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REVIEW

Ozanimod: A Practical Review for Nurses and Advanced Practice Providers

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Pages 15-31 | Received 01 Jul 2023, Accepted 12 Jan 2024, Published online: 01 Feb 2024

References

  • Choi D, Stewart AP, Bhat S. Ozanimod: a first-in-class sphingosine 1-phosphate receptor modulator for the treatment of ulcerative colitis. Ann Pharmacother. 2022;56(5):592–599.
  • Aoki M, Aoki H, Ramanathan R, Hait NC, Takabe K. Sphingosine-1-phosphate signaling in immune cells and inflammation: roles and therapeutic potential. Mediators Inflamm. 2016;2016:8606878.
  • Danese S, Furfaro F, Vetrano S. Targeting S1P in inflammatory bowel disease: new avenues for modulating intestinal leukocyte migration. J Crohns Colitis. 2018;12(suppl_2):56.
  • Schwab SR, Cyster JG. Finding a way out: lymphocyte egress from lymphoid organs. Nat Immunol. 2007;8(12):1295–1301.
  • 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):1778–1792.
  • Bristol Myers Squibb. Zeposia [Package Insert]. Princeton, NJ: Bristol Myers Squibb; 2023.
  • Harris S, Tran JQ, Southworth H, Spencer CM, Cree BAC, Zamvil SS. Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS. Neurol Neuroimmunol Neuroinflamm. 2020;7:e839.
  • Selkirk JV, Yan G, Ching N, Paget K, Brand M, Hargreaves R In vitro assessment of the binding and functional responses of ozanimod and its circulating metabolites across human sphingosine 1-phosphate receptors [poster]. Presented at: Annual Meeting of the American Academy of Neurology; 2020; Toronto, ON, Canada.
  • Sands BE, Schreiber S, Blumenstein I, Chiorean MV, Ungaro RC, Rubin DT. Clinician’s guide to using ozanimod for the treatment of ulcerative colitis. J Crohns Colitis. 2023;jjad112.
  • Ghasemi N, Razavi S, Nikzad E. Multiple sclerosis: pathogenesis, symptoms, diagnoses and cell-based therapy. Cell J. 2017;19(1):1–10.
  • Celgene Corporation. Zeposia [Product Monograph]. Mississauga, ON, Canada: Celgene Inc.; 2020.
  • Celgene Distribution B.V. Zeposia [Summary of Product Characteristics]. Utrecht, Netherlands: Celgene Distribution B.V.; 2023.
  • Olivera P, Danese S, Peyrin-Biroulet L. Next generation of small molecules in inflammatory bowel disease. Gut. 2017;66(2):199–209.
  • Sandborn WJ, Feagan BG, Wolf DC, et al. Ozanimod induction and maintenance treatment for ulcerative colitis. N Engl J Med. 2016;374(18):1754–1762.
  • Sandborn WJ, Feagan BG, D’Haens G, et al. Ozanimod as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2021;385(14):1280–1291.
  • Sandborn WJ, Feagan BG, Hanauer S, et al. Long-term efficacy and safety of ozanimod in moderately to severely active ulcerative colitis: results from the open-label extension of the randomized, phase 2 TOUCHSTONE study. J Crohns Colitis. 2021;15(7):1120–1129.
  • Danese S, Panaccione R, Abreu MT, et al. Efficacy and safety of approximately 3 years of continuous ozanimod in moderately to severely active ulcerative colitis: interim analysis of the True North open-label extension. J Crohns Colitis. 2023;jjad146.
  • 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):1021–1033.
  • 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):1009–1020.
  • 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. 2022;28(12):1944–1962.
  • Chun J, Giovannoni G, Hunter SF. Sphingosine 1-phosphate receptor modulator therapy for multiple sclerosis: differential downstream receptor signalling and clinical profile effects. Drugs. 2021;81(2):207–231.
  • Schmouder R, Serra D, Wang Y, et al. FTY720: placebo-controlled study of the effect on cardiac rate and rhythm in healthy subjects. J Clin Pharmacol. 2006;46(8):895–904.
  • Tran JQ, Hartung JP, Peach RJ, et al. Results from the first-in-human study with ozanimod, a novel, selective sphingosine-1-phosphate receptor modulator. J Clin Pharmacol. 2017;57(8):988–996.
  • D’Haens G, Irving P, Colombel J-F, et al. Effect of ozanimod treatment and discontinuation on absolute lymphocyte count in patients with moderately to severely active ulcerative colitis: results from a phase 3 randomized trial [abstract P0386]. United Eur Gastroenterol J. 2021;9(S8):5.
  • Bauer J, Gold R, Adams O, Lassmann H. Progressive multifocal leukoencephalopathy and immune reconstitution inflammatory syndrome (IRIS). Acta Neuropathol. 2015;130(6):751–764.
  • Afsari S, Henry A, Comi G, et al. Pregnancy outcomes in the ozanimod clinical development program in relapsing multiple sclerosis, ulcerative colitis, and Crohn’s disease [poster]. Presented at: Annual Meeting of the Consortium of Multiple Sclerosis Centers; October 25–28, 2021; Orlando, FL.
  • Dubinsky MC, Mahadevan U, Charles L, et al. Pregnancy outcomes in the ozanimod clinical development program in relapsing multiple sclerosis, ulcerative colitis, and Crohn’s disease [abstract DOP53]. J Crohns Colitis. 2021;15(Supplement_1).
  • García-Enguídanos A, Calle ME, Valero J, Luna S, Domínguez-Rojas V. Risk factors in miscarriage: a review. Eur J Obstet Gynecol Reprod Biol. 2002;102(2):111–119.
  • Rossen LM, Ahrens KA, Branum AM. Trends in risk of pregnancy loss among US women, 1990-2011. Paediatr Perinat Epidemiol. 2018;32(1):19–29.
  • Chawanpaiboon S, Vogel JP, Moller AB, et al. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019;7(1):e37–e46.
  • Cohen NA, Choi D, Choden T, Cleveland NK, Cohen RD, Rubin DT. Ozanimod in the treatment of ulcerative colitis: initial real-world data from a large tertiary center. Clin Gastroenterol Hepatol. 2023;21(9):2407–2409.e2402.
  • Osterman MT, Longman R, Sninsky C, et al. Rapid induction effects of ozanimod on clinical symptoms and inflammatory biomarkers in patients with moderately to severely acute ulcerative colitis: results from the induction phase of True North [abstract 460]. Gastroenterology. 2021;160(6 suppl):78.
  • Siegmund B, Axelrad J, Pondel M, et al. Rapidity of ozanimod-induced symptomatic response and remission in patients with moderately to severely active ulcerative colitis: results from the induction period of True North [abstract DOP43]. J Crohns Colitis. 2022;16(suppl 1).
  • Panaccione R, Afzali A, Hudesman D, et al. Extended therapy with ozanimod for delayed responders to ozanimod in moderately to severely acute ulcerative colitis: data from the True North open-label extension study [abstract Tu1450]. Gastroenterology. 2022;162(7 suppl).
  • Baldo BA, Rose MA. The anaesthetist, opioid analgesic drugs, and serotonin toxicity: a mechanistic and clinical review. Br J Anaesth. 2020;124(1):44–62.
  • Hu S, Chen Y, Chen Y, Wang C. Depression and anxiety disorders in patients with inflammatory bowel disease. Front Psychiatry. 2021;12:714057.
  • Colombel J-F, Charles L, Petersen A, et al. Safety of concurrent administration of ozanimod and serotonergic antidepressants in patients with ulcerative colitis [abstract PO441]. United Eur Gastroenterol J. 2021;9(S8).
  • Iancovici L, Khateeb D, Harel O, et al. Rheumatoid arthritis patients treated with Janus kinase inhibitors show reduced humoral immune responses following BNT162b2 vaccination. Rheumatology (Oxford). 2022;61(8):3439–3447.
  • Edelman-Klapper H, Zittan E, Bar-Gil Shitrit A, et al. Lower serologic response to COVID-19 mRNA vaccine in patients with inflammatory bowel diseases treated with anti-TNFα. Gastroenterology. 2022;162(2):454–467.
  • Cree BAC, Maddux R, Bar-Or A, et al. Serologic response to SARS-CoV-2 vaccines in DAYBREAK participants with relapsing multiple sclerosis receiving ozanimod [oral presentation OPR-162]. Presented at: Annual Congress of the European Academy of Neurology; June 25-28, 2022; Vienna, Austria.
  • Jarvi NL, Balu-Iyer SV. Immunogenicity challenges associated with subcutaneous delivery of therapeutic proteins. Biodrugs. 2021;35(2):125–146.
  • Alqahtani MS, Kazi M, Alsenaidy MA, Ahmad MZ. Advances in oral drug delivery. Front Pharmacol. 2021;12:618411.
  • Jonaitis L, Marković S, Farkas K, et al. Intravenous versus subcutaneous delivery of biotherapeutics in IBD: an expert’s and patient’s perspective. BMC Proc. 2021;15(Suppl 17).
  • Hanauer S, Panaccione R, Danese S, et al. Tofacitinib induction therapy reduces symptoms within 3 days for patients with ulcerative colitis. Clin Gastroenterol Hepatol. 2019;17(1):139–147.
  • Loftus EV. A practical approach to JAK inhibitors for inflammatory bowel disease in 2020. Pract Gastroenterol. 2020;XLIV(5):36–40.
  • Shim HH, Chan PW, Chuah SW, Schwender BJ, Kong SC, Ling KL. A review of vedolizumab and ustekinumab for the treatment of inflammatory bowel diseases. JGH Open. 2018;2(5):223–234.
  • Murray A, Nguyen TM, Parker CE, Feagan BG, MacDonald JK. Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2020;8(8):5676.
  • Burr NE, Gracie DJ, Black CJ, Ford AC. Efficacy of biological therapies and small molecules in moderate to severe ulcerative colitis: systematic review and network meta-analysis. Gut. 2021;gutjnl-2021–326390.
  • Feagan BG, Sandborn WJ, Gasink C, et al. Ustekinumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2016;375(20):1946–1960.
  • Colombel JF, Sandborn WJ, Ghosh S, et al. Four-year maintenance treatment with Adalimumab in patients with moderately to severely active ulcerative colitis: data from ULTRA 1, 2, and 3. Am J Gastroenterol. 2014;109(11):1771–1780.
  • Pfizer Labs. Xeljanz [Package Insert]. New York, NY: Pfizer Labs; 2022.
  • Abbott Laboratories. Humira [Package Insert]. North Chicago, IL: Abbott Laboratories (AbbVie); 2021.
  • Janssen Biotech, Inc. Remicade [Package Insert]. Horsham, PA: Janssen Biotech, Inc.; 2021.
  • Degagné E, Saba JD. S1pping fire: sphingosine-1-phosphate signaling as an emerging target in inflammatory bowel disease and colitis-associated cancer. Clin Exp Gastroenterol. 2014;7:205–214.