Efficacy and safety of ozanimod in multiple sclerosis
Ozanimod, an oral immunomodulator, selectively targets sphingosine 1-phosphate receptors 1 and 5. Evaluate efficacy, safety, and tolerability of ozanimod in relapsing multiple sclerosis. In the RADIANCE Part A phase II study (NCT01628393), participants with relapsing multiple sclerosis were randomiz...
| Autores: | , , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Fecha de publicación: | 2018 |
| País: | España |
| Institución: | Universitat Autònoma de Barcelona |
| Repositorio: | Dipòsit Digital de Documents de la UAB |
| Idioma: | inglés |
| OAI Identifier: | oai:ddd.uab.cat:227974 |
| Acceso en línea: | https://ddd.uab.cat/record/227974 https://dx.doi.org/urn:doi:10.1177/1352458518789884 |
| Access Level: | acceso abierto |
| Palabra clave: | Clinical trial Disease-modifying therapies MRI Relapsing/remitting T2 lesions Multiple sclerosis |
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Efficacy and safety of ozanimod in multiple sclerosisDose-blinded extension of a randomized phase II studyCohen, Jeffrey A.|||0000-0001-9245-9772Comi, Giancarlo|||0000-0002-6989-1054Arnold, Douglas Lorne|||0000-0003-4266-0106Bar-Or, Amit|||0000-0001-7179-0335Selmaj, Krzysztof W.|||0000-0003-1213-7218Steinman, Lawrence|||0000-0002-2437-2250Havrdova, Eva KCree, Bruce A. C.|||0000-0001-7689-2533Montalbán, XavierHartung, Hans-Peter|||0000-0002-0614-6989Huang, VivianFrohna, PaulSkolnick, Brett E.Kappos, Ludwig|||0000-0003-4175-5509Clinical trialDisease-modifying therapiesMRIRelapsing/remittingT2 lesionsMultiple sclerosisOzanimod, an oral immunomodulator, selectively targets sphingosine 1-phosphate receptors 1 and 5. Evaluate efficacy, safety, and tolerability of ozanimod in relapsing multiple sclerosis. In 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). A 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. Ozanimod 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. 22018-01-0120182018-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/227974https://dx.doi.org/urn:doi:10.1177/1352458518789884reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2279742026-06-06T12:50:31Z |
| dc.title.none.fl_str_mv |
Efficacy and safety of ozanimod in multiple sclerosis Dose-blinded extension of a randomized phase II study |
| title |
Efficacy and safety of ozanimod in multiple sclerosis |
| spellingShingle |
Efficacy and safety of ozanimod in multiple sclerosis Cohen, Jeffrey A.|||0000-0001-9245-9772 Clinical trial Disease-modifying therapies MRI Relapsing/remitting T2 lesions Multiple sclerosis |
| title_short |
Efficacy and safety of ozanimod in multiple sclerosis |
| title_full |
Efficacy and safety of ozanimod in multiple sclerosis |
| title_fullStr |
Efficacy and safety of ozanimod in multiple sclerosis |
| title_full_unstemmed |
Efficacy and safety of ozanimod in multiple sclerosis |
| title_sort |
Efficacy and safety of ozanimod in multiple sclerosis |
| dc.creator.none.fl_str_mv |
Cohen, Jeffrey A.|||0000-0001-9245-9772 Comi, Giancarlo|||0000-0002-6989-1054 Arnold, Douglas Lorne|||0000-0003-4266-0106 Bar-Or, Amit|||0000-0001-7179-0335 Selmaj, Krzysztof W.|||0000-0003-1213-7218 Steinman, Lawrence|||0000-0002-2437-2250 Havrdova, Eva K Cree, Bruce A. C.|||0000-0001-7689-2533 Montalbán, Xavier Hartung, Hans-Peter|||0000-0002-0614-6989 Huang, Vivian Frohna, Paul Skolnick, Brett E. Kappos, Ludwig|||0000-0003-4175-5509 |
| author |
Cohen, Jeffrey A.|||0000-0001-9245-9772 |
| author_facet |
Cohen, Jeffrey A.|||0000-0001-9245-9772 Comi, Giancarlo|||0000-0002-6989-1054 Arnold, Douglas Lorne|||0000-0003-4266-0106 Bar-Or, Amit|||0000-0001-7179-0335 Selmaj, Krzysztof W.|||0000-0003-1213-7218 Steinman, Lawrence|||0000-0002-2437-2250 Havrdova, Eva K Cree, Bruce A. C.|||0000-0001-7689-2533 Montalbán, Xavier Hartung, Hans-Peter|||0000-0002-0614-6989 Huang, Vivian Frohna, Paul Skolnick, Brett E. Kappos, Ludwig|||0000-0003-4175-5509 |
| author_role |
author |
| author2 |
Comi, Giancarlo|||0000-0002-6989-1054 Arnold, Douglas Lorne|||0000-0003-4266-0106 Bar-Or, Amit|||0000-0001-7179-0335 Selmaj, Krzysztof W.|||0000-0003-1213-7218 Steinman, Lawrence|||0000-0002-2437-2250 Havrdova, Eva K Cree, Bruce A. C.|||0000-0001-7689-2533 Montalbán, Xavier Hartung, Hans-Peter|||0000-0002-0614-6989 Huang, Vivian Frohna, Paul Skolnick, Brett E. Kappos, Ludwig|||0000-0003-4175-5509 |
| author2_role |
author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Clinical trial Disease-modifying therapies MRI Relapsing/remitting T2 lesions Multiple sclerosis |
| topic |
Clinical trial Disease-modifying therapies MRI Relapsing/remitting T2 lesions Multiple sclerosis |
| description |
Ozanimod, an oral immunomodulator, selectively targets sphingosine 1-phosphate receptors 1 and 5. Evaluate efficacy, safety, and tolerability of ozanimod in relapsing multiple sclerosis. In 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). A 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. Ozanimod 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. |
| publishDate |
2018 |
| dc.date.none.fl_str_mv |
2 2018-01-01 2018 2018-01-01 |
| dc.type.none.fl_str_mv |
Article http://purl.org/coar/resource_type/c_6501 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
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article |
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https://ddd.uab.cat/record/227974 https://dx.doi.org/urn:doi:10.1177/1352458518789884 |
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https://ddd.uab.cat/record/227974 https://dx.doi.org/urn:doi:10.1177/1352458518789884 |
| dc.language.none.fl_str_mv |
Inglés eng |
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Inglés |
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eng |
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open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by-nc/4.0/ |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by-nc/4.0/ |
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openAccess |
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