PMID- 35994200 OWN - NLM STAT- MEDLINE DCOM- 20220926 LR - 20231106 IS - 1179-1950 (Electronic) IS - 0012-6667 (Print) IS - 0012-6667 (Linking) VI - 82 IP - 12 DP - 2022 Aug TI - Ozanimod: A Review in Ulcerative Colitis. PG - 1303-1313 LID - 10.1007/s40265-022-01762-8 [doi] AB - Ozanimod (Zeposia((R))) 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. CI - (c) 2022. Springer Nature. FAU - Paik, Julia AU - Paik J AD - Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. demail@springer.com. LA - eng PT - Journal Article PT - Review DEP - 20220822 PL - New Zealand TA - Drugs JT - Drugs JID - 7600076 RN - 0 (Biological Products) RN - 0 (Indans) RN - 0 (Oxadiazoles) RN - 0 (Sphingosine-1-Phosphate Receptors) RN - Z80293URPV (ozanimod) SB - IM EIN - Drugs. 2022 Sep 1;:. PMID: 36050602 MH - Administration, Oral MH - Adult MH - *Biological Products/therapeutic use MH - *Colitis, Ulcerative/drug therapy MH - Humans MH - Indans MH - Oxadiazoles MH - Randomized Controlled Trials as Topic MH - Remission Induction MH - Sphingosine-1-Phosphate Receptors PMC - PMC9499884 OAB - Ulcerative colitis is a chronic inflammatory bowel disease involving a dysregulated immune response in the intestinal mucosa. Conventional therapy options for moderate to severe ulcerative colitis are initially effective, but associated with increased risk of adverse events, resistance to treatment, or loss of response over time. Consequently, small molecule drugs have become of interest as alternative treatment options. Ozanimod (Zeposia((R))) is an oral drug that targets and modulates the activity of sphingosine-1-phosphate receptors to reduce the movement of lymphocytes from the lymph nodes to sites of inflammation. Compared with placebo, ozanimod significantly improved rates of clinical remission and was generally well tolerated in adults with moderately to severely active ulcerative colitis. Findings from open-label extension studies suggest that ozanimod remains efficacious and generally well tolerated with long-term use. Although further data will be beneficial, ozanimod expands the treatment options for adults with moderately to severely active ulcerative colitis. OABL- eng COIS- Julia Paik is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content. EDAT- 2022/08/23 06:00 MHDA- 2022/09/28 06:00 PMCR- 2022/08/22 CRDT- 2022/08/22 11:26 PHST- 2022/08/02 00:00 [accepted] PHST- 2022/08/23 06:00 [pubmed] PHST- 2022/09/28 06:00 [medline] PHST- 2022/08/22 11:26 [entrez] PHST- 2022/08/22 00:00 [pmc-release] AID - 10.1007/s40265-022-01762-8 [pii] AID - 1762 [pii] AID - 10.1007/s40265-022-01762-8 [doi] PST - ppublish SO - Drugs. 2022 Aug;82(12):1303-1313. doi: 10.1007/s40265-022-01762-8. Epub 2022 Aug 22.