Etrasimod shows promise in eosinophilic oesophagitis

In the treatment of eosinophilic oesophagitis, the use of etrasimod is well tolerated and results in sustained histological and endoscopic improvements and symptom reduction, according to the results of a phase II study.

The study included 108 adult patients with a previous diagnosis of eosinophilic oesophagitis and histologically active disease. These patients were randomly assigned to receive treatment with oral etrasimod at 2 mg (n=41, 51 percent male) or 1 mg (n=39, 56 percent male) or matching placebo (n=28, 50 percent male) for 24 weeks. During the 28-week extension period, patients in the etrasimod groups continued receiving their assigned doses, while those in the placebo group were randomly assigned to receive etrasimod at 2 or 1 mg.

The primary endpoint was the percentage change from baseline in oesophageal peak eosinophil count (PEC) at week 16. Safety was evaluated up to week 52. The full analysis set and safety set included all patients who received at least one study treatment dose.

A total of 85 patients (79 percent) completed the double-blind period and entered the extension period. Median percentage changes from baseline in PEC at week 16 were significantly greater in the 2-mg etrasimod group vs the placebo group (−58.4 percent vs –21.5 percent; p=0.010). No significant difference was observed between the 1-mg group and the placebo group (−39.4 percent vs –21.5 percent; p=0.29).

In terms of safety, the most common treatment-emergent adverse events recorded during the double-blind period were gastrointestinal disorders (27 percent in the etrasimod 2-mg group, 33 percent in the etrasimod 1-mg group, and 50 percent in the placebo group). Two patients in the etrasimod 2-mg group and one in the placebo group had bradycardia events, which were mild or moderate in severity.

There were no reports of serious treatment-emergent adverse events or deaths.