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EfficacyEfficacy DataTrial DesignClinical RemissionEndoscopic ImprovementBio/JAKi Subgroups DataIsolated ProctitisSafetyAdverse eventsCardiac and ocular adverse eventsGetting StartedResourcesEventsMaterialsVideos
VELSIPITY demonstrated a favorable safety profile

Pooled analysis of data from 3 randomized, 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)
VELSIPITY
(n=629; 288.1 PY)
Placebo
(n=314; 115.1 PY)
VELSIPITY
(n=956; 769.3 PY)
Any AE leading to study
treatment discontinuation
5% (0.11) 3% (0.07) 7% (0.08)
Serious infections 1% (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)
Bradycardia 2% (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)
Hypertension 2% (0.04) 1% (0.03) 2% (0.03)
Macular edema <1% (<0.01) <1% (<0.01) <1% (<0.01)
Malignancies 0% (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.1References: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 ARsLoading
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