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EfficacyEfficacy Home PageTrial DesignClinical RemissionEarly Symptomatic ResponseEndoscopic ImprovementBio/JAKi Subgroups DataIsolated ProctitisSafetyAdverse eventsCardiac and ocular adverse eventsGetting StartedResourcesMaterialsVideosPrescribing InformationPrescribing Information 
Efficacy Data

As an oral treatment intentionally designed for advanced use, VELSIPITY® helped calm the chaos of uncontrolled UC across multiple endpoints1–3

Significant and sustained clinical remission* vs placebo in ELEVATE UC 52 and ELEVATE UC 12, with 100% of patients who achieved clinical remission in ELEVATE UC 52 being steroid free1†

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Symptomatic response as early as day 2 vs placebo in a pooled analysis of patients in ELEVATE UC 52 and ELEVATE UC 122

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Endoscopic improvement‡ with VELSIPITY vs placebo in ELEVATE UC 52 and ELEVATE UC 12, further demonstrating the effectiveness of treatment1

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Clinical and symptomatic remission were achieved in patients with isolated proctitis in both ELEVATE UC 52 and ELEVATE UC 12 vs placebo3

 See the Data LoadingClinical remission was defined as a stool frequency (SF) subscore of 0 (or of 1 with a ≥1-point decrease from baseline), a rectal bleeding (RB) subscore of 0, and an endoscopy score (ES) ≤1 (excluding friability).1Corticosteroid-free remission was defined as clinical remission at week 52 without receiving corticosteroids for ≥12 weeks prior to week 52.1Endoscopic improvement was defined as an endoscopy score (ES) ≤1 (excluding friability).1Trial Design

Read about the trial design of VELSIPITY®.

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▼ 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:

VELSIPITY® (etrasimod) Summary of Product Characteristics. Available online at medicines.ie.Dubinsky MC, Vermeire S, Chaparro M, et al. Symptomatic improvement observed within 2 days of etrasimod induction therapy: results from ELEVATE UC 52 and ELEVATE UC 12 studies in patients with ulcerative colitis. United European Gastroenterol J. 2023;11(suppl 8):201-534. Poster presented at: 31st United European Gastroenterology (UEG) Week 2023; Oct 14-17, 2023; Copenhagen, Denmark. Abstract ID: MP359. https://onlinelibrary.wiley.com/doi/epdf/10.1002/ueg2.12460. Accessed December 18, 2023.Peyrin-Biroulet L, Dubinsky MC, Sands BE, et al. Efficacy and safety of etrasimod in patients with moderate to severe isolated proctitis relative to those with more extensive colitis: results from the phase 3 ELEVATE UC 52 and ELEVATE UC 12 trials. United European Gastroenterol J. 2023;11(suppl 8):201-534. Poster presented at: 31st United European Gastroenterology (UEG) Week 2023; Oct 14-17, 2023; Copenhagen, Denmark. Abstract ID: MP429. https://onlinelibrary.wiley.com/doi/epdf/10.1002/ueg2.12460. Accessed December 18, 2023.

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Further information available on request

PP-V1A-IRL-0024 Date of preparation February 2025

Efficacy

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