Efficacy and Safety of Etrasimod in Moderate-To-Severe Ulcerative Colitis: A GRADE-Based Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Anurag Jha, Nirmal Paudel, Khawaja Arham Jawaid et al.
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In 30 seconds
This GRADE-based systematic review and meta-analysis pooled four randomized controlled trials comparing etrasimod with placebo in 1,239 adults with moderately to severely active ulcerative colitis. At 12 weeks, etrasimod increased clinical remission (RR = 2.92, 95% CI 1.71-4.98) and improved clinical response and endoscopic outcomes. Beyond 40 weeks, benefits across clinical and endoscopic outcomes persisted, including higher steroid-free remission. Any treatment-emergent adverse event was slightly more frequent with etrasimod; serious adverse events and adverse-event discontinuations did not differ significantly.
Key findings
- At 12 weeks, clinical remission was more likely with etrasimod than placebo (RR = 2.92, 95% CI 1.71-4.98; I 2 = 57%).
- Beyond 40 weeks, clinical remission favored etrasimod (RR = 4.28, 95% CI 2.72-6.73; I 2 = 0%).
- Any treatment-emergent adverse event was slightly more frequent with etrasimod (RR = 1.15, 95% CI 1.04-1.28; I 2 = 0%).
- Serious adverse events and discontinuations due to adverse events did not differ significantly between groups.
Why it matters
The pooled trial evidence suggests etrasimod can improve both clinical and endoscopic outcomes in adults with moderate-to-severe ulcerative colitis, with benefits reported at induction and beyond 40 weeks. The modest increase in any treatment-emergent adverse events is relevant when weighing efficacy against tolerability; the analysis did not find significant differences in serious adverse events or adverse-event discontinuations.
What to keep in mind
The meta-analysis included only four trials, and heterogeneity was moderate for some outcomes, including 12-week clinical remission (I 2 = 57%).