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Ozanimod treatment prompted substantial response after failure of response to induction

Presented by
Prof. Remo Panaccione, University of Calgary, Canada
UEGW 2022
Phase 3, True North
Continued ozanimod treatment for the induction of non-responders in the phase 3 True North trial, induced symptomatic clinical response in nearly half of the patients with ulcerative colitis (UC) after 10 weeks in an open-label extension trial (OLE). Furthermore, clinical remission was reached by 19.3% at this timepoint.

“Ozanimod is an oral, sphingosine-1-phosphate (S1P) receptor modulator that selectively targets S1P1 and S1P5 and is approved by the European Union and the USA for the treatment of moderately to severely active UC,” Prof. Remo Panaccione (University of Calgary, Canada) informed [1]. The compound has been evaluated in the randomised, phase 3 True North trial (NCT02435992), which found it to be significantly beneficial over placebo in clinical, endoscopic, and histologic measures. The 150 post-induction non-responders from cohort 1 of the True North trial were enrolled in the OLE. At baseline of True North, the OLE cohort had a mean age of 38.6 years, participants were diagnosed with UC at a mean of 6.6 years ago, and 66% were men. Extensive disease was present in 44%, one-third of the participants used corticosteroids, and 36.7% had been exposed to a TNF inhibitor. The mean total Mayo score was 9.2 at baseline, which was slightly improved to 8.5 at week 10.

At weeks 5 and 10 of the OLE, symptomatic clinical response was attained by 44.0% and 48.7% of the previous non-responders, respectively. Stratifying according to prior biologic exposure resulted in similar proportions achieving symptomatic clinical response: 43.7% for bio-naïve and 45.2% for bio-exposed at week 5, along with 48.3% and 50.0% at week 10, respectively. Due to the relatively small subgroups, further predictive analyses on that effect are scheduled. Prof. Panaccione also remarked that the higher bar of symptomatic clinical remission was achieved by an additional 16.0% at week 5, which increased to 19.3% at week 10.

“In conclusion, patients with moderately to severely active UC, who failed to respond to an initial 10 weeks of ozanimod, may benefit from an additional 5 to 10 weeks of treatment,” Prof. Panaccione stated.

  1. Panaccione R, et al. Extended therapy with ozanimod for delayed responders to ozanimod in moderately to severely active ulcerative colitis: data from the True North open-label extension study. OP196, UEG Week 2022, 8–11 October, Vienna, Austria.

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