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EffektEffektdataStudiedesignKlinisk remisjonTidlig symptomatisk responsEndoskopisk forbedringBiologiske/JAKi-undergrupperIsolert proktittSikkerhetBivirkningerHjerte- og øyebivirkningerKom i gangOpplæringsmateriellMateriellVideo
Isolert proktitt

Clinical Remission

Symptomatic Remission

Tab Number 3

Tab Number 4

Tab Number 5

The only advanced therapy* proven to help patients calm the UC symptoms of isolated proctitis in phase 3 randomized clinical trialsVELSIPITY induced and sustained clinical remission in patients with isolated proctitis in ELEVATE UC 52 and ELEVATE UC 121
Graph made by Pfizer from figures in ref 1. figure 1A
 
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.2Subjects 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 UC 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
Graph made by Pfizer from figures in ref. 1 Figure 2B
 
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.3Subjects 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.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.
Safety Profile

See the demonstrated safety profile of VELSIPITY.

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Preparatomtale

 
PP-V1A-NOR-0028 | Utarbeidet 11.2024

Pfizer AS, Org.nr 915 213 596

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Besøksadresse: Drammensveien 288, 0283 Oslo

Tlf.: +47 67 52 61 00


PP-BCP-NOR-0001 juni 2023

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