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Poster #: P1049�Real-world effectiveness and safety of etrasimod in Ulcerative Colitis: interim analysis of the EFFECT-UC study�

P.M. Irving, R. Battat, S. Mehta, P. Harrow, D. Gaya, A. Walsh, T. Kucharzik, C. Maaser, E. Jörgensen, Y. Leung, E. Binder, M. Kudela, B. Sahin, T. Meng, A. Falsafi, K. Wosik, S. Hahne, U. Helwig

Slides compiled by Dr. Waqqas Afif

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Introduction

Background & Objectives

  • Etrasimod is an oral, once-daily, selective S1P receptor modulator for the treatment of UC
  • To report an interim analysis of the first prospective real-world data for etrasimod up to 24 weeks of treatment

Methods

  • EFFECT-UC is an ongoing, prospective, non-interventional study enrolling adults with active UC starting etrasimod in routine care
  • Descriptive analyses are presented as observed up to Week 24 with no imputation for missing data

UC, ulcerative colitis; S1P, sphingosine 1-phosphate; PRO2, patient-reported outcome 2; SFS, stool frequency subscore; RBS, rectal bleeding subscore; NRS, numerical rating scale; CRP, C-reactive protein.

Irving PM et al. ECCO 2026 (Abstract citation ID: jjaf231.1230, P1049).

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Results

  • 121 patients (UK n: 59, Germany n:57: Canada n=5) had enrolled in the study

CD, Crohn’s disease; UC, ulcerative colitis; NRS, numerical rating scale; PRO2, patient-reported outcome 2; SFS, stool frequency subscore; RBS, rectal bleeding subscore; TNF, tumor necrosis factor; JAKi, Janus kinase inhibitor; S1P, sphingosine 1-phosphate.�Irving PM et al. ECCO 2026 (Abstract citation ID: jjaf231.1230, P1049).

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Demographics and baseline characteristics

Demographics (N=121)

Age (years), mean (SEM)

40.2 (1.1)

Median (range)

38.0 (19.0–64.0)

Female, n (%)

49 (40.5)

BMI (kg/m²), mean (SEM)

26.5 (0.5)

Disease activity

Duration of UC (years), mean (SEM) (N=115)

7.8 (0.8)

Median (range)

5.0 (0.0–36.0)

Extent of disease, n (%) (N=49)

Ulcerative proctitis

6 (12.2)

Proctosigmoiditis

6 (12.2)

Left-sided colitis

22 (44.9)

Pancolitis

15 (30.6)

MMS, mean (median) (N=36)

4.9 (5.0)

Mayo ES, mean (median) (N=39)

2.3 (2.0)

Mayo ES of 3, n (%)

11 (28.2)

PROs (N=113)

PRO2, mean (median)

2.5 (2.0)

SFS

1.6 (2.0)

RBS

0.9 (1.0)

Bowel urgency NRS, mean (median)

5.4 (6.0)

Abdominal pain NRS, mean (median)

2.8 (2.0)

Biomarkers

fCAL (µg/g), median (range) (N=67)

560.0 (9.0–8000.0)

hsCRP (mg/L), median (range) (N=93)

1.8 (0.1–72.0)

Prior/Concomitant therapies (N=121)

Line of therapy, n (%)

No previous advanced therapy

73 (60.3%)

1 previous advanced therapy

21 (17.4%)

≥2 previous advanced therapies

27 (22.3%)

Prior advanced therapies for UC, n (%)

Biologics

45 (37.2%)

TNFα inhibitor

35 (28.9%)

Integrin inhibitor

25 (20.7%)

Interleukin-12/23 inhibitor

13 (10.7%)

JAKi

14 (11.6%)

S1P receptor modulator

1 (0.8%)

Concomitant CS use, n (%)

40 (33.1%)

Concomitant 5-ASA, n (%)

56 (46.3%)

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Results

PRO2, patient-reported outcome 2; SFS, stool frequency subscore; RBS, rectal bleeding subscore; NRS, numerical rating scale; CRP, C-reactive protein; UC, ulcerative colitis.

Irving PM et al. ECCO 2026 (Abstract citation ID: jjaf231.1230, P1049).

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  • Safety was consistent with the known profile of etrasimod, with no new safety signals identified

Effectiveness outcomes

Patient-reported outcomes over time

Note: Data at the bottom of each data bar are n/N; data in brackets are 95% CI.

Note: Bowel urgency and abdominal pain are assessed using an 11-point NRS. Scores ranged from 0 (“no urgency” and “none”, respectively) to 10 (“worst possible urgency” and “worst possible pain”, respectively).z

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Conclusions

  • Etrasimod demonstrated clinically meaningful improvements for up to 24 weeks of treatment in patients with active UC
  • Similar results to those observed in randomised, placebo-controlled clinical trials

Significance to clinical practice

    • Real world evidence supporting the use of etrasimod in clinical practice
    • Only clinical data presented in this interim results with no biomarkers or endoscopy
    • Only as observed data presented with no imputation for missing data

UC, ulcerative colitis.

Irving PM et al. ECCO 2026 (Abstract citation ID: jjaf231.1230, P1049).

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