P5351 - Efficacy and Safety of Etrasimod for Moderate to Severe Ulcerative Colitis: A Meta-Analysis of Randomized Controlled Trials

Prince Shah-Riar, MD¹, Aditi Saha, MBBS², Sabbir Ahmad. Osmani, MBBS³, Khalifa Augi, MD⁴, Asif Zamir, MD, FACG⁵
1DHR Health, Edinburg, Tx, McAllen, TX; 2University of Dhaka, Cleveland, OH; 3Shaheed Ziaur Rahman Medical College and Hospital, Dhaka, Dhaka, Bangladesh; 4DHR Health, McAllen, TX; 5DHR Health Gastroenterology, Edinburg, TX

Introduction: Ulcerative colitis (UC) is a chronic inflammatory condition requiring durable remission with minimal systemic toxicity. Etrasimod, a selective sphingosine-1-phosphate (S1P) receptor modulator, offers a novel mechanism targeting lymphocyte trafficking. While individual trials show efficacy, an aggregated evaluation across clinical and endoscopic endpoints remains lacking.

Methods: A systematic search (2015–2025) across PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and related databases identified randomized controlled trials comparing etrasimod to placebo or standard care in adults with moderate to severe UC. Outcomes included clinical remission (primary), clinical response, endoscopic and histologic improvement, steroid-free remission, symptomatic remission, and adverse events. Meta-analysis was conducted using RevMan 5.4 with a random-effects model to calculate pooled odds ratios (ORs) and 95% confidence intervals (CIs).

Results: Six studies involving 689 patients met inclusion criteria. Etrasimod significantly improved:

• Clinical remission (OR 4.73; 95% CI: 2.57–8.71),


• Clinical response (OR 3.81; 95% CI: 2.61–7.03),


• Endoscopic improvement (OR 6.06; 95% CI: 3.96–9.27),


• Histologic healing (OR 6.05; 95% CI: 2.70–13.54),


• Steroid-free clinical remission (OR 5.19; 95% CI: 2.94–9.15),


• Symptomatic remission (OR 3.67; 95% CI: 2.50–5.39).
  No significant increase in serious adverse events (OR 1.02; 95% CI: 0.55–1.88), anemia (OR 0.85; 95% CI: 0.44–1.65), or UC worsening (OR 0.85; 95% CI: 0.44–1.65) was observed.

Discussion: Etrasimod demonstrates consistent efficacy across multiple remission endpoints and maintains a favorable safety profile. These findings highlight its potential as a promising oral agent in the treatment algorithm for moderate to severe UC.


Figure: Forest Plots of Clinical and Endoscopic Outcomes with Etrasimod in Ulcerative Colitis


Figure: Forest Plots of Safety Outcomes with Etrasimod in Ulcerative Colitis

Disclosures:
Prince Shah-Riar indicated no relevant financial relationships.
Aditi Saha indicated no relevant financial relationships.
Sabbir Osmani indicated no relevant financial relationships.
Khalifa Augi indicated no relevant financial relationships.
Asif Zamir indicated no relevant financial relationships.

Prince Shah-Riar, MD¹, Aditi Saha, MBBS², Sabbir Ahmad. Osmani, MBBS³, Khalifa Augi, MD⁴, Asif Zamir, MD, FACG⁵. P5351 - Efficacy and Safety of Etrasimod for Moderate to Severe Ulcerative Colitis: A Meta-Analysis of Randomized Controlled Trials, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.