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EfficacyEfficacy Home PageTrial DesignClinical RemissionEarly Symptomatic ResponseEndoscopic ImprovementBio/JAKi Subgroups DataIsolated ProctitisSafetyAdverse eventsCardiac and ocular adverse eventsGetting StartedResourcesMaterialsVideosPrescribing InformationPrescribing Information 
VELSIPITY® demonstrated a favourable safety profile

Pooled analysis of data from 3 randomised, double-blind, placebo-controlled phase 2 and phase 3 trials and interim data from the ongoing OLE studies demonstrated mostly mild to moderate AEs for up to 2.5 years1:

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 PLACEBO-CONTROLLED COHORT
(phase 2 and phase 3 studies)*		All UC COHORT
(phase 2 and phase 3 , OLE)†‡§
% of patients with an event
(exposure-adjusted
incidence rates per 100 PY)		VELSIPITYPlacebo
(n=314; 115.1 PY)		VELSIPITY
Any AE leading to study
treatment discontinuation		5% (0.11)3% (0.07)7% (0.08)
Serious infections1% (0.01)2% (0.04)2% (0.02)
Herpes zoster<1% (<0.01)1% (0.02)1% (<0.01)
Opportunistic infections<1% (<0.01)<1% (<0.01)<1% (<0.01)
Bradycardia2% (0.04)0% (0)2% (0.02)
AV block, first degree<1% (<0.01)0% (0)<1% (<0.01)
AV block, second degree
(Mobitz type 1)		<1% (<0.01)0% (0)<1% (<0.01)
Hypertension2% (0.04)1% (0.03)2% (0.03)
Macular edema<1% (<0.01)<1% (<0.01)<1% (<0.01)
Malignancies0% (0)0% (0)<1% (<0.01)
Alanine aminotransferase
increased		2% (0.04)1% (0.02)3% (0.03)
Gamma-glutamyl transferase
increased		2% (0.04)1% (0.02)3% (0.04)
Placebo-controlled cohort: Patients who received either placebo or VELSIPITY as part of 1 phase 2 study (VELSIPITY 1 mg or 2 mg for 12 weeks; NCT02447302) or 2 phase 3 studies (VELSIPITY 2 mg for 12 weeks or 52 weeks; NCT03945188 and NCT03996369).1All UC cohort: All patients who received ≥1 dose of VELSIPITY (NCT02447302, NCT03945188, NCT03996369, NCT02536404, NCT03950232, and open-label period of NCT04176588; data cutoff January 31, 2022).11 event of death occurred in the all UC cohort; this was a serious AE of neuroendocrine tumor resulting in death that was assessed by the investigator as not related to study treatment.1No events of posterior reversible encephalopathy syndrome were reported.1▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.References:Vermeire S, Peyrin-Biroulet L, Panés J, et al. Etrasimod for the treatment of ulcerative colitis: up to 2.5 years of pooled safety data from global clinical trials. J Crohns Colitis. 2023;17(suppl 1):i619-i620. Abstracts of the 18th
Congress of ECCO 2023—European Crohn’s and Colitis Organisation; March 1-4, 2023; Copenhagen, Denmark. Abstract ID: P490. jjac190.0620. https://academic.oup.com/ecco-jcc/article/17/
Supplement_1/i619/7009929. Accessed December 18, 2023. Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies [published correction appears in Lancet. 2023;401(10381):1000]. Lancet. 2023;401(10383):1159-1171.Safety

Cardiac and Ocular ARs

See the incidence of these events in ELEVATE UC 52 and ELEVATE UC 12.

 SEE ARsLoadingLegal Category S1A
Further information available on request

PP-V1A-IRL-0037 Date of preparation June 2025

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