Long-term use of etrasimod in UC safe and well-tolerated

Etrasimod was well-tolerated and had a favourable safety profile in patients with ulcerative colitis (UC) who were exposed to this agent for up to 4 years. The incidence of treatment-emergent adverse events (TEAEs) remained stable over this period, further informing the community about the benefit-risk profile of this drug.

Prof. Séverine Vermeire (KU Leuven, Belgium) outlined that 854 participants with UC had entered the etrasimod open-label extension programme from the completed phase 2 (OASIS; OASIS OLE), phase 3 (ELEVATE UC 52; ELEVATE UC 12), and ongoing ELEVATE UC OLE and ES101002 OLE trials (n=1,196). She presented an updated long-term safety analysis of the use of etrasimod in the UC population [1]. Almost all participants were exposed to the 2 mg dose of etrasimod.

The total exposure to etrasimod comprised 1,619.5 patient-years (PYs). The incidence rate (IR) of any TEAEs was 163.35 per 100 PYs. The corresponding rates for treatment-related AEs, serious TEAEs, and TEAEs leading to study discontinuation were 30.98, 7.95, and 7.89 per 100 PYs, respectively. “There were 3 deaths during the follow-up period,” stated Prof. Vermeire. “One patient had a cardiac arrest during colectomy, another patient died from a neuro-endocrine tumour, and the third death occurred in a patient with acute leukaemia who had a cardiac arrest.”

Serious infections were infrequent, with an IR of 1.71 per 100 PYs. For herpes zoster, the IR was 0.54 per 100 PYs. “Only 13 patients discontinued the study drug due to an infection,” added Prof. Vermeire. For bradycardia, the IR had been 1.01 per 100 PYs after 2.5 years of follow-up and had dropped to 0.72 per 100 PYs at 4 years of follow-up. Similarly, the IR of macular oedema was 0.25 per 100 PYs after 2.5 years of follow-up and was 0.18 per 100 PYs at 4 years of follow-up. “These events were non-serious, rarely led to study discontinuation, and mostly resolved without intervention.”

In conclusion, etrasimod remained well-tolerated in patients with UC, with a favourable safety profile that did not change with longer-term treatment exposure.

1. Vermeire S, et al. Etrasimod for the treatment of Ulcerative Colitis: Up to 4 years of safety data from the global clinical programme. DOP18, 20th Congress of ECCO, 19–22 February 2025, Berlin, Germany.

Copyright ©2025 Medicom Medical Publishers



Posted on 8 April 20258 April 2025