Ixekizumab efficacy and safety with and without concomitant conventional disease-modifying antirheumatic drugs (cDMARDs) in biologic DMARD (bDMARD)-naïve patients with active psoriatic arthritis (PsA): results from SPIRIT-P1

RMD Open
Laura C CoatesPhilip J Mease

Abstract

To evaluate the efficacy and safety of ixekizumab alone or with concomitant conventional disease-modifying antirheumatic drugs (cDMARDs) versus placebo in patients with active psoriatic arthritis (PsA) as part of a SPIRIT-P1 subgroup analysis (NCT01695239). Patients were stratified by cDMARD use (concomitant cDMARDs use (including methotrexate) or none (past or naïve use)) and randomly assigned to treatment groups (ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W) or placebo). Efficacy was evaluated versus placebo at week 24 by the American College of Rheumatology criteria (ACR20/50/70), modified total Sharp score and Health Assessment Questionnaire-Disability Index (HAQ-DI). Safety was assessed according to cDMARD status. Regardless of concomitant cDMARD usage, ACR20, ACR50 and ACR70 response rates were significantly higher versus placebo with IXEQ4W and IXEQ2W. The proportion of patients achieving HAQ-DI minimal clinically important difference was significantly higher versus placebo with IXEQ4W with concomitant cDMARD use and IXEQ2W, regardless of concomitant cDMARD use. Treatment-emergent adverse events (AE) were more frequent versus placebo for either ixekizumab-dosing regimen, regardless of concomitant cDMA...Continue Reading

Citations

Jun 1, 2018·Expert Review of Anti-infective Therapy·Delia GolettiFabrizio Cantini
Oct 27, 2018·Expert Review of Clinical Immunology·Darren D O'Rielly, Proton Rahman
Dec 28, 2018·Expert Review of Clinical Immunology·Christoffer BlegvadClaus Zachariae
Mar 21, 2019·Current Rheumatology Reports·Ippei MiyagawaYoshiya Tanaka
May 10, 2020·RMD Open·Philippe CarronFilip Van den Bosch
Aug 27, 2019·Frontiers in Pharmacology·Lazaros I SakkasDimitrios P Bogdanos
Apr 21, 2020·Immunological Medicine·Ippei Miyagawa, Yoshiya Tanaka
Nov 11, 2020·Immunotherapy·Eric Lespessailles, Hechmi Toumi
Oct 18, 2018·Praxis·Christina Ryser, Adrian Ciurea
Jun 7, 2019·Best Practice & Research. Clinical Rheumatology·Anna Molto, Joachim Sieper

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Clinical Trials Mentioned

NCT01695239

Software Mentioned

GRAPPA

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