Ozanimod in the Treatment of Ulcerative Colitis: Initial Real-World Data From a Large Tertiary Center

Cohen, Nathaniel A.; Choi, David; Choden, Tenzin; Cleveland, Noa Krugliak; Cohen, Russell D.; Rubin, David T.

doi:10.1016/j.cgh.2022.03.035

Cited by 9 publications

(15 citation statements)

References 3 publications

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“…In the first real-world experience in relatively treatment-refractory UC patients, ozanimod showed a good tolerability and an efficiency and safety profile consistent with trials’ results [ 47 ]. Of note, despite the small sample size, efficiency was not significantly affected by prior therapy exposure [ 47 ].…”

Section: S1p Modulators In Ibd: From Clinical Trials To Real Worldsupporting

confidence: 60%

Sphingosine 1-Phosphate Modulation in Inflammatory Bowel Diseases: Keeping Lymphocytes Out of the Intestine

et al. 2022

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Inflammatory bowel diseases (IBDs) are chronic and disabling conditions that, uncontrolled, lead to irreversible bowel damage and associated comorbidities. Despite the new era of biological therapies, IBDs remain not curative. The treatment purpose is to induce endoscopic remission, reduce the progression of the disease and improve the quality of life. Optimal and early treatment could enable the prevention of their complications. Small molecules, administrated as oral agents, have the capacity of overcoming the limitations of biologic agents (i.e., parenteral administration, rapidity of action and primary and secondary non-responsiveness). Of special interest are results from the use of oral sphingosine 1-phosphate (S1P) receptor modulators (ozanimod, etrasimod, fingolimod and laquinimod), based on S1P activities to target lymphocyte recirculation in the mucosa, acting as immunosuppressive agents. Most S1P modulators are reported to be safe and effective in the treatment of both UC and CD. High and satisfactory rates of clinical remission as well as endoscopic improvement and remission can be achieved with these molecules. Safety alarms remain rather low, although the S1P binding to two of its G protein-coupled receptors, 2 and 3 (S1PR2 and S1PR3), may be associated with cardiovascular risks. Cost-effectiveness studies and head-to-head trials are needed to better define their place in therapy. This review summarizes these emerging data published by PubMed and EMBASE databases and from ongoing clinical trials on the safety and efficacy of selectivity of S1P modulators in the treatment of IBD.

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Section: S1p Modulators In Ibd: From Clinical Trials To Real Worldsupporting

confidence: 60%

Sphingosine 1-Phosphate Modulation in Inflammatory Bowel Diseases: Keeping Lymphocytes Out of the Intestine

et al. 2022

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“…Experienced anti‐TNF patients had a higher percentage of clinical remission with ozanimod compared to PBO, but a lower percentage compared to anti‐TNF‐naive patients 101 . One study reporting real‐world data from a large tertiary center has just been published by Cohen and colleague 102 . Ozanimod was well‐tolerated but had modest effectiveness in a relatively treatment‐refractory cohort of UC patients 102 .…”

Section: Drug Being Evaluated In a Phase 3 Clinical Trialmentioning

confidence: 99%

“…Ozanimod and etrasimod are lymphocytes migration inhibitors that appear to be active in both UC (for which it is already approved in the US) and CD for ozanimod and in UC for etrasimod. The adverse events described with this class of treatment are risk of lymphopenia, bradycardia, macula edema, herpes zoster infection and elevated liver aminotransferase level 101–103,112 . Furthermore, it should be noted that a case of PML has been reported with ozanimod 120 .…”

Section: Drug Being Evaluated In a Phase 3 Clinical Trialmentioning

confidence: 99%

“…One study reporting real‐world data from a large tertiary center has just been published by Cohen and colleague 102 . Ozanimod was well‐tolerated but had modest effectiveness in a relatively treatment‐refractory cohort of UC patients 102 . STEPSTONE was the phase 2 study assessing ozanimod in 69 moderate to severe CD patients 103 .…”

Section: Drug Being Evaluated In a Phase 3 Clinical Trialmentioning

confidence: 99%

“…The adverse events described with this class of treatment are risk of lymphopenia, bradycardia, macula edema, herpes zoster infection and elevated liver aminotransferase level. [101][102][103]112 Furthermore, it should be noted that a case of PML has been reported with ozanimod. 120 As the risk of PML increases under S1P modulators seems to increase with treatment duration, the occurrence of this type of complication under long-term treatment should be carefully monitored.…”

Section: S1p Receptor Agonists/sphingosine-1-phosphate Modulatorsmentioning

confidence: 99%

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Landscape of new drugs and targets in inflammatory bowel disease

et al. 2022

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Although the therapeutic armamentarium of Inflammatory bowel diseases (IBD) physicians has expanded rapidly in recent years, a proportion of patients remain with a suboptimal response to medical treatment due to primary no response, loss of response or intolerance to currently available drugs. Our growing knowledges of IBD pathophysiology has led to the development of a multitude of new therapies over time, which may, 1 day, be able to address this unmet medical need. This review aims to provide physicians an update of emerging therapies in IBD by focusing on drugs currently in phase 3 clinical trials. Among the most promising molecules are anti-IL-23, JAK-inhibitors, anti-integrins and S1P modulators. While the results in terms of efficacy and safety are fairly clear for some classes, the question of safety remains more uncertain for other classes. Molecules at a more preliminary stage of development (phase 1 and 2), one of which may 1 day offer an optimal benefit-risk ratio, will also be presented as well as their respective mechanisms of action.

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Real World Clinical Effectiveness and Safety of Ozanimod in the Treatment of Ulcerative Colitis: 1-Year Follow-Up from a Tertiary Center

Cohen,

Choi,

Garcia

et al. 2023

Dig Dis Sci

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Ozanimod in the Treatment of Ulcerative Colitis: Initial Real-World Data From a Large Tertiary Center

Cited by 9 publications

References 3 publications

Sphingosine 1-Phosphate Modulation in Inflammatory Bowel Diseases: Keeping Lymphocytes Out of the Intestine

Sphingosine 1-Phosphate Modulation in Inflammatory Bowel Diseases: Keeping Lymphocytes Out of the Intestine

Landscape of new drugs and targets in inflammatory bowel disease

Real World Clinical Effectiveness and Safety of Ozanimod in the Treatment of Ulcerative Colitis: 1-Year Follow-Up from a Tertiary Center

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