, Thomas, Lee, De-Hyung, Klehmet, Juliane, Hotter, Benjamin, Hoffmann, Olaf, Baum, Petra, Zschuentzsch, Jana, Pitarokoili, Kalliopi, Stettner, Mark, Bereczki, Dániel, Pánczél, Gyula, Abraham, Alon, Dori, Amir, Lampl, Yair, Manganelli, Fiore, Morino, Stefania, Padovani, Alessandro, Siciliano, Gabriele, Schenone, Angelo, Magri, Francesca, Mazzeo, Anna, Giannini, Fabio, Sorbi, Sandro, Chiò, Adriano, Kuwahara, Motoi, Okuno, Tatsusada, Okamoto, Tomoko, Kokubun, Norito, Nishiyama, Kazutoshi, Kaida, Kenichi, Bokuda, Kota, Katsuno, Masahisa, Yabe, Ichiro, Saji, Etsuji, Yokota, Takanori, Hatanaka, Yuki, Nakahara, Jin, Sugimoto, Takamichi, Tanaka, Fumiaki, Tomita, Satoshi, Yamano, Yoshihisa, Hayashi, Tomohiro, Yamazaki, Hiroki, Tokashiki, Takashi, Horiuchi, Kazuhiro, Karelis, Guntis, Eftimov, Filip, Banach, Marta, Chyrchel-Paszkiewicz, Urszula, Kochanowicz, Jan, Selmaj, Krzysztof, Zielinski, Tomasz, Banaszkiewicz, Krzysztof, Mitrea, Dan, Scutaru-Kadar, Ana-Maria, Axelerad, Any, Stuchevskaya, Fatima, Boyko, Alexey, Khabirov, Farit, Trushnikova, Tatiana, Goncharova, Zoya, Suponeva, Natalia, Dorogov, Nikolay, Yakupov, Eduard, Raicevic, Ranko, Miletic Drakulic, Svetlana, Cabrera Serrano, Macarena, Muñoz Blanco, Jose Luis, Guerrero Sola, Antonio, Aguera Morales, Eduardo, Diaz Marin, Carmen, Juntas Morales, Raúl, Yeh, Jiann-Horng, Sung, Jia-Ying, Huang, Han-Wei, Tsai, Nai-Wen, Guo, Yuh-Cherng, Chao, Chi-Chao, Ro, Long-Sun, Sengun, Ihsan, Terzi, Murat, Alpaydin Baslo, Sezin, Koç, Filiz, Necdet Karli, Hamdi, Shulga, Olga, Smolko, Dmytro, Doroshenko, Oleksandr, Tomakh, Nataliya, Kyrychenko, Alla, Seliuk, Olga, Kalbus, Oleksandr, Skrypchenko, Iryna, Novakovska, Olha, Carod-Artal, Francisco Javier, Rinaldi, Simon, Brennan, Kathryn, Ellis, Simon, Carr, Aisling, Matthews, Emma, Traub, Rebecca, Mozaffar, Tahseen, Elliott, Matthew, Bhavaraju-Sanka, Ratna, Nance, Christopher, Levine, Todd, Lisak, Robert, Pasnoor, Mamatha, Pulley, Michael, Roy, Bhaskar, Govindarajan, Raghav, Sahagian, Gregory, Khella, Sami, Jacob, Daniel, Kushlaf, Hani, Sivakumar, Kumaraswamy, Melamed, Isaac, Sharma, Khema, Quick, Adam, Ubogu, Eroboghene, Lacomis, David, Isa, Arnaldo, Brannagan, Thomas, Chen, Shan, Katz, Jonathan, Feinberg, Marc, Pavlakis, Pantelis, Lange, Dale, Gudesblatt, Mark, Tandan, Rup, Gable, Karissa, Rivner, Michael, Barnes, Benjamin, Luke, Donna, Mahuwala, Zabeen, Macwan, Samir, Kwon, Patrick, Scott, James, Altamimi, Sadiq, Sabharwal, Priyanka, Allen, Jeffrey A, Lin, Jie, Basta, Ivana, Dysgaard, Tina, Eggers, Christian, Guptill, Jeffrey T, Gwathmey, Kelly G, Hewamadduma, Channa, Hofman, Erik, Hussain, Yessar M, Kuwabara, Satoshi, Le Masson, Gwendal, Leypoldt, Frank, Chang, Ting, Lipowska, Marta, Lowe, Murray, Lauria, Giuseppe, Querol, Luis, Simu, Mihaela-Adriana, Suresh, Niraja, Tse, Anissa, Ulrichts, Peter, Van Hoorick, Benjamin, Yamasaki, Ryo, Lewis, Richard A, and van Doorn, Pieter A

Published
2024
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7. Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study

Author

Cohen, Jeffrey A, Comi, Giancarlo, Arnold, Douglas L, Bar-Or, Amit, Selmaj, Krzysztof W, Steinman, Lawrence, Havrdová, Eva K, Cree, Bruce AC, Montalbán, Xavier, Hartung, Hans-Peter, Huang, Vivian, Frohna, Paul, Skolnick, Brett E, Kappos, Ludwig, and Investigators, for the RADIANCE Trial

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Neurosciences, Multiple Sclerosis, Brain Disorders, Clinical Research, Neurodegenerative, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adolescent, Adult, Double-Blind Method, Female, Humans, Indans, Magnetic Resonance Imaging, Male, Middle Aged, Multiple Sclerosis, Relapsing-Remitting, Outcome Assessment, Health Care, Oxadiazoles, Sphingosine 1 Phosphate Receptor Modulators, Young Adult, Clinical trial, disease-modifying therapies, MRI, relapsing, remitting, T2 lesions, multiple sclerosis, RADIANCE Trial Investigators, relapsing/remitting, Neurology & Neurosurgery, Clinical sciences, Biological psychology
Abstract

BackgroundOzanimod, an oral immunomodulator, selectively targets sphingosine 1-phosphate receptors 1 and 5.ObjectiveEvaluate efficacy, safety, and tolerability of ozanimod in relapsing multiple sclerosis.MethodsIn the RADIANCE Part A phase II study (NCT01628393), participants with relapsing multiple sclerosis were randomized (1:1:1) to once-daily ozanimod hydrochloride (0.5 or 1 mg) or placebo. After 24 weeks, participants could enter a 2-year, dose-blinded extension. Ozanimod-treated participants continued their assigned dose; placebo participants were re-randomized (1:1) to ozanimod hydrochloride 0.5 or 1 mg (equivalent to ozanimod 0.46 and 0.92 mg).ResultsA total of 223 (89.6%) of the 249 participants completed the blinded extension. At 2 years of the extension, the percentage of participants who were gadolinium-enhancing lesion-free ranged from 86.5% to 94.6%. Unadjusted annualized relapse rate during the blinded extension (week 24-end of treatment) was 0.32 for ozanimod hydrochloride 0.5 mg → ozanimod hydrochloride 0.5 mg, 0.18 for ozanimod hydrochloride 1 mg → ozanimod hydrochloride 1 mg, 0.30 for placebo → ozanimod hydrochloride 0.5 mg, and 0.18 for placebo → ozanimod hydrochloride 1 mg. No second-degree or higher atrioventricular block or serious opportunistic infection was reported.ConclusionOzanimod demonstrated sustained efficacy in participants continuing treatment up to 2 years and reached similar efficacy in participants who switched from placebo; no unexpected safety signals emerged.

Published
2019

8. 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 J., Hartung, Hans-Peter, Qian, Peiqing, Wray, Sibyl, Robertson, Derrick, Selmaj, Krzysztof, Wynn, Daniel, Mok, Koby, Xu, Yihuan, Bodhinathan, Karthik, Miskin, Hari P., and Cree, Bruce A. C.

Subjects
ANTIBODY-dependent cell cytotoxicity, INTRAVENOUS therapy, MULTIPLE sclerosis, DISEASE relapse, MONOCLONAL antibodies
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 or ≥3 years following diagnosis), treatment history (treatment naïve or previously treated), 0 or ≥1 Gd+ T1 lesions at baseline, and Expanded Disability Status Scale score ≤ 3.5 or >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. [ABSTRACT FROM AUTHOR]

Published
2024
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9. No evidence of disease activity (NEDA) analysis by epochs in patients with relapsing multiple sclerosis treated with ocrelizumab vs interferon beta-1a

Author

Havrdová, Eva, Arnold, Douglas L, Bar-Or, Amit, Comi, Giancarlo, Hartung, Hans-Peter, Kappos, Ludwig, Lublin, Fred, Selmaj, Krzysztof, Traboulsee, Anthony, Belachew, Shibeshih, Bennett, Iain, Buffels, Regine, Garren, Hideki, Han, Jian, Julian, Laura, Napieralski, Julie, Hauser, Stephen L, and Giovannoni, Gavin

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Brain Disorders, Multiple Sclerosis, Clinical Trials and Supportive Activities, Clinical Research, Neurodegenerative, Neurosciences, Autoimmune Disease, MRI activity, NEDA, disability progression, disease activity, relapse, Epidemiology, Health services and systems
Abstract

BackgroundNo evidence of disease activity (NEDA; defined as no 12-week confirmed disability progression, no protocol-defined relapses, no new/enlarging T2 lesions and no T1 gadolinium-enhancing lesions) using a fixed-study entry baseline is commonly used as a treatment outcome in multiple sclerosis (MS).ObjectiveThe objective of this paper is to assess the effect of ocrelizumab on NEDA using re-baselining analysis, and the predictive value of NEDA status.MethodsNEDA was assessed in a modified intent-to-treat population (n = 1520) from the pooled OPERA I and OPERA II studies over various epochs in patients with relapsing MS receiving ocrelizumab (600 mg) or interferon beta-1a (IFN β-1a; 44 μg).ResultsNEDA was increased with ocrelizumab vs IFN β-1a over 96 weeks by 75% (p

Published
2018

10. OCARINA II, Phase III Study: Results of Subcutaneous Ocrelizumab Administration in Patients with Multiple Sclerosis (S31.006)

Author

Newsome, Scott, primary, Krzystanek, Ewa, additional, Selmaj, Krzysztof, additional, Goldstick, Lawrence, additional, Figueiredo, Catarina, additional, Townsend, Ben, additional, Wolf, Christian, additional, Zecevic, Dusanka, additional, Giacobino, Caroline, additional, Bortolami, Oscar, additional, Shen, Yun-An, additional, Kletzl, Heidemarie, additional, Clinch, Susanne, additional, and Centonze, Diego, additional

Published
2024
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11. Long-term Efficacy of the Sphingosine 1-Phosphate Receptor Modulator Ozanimod by Age Category in Patients with Relapsing Multiple Sclerosis: Final Results from Two Phase 3 Trials and an Open-label Extension Trial (P2-6.007)

Author

Steinman, Lawrence, primary, Selmaj, Krzysztof, additional, Comi, Giancarlo, additional, Bar-Or, Amit, additional, Arnold, Douglas, additional, Hartung, Hans-Peter, additional, Montalban, Xavier, additional, Havrdova, Eva, additional, Sheffield, James, additional, Cheng, Chun-Yen, additional, Reardon, Jennifer, additional, Riolo, Jon, additional, Deboer, Erik, additional, Kappos, Ludwig, additional, Cohen, Jeffrey, additional, and Cree, Bruce, additional

Published
2024
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12. Safety Patterns over Time with Ozanimod During an Open-label Extension Trial in Patients with Relapsing Multiple Sclerosis (P10-6.012)

Author

Selmaj, Krzysztof, primary, Ziemssen, Tjalf, additional, Comi, Giancarlo, additional, Hartung, Hans-Peter, additional, Reardon, Jennifer, additional, Thorpe, Andrew, additional, Riolo, Jon, additional, Cheng, Chun-Yen, additional, Sheffield, James, additional, Krakovich, Anthony, additional, Vermersch, Patrick, additional, and Cree, Bruce, additional

Published
2024
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13. Myelin-oligodendrocyte glycoprotein antibody-associated disease

Author

Marignier, Romain, Hacohen, Yael, Cobo-Calvo, Alvaro, Pröbstel, Anne-Katrin, Aktas, Orhan, Alexopoulos, Harry, Amato, Maria-Pia, Asgari, Nasrin, Banwell, Brenda, Bennett, Jeffrey, Brilot, Fabienne, Capobianco, Marco, Chitnis, Tanuja, Ciccarelli, Olga, Deiva, Kumaran, De Sèze, Jérôme, Fujihara, Kazuo, Jacob, Anu, Kim, Ho Jin, Kleiter, Ingo, Lassmann, Hans, Leite, Maria-Isabel, Linington, Christopher, Meinl, Edgar, Palace, Jacqueline, Paul, Friedemann, Petzold, Axel, Pittock, Sean, Reindl, Markus, Sato, Douglas Kazutoshi, Selmaj, Krzysztof, Siva, Aksel, Stankoff, Bruno, Tintore, Mar, Traboulsee, Anthony, Waters, Patrick, Waubant, Emmanuelle, Weinshenker, Brian, Derfuss, Tobias, Vukusic, Sandra, and Hemmer, Bernhard

Published
2021
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14. Pregnancy Outcomes in the Ozanimod Clinical Development Program in Patients With Ulcerative Colitis, Crohn's Disease, and Relapsing Multiple Sclerosis

Author

Dubinsky, Marla C., Charles, Lorna, Selmaj, Krzysztof W., Comi, Giancarlo, Krakovich, Anthony, Rosen, Melissa, van der Woude, C. Janneke, Mahadevan, Uma, Dubinsky, Marla C., Charles, Lorna, Selmaj, Krzysztof W., Comi, Giancarlo, Krakovich, Anthony, Rosen, Melissa, van der Woude, C. Janneke, and Mahadevan, Uma

Abstract

This study evaluated pregnancy outcomes in patients with ulcerative colitis, Crohn's disease, or multiple sclerosis and in healthy volunteers treated with ozanimod. There was no increased incidence of fetal abnormalities or adverse pregnancy outcomes with ozanimod exposure during early pregnancy.

Published
2024

16. Characterizing absolute lymphocyte count profiles in dimethyl fumarate-treated patients with MS: Patient management considerations.

Author

Fox, Robert, Chan, Andrew, Gold, Ralf, Phillips, J, Selmaj, Krzysztof, Chang, Ih, Novas, Mark, Rana, Jitesh, and Marantz, Jing

Abstract

BACKGROUND: Delayed-release dimethyl fumarate (DMF), indicated for the treatment of patients with relapsing-remitting multiple sclerosis (MS), is a disease-modifying therapy with potential immunomodulatory and neuroprotective effects. In clinical trials, DMF was associated with reduced white blood cell and absolute lymphocyte counts. Current US prescribing information recommends obtaining a complete blood count, including absolute lymphocyte count (ALC), before initiating and during DMF treatment. METHODS: We conducted an integrated analysis of phase 2b/3/long-term extension studies of DMF in MS (N = 2,470) to characterize ALC profiles. RESULTS: Mean ALCs decreased by 30% during the first year and then plateaued, remaining above the lower limit of normal (LLN). Among patients treated ≥6 months (N = 2,099), 2.2% experienced ALCs

Published
2016

21. Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial

Author

Agüera Morales, Eduardo, Al Khedr, Abdullatif, Ampapa, Radek, Arroyo, Rafael, Belkin, Martin, Bonek, Robert, Boyko, Alexey, Capra, Ruggero, Centonze, Diego, Clavelou, Pierre, Debouverie, Marc, Drulovic, Jelena, Edwards, Keith, Evangelou, Nikos, Evdoshenko, Evgeniy, Fernández, Oscar, Fernández Sánchez, Victoria, Freedman, Mark, Freedman, Steven, Fryze, Waldemar, Garcia-Merino, Antonio, Gavric-Kezic, Mira, Ghezzi, Angel, Gout, Olivier, Grimaldi, Luigi, Hendin, Barry, Hertmanowska, Hanka, Hintzen, Rogier, Hradilek, Pavel, Hupperts, Raymond, Ilkowski, Jan, Ivashinenkova, Evelina, Izquierdo, Guillermo, Jacques, Francois, Jakab, Gabor, Khabirov, Farit, Klodowska-Duda, Gabriela, Komoly, Samuel, Kostic, Smiljana, Kovarova, Ivana, Kremenchuzky, Marcelo, Laganke, Christopher, LaPierre, Yves, Maciejowski, Maciej, Maison, Francois Grand, Marfia, Girolama Alessandra, Martínez Yélamos, Sergio, Meluzinova, Eva, Montalban, Xavier, Murray, Ronald, Naismith, Robert, Newsome, Scott, Nguyen, Viet, Oreja, Delia, Pardo, Gabriel, Pasechnik, Elena, Patti, Francesco, Potemkowski, Andrzej, Prokopenko, Semen, Qian, Peiqing, Rodríguez-Antigüedad, Alfredo, Rossman, Howard, Rozsa, Csilla, Sánchez López, Fernando, Selmaj, Krzysztof, Silber, Eli, Stepien, Adam, Stepniewska, Anna, Swiat, Maciej, Toncev, Gordana, Tourbah, Ayman, Trushnikova, Tatyana, Uccelli, Antonio, Vachova, Marta, Valis, Martin, Vecsei, Laszlo, Wiertlewski, Sandrine, Zaffaroni, Mauro, Zielinski, Tomasz, Cadavid, Diego, Mellion, Michelle, Edwards, Keith R, Calabresi, Peter A, Drulović, Jelena, Giovannoni, Gavin, Hartung, Hans-Peter, Arnold, Douglas L, Fisher, Elizabeth, Rudick, Richard, Mi, Sha, Chai, Yi, Li, Jie, Zhang, Yiwei, Cheng, Wenting, Xu, Lei, Zhu, Bing, Green, Susan M, Chang, Ih, Deykin, Aaron, and Sheikh, Sarah I

Published
2019
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22. Concurrent administration of serotonergic antidepressants and ozanimod in participants with relapsing multiple sclerosis from the open-label extension DAYBREAK trial

Author

Naismith, Robert T, primary, Cohen, Jeffrey A, additional, Bar-Or, Amit, additional, Comi, Giancarlo, additional, Selmaj, Krzysztof W, additional, Hartung, Hans-Peter, additional, Sheffield, James K, additional, Krakovich, Anthony, additional, Tatosian, Daniel, additional, Cheng, Chun-Yen, additional, Reardon, Jennifer, additional, Khaychuk, Vadim, additional, Riolo, Jon V, additional, Silva, Diego, additional, and Cree, Bruce AC, additional

Published
2023
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24. Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study

Author

Brochet, Bruno, primary, Solari, Alessandra, additional, Lechner-Scott, Jeannette, additional, Piehl, Fredrik, additional, Langdon, Dawn, additional, Hupperts, Raymond, additional, Selmaj, Krzysztof, additional, Patti, Francesco, additional, Brieva, Luis, additional, Maida, Eva Maria, additional, Alexandri, Nektaria, additional, Smyk, Andrzej, additional, Nolting, Axel, additional, Keller, Birgit, additional, Montalban, Xavier, additional, and Kubala Havrdova, Eva, additional

Published
2023
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25. 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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29. Oral fingolimod for chronic inflammatory demyelinating polyradiculoneuropathy (FORCIDP Trial): a double-blind, multicentre, randomised controlled trial

Author

Day, Timothy, Spies, Judith, Roberts, Leslie, Van Damme, Philip, Van den Bergh, Peter YK, Maertens de Noordhout, Alain, Dionne, Annie, Larue, Sandrine, Massie, Rami, Melanson, Michel, Camu, William, De Seze, Jérôme, Le Masson, Gwendal, Pouget, Jean, Schmidt, Jens, Kimiskidis, Vasilios K, Chapman, Joab, Drory, Vivian E, Fazio, Raffaella, Gallia, Francesca, Kusunoki, Susumu, Mori, Masahiro, Iijima, Masahiro, Okamoto, Tomoko, Baba, Masayuki, Faber, Catharina G, van Schaik, Ivo N, Fryze, Waldemar, Motta, Ewa, Selmaj, Krzysztof, Casasnovas, Carlos, Sola, Antonio Guerrero, Illa, Isabel, Holt, James, Miller, James AL, Lunn, Michael P, Brannagan, Thomas H, III, Brown, Martin, Kelemen, John, Iyadurai, Stanley, Rezania, Kourosh, Sharma, Khema R, Tandan, Rup, Gudesblatt, Mark, Lawson, Victoria, Amato, Anthony A, Hughes, Richard, Dalakas, Marinos C, Merkies, Ingemar, Latov, Norman, Léger, Jean-Marc, Nobile-Orazio, Eduardo, Sobue, Gen, Genge, Angela, Cornblath, David, Merschhemke, Martin, Ervin, Carolyn Marie, Agoropoulou, Catherine, and Hartung, Hans-Peter

Published
2018
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30. 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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34. Safety of the Concurrent Administration of Serotonergic Antidepressants and Ozanimod in Patients With Relapsing Multiple Sclerosis (P7-3.013)

Author

Naismith, Robert T., primary, Cohen, Jeffrey A., additional, Bar-Or, Amit, additional, Comi, Giancarlo, additional, Selmaj, Krzysztof W., additional, Hartung, Hans-Peter, additional, Sheffield, James K., additional, Krakovich, Anthony, additional, Cheng, Chun-Yen, additional, Reardon, Jennifer, additional, Riolo, Jon V., additional, Silva, Diego, additional, and Cree, Bruce A. C., additional

Published
2023
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35. 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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38. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: Up to 5 years of follow-up in the DAYBREAK open-label extension trial

Author

Cree, Bruce A.C, Selmaj, Krzysztof W., Steinman, Lawrence, Comi, Giancarlo, Bar-Or, Amit, Arnold, Douglas Lorne, Hartung, Hans-Peter, Montalban, Xavier, Kubala Havrdova, Eva, Sheffield, James K., Minton, Neil, Cheng, Chun Yen, Silva, Diego, Kappos, Ludwig, Cohen, Jeffrey A., Universitat Autònoma de Barcelona, Institut Català de la Salut, [Cree BA] Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA. [Selmaj KW] Center for Neurology, Łódź, Poland and Collegium Medicum, Department of Neurology, University of Warmia and Mazury in Olsztyn, Olsztyn, Poland. [Steinman L] Department of Neurology and Neurological Sciences, Beckman Center for Molecular Medicine, Stanford University Medical Center, Stanford, CA, USA. [Comi G] Vita-Salute San Raffaele University and Casa di Cura del Policlinico, Milan, Italy. [Bar-Or A] Center for Neuroinflammation and Experimental Therapeutics, and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. [Arnold DL] NeuroRx Research and Montréal Neurological Institute, McGill University, Montréal, QC, Canada. [Montalbán X] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Immunologic Factors [CHEMICALS AND DRUGS], Immunoteràpia, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Sphingosine 1-phosphate receptor modulators, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Multiple sclerosis, Ozanimod, Multiple Sclerosis, Relapsing-Remitting, Recurrence, Extension study, Humans, Other subheadings::/therapeutic use [Other subheadings], Sphingosine-1-Phosphate Receptors, acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::factores inmunitarios [COMPUESTOS QUÍMICOS Y DROGAS], Oxadiazoles, Otros calificadores::/uso terapéutico [Otros calificadores], Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis [DISEASES], diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Clinical efficacy, Neurology, Adverse events, Indans, enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple [ENFERMEDADES], Avaluació de resultats (Assistència sanitària), Neurology (clinical), Esclerosi múltiple - Tractament, Follow-Up Studies
Abstract

Multiple sclerosis; Clinical efficacy; Ozanimod Esclerosis múltiple; Eficacia clínica; Ozanimod Esclerosi múltiple; Eficàcia clínica; Ozanimod Background: Ozanimod, an oral sphingosine 1-phosphate receptor 1 and 5 modulator, is approved in multiple countries for treatment of relapsing forms of MS. Objective: To characterize long-term safety and efficacy of ozanimod. Methods: Patients with relapsing MS who completed a phase 1‒3 ozanimod trial were eligible for an open-label extension study (DAYBREAK) of ozanimod 0.92 mg/d. DAYBREAK began 16 October 2015; cutoff for this interim analysis was 2 February 2021. Results: This analysis included 2494 participants with mean 46.8 (SD 11.9; range 0.033‒62.7) months of ozanimod exposure in DAYBREAK. During DAYBREAK, 2143 patients (85.9%) had treatment-emergent adverse events (TEAEs; similar in nature to those in the parent trials), 298 (11.9%) had a serious TEAE, and 75 (3.0%) discontinued treatment due to TEAEs. Serious infections (2.8%), herpes zoster infections (1.7%), confirmed macular edema cases (0.2%), and cardiac TEAEs (2.8%) were infrequent. Adjusted annualized relapse rate was 0.103 (95% confidence interval, 0.086‒0.123). Over 48 months, 71% of patients remained relapse free. Adjusted mean numbers of new/enlarging T2 lesions/scan and gadolinium-enhancing lesions were low and similar across parent trial treatment subgroups. Conclusions: This long-term extension of ozanimod trials confirmed a favorable safety/tolerability profile and sustained benefit on clinical and magnetic resonance imaging measures of disease activity. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The ozanimod RMS trials were supported by Celgene International II. The sponsor was involved in data analysis and interpretation, and manuscript preparation, review, and approval. All authors vouch for data accuracy, reviewed all drafts, and approved the final manuscript.

Published
2022
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40. Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies

Author

Dayan, Colin M., primary, Lecumberri, Beatriz, additional, Muller, Ilaria, additional, Ganesananthan, Sashiananthan, additional, Hunter, Samuel F., additional, Selmaj, Krzysztof W., additional, Hartung, Hans-Peter, additional, Havrdova, Eva K., additional, LaGanke, Christopher C., additional, Ziemssen, Tjalf, additional, Van Wijmeersch, Bart, additional, Meuth, Sven G., additional, Margolin, David H., additional, Poole, Elizabeth M., additional, Baker, Darren P., additional, and Senior, Peter A., additional

Published
2023
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42. sj-docx-1-mso-10.1177_20552173221142741 - Supplemental material for Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies

Author

Dayan, Colin M., Lecumberri, Beatriz, Muller, Ilaria, Ganesananthan, Sashiananthan, Hunter, Samuel F., Selmaj, Krzysztof W., Hartung, Hans-Peter, Havrdova, Eva K., LaGanke, Christopher C., Ziemssen, Tjalf, Van Wijmeersch, Bart, Meuth, Sven G., Margolin, David H., Poole, Elizabeth M., Baker, Darren P., and Senior, Peter A.

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

Supplemental material, sj-docx-1-mso-10.1177_20552173221142741 for Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies by Colin M. Dayan, Beatriz Lecumberri, Ilaria Muller, Sashiananthan Ganesananthan, Samuel F. Hunter, Krzysztof W. Selmaj, Hans-Peter Hartung, Eva K. Havrdova, Christopher C. LaGanke, Tjalf Ziemssen, Bart Van Wijmeersch, Sven G. Meuth, David H. Margolin, Elizabeth M. Poole, Darren P. Baker and Peter A. Senior in Multiple Sclerosis Journal – Experimental, Translational and Clinical

Published
2023
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45. Improvements in Quality of Life Over 2 Years in Patients Treated with Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis: Final Analysis of CLARIFY-MS

Author

Solari, Alessandra, Montalban, Xavier, Lechner-Scott, Jeannette, Piehl, Fredrik, Brochet, Bruno, Langdon, Dawn, Hupperts, Raymond, Selmaj, Krzysztof, Havrdova, Eva K., Patti, Francesco, Brieva, Luis, Maida, Eva Maria, Alexandri, Nektaria, Smyk, Andrzej, Nolting, Axel, Keller, Birgit, and on behalf of the CLARIFY-MS Investigators

Published
2023
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47. B

Author

Epstein, Marcelo, Ebner, Ford, Popescu, Maria, Haber, Suzanne N., Hening, Wayne, Harrington, Deborah L., Poizner, Howard, Hikosaka, Okihide, Ide, Chizuka, Körding, Konrad, Wagner, Hermann, Gheusi, Gilles, Tzschentke, Thomas M., Schütte, Michael, Berkowicz, Tomasz, Selmaj, Krzysztof, McAlpine, David, Herzog, Michael, Maier, Alexander, Leopold, David A., Freeman, Ralph D., Engel, Bernard T., Mansergh, Fiona, Wride, Michael, Gillette, Martha U., Herzog, Walter, Boeker, Heinz, Kentridge, Robert W., Kannan, Hiroshi, Staddon, James M., Patel, Toshal, Smith, Terence, Haghighi, Pejmun, Yoshida, Michio, Shimamura, Kenji, Gross, Ted S., Warner, Sarah E., Katayama, Yoshifumi, Bouras, Constantin, Giannakopoulos, Panteleimon, Kövari, Enikö, Butler, Ann B., Khan, Haider Ali, Ballani, Nasser S., Molinero, Amalia, Quintana, Albert, Penkowa, Milena, Hidalgo, Juan, Frank, Marcos G., Ballanyi, Klaus, Ruangkittisakul, Araya, Gelperin, Alan, Scudder, Charles, Ait-Haddou, Rachid, Kaneko, Chris R. S., Moschovakis, Adonis, Kitama, Toshihiro, Ramirez, Jan-Marino, Binder, Marc D., editor, Hirokawa, Nobutaka, editor, and Windhorst, Uwe, editor

Published
2009
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49. Nowe kierunki rozwoju terapii okrelizumabem w stwardnieniu rozsianym: wyższe dawkowanie i terapia podskórna.

Author

Selmaj, Krzysztof and Selmaj, Igor

Abstract

Copyright of Current Neurology / Aktualno?ci Neurologiczne is the property of Medical Communications Sp. z o.o. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2023
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