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EfficacyEfficacy DataTrial DesignClinical RemissionEndoscopic ImprovementBio/JAKi Subgroups DataIsolated ProctitisSafetyAdverse eventsCardiac and ocular adverse eventsGetting StartedResourcesEventsMaterialsVideos
Cardiac and ocular adverse events (AEs) with VELSIPITY1,2

Incidence of these events in ELEVATE UC 52 and ELEVATE UC 122

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  ELEVATE UC 52 ELEVATE UC 12
Adverse events VELSIPITY (n=289) Placebo (n=144) VELSIPITY (n=238) Placebo (n=116)
Bradycardia <1% 0% <1% 0%
Sinus bradycardia <0% 0% <2% 0%
AV block, first degree <1% 0% <1% 0%
AV block, second degree (Mobitz type I) <1% 0% <0% 0%
Macular edema <1% 0% <1% 1%

Transient, first-dose decreases in heart rate or AV conduction delays may occur1,2

  • Initiation of VELSIPITY may result in a transient decrease in heart rate and AV conduction delays
  • On day 1, after the first dose of VELSIPITY, the greatest mean decrease from baseline in heart rate was observed at hour 2 or hour 3 post dose
  • Patients who experienced bradycardia were generally asymptomatic
  • Few patients experienced symptoms, such as dizziness, and these symptoms resolved without intervention

All macular edema events were resolved in the phase 3 trials1,2

  • Risk of macular edema is higher if patients have diabetes, uveitis, or certain other eye problems
  • An eye exam of the fundus, including the macula, is recommended near the start of treatment in all patients and at any time if there is any change in vision while taking VELSIPITY
  • Patients who present with visual symptoms of macular edema should be evaluated; if confirmed, treatment with etrasimod should be discontinued

Cardiac contraindications1

  • VELSIPITY is contraindicated in patients with certain preexisting cardiac abnormalities*
The information above pertains to cardiac and ocular AEs associated with required baseline assessments. Please see Summary of Product Characteristics for all adverse events.Patients in the last 6 months who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or New York Heart Association (NYHA) class III or class IV heart failure. Patients with history or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block, unless patient has a functioning pacemaker.1ReferencesReferences:VELSIPITY (etrasimod) Summary of Product Characteristics. Brussels, Belgium: Pfizer Europe; February 2024.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 Getting Started on VELSIPITY

Discover how to get your patients started on treatment.

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