VELSIPITY (etrasimod) | Tidlig symptomatisk respons

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Tidlig symptomatisk respons

VELSIPITY

Symptomatisk respons vs placebo så tidlig som ved uke 2¹

Graph is made by Pfizer based on reference 1

En større andel av pasientene som ble behandlet med Velsipity hadde symptomatisk remisjon sammenlignet med de som ble behandlet med placebo ved uke 2¹
Pasienter i Velsipity-gruppen viste reduksjon i subscore for rektal blødning og avføringsfrekvens så tidlig som i uke 2¹
I samsvar med den foreslåtte virkningsmekanismen ble gjennomsnittlig lymfocyttall hos pasienter behandlet med Velsipity redusert til rundt 50 % av det ved baseline ved uke 2 og ble opprettholdt gjennom hele behandlingsperioden¹

References

Patients with ulcerative colitis included those with a modified Mayo score of 5–9¹

p≤0·05; data based on Cochran-Mantel-Haenszel analysis of the full analysis set (all randomly assigned patients who received at least one dose of study drug) and non-responder imputation. Significance is represented using nominal two-sided p values to test the hypothesis of the risk difference for etrasimod minus placebo being 0, based on the estimated common risk difference using Mantel-Haenszel weights.¹

Avføringstrang (Bowel urgency)

VELSIPITY roet ned avføringstrang ved uke 12 vs placebo²

A greater proportion of patients treated with Velsipity had symptomatic remission compared with those treated with placebo by week 2¹

Graph is made by Pfizer and is based on reference 2

References

Patients with isolated proctitis (the subgroup of patients most likely to suffer from urgency) treated with Velsipity had significant improvements in bowel urgency NRS at Week 12 compared with those receiving placebo.²

This significant change was not seen in Week 52 data, probably due to the “as observed” nature of the data (with no imputation for missing data), whereby patients without improvement in their symptoms in both the placebo and Velsipity arms would have discontinued the study after Week 12 (at which time they could enter the open-label extension) and prior to Week 52, resulting in a low sample size, composed mostly of responders, for analysis with Velsipity had significant improvements in bowel urgency NRS at Week 12 compared with those receiving placebo.²

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

Endoskopisk forbedring

Se hvordan pasienter oppnådde endoskopisk forbedring med VELSIPITY.

Endoskopisk forbedring

Referanser:

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-0034 | Utarbeidet 02.2025

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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