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EfficacyEfficacy DataTrial DesignClinical RemissionEndoscopic ImprovementBio/JAKi Subgroups DataIsolated ProctitisSafetyAdverse eventsCardiac and ocular adverse eventsGetting StartedResourcesEventsMaterialsVideos
Isolated Proctitis

Clinical Remission

Symptomatic Remission

Tab Number 3

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Isolated proctitis patients were included in the ELEVATE UC phase 3 randomized clinical trials
VELSIPITY induced and sustained clinical remission in patients with isolated proctitis in ELEVATE UC 52 and ELEVATE UC 121
Advanced therapies include S1P receptor modulators, biologics, and JAK inhibitors.2Clinical 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).3Analysis of outcomes was not powered for statistical significance. Nominal P values are reported without adjustment for multiple comparisons.2,4Subjects with isolated proctitis at baseline (defined as <10 cm of rectal involvement) met all other eligibility criteria for inclusion: an mMS of 4 to 9, a centrally read endoscopic subscore (ES) ≥2, and a rectal bleeding (RB) subscore ≥1.2
Isolated proctitis patients were included in the ELEVATE UC phase 3 randomized clinical trials
A greater proportion of patients with isolated proctitis achieved symptomatic remission with VELSIPITY vs placebo in ELEVATE UC 52 and ELEVATE UC 121
Symptomatic remission was defined as a stool frequency (SF) subscore of 0 (or 1 with a ≥1-point decrease from baseline) and a rectal bleeding (RB) subscore of 0.2Analysis of outcomes by prior treatment was not powered for statistical significance. Nominal P values are reported without adjustment for multiple comparisons.3,4Subjects with isolated proctitis at baseline (defined as <10 cm of rectal involvement) met all other eligibility criteria for inclusion: an mMS of 4 to 9, a centrally read endoscopic subscore (ES) ≥2, and a rectal bleeding (RB) subscore ≥1.3
References: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.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.VELSIPITY (etrasimod) Summary of Product Characteristics. Brussels, Belgium: Pfizer Europe; February 2024.Data on file. Pfizer Inc.
Safety Profile

See the demonstrated safety profile of VELSIPITY.

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