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

VELSIPITY® helped quickly calm the chaos of UC symptoms

Symptomatic response vs placebo as early as day 21

  • This was a post hoc analysis of daily e-diary data collected on rectal bleeding (RB) and stool frequency (SF) from patients enrolled in the ELEVATE UC 52 and ELEVATE UC 12 trials
  • Daily Mayo, RB and SF subscores and partial modified Mayo score (pMMS; RB subscore + SF subscore), as well as change from baseline during the first 28 days of therapy, were calculated from patient e-diary responses1
  • The Mantel–Haenszel weighted test was used to assess the adjusted risk differences in proportions of responders between treatment groups1
ReferencesAdjusted differences with nominal P values of P<0.05 were considered significant.1Adjusted differences were based on estimated common risk difference using Mantel–Haenszel weights and stratified by actual naive to Biologic/JAKi therapy at study entry (Yes/No), actual baseline corticosteroid use (Yes/No), and actual baseline disease activity (an mMS of 4 to 6 or an mMS of 7 to 9).1The Mantel–Haenszel weighted test was used to assess the adjusted risk differences in proportions of responders between treatment groups.1Symptomatic response was defined as patients with a ≥30% change from baseline decrease in a partial modified Mayo score (pMMS).1Bowel urgency

VELSIPITY® helped calm bowel urgency vs placebo

A greater proportion of patients experienced clinically meaningful improvements in bowel urgency with VELSIPITY® vs placebo in ELEVATE UC 522

ReferencesClinically meaningful improvement in bowel urgency defined as BU NRS ≥3-point decrease from baseline (BU NRS ≤1).2
Endoscopic improvement

See how patients achieved endoscopic improvement with VELSIPITY®.

SEE ENDOSCOPIC DATA Loading
▼ 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: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.Dubinsky M, Bleakman AP, Panaccione R, et al. Bowel urgency in ulcerative colitis: current perspectives and future directions. Am J Gastroenterol. 2023;118(11):1940-1953.Legal Category S1A
Further information available on request


PP-V1A-0024 Date of preparation February 2025
Efficacy

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