460 Rapid Induction Effects of Ozanimod on Clinical Symptoms and Inflammatory Biomarkers in Patients With Moderately to Severely Active Ulcerative Colitis: Results From the Induction Phase of True North

Osterman, Mark T.; Longman, Randy; Sninsky, Charles A.; Hanauer, Stephen B.; Feagan, Brian G.; Chitkara, Denesh K.; Hua, Steven; Petersen, AnnKatrin; Afzali, Anita; Ponich, Terry; Siegmund, Britta; Sandborn, William J.

doi:10.1016/s0016-5085(21)00965-3

Cited by 3 publications

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“…However, these analyses assess outcomes on day 14 rather than earlier time points, and except for upadacitinib, they do not include drug effects on patient-reported urgency or incontinence. 25 , 31–33 In TOUR, an increase in stool frequency and occurrence of rectal bleeding was reported by more than two-thirds of patients. In contrast, nearly all patients (90%) documented daily urgency at baseline, and 7% of patients also experienced incontinence.…”

Section: Discussionmentioning

confidence: 99%

Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting

Long

Afzali²,

Fischer

et al. 2022

Inflammatory Bowel Diseases

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Background Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Using a novel electronic reporting tool, we aimed to prospectively describe the onset of tofacitinib efficacy during induction therapy in a real-world study. Methods Patient-reported outcome data (PROs) including the simple clinical colitis activity index (SCCAI), PRO Measurement Identification Systems (PROMIS) measures, and adverse events were collected daily for the first 14 days and at day 28 and 56. Paired t tests and P for trend were utilized to compare changes in SCCAI over time. Bivariate analyses and logistic regression models were performed to describe response (SCCAI <5) and remission (SCCAI ≤2) by clinical factors. Results Of all included patients (n = 96), 67% had failed ≥2 biologics, and 61.5% were on concomitant steroids. Starting at day 3, PROs showed significant and persistent decline of the mean SCCAI (−1.1, P < 000.1) including significantly lower SCCAI subscores for stool frequency (−0.3; P < .003), bleeding (−0.3; P < .0002) and urgency (−0.2; P < .001). Steroid-free remission at day 14, 28, and 56 was achieved in 25%, 30.2%, and 29.2% of patients, respectively. Neither prior biologics nor endoscopic severity were independently predictive of response or remission in multivariate models. Numeric improvements in all PROMIS measures (anxiety, depression, social satisfaction) were seen through day 56. Rates of discontinuation due to adverse events were low. Conclusions In this prospective real-world study, tofacitinib resulted in a rapid and persistent improvement in UC disease activity PROs. The safety findings were consistent with the established safety profile of tofacitinib.

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Section: Discussionmentioning

confidence: 99%

Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting

Long

Afzali²,

Fischer

et al. 2022

Inflammatory Bowel Diseases

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“…Post hoc analyses from the phase 3 True North trial demonstrated an improvement in rectal bleeding and stool frequency subscores as early as Weeks 2 and 5, respectively, compared with placebo. 49 Similarly, significantly higher rates of symptomatic response and remission were observed for ozanimod compared with placebo as early as 2 weeks and 5 weeks, respectively. 50 Real-world data also demonstrated efficacy as early as 2 weeks, with 7/16 patients [44%] achieving clinical response and 3/16 [19%] clinical remission; one patient [6%] achieved corticosteroid-free remission following 2 weeks of ozanimod.…”

Section: Guide To Using Ozanimod For the Treatment Of Ucmentioning

confidence: 92%

Clinician’s Guide to Using Ozanimod for the Treatment of Ulcerative Colitis

Sands

Schreiber

Blumenstein

et al. 2023

Journal of Crohn's and Colitis

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The emergence of advanced therapies (eg, biologics, Janus kinase inhibitors) over the past few decades has revolutionized the treatment of ulcerative colitis. However, the limitations of these therapies leave an unmet need for safer and more effective or convenient treatment options. There is growing interest in the development of novel oral small molecule therapies for the treatment of ulcerative colitis. Ozanimod is an oral small molecule therapy that is approved in the United States, the European Union, and other countries as the first sphingosine 1-phosphate receptor modulator for the treatment of moderately to severely active ulcerative colitis in adults. This review provides guidance for ozanimod use for the treatment of ulcerative colitis based on the prescribing information, clinical trial and real-world data, and the authors’ clinical experiences. This guidance outlines patient characteristics to consider when deciding if ozanimod treatment is suitable and describes how to educate patients on risks and best practices. It also details the nature and frequency of monitoring during treatment, which should be adapted to the individual patient based on preexisting risk factors and events that possibly occur during treatment. This review also provides insights into the patient characteristics and clinical scenarios best suited for ozanimod treatment based on its efficacy and safety profile and the comparative risks with other therapies.

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“…Based on clinical trial and realworld data, patients should expect symptomatic improvement as early as 2 weeks after initiating treatment. 15,[31][32][33] If symptoms do not improve or patients do not respond to ozanimod initially (ie, within 10 weeks), clinical trial data suggest that extended induction treatment should be considered for an additional 5-10 weeks to achieve a symptomatic response. 34 Evaluation of inflammatory biomarkers (eg, C-reactive protein, fecal calprotectin) and intestinal ultrasound (IUS; a new point-of-care imaging technique that correlates with endoscopy for assessment of intestinal healing) should be performed at 3 months post-treatment initiation.…”

Section: Treatment Duration and Efficacy Monitoringmentioning

confidence: 99%

Ozanimod: A Practical Review for Nurses and Advanced Practice Providers

Rubin,

Kutz

2024

NRR

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Ozanimod is the first sphingosine 1-phosphate (S1P) receptor modulator approved for the treatment of moderately to severely active ulcerative colitis (UC). In clinical trials, participants with moderately to severely active UC who received once-daily oral ozanimod demonstrated significantly improved rates of clinical, endoscopic, and histologic outcomes than participants receiving placebo. Ozanimod is also approved for the treatment of relapsing forms of multiple sclerosis (MS). This review summarizes safety data from UC and MS clinical trials and discusses treatment considerations when using ozanimod in clinical practice. Ozanimod is an oral, small molecule agent with a novel mechaism of action that differentiates it from other UC therapies. Ozanimod was generally well tolerated in clinical trials, and the incidence of adverse events of special interest based on prior associations with S1P receptor modulation was low overall. Of note, the risk for clinically significant bradycardia upon treatment initiation was mitigated by gradual dose titration, few patients experienced lymphopenia or serious infections, macular edema and malignancy occurred infrequently, and most hepatic events were transient and did not require treatment discontinuation. Given the safety and efficacy profile of ozanimod, it may be an early treatment option in patients with moderate disease or in those hesitant to use biologics, and it could also be beneficial after other treatments have failed. Further investigation is needed to determine the positioning of ozanimod within the UC treatment armamentarium. Plain Language Summary:This article provides information about the use of ozanimod in treating patients with moderately to severely active ulcerative colitis (UC) and offers practical guidance for nurses, nurse practitioners, and other healthcare providers to help address questions that may come up in clinical practice. Ozanimod is an oral medication that improves UC symptoms as well as current biologics, while also reducing the need for corticosteroids, a key aspect in treating UC. Ozanimod may be used either after a patient has failed a biologic or as an early treatment option before starting a biologic in patients with moderate UC who may be hesitant to start biologics. This article includes tools to help guide clinical practice decision-making, educate on possible adverse events, and provide the monitoring necessary to ensure patient safety and best practices in the use of ozanimod.

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460 Rapid Induction Effects of Ozanimod on Clinical Symptoms and Inflammatory Biomarkers in Patients With Moderately to Severely Active Ulcerative Colitis: Results From the Induction Phase of True North

Cited by 3 publications

References 0 publications

Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting

Tofacitinib Response in Ulcerative Colitis (TOUR): Early Response After Initiation of Tofacitinib Therapy in a Real-world Setting

Clinician’s Guide to Using Ozanimod for the Treatment of Ulcerative Colitis

Ozanimod: A Practical Review for Nurses and Advanced Practice Providers

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