Αρχειοθήκη ιστολογίου

Τρίτη 6 Φεβρουαρίου 2018

Efficacy and safety of continuous every 2-week dosing of ixekizumab over 52 weeks in patients with moderate-to-severe plaque psoriasis in a randomized phase 3 trial (IXORA-P)

Abstract

Introduction

Ixekizumab is an interleukin-17A antagonist approved for treatment of moderate-to-severe plaque psoriasis with recommended 160-mg starting dose, then 80 mg every 2 weeks (Q2W) through Week 12, and every 4 weeks (Q4W) thereafter. This study evaluated continuous every 2-week dosing (Q2W) over 52 weeks.

Methods

In this Phase 3, multicentre, double-blinded, parallel-group trial, three ixekizumab dosing regimens were assessed for efficacy and safety at Week 52 in patients with moderate-to-severe plaque psoriasis randomized at a 2:1:1 ratio to continuous Q2W (N=611), continuous Q4W (N=310), or dose adjustment per protocol (Q4W/Q2W, N=306), each with a 160-mg starting dose. Dose adjustment was determined by predefined criteria to which investigators were blinded; 72 (23.5%) patients in the Q4W/Q2W group adjusted dose. Efficacy outcomes were evaluated using logistic regression.

Results

Co-primary endpoints were met at Week 52; Psoriasis Area and Severity Index 75 responses for Q2W and Q4W dose groups were 85.9% and 79.0%, respectively (p=0.006), and static Patient Global Assessment 0/1 responses for Q2W and Q4W dose groups were 78.6% and 70.6%, respectively (p=0.005). Treatment-emergent and serious adverse events were comparable across dose groups.

Conclusions

Ixekizumab Q2W had higher efficacy at Week 52 compared to Q4W, with no increase in safety events.

This article is protected by copyright. All rights reserved.



http://ift.tt/2E644Ye

Δεν υπάρχουν σχόλια:

Δημοσίευση σχολίου