Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year
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ORIGINAL RESEARCH
Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2) Ana-Maria Orbai
. Jordi Grataco´s . Anthony Turkiewicz . Stephen Hall .
Eva Dokoupilova . Bernard Combe . Peter Nash . Gaia Gallo . Clinton C. Bertram . Amanda M. Gellett . Aubrey Trevelin Sprabery . Julie Birt . Lisa Macpherson . Vladimir J. Geneus . Arnaud Constantin Received: October 19, 2020 / Accepted: November 16, 2020 Ó The Author(s) 2020
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40744020-00261-0) contains supplementary material, which is available to authorized users.
intolerance to one or two tumor necrosis factor inhibitors. Methods: In the SPIRIT-P2 study (ClinicalTrials.gov ID: NCT02349295), patients were randomized to placebo or ixekizumab 80 mg every 4 weeks (IXE Q4W) or every 2 weeks (IXE Q2W) following a 160-mg starting dose. During the extension period (weeks 24–156), patients maintained their original ixekizumab dose, and placebo patients received IXE Q4W or IXE Q2W (1:1). Exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) are presented. Results: Of 363 patients enrolled in the study, 310 entered the extension period. In all patients
A.-M. Orbai (&) Johns Hopkins University School of Medicine, Baltimore, MD, USA e-mail: [email protected]
E. Dokoupilova Department of Pharmaceutical Technology, Faculty of Pharmacy, Masaryk University, Brno, Czech Republic
J. Grataco´s Rheumatology Department, Hospital Universitari Parc Taulı´, Sabadell, Barcelona, Spain
B. Combe CHU Montpellier and Montpellier University, Montpellier, France
J. Grataco´s Medicine Department, Universitat Auto`noma de Barcelona, Sabadell, Barcelona, Spain
P. Nash School of Medicine, Griffith University, Brisbane, Australia
A. Turkiewicz Rheumatology Associates Clinical Research Unit, Birmingham, AL, USA
G. Gallo C. C. Bertram A. M. Gellett A. T. Sprabery J. Birt L. Macpherson V. J. Geneus Eli Lilly and Company, Indianapolis, IN, USA
S. Hall Monash University, Melbourne, VIC, Australia
A. Constantin Hospital Pierre-Paul Riquet and Universite´ Toulouse III, Toulouse, France
ABSTRACT Purpose: Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A. The objective of this study was to assess the long-term efficacy and safety (to week 156) of ixekizumab in patients with active psoriatic arthritis and inadequate response or
E. Dokoupilova Medical Plus, s.r.o., Uherske´ Hradisˇteˇ, Czech Republic
Rheumatol Ther
treated with IXE Q4W and IXE Q2W at week 0, responses persisted to week 156. At week 156, clinical responses (observed) in patients treated with IXE Q4W and IXE Q2W were assessed [American College of Rheumatology (ACR) response criteria and minimal disease activity (MDA) criteria]: 84 and 85% showed 20% improvement (ACR20); 60 and 58% showed 50% improvement (ACR50); 35 and 47% showed 70% improvement (ACR70), respectively; and 48 and 54% showed M
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