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

Clinical Remission

Symptomatic Remission

Tab Number 3

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The only advanced therapy* proven to help patients calm the chaos of symptoms of isolated proctitis in phase 3 randomised clinical trialsVELSIPITY® 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
VELSIPITY® helped calm the chaos of symptoms among patients with isolated proctitisA 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
▼ 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:Peyrin-Biroulet L, Dubinsky MC, Sands BE, et al. Efficacy and safety of etrasimod in patients with moderately to severely active isolated proctitis: results from the phase 3 ELEVATE UC clinical programme [published online ahead of print April 2024]. J Crohns Colitis. 2024. https://academic.oup.com/ecco-jcc/advance- article doi/10.1093/ecco-jcc/jjae038/7645267. Accessed May 8, 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.VELSIPITY® (etrasimod) Summary of Product Characteristics. Available online at medicines.ie.Data on file. Pfizer Inc.
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PP-V1A-IRL-0053 Date of Preparation: June 2025
Safety Profile

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