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Fast recapture of response with ozanimod after withdrawal in UC

Presented By
Dr Anita Afzali, University of Cincinnati College of Medicine, OH, USA
UEGW 2022
Phase 3, True North

Post-hoc analysis of the True North trial, in patients with active ulcerative colitis (UC) who relapsed after withdrawal of ozanimod during the maintenance period, investigated their response after re-introduction of the medication. Almost 60% of these patients recaptured clinical response within 10 weeks of re-initiation. 

In the True North trial (NCT02435992), treatment with the selective, sphingosine-1-phosphate (S1P) receptor modulator ozanimod demonstrated significant improvements regarding the incidence of clinical remission and key secondary clinical, endoscopic, and histologic endpoints among patients with UC [1]. These endpoints were assessed after 10 weeks, at the end of the double-blind induction period, and after 52 weeks of treatment, at the end of the maintenance period [1]. Dr Anita Afzali (University of Cincinnati College of Medicine, OH, USA) presented a post-hoc analysis from the True North open-label extension (OLE) study, to assess recapture of response in patients who lost response while receiving placebo during the True North maintenance period and subsequently received ozanimod in the OLE [2].

In the True North study, participants were randomised 2:1 to receive double-blind ozanimod 0.92 mg or placebo (cohort 1) or open-label ozanimod 0.92 mg (cohort 2). Participants who achieved clinical response with ozanimod at the end of the induction period at 10 weeks (n=457) were re-randomised to placebo during the maintenance period of 42 weeks (n=227). Those who experienced disease relapse after discontinuing the treatment (n=77) subsequently received open-label re-induction with ozanimod.

Compared with all ozanimod-treated participant groups at induction baseline (cohort 1 and 2), a higher proportion of participants who lost response on placebo during the maintenance period were receiving corticosteroids at screening (41.6% vs 30.5% for cohort 1 and 36.2% for cohort 2) and had a history of prior biologic use (49.4% vs 32.4% for cohort 1 and 43.9% for cohort 2). More than half of the patients in this subgroup (56%; 43/77) achieved symptomatic clinical response within 5 weeks of re-initiating open-label ozanimod and maintained it until 10 weeks of the OLE (58%; 45/77). The response rates were similar in biologic-naïve participants and participants with prior biologic exposure. The mean partial Mayo score and subscores (rectal bleeding, stool frequency subscore, and Physician’s Global Assessment) decreased 5 weeks after the reintroduction, and further reductions occurred at week 10 of the OLE.

The authors concluded that almost 60% of participants who relapsed after ozanimod withdrawal during True North’s randomised maintenance period recaptured symptomatic clinical response by 10 weeks after ozanimod re-initiation. Furthermore, most of them presented these responses as early as 5 weeks after re-initiation.

  1. Sandborn WJ, et al. N Engl J Med. 2021;385:1280–91.
  2. Afzali A, et al. Recapture of response with ozanimod in patients with moderately to severely active ulcerative colitis who withdrew therapy: data from the True North open-label extension study. MP248, UEG Week 2022, 8–11 October, Vienna, Austria.

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