Durable efficacy across ~4 years (interim analysis)

Durable efficacy across ~4 years (interim analysis)

TRUE NORTH OLE study design1

The objective of this interim analysis of the ongoing TRUE NORTH OLE study was to evaluate the long-term efficacy and safety profile of ZEPOSIA in patients with UC with approximately 4 years of continuous treatment​.1

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Adapted from D’Haens G et al. 2024.1

*Includes only patients from the TRUE NORTH study who completed maintenance (Week 52) in clinical response (i.e., reduction from baseline in the 3-component Mayo score [sum of RBS, SFS, and Mayo endoscopy subscore] of ≥2 points and ≥35% and a reduction from baseline in the RBS of ≥1 point or an absolute RBS of ≤1 point).1
†At data cutoff, patients had either completed ≥142 weeks of ZEPOSIA treatment during the OLE study or discontinued prior to completing OLE Week 142.1

OLE, open-label extension; RBS, rectal-bleeding subscore; SFS, stool-frequency subscore; TNFi, tumour necrosis factor inhibitor; UC, ulcerative colitis. ​

ZEPOSIA demonstrated durable clinical remission and CS-free remission for up to 4 years (interim analysis)*†1

Clinical remission and CS-free
remission in the OLE study‡§1

Adapted from D’Haens G et al. 2024.1

*This was an interim analysis of the TRUE NORTH OLE study, with the data cutoff date being 30 June, 2023. Study analysis presented for the TRUE NORTH OLE only includes patients who completed the TRUE NORTH maintenance period (Week 52) and were clinical responders.1
†The data presented are based on OC analysis. Denominators for the OC analysis were based on the number of patients who completed the OLE timepoint and had data available.1
‡Clinical remission was defined as RBS=0, SFS ≤1 (and a decrease of ≥1 point from the baseline SFS), and Mayo endoscopy subscore ≤1.1
§Corticosteroid-free remission was defined as clinical remission while off corticosteroids for ≥12 weeks.1

CS, corticosteroid; OLE, open-label extension; OC, observed case; RBS, rectal-bleeding subscore; SFS, stool-frequency subscore. ​

ZEPOSIA demonstrated long-lasting improvements in partial Mayo score for up to 4 years (interim analysis)*†3,4

Mean partial Mayo score in
the OLE study†3,4

Adapted from Danese S et al. 2023 & BMS Data on File.3,4

*This was an interim analysis of the TRUE NORTH OLE study, with the data cutoff date being 10 January, 2022. Study analysis presented for the TRUE NORTH OLE only includes patients who completed the TRUE NORTH maintenance period (Week 52) and were clinical responders.3
†Partial Mayo score was defined as the sum of the RBS, SFS, and Physician’s Global Assessment subscore.3

BL, baseline; OLE, open-label extension; RBS, rectal-bleeding subscore; SFS, stool-frequency subscore.

References

  1. D’Haens G et al. Oral presentation at: European Crohn’s and Colitis Organisation; Stockholm, Sweden; 21–24 February, 2024. Poster: P1009.
  2. Sandborn WJ et al. N Engl J Med. 2021;385(14):1280–1291.
  3. Danese S et al. Oral presentation at: European Crohn’s and Colitis Organisation, Copenhagen, Denmark; 1–4 March, 2023. Presentation DOP37.
  4. BMS Data on File.

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