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

As an oral treatment intentionally designed for first-line advanced use, VELSIPITY helped calming (reducing) the symptoms of 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†

Klinisk remisjonLoading

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

Tidlig symptomatisk responsLoading

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

Endoskopisk forbedringLoading

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

Isolert proktittLoading
Clinical 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.

Studiedesign Loading

References:

VELSIPITY (etrasimod) Summary of Product Characteristics.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.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, Journal of Crohn's and Colitis, 2024 Aug 14;18(8):1270-1282.
Effekt

Preparatomtale

 

PP-V1A-NOR-0013 | Utarbeidet 08.2024

Pfizer AS, Org.nr 915 213 596

Postadresse: Postboks 3, 1324 Lysaker
Besøksadresse: Drammensveien 288, 0283 Oslo

Tlf.: +47 67 52 61 00


PP-BCP-NOR-0001 juni 2023

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