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EFFICACY AND SAFETY OF ETRASIMOD IN PATIENTS WITH ULCERATIVE COLITIS ACCORDING TO SEX IN THE ELEVATE UC CLINICAL PROGRAMME

Joana Torres 1, Robert Battat 2, Andres Yarur 3, Martina Goestch 4, Eugenia Kunina 4, Linxi Han 5, Alexis B. Dalam 6, Karolina Wosik 7, Irina Blumenstein 8

Affiliations

1 Division of Gastroenterology, Hospital Beatriz Ângelo, Loures, Portugal|||Division of Gastroenterology, Hospital da Luz, Lisbon, Portugal

2 Division of Gastroenterology, Centre Hospitalier de l'Université de Montreal, Montreal, QC, Canada

3 Inflammatory Bowel Disease Center and Division of Gastroenterology and Hepatology, Cedars-Sinai Medical Center, Los Angeles, CA, United States

4 Pfizer AG, Zürich, Switzerland

5 Pfizer R&D UK Ltd, Walton Oaks, United Kingdom

6 Pfizer Inc, Manilla, Philippines

7 Pfizer Canada, Kirkland, QC, Canada

8 Goethe University Frankfurt, Frankfurt University Hospital, Medical Clinic 1, Frankfurt am Main, Germany

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Abstract

Introduction

Sex-based differences have shown to impact ulcerative colitis (UC) treatment outcomes and need to be considered when managing therapy strategies for patients with UC. Etrasimod is an oral, once‑daily (QD), selective sphingosine 1‑phosphate (S1P)_1,4,5 receptor modulator for the treatment of moderately to severely active UC.

Aims & Methods

This pre-defined subgroup analysis reports on efficacy and safety outcomes in male and female patients receiving etrasimod 2 mg QD or placebo in the phase 3 ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369) trials. Key efficacy endpoints were assessed in patients with a baseline modified Mayo score 5–9 at Week 12 (data pooled from both trials) and Week 52 (ELEVATE UC 52 only). Safety was assessed in the pooled ELEVATE UC 52 and ELEVATE UC 12 safety population.

Results

In the pooled population, a total of 269 male and 227 female patients received etrasimod; 150 and 97, respectively, received placebo. Significantly more male and female patients receiving etrasimod vs placebo achieved clinical remission (Week 12 – male: percentage difference for etrasimod vs placebo [Δ] 10.7, female: Δ 19.7; Week 52 – male: Δ 21.5, female: Δ 29.1; all p < 0.01), symptomatic remission (Week 12 – male: Δ 21.4, female: Δ 20.6; Week 52 – male: Δ 26.4, female: Δ 22.5; all p < 0.01), endoscopic improvement (Week 12 – male: Δ 12.7, female: Δ 21.2; Week 52 – male: Δ 21.9, female: Δ 32.5; all p < 0.01) and endoscopic improvement-histologic remission (Week 12 – male: Δ 9.9, female: Δ 16.7; Week 52 – male: Δ 14.1, female: Δ 24.1; all p < 0.01; Table). Similar findings were seen for corticosteroid‑free and sustained clinical remission (Table). Similar proportions of treatment‑emergent adverse events (TEAEs; 56.8% and 64.6%), serious TEAEs (4.9% and 5.0%) and TEAEs leading to discontinuations (3.8% and 5.8%) were reported in male and female patients receiving etrasimod and were comparable to those receiving placebo.

Table. Efficacy endpoints at Week 12 (pooled from both trials) and Week 52 (ELEVATE UC 52 only) in the ELEVATE UC clinical programme in patients with baseline MMS 5–9 according to sex
Efficacy endpoints, n (%) Δ (95% CI) p value	Week 12 Male (N = 419) Female (N = 324)				Week 52 Male (N = 224) Female (N = 185)
Efficacy endpoints, n (%) Δ (95% CI) p value	Placebo QD (N1 = 150)	Etrasimod 2 mg QD (N1 = 269)	Placebo QD (N1 = 97)	Etrasimod 2 mg QD (N1 = 227)	Placebo QD (N1 = 80)	Etrasimod 2 mg QD (N1 = 144)	Placebo QD (N1 = 55)	Etrasimod 2 mg QD (N1 = 130)
Clinical remission^a	15 (10.0)	57 (21.2) 10.7 (4.0, 17.5) 0.002	12 (12.4)	72 (31.7) 19.7 (10.7, 28.8) < 0.001	5 (6.3)	41 (28.5) 21.5 (12.3, 30.8) < 0.001	4 (7.3)	47 (36.2) 29.1 (18.3, 39.9) < 0.001
Symptomatic remission^b	35 (23.3)	121 (45.0) 21.4 (12.4, 30.5) < 0.001	27 (27.8)	109 (48.0) 20.6 (9.4, 31.8) < 0.001	11 (13.8)	58 (40.3) 26.4 (15.3, 37.5) < 0.001	14 (25.5)	61 (46.9) 22.5 (8.4, 36.6) 0.002
Endoscopic improvement^c	22 (14.7)	75 (27.9) 12.7 (5.0, 20.5) 0.001	18 (18.6)	89 (39.2) 21.2 (11.2, 31.1) < 0.001	8 (10.0)	47 (32.6) 21.9 (11.6, 32.1) < 0.001	6 (10.9)	55 (42.3) 32.5 (20.6, 44.5) < 0.001
Endoscopic improvement-histologic remission^d	11 (7.3)	47 (17.5) 9.9 (3.7, 16.1) 0.002	5 (5.2)	47 (20.7) 16.7 (9.7, 23.6) < 0.001	7 (8.8)	34 (23.6) 14.1 (4.6, 23.6) 0.003	4 (7.3)	39 (30.0) 24.1 (13.8, 34.4) < 0.001
Corticosteroid-free clinical remission^e	-				5 (6.3)	41 (28.5) 21.5 (12.3, 30.8) < 0.001	4 (7.3)	47 (36.2) 29.1 (18.3, 39.9) < 0.001
Sustained clinical remission^f	-				1 (1.3)	17 (11.8) 10.2 (4.3, 16.0) < 0.001	2 (3.6)	32 (24.6) 22.2 (13.4, 31.1) < 0.001
Δ is based on estimated common risk difference using the Cochran–Mantel–Haenszel test within each subgroup, stratified by naïve to biologics/Janus kinase inhibitor therapy at study entry (yes/no), baseline corticosteroid use (yes/no) and baseline disease activity (MMS: 4–6 or 7–9); stratification to study was also performed for the pooled analyses. The 2-sided p value is to test the hypothesis of the risk difference being 0. ^aDefined as the composite of stool frequency subscore = 0 (or = 1 with a ≥1-point decrease from baseline), rectal bleeding subscore = 0 and endoscopic subscore ≤ 1 (excluding friability). ^bDefined as stool frequency subscore = 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding subscore = 0. ^cDefined as endoscopic subscore ≤ 1. ^dDefined as endoscopic subscore ≤ 1 with histologic remission (Geboes Index score < 2.0). ^eDefined as the proportion of patients with clinical remission at Week 52 who had not been receiving corticosteroid for ≥ 12 weeks immediately prior to Week 52. ^fDefined as the proportion of patients achieving clinical remission at both Week 12 and Week 52. Δ, percentage difference for etrasimod vs placebo; CI, confidence interval; MMS, modified Mayo score; N, number of patients within the subgroup; N1, number of patients in subgroup receiving treatment; n, number of patients achieving endpoint; QD, once daily; UC, ulcerative colitis.

Conclusion

Similar findings in male and female patients support the use of etrasimod in both to achieve symptomatic, endoscopic and histologic outcomes.

References

Disclaimer: Pfizer’s generative artificial intelligence tool MAIA was used to assist production of the abstract first draft. Authors reviewed/edited and take responsibility for the content.

Disclosure

JT receives advisory board fees from AbbVie, Lilly, Janssen and Pfizer Inc; research grants from AbbVie and Janssen; and speaker fees from AbbVie, Janssen, Lilly, Takeda and Pfizer Inc.
RB receives advisory board fees from AbbVie, Bristol Myers Squibb, Celltrion, Janssen, Lilly, Takeda and Pfizer Inc; and consultancy/speaker/moderator fees from AbbVie, Bristol Myers Squibb, Celltrion, Ferring, Janssen, Takeda and Pfizer Inc.
AJY receives consultancy fees from AbbVie, Arena, Bristol Myers Squibb, Celltrion, Pfizer Inc and Takeda; and lecture fees from AbbVie and Bristol Myers Squibb.
MG, EK are employees of Pfizer AG and shareholders of Pfizer Inc.
LH is an employee of Pfizer R&D UK Ltd.
ABD is an employee of Pfizer Inc, Philippines.
KW is an employee of Pfizer Canada Inc and shareholder of Pfizer Inc.
IB reports consulting and lecturer fees from AbbVie, Amgen, Biogen, Janssen‐Cilag, Celgene/BMS GmbH, Celltrion, Falk Foundation, Fresenius Kabi, Galapagos, Lilly,Merck, Pharmacosmos, Pfizer, Takeda, and Tillotts.

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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