A1 Refereed original research article in a scientific journal
A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naive patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial
Authors: Mease Philip J, Smolen Josef S, Behrens Frank, Nash Peter, Leage Soyi Liu, Li Lingnan, Tahir Hasan, Gooderham Melinda, Krishnan Eswar, Liu-Seifert Hong, Emery Paul, Pillai Sreekumar G, Helliwell Philip S; The SPIRIT H2H study group
Publisher: BMJ PUBLISHING GROUP
Publication year: 2020
Journal: Annals of the Rheumatic Diseases
Journal name in source: ANNALS OF THE RHEUMATIC DISEASES
Journal acronym: ANN RHEUM DIS
Volume: 79
Issue: 1
First page : 123
Last page: 131
Number of pages: 9
ISSN: 0003-4967
eISSN: 1468-2060
DOI: https://doi.org/10.1136/annrheumdis-2019-215386
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/51628331
Objectives To compare efficacy and safety of ixekizumab (IXE) to adalimumab (ADA) in biological disease-modifying antirheumatic drug-naive patients with both active psoriatic arthritis (PsA) and skin disease and inadequate response to conventional synthetic disease-modifying antirheumatic drug (csDMARDs).Methods Patients with active PsA were randomised (1:1) to approved dosing of IXE or ADA in an open-label, head-to-head, blinded assessor clinical trial. The primary objective was to evaluate whether IXE was superior to ADA at week 24 for simultaneous achievement of a >= 50% improvement from baseline in the American College of Rheumatology criteria (ACR50) and a 100% improvement from baseline in the Psoriasis Area and Severity Index (PASI100). Major secondary objectives, also at week 24, were to evaluate whether IXE was: (1) non-inferior to ADA for achievement of ACR50 and (2) superior to ADA for PASI100 response. Additional PsA, skin, treat-to-target and quality-of-life outcome measures were assessed at week 24.Results The primary efficacy endpoint was met (IXE: 36%, ADA: 28%; p=0.036). IXE was non-inferior for ACR50 response (IXE: 51%, ADA: 47%; treatment difference: 3.9%) and superior for PASI100 response (IXE: 60%, ADA: 47%; p=0.001). IXE had greater response versus ADA in additional PsA, skin, nail, treat-to-target and quality-of-life outcomes. Serious adverse events were reported in 8.5% (ADA) and 3.5% (IXE) of patients.Conclusions IXE was superior to ADA in achievement of simultaneous improvement of joint and skin disease (ACR50 and PASI100) in patients with PsA and inadequate response to csDMARDs. Safety and tolerability for both biologicals were aligned with established safety profiles.
Downloadable publication This is an electronic reprint of the original article. |  |
