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Post-hoc analysis: Clinical response** and remission* was observed in both TNFi-naive and TNFi-exposed patients starting at 4 weeks1,2
Clinical remission*
- Clinical remission was observed in both TNFi-naive and TNFi-exposed patients on ZEPOSIA at weeks 4 and 8, respectively2
Clinical response**
- Clinical response was observed in both TNFi-naive and TNFi-exposed patients on ZEPOSIA at weeks 4 and 8, respectively2
Bleeding
- With ZEPOSIA there was an observed reduction in rectal bleeding and stool frequency at 2 weeks (post-hoc analysis)1,3
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 three-component Mayo score and defined as a rectal-bleeding subscore of 0; a stool-frequency subscore of 1 or less, with a decrease of at least 1 point from baseline; and an endoscopy subscore of 1 or less (all on scales from 0 [none] to 3 [most severe]).3
**Clinical response was defined as a reduction in the total Mayo score of ≥3 points and ≥30% from baseline or in the three-component Mayo score of ≥2 points and ≥35% from baseline, as well as a reduction in the rectal-bleeding subscore of ≥1 point or an absolute rectal-bleeding subscore of ≤1 point.3
TNFi, tumour necrosis factor inhibitor; UC, ulcerative colitis.
Post-hoc analysis: Symptomatic remission* observed in patients treated with ZEPOSIA starting at Week 2,† 1 week after completing the 7-day dose titration2
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*RBS=0 points and SFS ≤1 point (and a decrease of ≥1 point from the baseline SFS).2
†ITT population, observed cases.
‡Data are based on the nonresponder imputation. Treatment differences and 2-sided 95% Wald CIs for comparison between ZEPOSIA (cohort 1) and
placebo are based on the CMH test, stratified by corticosteroid use at screening and prior TNFi use; the CMH test was not stratified by prior TNFi use for
the TNFi-naïve and TNFi-exposed patient subgroups. Light blue shading indicates the 1-week ZEPOSIA dose escalation period (0.23 mg on days 1−4, 0.46
mg on days 5−7, and 0.92 mg thereafter). Blue text for difference in patient proportions and 95% CI indicates significance (95% CI does not cross 0).2
CMH, Cochran-Mantel-Haenszel; RBS, rectal bleeding subscore; SFS, stool frequency subscore
References
- Sandborn WJ et al. NEJM 2021; 385(14):1280–1291.
- Siegmund B et al. Presented at: Congress of the European Crohn’s and Colitis Organisation Virtual Meeting; February 16–19, 2022.
- Zeposia (ozanimod) Summary of Product Characteristics, 2022.
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);
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Job: 2084-GB-2300276 Date of Preparation: June 2023