P030 Ozanimod Efficacy, Safety, and Histology in Patients with Moderate-to-Severe Ulcerative Colitis During Maintenance in the Phase 3 True North Study

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

doi:10.14309/01.ajg.0000722916.98351.89

Cited by 7 publications

(3 citation statements)

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“…All secondary endpoints met statistical significance including clinical response, endoscopic improvement, maintenance of clinical remission, corticosteroid‐free remission, mucosal healing and durable clinical remission ( P < 0.005 for all) 12 . In patients with prior anti‐TNF exposure, 28.9% vs 10.1% of patients achieved clinical remission and 55.3% vs 24.6% had a clinical response for ozanimod vs placebo ( P < 0.001 for both) 13 . In the induction study, the most common adverse events were anaemia (4.2% vs 5.6%), nasopharyngitis (3.5% vs 1.4%) and headache (3.3% vs 1.9%).…”

Section: Resultsmentioning

confidence: 91%

“…12 In patients with prior anti-TNF exposure, 28.9% vs 10.1% of patients achieved clinical remission and 55.3% vs 24.6% had a clinical response for ozanimod vs placebo (P < 0.001 for both). 13 In the induction study, the most common adverse events were anaemia (4.2% vs 5.6%), nasopharyngitis (3.5% vs 1.4%) and headache (3.3% vs 1.9%). The most common adverse events in the maintenance study were increased alanine aminotransferance (4.8% vs 0.4%) and headache (3.5% vs 0.04%).…”

Section: Ozanimodmentioning

confidence: 94%

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Review article: emerging drug therapies in inflammatory bowel disease

Grossberg

Papamichael

Cheifetz

2022

Aliment Pharmacol Ther

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Inflammatory bowel diseases (IBD), consisting of Crohn's disease (CD) and ulcerative colitis (UC), are chronic inflammatory conditions of the gastrointestinal tract. 1 Most patients with these conditions require long-term pharmacological therapy to induce and to maintain remission. These treatments reduce the risk of flare and the need for corticosteroids, hospitalisation and surgery. 2 Currently, approved biological and small molecule therapies for IBD are anti-TNF drugs (infliximab, adalimumab, golimumab, certolizumab), anti-integrin therapies (vedolizumab, natalizumab), anti-IL-12/23 therapy (ustekinumab), JAK inhibitor (tofacitinib) and S1P modulator (ozanimod). Despite the available treatments, many patients are in need of new options due to nonresponse, loss of response or intolerance to therapies. Research involving new IBD therapies is expanding rapidly with the development of drugs with novel mechanisms of action, more convenient modes of administration and possibly more favourable safety profiles. Many of these treatments are showing promising

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Section: Resultsmentioning

confidence: 91%

Section: Ozanimodmentioning

confidence: 94%

Review article: emerging drug therapies in inflammatory bowel disease

Grossberg

Papamichael

Cheifetz

2022

Aliment Pharmacol Ther

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“…At the end of the induction period, participants achieving clinical response (n=457) were re-randomised to ozanimod 1mg or placebo (up to week 52). Maintenance results are also published in abstract form only at present [186]. The primary endpoint was achieved by 37.0% and 18.5% in the ozanimod and placebo groups, respectively (P<0.0001).…”

Section: Ozanimod (Zeposia Rpc-1063)mentioning

confidence: 99%

Targeting Leukocyte Trafficking in Inflammatory Bowel Disease

et al. 2021

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In the last two decades, understanding of inflammatory bowel disease (IBD) immunopathogenesis has expanded considerably. Histopathological examination of the intestinal mucosa in IBD demonstrates the presence of a chronic inflammatory cell infiltrate. Research has focussed on identifying mechanisms of immune cell trafficking to the gastrointestinal tract that may represent effective gut-selective targets for IBD therapy whilst avoiding systemic immunosuppression that may be associated with off-target adverse effects such as infection and malignancy.Integrins are cell surface receptors that can bind to cellular adhesion molecules to mediate both leukocyte homing and retention. In 2014, Vedolizumab (Entyvio ® ) was the first anti-integrin (anti-α4ß7 monoclonal antibody) treatment to be approved for use in IBD. Several other anti-integrin therapies are currently in advanced stages of development, including novel orally administered small molecule drugs. Drugs targeting alternative trafficking mechanisms such as mucosal addressin cellular adhesion molecule-1 (MAdCAM-1) and sphingosine-1-phosphate (S1P) receptors are also being evaluated. Here, we summarise key established and emerging therapies targeting leukocyte trafficking that may play an important role in realising the goal of stratified precision-medicine in IBD care.

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