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Ozanimod: A Review in Ulcerative Colitis

Ozanimod (Zeposia(®)) is the first sphingosine-1-phosphate receptor (S1PR) modulator to be approved for the treatment of adults with moderately to severely active ulcerative colitis in the USA, and in adults with moderately to severely active ulcerative colitis who have had an inadequate or lost res...

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Autor principal: Paik, Julia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9499884/
https://www.ncbi.nlm.nih.gov/pubmed/35994200
http://dx.doi.org/10.1007/s40265-022-01762-8
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author Paik, Julia
author_facet Paik, Julia
author_sort Paik, Julia
collection PubMed
description Ozanimod (Zeposia(®)) is the first sphingosine-1-phosphate receptor (S1PR) modulator to be approved for the treatment of adults with moderately to severely active ulcerative colitis in the USA, and in adults with moderately to severely active ulcerative colitis who have had an inadequate or lost response to, or were intolerant of, either conventional therapy or a biologic in the EU. An oral agent, ozanimod is administered once daily as induction and maintenance therapy. In the randomized, double-blind, multinational phase 2 Touchstone and phase 3 True North clinical trials, ozanimod was effective in inducing clinical remission and maintaining remission relative to placebo in adults with moderately to severely active ulcerative colitis. Ozanimod was generally well tolerated in these studies, with manageable or transient adverse events (AEs). Current data from the Touchstone and True North open-label extensions are consistent with the primary studies with respect to therapeutic efficacy and tolerability, with no new safety signals observed. Although further data will be beneficial, ozanimod expands the treatment options for adults with moderately to severely active ulcerative colitis. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40265-022-01762-8.
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spelling pubmed-94998842022-09-24 Ozanimod: A Review in Ulcerative Colitis Paik, Julia Drugs Adis Drug Evaluation Ozanimod (Zeposia(®)) is the first sphingosine-1-phosphate receptor (S1PR) modulator to be approved for the treatment of adults with moderately to severely active ulcerative colitis in the USA, and in adults with moderately to severely active ulcerative colitis who have had an inadequate or lost response to, or were intolerant of, either conventional therapy or a biologic in the EU. An oral agent, ozanimod is administered once daily as induction and maintenance therapy. In the randomized, double-blind, multinational phase 2 Touchstone and phase 3 True North clinical trials, ozanimod was effective in inducing clinical remission and maintaining remission relative to placebo in adults with moderately to severely active ulcerative colitis. Ozanimod was generally well tolerated in these studies, with manageable or transient adverse events (AEs). Current data from the Touchstone and True North open-label extensions are consistent with the primary studies with respect to therapeutic efficacy and tolerability, with no new safety signals observed. Although further data will be beneficial, ozanimod expands the treatment options for adults with moderately to severely active ulcerative colitis. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40265-022-01762-8. Springer International Publishing 2022-08-22 2022 /pmc/articles/PMC9499884/ /pubmed/35994200 http://dx.doi.org/10.1007/s40265-022-01762-8 Text en © Springer Nature 2022, corrected publication 2022 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Adis Drug Evaluation
Paik, Julia
Ozanimod: A Review in Ulcerative Colitis
title Ozanimod: A Review in Ulcerative Colitis
title_full Ozanimod: A Review in Ulcerative Colitis
title_fullStr Ozanimod: A Review in Ulcerative Colitis
title_full_unstemmed Ozanimod: A Review in Ulcerative Colitis
title_short Ozanimod: A Review in Ulcerative Colitis
title_sort ozanimod: a review in ulcerative colitis
topic Adis Drug Evaluation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9499884/
https://www.ncbi.nlm.nih.gov/pubmed/35994200
http://dx.doi.org/10.1007/s40265-022-01762-8
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