Ozanimod: A Review in Relapsing Forms of Multiple Sclerosis

Klineova S, Lublin FD. Clinical course of multiple sclerosis. Cold Spring Harb Perspect Med. 2018;8(9): a028928.

Article  PubMed Central  Google Scholar 

Selkirk JV, Dines KC, Yan YG, et al. Deconstructing the pharmacological contribution of sphingosine-1 phosphate receptors to mouse models of multiple sclerosis using the species selectivity of ozanimod, a dual modulator of human sphingosine 1-phosphate receptor subtypes 1 and 5. J Pharmacol Exp Ther. 2021;379(3):386–99.

Article  CAS  Google Scholar 

Celgene Corporation. ZEPOSIA® (ozanimod) capsules, for oral use: US prescribing information. 2024. https://www.fda.gov/. Accessed 29 July 2024.

Consortium of Multiple Sclerosis Centers. Best practices in multiple sclerosis therapies. 2022. https:// www. mscare. org/ page/ practice_ guide lines. Accessed 29 July 2024.

Consortium of Multiple Sclerosis Centers. CMSC practical guidelines for the selection of disease-modifying therapies in multiple sclerosis. 2019. https://mscare.sharefile.com/share/view/s79d1bfdca884318b. Accessed 29 July 2024.

Coyle PK, Freedman MS, Cohen BA, et al. Sphingosine 1-phosphate receptor modulators in multiple sclerosis treatment: a practical review. Ann Clin Transl Neurol. 2024;11(4):842–55.

Article  CAS  PubMed Central  Google Scholar 

Novartis Pharmaceuticals Corporation. GILENYA® (fingolimod) capsules, for oral use: US prescribing information. 2024. https://www.fda.gov/. Accessed 29 July 2024.

Shirley M. Ozanimod in relapsing forms of multiple sclerosis: a profile of its use. Drugs Ther Perspect. 2021;37(4):143–9.

Article  Google Scholar 

Comi G, Kappos L, Selmaj KW, et al. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019;18(11):1009–20.

Article  CAS  Google Scholar 

Cohen JA, Comi G, Selmaj KW, et al. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019;18(11):1021–33.

Article  CAS  Google Scholar 

Cohen JA, Arnold DL, Comi G, et al. Safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2016;15(4):373–81.

Article  CAS  Google Scholar 

Cohen JA, Comi G, Arnold DL, et al. Efficacy and safety of ozanimod in multiple sclerosis: dose-blinded extension of a randomized phase II study. Mult Scler J. 2019;25(9):1255–62.

Article  CAS  Google Scholar 

Cree BA, Selmaj KW, Steinman L, et al. 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. Mult Scler J. 2022;28(12):1944–62.

Article  CAS  Google Scholar 

Selmaj KW, Steinman L, Comi G, et al. Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: final analysis of the DAYBREAK open-label extension study [abstract no. P090 plus poster]. In: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. 2024.

Naismith R, Zivadinov R, Morrow S, et al. Safety and efficacy of ozanimod over 1 year in patients with early relapsing multiple sclerosis: an interim analysis of the ENLIGHTEN study [abstract no. P690/186]. Mult Scler J. 2023;29(3 Suppl):596–7.

Google Scholar 

DeLuca J, Naismith RT, Morrow SA, et al. Changes in cognitive functioning over 1 year in ozanimod-treated patients with early relapsing multiple sclerosis: an interim analysis of the ENLIGHTEN study [abstract no. P354 plus poster]. In: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. 2024.

Zivadinov R, Bergsland N, Naismith RT, et al. Stable medulla oblongata volume, lateral ventricular volume, and physical disability during 1 year of ozanimod use for early relapsing MS [abstract no. DMT47 plus poster]. In: Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting. 2024.

Morrow SA, Zivadinov R, DeLuca J, et al. Patient-reported outcomes after 1 year of ozanimod use for early relapsing multiple sclerosis: an interim analysis of the ENLIGHTEN study [abstract no. P433 plus poster]. In: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. 2024.

Filippi M, Riolo J, Cohen J, et al. Relapse-associated worsening and progression-independent relapse activity in ozanimod-treated participants with relapsing multiple sclerosis from the RADIANCE and DAYBREAK trials [abstract no. P368/3053]. Mult Scler J. 2023;29(3 Suppl):1058–9.

Google Scholar 

Cree BAC, Selmaj KW, Steinman L, et al. 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 [abstract no. P091 plus poster]. In: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. 2024.

Centonze D, Hartung H-P, Montalbán X, et al. Long-term efficacy of ozanimod in disease-modifying treatment-naive vs experienced patients with relapsing multiple sclerosis [abstract no. P092 plus poster]. In: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. 2024.

Hartung H-P, Granziera C, Filippi M, et al. Influence of baseline Expanded Disability Status Scale (EDSS) score on long-term efficacy of ozanimod in participants with relapsing multiple sclerosis [abstract no. DMT24 plus poster]. In: Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting. 2024.

Brochet B, DeLuca J, Selmaj K, et al. Proportion of relapsing MS patients with low vs high annualised whole brain volume atrophy rates after 5–6 years of ozanimod and relationship to cognitive processing speed [abstract no. EP1082]. Mult Scler J. 2022;28(3 Suppl):860–1.

Google Scholar 

DeLuca J, Cohen JA, Cree BAC, et al. Effects of ozanimod on cognitive processing speed: updated findings from the phase 3 SUNBEAM and DAYBREAK extension trials [abstract no. P353 plus poster]. In: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. 2024.

Arnold D, Sheffield J, Montalban X, et al. Whole brain, cortical grey matter, and thalamic volume changes during 3 to five years of ozanimod in relapsing MS [abstract no. OPR-088]. Eur J Neurol. 2021;28(Suppl 1):122–3.

Google Scholar 

Selmaj KW, Ziemssen T, Comi G, et al. Safety patterns over time with ozanimod during an open-label extension trial in patients with relapsing multiple sclerosis [abstract no. P012]. In: American Academy of Neurology (AAN) Annual Meeting. 2024.

Tran JQ, Zhang P, Walker S, et al. Multiple-dose pharmacokinetics of ozanimod and its major active metabolites and the pharmacodynamic and pharmacokinetic interactions with pseudoephedrine, a sympathomimetic agent, in healthy subjects. Adv Ther. 2020;37(12):4944–58.

Article  CAS  PubMed Central  Google Scholar 

Zhang P, Yu K, Syto M, et al. Effect of ozanimod on the pressor effect of oral tyramine: a phase 1 study in healthy adults [abstract no. DMT44 plus poster]. In: Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting. 2024.

Naismith RT, Cohen JA, Bar-Or A, et al. Concurrent administration of serotonergic antidepressants and ozanimod in participants with relapsing multiple sclerosis from the open-label extension DAYBREAK trial. Mult Scler J. 2023;30(2):177–83.

Article  Google Scholar 

Hartung H-P, Steinman L, Bar-Or A, et al. Absolute lymphocyte count around infections during phase 3 and open-label extension trials of ozanimod in participants with relapsing multiple sclerosis [abstract no. P306/149]. Mult Scler J. 2023;29(3 Suppl):354.

Google Scholar 

Armuzzi A, Cross RK, Lichtenstein G, et al. Long-term cardiac safety of ozanimod in phase 3 clinical program of ulcerative colitis and relapsing multiple sclerosis [abstract no. DOP45]. J Crohns Colitis. 2022;16(Suppl 1):i094-i95.

Article  Google Scholar 

Gold R, Selmaj KW, Berkovich R, et al. Absence of rebound effect following ozanimod discontinuation among participants in the DAYBREAK open-label extension study [abstract no. P097 plus poster]. In: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. 2024.

Dubinsky MC, Charles L, Selmaj KW, et al. Pregnancy outcomes in the ozanimod clinical development program in patients with ulcerative colitis, Crohn’s disease, and relapsing multiple sclerosis. Inflamm Bowel Dis. 2024. https://doi.org/10.1093/ibd/izae011.

Article  Google Scholar 

Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: disease-modifying therapies for adults with multiple sclerosis: report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2018;90(17):777–88.

Article  Google Scholar 

Samjoo IA, Drudge C, Walsh S, et al. Comparative efficacy of therapies for relapsing multiple sclerosis: a systematic review and network meta-analysis. J Comp Eff Res. 2023;12(7): e230016.

Article  CAS  PubMed Central  Google Scholar 

Samjoo IA, Worthington E, Drudge C, et al. Efficacy classification of modern therapies in multiple sclerosis. J Comp Eff Res. 2021;10(6):495–507.

Article  Google Scholar 

Scolding N, Barnes D, Cader S, et al. Association of British Neurologists: revised (2015) guidelines for prescribing disease-modifying treatments in multiple sclerosis. Pract Neurol. 2015;15(4):273–9.

Article  Google Scholar 

Marques VD, Passos GRD, Mendes MF, et al. Brazilian consensus for the treatment of multiple sclerosis: Brazilian Academy of Neurology and Brazilian Committee on Treatment and Research in Multiple Sclerosis. Arq Neuropsiquiatr. 2018;76(8):539–54.

Article  Google Scholar 

Wiendl H, Gold R, Berger T, et al. Multiple Sclerosis Therapy Consensus Group (MSTCG): position statement on disease-modifying therapies for multiple sclerosis (white paper). Ther Adv Neurol Disord. 2021;14:17562864211039648.

Article  PubMed Central  Google Scholar 

Sun Y, Yang Y, Wang Z, et al. Ozanimod for treatment of relapsing-remitting multiple sclerosis in adults: a systematic review and meta-analysis of randomized controlled trials. Front Pharmacol. 2020;11: 589146.

Article  CAS  PubMed Central  Google Scholar 

Harris S, Tran JQ, Southworth H, et al. Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS. Neurol Neuroimmunol Neuroinflamm. 2020;7(5): e839.

Article  PubMed Central  Google Scholar 

Swallow E, Patterson-Lomba O, Yin L, et al. Comparative safety and efficacy of ozanimod versus fingolimod for relapsing multiple sclerosis. J Comp Eff Res. 2020;9(4):275–85.

Article  Google Scholar 

Hennessy B, Zierhut ML, Kracker H, et al. Comparative efficacy of relapsing multiple sclerosis therapies: model-based meta-analyses for confirmed disability accumulation and annualized relapse rate. Mult Scler Relat Disord. 2022;64:103908.

Article  CAS  Google Scholar 

Swallow E, Pham T, Patterson-Lomba O, et al. Comparative efficacy and safety of ozanimod and ponesimod for relapsing multiple sclerosis: a matching-adjusted indirect comparison. Mult Scler Relat Disord. 2023;71:104551.

Article  CAS  Google Scholar 

Novartis Pharmaceuticals Corporation. MAYZENT® (siponimod) tablets, for oral use: US prescribing information. 2024. https://www.fda.gov/ Accessed 29 July 2024.

Janssen Pharmaceuticals Inc. PONVORY® (ponesimod) tablets, for oral use: US prescribing information. 2024. https://www.fda.gov/ Accessed 29 July 2024.

Baker D, Forte E, Pryce G, et al. The impact of sphingosine-1-phosphate receptor modulators on COVID-19 and SARS-CoV-2 vaccination. Mult Scler Relat Disord. 2023;69:104425.

Article  CAS  Google Scholar 

Paul D, N’Dri L, Branchcomb T, et al. Real-world clinical outcomes for disease-modifying therapy-naïve and -experienced patients with multiple sclerosis treated with ozanimod: a US retrospective medical chart review [abstract no. P477 plus poster]. In: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. 2024.

Hadlock J, Huang L, Paul D, et al. Ozanimod use in patients with multiple sclerosis treated in a large US healthcare system: a retrospective case series [abstract no. P478 plus poster]. In: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. 2024.

Scott FL, Clemons B, Brooks J, et al. Ozanimod (RPC1063) is a potent sphingosine-1-phosphate receptor-1 (S1P1) and receptor-5 (S1P5) agonist with autoimmune disease-modifying activity. Br J Pharmacol. 2016;173(11):1778–92.

Article  CAS  PubMed Central  Google Scholar 

Harris S, Comi G, Cree BAC, et al. Plasma neurofilament light chain concentrations as a biomarker of clinical and radiologic outcomes in relapsing multiple sclerosis: post hoc analysis of phase 3 ozanimod trials. Eur J Neurol. 2021;28(11):3722–30.

Article  Google Scholar 

Briggs E, Chapel S, Zhang P, et al. Concentration-QTc modeling of ozanimod’s major active metabolites in adult healthy subjects. CPT Pharmacometr Syst Pharmacol. 2021;10(2):119–26.

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