- D’Haens G, et al. Etrasimod for moderately to severely active Crohn’s disease: results from the extension period of a phase 2 study. Abstract LB06, UEG Week 2024, 12–15 October, Vienna, Austria.
The selective S1P receptor modulator etrasimod was tested in the phase 2/3 CULTIVATE trial (NCT04173273) among patients with moderately to severely active CD. Prof. Geert D’Haens (Amsterdam University Medical Center, the Netherlands) presented data from the extension phase of ‘substudy A,’ a phase 2 study within the CULTIVATE trial1.
In this substudy, 65 participants who were refractory to at least 1 CD therapy were randomised 1:1 to etrasimod 2 mg or 3 mg daily. After 14 weeks, non-responders were re-randomised to the 2 or 3 mg arm. This analysis looked primarily at the endoscopic response after 52 weeks of therapy. An endoscopic response was defined as endoscopic remission or at least a 50% reduction in Simple Endoscopic Score (SES)-CD.
In the treat-through analysis, 19.5% of the participants in the 3 mg arm and 14.3% of those in the 2 mg arm achieved an endoscopic response. Furthermore, clinical remission according to Crohn's Disease Activity Index (CDAI) was reached by 34.1% and 28.6% of the participants in the 3 mg and 2 mg arms, respectively. Also, clinical remission according to patient-reported outcome (PRO2) was observed in 36.6% and 19.0% of the participants.
“Etrasimod was well tolerated,” according to Prof. D’Haens. The most common treatment-emergent adverse events in the 2 mg and 3 mg arms were worsening of CD (25.0% and 21.6%, respectively), headache (10.7% and 16.2%), arthralgia (10.7% and 13.5%), and COVID-19 (10.7% and 24.3%). “Severe infections were seen in 3.6% and 5.4% of the patients in the 2 and 3 mg arms,” added Prof. D’Haens. Finally, 2 participants in the 3 mg arm had a first-degree AV block, 1 participant in the 2 mg experienced bradycardia, and 1 participant in the 3 mg arm had hypertension.
“Etrasimod may be an effective agent in moderately to severely active CD, with higher efficacy at the 3 mg dose,” decided Prof. D’Haens. “Placebo-controlled studies are ongoing.”