Clinical remission (primary endpoint)

Clinical remission (primary endpoint)

Significantly more patients achieved clinical remission* with ZEPOSIA
at Week 10 and at Week 52 vs placebo1,2

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Adapted from Sandborn WJ et al. 2021.1

*Clinical remission was assessed using the 3-component Mayo score and defined as a RBS of 0; a SFS of 1 or less, with a decrease of at least 1 point from baseline; and an endoscopy subscore of 1 or less without friability (all on scales from 0 [none] to 3 [most severe]).1,2​
Clinical response was defined as a reduction from baseline in the 9-point Mayo score of ≥2 points and ≥35%, and a reduction from baseline in the RBS of ≥1 point or an absolute RBS of ≤1 point.2

CI, confidence interval; RBS, rectal-bleeding subscore; SFS, stool-frequency subscore.

ZEPOSIA delivers lasting clinical remission,*1,2 particularly
​in patients with moderate UC (post hoc analysis)3

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Adapted from Sandborn WJ et al. 20211 & Peyrin-Biroulet L et al. 2022.3

This was a post-hoc analysis and should be interpreted with caution. The results for individual subgroups are not powered to draw meaningful conclusions and should therefore be interpreted with caution.

*Clinical remission was assessed using the 3-component Mayo score and defined as a RBS of 0; a SFS of 1 or less, with a decrease of at least 1 point from baseline; and an endoscopy subscore of 1 or less without friability (all on scales from 0 [none] to 3 [most severe]).1,2
Clinical response was defined as a reduction from baseline in the 9-point Mayo score of ≥2 points and ≥35%, and a reduction from baseline in the RBS of ≥1 point or an absolute RBS of ≤1 point.2​
Of the total TRUE NORTH population (N=1,012) at baseline, 39.8% (n=403) of patients had moderate disease and 60.2% (n=609) had severe disease (defined as Mayo endoscopic score of 3).3​

CI, confidence interval; RBS, rectal-bleeding subscore; SFS, stool-frequency subscore; UC, ulcerative colitis.

References

  1. Sandborn WJ et al. N Engl J Med. 2021;385(14):1280–1291.​
  2. ZEPOSIA (ozanimod) Summary of Product Characteristics, 2023.​
  3. Peyrin-Biroulet L et al. Poster presented at: United European Gastroenterology Week 2022; Vienna, Austria, and Virtual; 8–11 October, 2022. Poster: MP247.​

Adverse events should be reported. Reporting forms and information can be found at: UK – www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store. Ireland-via HPRA Pharmacovigilance at www.hpra.ie Adverse events should also be reported to Bristol-Myers Squibb via medical.information@bms.com or 0800 731 1736 (UK); 1800 749 749 (Ireland).

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Job: 2084-GB-2300276 Date of Preparation: June 2023