P025 Ozanimod Efficacy, Safety, and Histology in Patients with Moderate-to-Severe Ulcerative Colitis During Induction in the Phase 3 True North Study

William, Sandborn; D’Haens, Geert; Wolf, Dominik; Hanauer, Stephen B.; Igor, Jovanovic; Ghosh, Subrata; Petersen, AnnKatrin; Steven, Hua; Hwan, Lee Ji; Laurent, Charles; Usiskin, Keith; Danese, Silvio; Feagan, B G

doi:10.14309/01.ajg.0000722896.32651.d6

Cited by 11 publications

(12 citation statements)

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“…Elevated liver aminotransferase levels were more common with ozanimod. [36][37][38] Ozanimod has been approved for treatment of moderate to severe UC by FDA and European Commission. In stepstone phase II prospective single-arm CD trial, clinical remission was shown in 39.1%, and response in 56.5% of patients at week 12.…”

Section: S1p Receptor Modulatorsmentioning

confidence: 99%

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IBD therapeutics: what is in the pipeline?

Toskas

Akbar

2022

Frontline Gastroenterol

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Inflammatory bowel disease (IBD) is an idiopathic long-term relapsing and remitting disorder including ulcerative colitis and Crohn’s disease. The aim of therapy is to induce and maintain remission. Anti-TNF therapies dramatically improved clinical outcomes but primary failure or secondary loss is a common problem as well as potential side effects potentially limiting efficacy and long-term use. The advent of new targeted agents with the potential for greater safety is welcomed in IBD and offers the potential for different agents as the disease becomes refractory or even combination therapies to maximise effectiveness without compromising safety in the future. More data are required to understand the best positioning in pathways and longer-term safety effects.

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Section: S1p Receptor Modulatorsmentioning

confidence: 99%

“…Serious infection occurred in <2%. Elevated liver aminotransferase levels were more common with ozanimod 36–38. Ozanimod has been approved for treatment of moderate to severe UC by FDA and European Commission.…”

Section: Novel Therapiesmentioning

confidence: 99%

IBD therapeutics: what is in the pipeline?

Toskas

Akbar

2022

Frontline Gastroenterol

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“…A phase 3 trial, True North, evaluated ozanimod as an induction and maintenance therapy versus placebo in patients with UC with efficacy for clinical remission, endoscopic and histological improvement in patients with moderate to severe UC [61].…”

Section: Sphingosine 1-posphate Receptor Modulatormentioning

confidence: 99%

“…In summary, ozanimod is a recently approved oral medication for treatment of moderate to severe UC [61] with limited real world experience in UC, hence, most real world safety data comes from the MS patient population. Longer term and comparative efficacy and safety data are needed determine where this agent fits amongst alternative IBD therapies [63].…”

Section: Sphingosine 1-posphate Receptor Modulatormentioning

confidence: 99%

Immunomodulatory Agents for Treatment of Patients with Inflammatory Bowel Disease (Review safety of anti-TNF, Anti-Integrin, Anti IL-12/23, JAK Inhibition, Sphingosine 1-Phosphate Receptor Modulator, Azathioprine / 6-MP and Methotrexate)

Sattler

Hanauer

Malter

2021

Curr Gastroenterol Rep

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Purpose of the ReviewAs treatment options for Inflammatory Bowel Disease (IBD) expand each class of medication will have specific safety concerns and side-effect profiles that need to be considered for optimal treatment of patients. We will review the most recent safety data for the newly approved immunomodulator therapies for the treatment of IBD. Recent Findings There are a growing number of publications outlining safety concerns for medications used to treat IBD. We reviewed safety profile of anti-tumor necrosis factor antibodies (TNF) with specific attention to combination therapy (anti-TNF plus immunomodulator). Recent publications have demonstrated increased risk of serious infection and malignancy (lymphoma and overall cancer rates) in patients receiving anti-TNF combination therapy when compared with patients receiving anti-TNF monotherapy or immunomodulator monotherapy. Recent publications on Janus Kinase Inhibitors indicate an increased risk of infection, specifically Herpes Zoster, and increased risk of major cardiovascular events and venous thromboembolic events resulting in a black box warning for the medication. In contrast, anti-interleukin 12/23 agents and gut selective anti-integrin antibody agents have demonstrated a favorable side-effect profile with low rates of infection and malignancy. The latest class of medications to be approved, sphingosine 1-phosphate (S1P) receptor modulators, have cardiac and infectious precautions. Summary The field of IBD treatment is rapidly evolving with several mechanistic classes of medications now available. While corticosteroids continue to be associated with the greatest, overall, safety risks, each of the newer mechanistic classes have unique safety concerns. In the future, as we gain more experience with these agents, we will need to continue to evaluate the safety profile of our therapies used alone or in combination to make informed treatment decisions with our patients.

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“…Zellwanderung, im englischen Sprachgebrauch "cell trafficking", beschreibt die Gesamtheit aller passiven und aktiven Bewegungen, die Zellen vollführen [3] Darüber hinaus sind mehrere weitere Antikörper und "small molecules" in der Entwicklung. Für den S1PR-Modulator Ozanimod liegen bereits positive Daten aus Phase-3-Studien [6] und seit Kurzem eine FDA-Zulassung für den Einsatz bei Colitis ulcerosa vor. Mehrere weitere S1PR-Modulatoren werden gegenwärtig in fortgeschrittenen Studienprogrammen evaluiert.…”

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Zellmigration als therapeutischer Zielprozess

Zundler¹

2021

Drug Res (Stuttg)

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P025 Ozanimod Efficacy, Safety, and Histology in Patients with Moderate-to-Severe Ulcerative Colitis During Induction in the Phase 3 True North Study

Cited by 11 publications

References 0 publications

IBD therapeutics: what is in the pipeline?

IBD therapeutics: what is in the pipeline?

Immunomodulatory Agents for Treatment of Patients with Inflammatory Bowel Disease (Review safety of anti-TNF, Anti-Integrin, Anti IL-12/23, JAK Inhibition, Sphingosine 1-Phosphate Receptor Modulator, Azathioprine / 6-MP and Methotrexate)

Zellmigration als therapeutischer Zielprozess

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