CULTIVATE: Good signal for etrasimod in Crohn’s disease

Etrasimod was associated with favourable efficacy outcomes and tolerability in patients with moderately to severely active Crohn’s disease (CD) in the extension period of a phase 2 trial. Placebo-controlled studies are needed to further explore the potential of etrasimod in the CD population.

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 trial [1].

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.”

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   1. 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.

Medical writing support was provided by Robert van den Heuvel.
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Posted on 15 October 202416 October 2024